Guidelines on myocardial revascularization

ESC/EACTS GUIDELINES

Guidelines on myocardial revascularizationThe Task Force on Myocardial Revascularization of the EuropeanSociety of Cardiology (ESC) and the European Association forCardio-Thoracic Surgery (EACTS)

Developed with the special contribution of the European Associationfor Percutaneous Cardiovascular Interventions (EAPCI)

Authors/Task Force Members: William Wijns (Chairperson) (Belgium)*, Philippe Kolh(Chairperson) (Belgium)*, Nicolas Danchin (France), Carlo Di Mario (UK),Volkmar Falk (Switzerland), Thierry Folliguet (France), Scot Garg (The Netherlands),Kurt Huber (Austria), Stefan James (Sweden), Juhani Knuuti (Finland), JoseLopez-Sendon (Spain), Jean Marco (France), Lorenzo Menicanti (Italy)Miodrag Ostojic (Serbia), Massimo F. Piepoli (Italy), Charles Pirlet (Belgium),Jose L. Pomar (Spain), Nicolaus Reifart (Germany), Flavio L. Ribichini (Italy),Martin J. Schalij (The Netherlands), Paul Sergeant (Belgium), Patrick W. Serruys(The Netherlands), Sigmund Silber (Germany), Miguel Sousa Uva (Portugal),David Taggart (UK)

ESC Committee for Practice Guidelines: Alec Vahanian (Chairperson) (France), Angelo Auricchio (Switzerland),Jeroen Bax (The Netherlands), Claudio Ceconi (Italy), Veronica Dean (France), Gerasimos Filippatos (Greece),Christian Funck-Brentano (France), Richard Hobbs (UK), Peter Kearney (Ireland), Theresa McDonagh (UK),Bogdan A. Popescu (Romania), Zeljko Reiner (Croatia), Udo Sechtem (Germany), Per Anton Sirnes (Norway),Michal Tendera (Poland), Panos E. Vardas (Greece), Petr Widimsky (Czech Republic)

EACTS Clinical Guidelines Committee: Philippe Kolh (Chairperson) (Belgium), Ottavio Alfieri (Italy), Joel Dunning(UK), Stefano Elia (Italy), Pieter Kappetein (The Netherlands), Ulf Lockowandt (Sweden), George Sarris (Greece),Pascal Vouhe (France)

Document Reviewers: Peter Kearney (ESC CPG Review Coordinator) (Ireland), Ludwig von Segesser (EACTSReview Coordinator) (Switzerland), Stefan Agewall (Norway), Alexander Aladashvili (Georgia),Dimitrios Alexopoulos (Greece), Manuel J. Antunes (Portugal), Enver Atalar (Turkey), Aart Brutel de la Riviere

Other ESC entities having participated in the development of this document:Associations: Heart Failure Association (HFA), European Association for Cardiovascular Prevention and Rehabilitation (EACPR), European Heart Rhythm Association (EHRA), Euro-pean Association of Echocardiography (EAE).Working Groups: Acute Cardiac Care, Cardiovascular Surgery, Thrombosis, Cardiovascular Pharmacology and Drug Therapy.Councils: Cardiovascular Imaging, Cardiology Practice.

* Corresponding authors (the two chairpersons contributed equally to this document): William Wijns, Cardiovascular Center, OLV Ziekenhuis, Moorselbaan 164, 9300 Aalst,Belgium. Tel: +32 53 724 439, Fax: +32 53 724 185, Email: [email protected]

Disclaimer. The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written. Healthprofessionals are encouraged to take them fully into account when exercising their clinical judgement. The guidelines do not, however, override the individual responsibility of healthprofessionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and where appropriate and necessary the patientsguardian or carer. It is also the health professionals responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription.

& The European Society of Cardiology 2010. All rights reserved. For Permissions please email: [email protected].

Philippe Kolh, Cardiovascular Surgery Department, University Hospital (CHU, ULg) of Liege, Sart Tilman B 35, 4000 Liege, Belgium. Tel: +32 4 366 7163, Fax: +32 4 366 7164,Email: [email protected] content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only. No commercial use is authorized. No part of theESC Guidelines may be translated or reproduced in any form without written permission from the ESC. Permission can be obtained upon submission of a written request to OxfordUniversity Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC.

European Heart Journal (2010) 31, 25012555doi:10.1093/eurheartj/ehq277

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(The Netherlands), Alexander Doganov (Bulgaria), Jaan Eha (Estonia), Jean Fajadet (France), Rafael Ferreira(Portugal), Jerome Garot (France), Julian Halcox (UK), Yonathan Hasin (Israel), Stefan Janssens (Belgium),Kari Kervinen (Finland), Gunther Laufer (Austria), Victor Legrand (Belgium), Samer A.M. Nashef (UK),Franz-Josef Neumann (Germany), Kari Niemela (Finland), Petros Nihoyannopoulos (UK), Marko Noc (Slovenia),Jan J. Piek (The Netherlands), Jan Pirk (Czech Republic), Yoseph Rozenman (Israel), Manel Sabate (Spain),Radovan Starc (Slovenia), Matthias Thielmann (Germany), David J. Wheatley (UK), Stephan Windecker(Switzerland), Marian Zembala (Poland)

The disclosure forms of the authors and reviewers are available on the ESC website www.escardio.org/guidelines

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords: Bare metal stents Coronary artery bypass grafting Coronary artery disease Drug-eluting stents EuroSCORE Guidelines Heart team Myocardial infarction Myocardial ischaemia Myocardial revascularization Optimal medical therapy Percutaneous coronary intervention Recommendation Risk stratification Stable angina SYNTAX score Unstable angina

Table of ContentsAbbreviations and acronyms . . . . . . . . . . . . . . . . . . . . . . . .2503

1. Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2504

2. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2504

3. Scores and risk stratification, impact of comorbidity . . . . . . .2505

4. Process for decision making and patient information . . . . . . .2505

4.1 Patient information . . . . . . . . . . . . . . . . . . . . . . . . . .2505

4.2 Multidisciplinary decision making (Heart Team) . . . . . . .2507

5. Strategies for pre-intervention diagnosis and imaging . . . . . .2508

5.1 Detection of coronary artery disease . . . . . . . . . . . . . .2509

5.2 Detection of ischaemia . . . . . . . . . . . . . . . . . . . . . . .2509

5.3 Hybrid/combined imaging . . . . . . . . . . . . . . . . . . . . . .2510

5.4 Invasive tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2510

5.5 Prognostic value . . . . . . . . . . . . . . . . . . . . . . . . . . . .2510

5.6 Detection of myocardial viability . . . . . . . . . . . . . . . . .2510

6. Revascularization for stable coronary artery disease . . . . . . .2511

6.1 Evidence basis for revascularization . . . . . . . . . . . . . . .2511

6.2 Impact of ischaemic burden on prognosis . . . . . . . . . . .2511

6.3 Optimal medical therapy vs. percutaneous coronary

intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2511

6.4 Percutaneous coronary intervention with drug-eluting

stents vs. bare metal stents . . . . . . . . . . . . . . . . . . . . .2511

6.5 Coronary artery bypass grafting vs. medical therapy . . . .2512

6.6 Percutaneous coronary intervention vs. coronary artery

bypass grafting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2512

6.7 Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . .2513

7. Revascularization in non-ST-segment elevation acute coronary

syndromes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2513

7.1 Intended early invasive or conservative strategies . . . . . .2514

7.2 Risk stratification . . . . . . . . . . . . . . . . . . . . . . . . . . .2514

7.3 Timing of angiography and intervention . . . . . . . . . . . . .2514

7.4 Coronary angiography, percutaneous coronary

intervention, and coronary artery bypass grafting . . . . . .2515

7.5 Patient subgroups . . . . . . . . . . . . . . . . . . . . . . . . . . .2516

8. Revascularization in ST-segment elevation myocardial

infarction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2516

8.1 Reperfusion strategies . . . . . . . . . . . . . . . . . . . . . . . .2516

8.1.1 Primary percutaneous coronary intervention . . . . . . .2516

8.1.2 Fibrinolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2516

8.1.3 Delayed percutaneous coronary intervention . . . . . .2517

8.1.4 Coronary artery bypass grafting . . . . . . . . . . . . . . .2518

8.2 Cardiogenic shock and mechanical complications . . . . . .2518

8.2.1 Cardiogenic shock . . . . . . . . . . . . . . . . . . . . . . . .2518

8.2.2 Mechanical complications . . . . . . . . . . . . . . . . . . .2518

8.2.3. Circulatory assistance . . . . . . . . . . . . . . . . . . . . .2518

9. Special conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2519

9.1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2519

9.1.1 Indications for myocardial revascularization . . . . . . . .2519

9.1.2 Type of intervention: coronary artery bypass grafting vs.

percutaneous coronary intervention . . . . . . . . . . . .2520

9.1.3 Specific aspects of percutaneous coronary

intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . .2520

9.1.4 Type of coronary artery bypass grafting

intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . .2520

9.1.5 Antithrombotic pharmacotherapy . . . . . . . . . . . . . .2520

9.1.6 Antidiabetic medications . . . . . . . . . . . . . . . . . . . .2520

9.2 Myocardial revascularization in patients with chronic kidney

disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2521

9.3 Myocardial revascularization in patients requiring valve

surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2524

9.4 Associated carotid/peripheral arterial disease . . . . . . . . .2524

9.4.1 Associated coronary and carotid artery disease . . . . .2524

9.4.2 Associated coronary and peripheral arterial disease . .2526

9.5 Myocardial revascularization in chronic heart failure . . . .2527

9.6 Crossed revascularization procedures . . . . . . . . . . . . . .2528

9.6.1 Revascularization for acute graft failure . . . . . . . . . .2528

9.6.2 Revascularization for late graft failure . . . . . . . . . . .2528

9.6.3 Revascularization for acute failure after percutaneous

coronary intervention . . . . . . . . . . . . . . . . . . . . . .2529

9.6.4 Elective revascularization for late failure after

percutaneous coronary intervention . . . . . . . . . . . .2529

9.6.5 Hybrid procedures . . . . . . . . . . . . . . . . . . . . . . . .2530

9.7 Arrhythmias in patients with ischaemic heart disease . . . .2531

9.7.1 Atrial fibrillation . . . . . . . . . . . . . . . . . . . . . . . . .2531

9.7.2 Supraventricular arrhythmias other than atrial

fibrillation or flutter . . . . . . . . . . . . . . . . . . . . . . .2531

9.7.3 Ventricular arrhythmias . . . . . . . . . . . . . . . . . . . . .2532

ESC/EACTS Guidelines2502

9.7.4 Concomitant revascularization in heart failure patients

who are candidates for resynchronization therapy . . .2532

10. Procedural aspects of coronary artery bypass grafting . . . . .2532

10.1 Pre-operative management . . . . . . . . . . . . . . . . . . .2532

10.2 Surgical procedures . . . . . . . . . . . . . . . . . . . . . . . .2532

10.2.1 Coronary vessel . . . . . . . . . . . . . . . . . . . . . . .2533

10.2.2 Bypass graft . . . . . . . . . . . . . . . . . . . . . . . . . .2533

10.3 Early post-operative risk . . . . . . . . . . . . . . . . . . . . .2533

11. Procedural aspects of percutaneous coronary intervention . .2534

11.1 Impact of clinical presentation . . . . . . . . . . . . . . . . .2534

11.2 Specific lesion subsets . . . . . . . . . . . . . . . . . . . . . .2534

11.3 Drug-eluting stents . . . . . . . . . . . . . . . . . . . . . . . .2535

11.4 Adjunctive invasive diagnostic tools . . . . . . . . . . . . . .2537

12. Antithrombotic pharmacotherapy . . . . . . . . . . . . . . . . . .2537

12.1 Elective percutaneous coronary intervention . . . . . . . .2539

12.2 Non-ST-segment elevation acute coronary syndrome . .2539

12.3 ST-segment elevation myocardial infarction . . . . . . . .2540

12.4 Points of interest and special conditions . . . . . . . . . .2540

13. Secondary prevention . . . . . . . . . . . . . . . . . . . . . . . . . .2544

13.1 Background and rationale . . . . . . . . . . . . . . . . . . . .2544

13.2 Modalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2544

13.3 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2545

14. Strategies for follow-up . . . . . . . . . . . . . . . . . . . . . . . . .2545

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2547

Abbreviations and acronyms

ACC American College of CardiologyACE angiotensin-converting enzymeACEF age, creatinine, ejection fractionACS acute coronary syndromeAF atrial fibrillationAHA American Heart AssociationAHF acute heart failureAMI acute myocardial infarctionaPTT activated partial thromboplastin timeASA acetylsalicylic acidBiVAD biventricular assist deviceBMI body mass indexBMS bare metal stentBTT bridge to transplantationCABG coronary artery bypass graftingCAD coronary artery diseaseCAS carotid artery stentingCEA carotid endarterectomyCHADS2 CHF, hypertension, age, diabetes, strokeCHF chronic heart failureCI confidence intervalCIN contrast-induced nephropathyCKD chronic kidney diseaseCPB cardiopulmonary bypassCRT cardiac resynchronization therapyCT computed tomographyCTO chronic total occlusionCVA cerebrovascular accidentDAPT dual antiplatelet therapy

DES drug-eluting stentDT destination therapyEACTS European Association for Cardio-Thoracic SurgeryEBAC European Board for Accreditation in CardiologyECG electrocardiogramECMO extracorporeal membrane oxygenatorEF ejection fractionEMS emergency medical serviceESC European Society of CardiologyESRD end stage renal diseaseFFR fractional flow reserveFMC first medical contactGFR glomerular filtration rateGIK glucose insulin potassiumGP general physicianGPIIbIIIa glycoprotein IIbIIIaHF heart failureHR hazard ratioIABP intra-aortic balloon pumpICD implantable cardioverter defibrillatorICU intensive care unitITA internal thoracic arteryi.v. intravenousIVUS intravascular ultrasoundLA left atriumLAD left anterior descendingLCx left circumflexLM left mainLMWH low molecular weight heparinLV left ventricleLVAD left ventricular assist deviceLVEF left ventricular ejection fractionMACCE major adverse cardiac and cerebral eventMACE major adverse cardiac eventMDCT multidetector computed tomographyMI myocardial infarctionMIDCAB minimally invasive direct coronary artery bypassMPS myocardial perfusion stressMR mitral regurgitationMRI magnetic resonance imagingMVD multivessel diseaseNCDR National Cardiovascular Database RegistryNPV negative predictive valueNSTE-ACS non-ST-segment elevation acute coronary syndromeNYHA New York Heart AssociationOCT optical coherence tomographyOMT optimal medical therapyOR odds ratioPAD peripheral arterial diseasePCI percutaneous coronary interventionPES paclitaxel-eluting stentPET positron emission tomographyPPV positive predictive valueRCA right coronary arteryRCT randomized clinical trials.c. subcutaneousSCD sudden cardiac deathSES sirolimus-eluting stent

ESC/EACTS Guidelines 2503

SPECT single photon emission computed tomographySTEMI ST-segment elevation myocardial infarctionSVG saphenous vein graftSVR surgical ventricular reconstructionTIA transient ischaemic attackTVR target vessel revascularizationUFH unfractionated heparinVD vessel diseaseVSD ventricular septal defectVT ventricular tachycardiaZES zotarolimus-eluting stent

1. PreambleGuidelines and Expert Consensus Documents summarize andevaluate all available evidence with the aim of assisting physiciansin selecting the best management strategy for an individualpatient suffering from a given condition, taking into account theimpact on outcome and the riskbenefit ratio of diagnostic ortherapeutic means. Guidelines are no substitutes for textbooksand their legal implications have been discussed previously. Guide-lines and recommendations should help physicians to makedecisions in their daily practice. However, the ultimate judgementregarding the care of an individual patient must be made by his/herresponsible physician(s).

The recommendations for formulating and issuing ESC Guide-lines and Expert Consensus Documents can be found on theESC website (http://www.escardio.org/knowledge/guidelines/rules).

Members of this Task Force were selected by the European Societyof Cardiology (ESC) and the European Association forCardio-Thoracic Surgery (EACTS) to represent all physicians involvedwith the medical and surgical care of patients with coronary arterydisease (CAD). A critical evaluation of diagnostic and therapeutic pro-cedures is performed including assessment of the riskbenefit ratio.Estimates of expected health outcomes for society are included,where data exist. The level of evidence and the strength of recommen-dationof particular treatment options areweighedand graded accord-ing to predefined scales, as outlined in Tables 1 and 2.

The members of the Task Force have provided disclosure state-ments of all relationships that might be perceived as real or poten-tial sources of conflicts of interest. These disclosure forms are kepton file at European Heart House, headquarters of the ESC. Anychanges in conflict of interest that arose during the writingperiod were notified to the ESC. The Task Force report receivedits entire financial support from the ESC and EACTS, without anyinvolvement of the pharmaceutical, device, or surgical industry.

ESC and EACTS Committees for Practice Guidelines areresponsible for the endorsement process of these joint Guidelines.The finalized document has been approved by all the expertsinvolved in the Task Force, and was submitted to outside special-ists selected by both societies for review. The document is revised,and finally approved by ESC and EACTS and subsequently pub-lished simultaneously in the European Heart Journal and the Euro-pean Journal of Cardio-Thoracic Surgery.

After publication, dissemination of the Guidelines is of para-mount importance. Pocket-sized versions and personal digitalassistant-downloadable versions are useful at the point of care.

Some surveys have shown that the intended users are sometimesunaware of the existence of guidelines, or simply do not translatethem into practice. Thus, implementation programmes are neededbecause it has been shown that the outcome of disease may befavourably influenced by the thorough application of clinicalrecommendations.

2. IntroductionMyocardial revascularization has been an established mainstay in thetreatment of CAD for almost half a century. Coronary artery bypassgrafting (CABG), used in clinical practice since the 1960s, is arguablythe most intensively studied surgical procedure ever undertaken,while percutaneous coronary intervention (PCI), used for overthree decades, has been subjected to more randomized clinicaltrials (RCTs) than any other interventional procedure. PCI wasfirst introduced in 1977 by Andreas Gruentzig and by themid-1980s was promoted as an alternative to CABG. While bothinterventions have witnessed significant technological advances, inparticular the use of drug-eluting stents (DES) in PCI and of arterial

Table 1 Classes of recommendations

Classes of recommendations

Definition

Class I Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective.

Class II Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure.

Class IIa Weight of evidence/opinion is in favour of usefulness/efficacy.

Class IIb Usefulness/efficacy is less well established by evidence/opinion.

Class III Evidence or general agreement that the given treatment or procedure is not useful/effective, and in some cases may be harmful.

Table 2 Levels of evidence

Level of evidence A

Data derived from multiple randomized clinical trials or meta-analyses.

Level of evidence B

Data derived from a single randomized clinical trial or large non-randomized studies.

Level of evidence C

Consensus of opinion of the experts and/or small studies, retrospective studies, registries.


grafts in CABG, their role in the treatment of patients presentingwith stable CAD is being challenged by advances in medical treat-ment, referred to as optimal medical therapy (OMT), whichinclude intensive lifestyle and pharmacological management. Fur-thermore, the differences between the two revascularization strat-egies should be recognized. In CABG, bypass grafts are placed tothe mid-coronary vessel beyond the culprit lesion(s), providingextra sources of nutrient blood flow to the myocardium and offeringprotection against the consequences of further proximal obstructivedisease. In contrast, coronary stents aim to restore the normal con-ductance of the native coronary vasculature without offering protec-tion against new disease proximal to the stent.

Even with this fundamental difference in the mechanisms ofaction between the two techniques, myocardial revascularizationprovides the best results when focusing on the relief of ischaemia.In patients presenting with unstable angina, non-ST-segmentelevation acute coronary syndrome (NSTE-ACS), and ST-segmentelevation myocardial infarction (STEMI), myocardial ischaemia isobvious and life-threatening. Culprit coronary stenoses are easilyidentified by angiography in the vast majority of cases. By contrast,in patients with stable CAD and multivessel disease (MVD) in par-ticular, identification of the culprit stenosis or stenoses requiresanatomical orientation by angiography combined with functionalevaluation, obtained either by non-invasive imaging before cathe-terization, or during the invasive procedure using pressure-derivedfractional flow reserve (FFR) measurements.

Many conditions, stable or acute, can be treated in different ways,including PCI or surgical revascularization. The advances in technologyimply that most coronary lesions are technically amenable to PCI;however, technical feasibility is only one element of the decision-making process, which should incorporate clinical presentation, sever-ity of angina, extent of ischaemia, response to medical therapy, andextent of anatomical disease by angiography. Both revascularizationmethods carry procedure-related risks that are different to someextent in nature, rate, and time domain. Thus patients and physiciansneed to balance short-term convenience of the less invasive PCI pro-cedure against the durability of the more invasive surgical approach.1

Formulation of the best possible revascularization approach,taking into consideration the social and cultural context also, willoften require interaction between cardiologists and cardiac sur-geons, referring physicians or other specialists as desirable. Patientsneed help in taking informed decisions about their treatment, andthe most valuable advice will likely be provided to them by theHeart Team. Recognizing the importance of the interactionbetween (interventional) cardiologists and cardiac surgeons, the lea-dership of both the ESC and EACTS has given this Joint Task Force,their respective Guideline Committee, and the reviewers of thisdocument the mission to draft balanced, patient-centred, evidence-driven practice guidelines on myocardial revascularization.

3. Scores and risk stratification,impact of comorbidityMyocardial revascularization is appropriate when the expectedbenefits, in terms of survival or health outcomes (symptoms, func-tional status, and/or quality of life), exceed the expected negative con-sequences of the procedure. Therefore, risk assessment is an

important aspect of contemporary clinical practice, being of value toclinicians and patients. Over the long term, it allows quality controland the assessment of health economics, while also serving as ameans for individual operators, institutions and regulatory bodies toassess and compare performance. Numerous different models havebeen developed for risk stratification, and those in current clinicaluse are summarized in Table 3. Comparative analyses of thesemodels are limited because available studies have largely evaluatedindividual risk models in different patient populations with differentoutcome measures reported at various time points. These limitationsrestrict the ability to recommend one specific risk model; however:

The EuroSCORE validated to predict surgical mortality wasrecently shown to be an independent predictor of majoradverse cardiac events (MACEs) in studies with both percuta-neous and surgical treatment arms.2,3 Therefore, it can beused to determine the risk of revascularization irrespective of,and even before, the selection of treatment strategy. It haslittle role, however, in determining optimal treatment.

The SYNTAX score has been shown to be an independent pre-dictor of MACE in patients treated with PCI but not withCABG.4 Therefore it has a role in aiding the selection ofoptimal treatment by identifying those patients at highest riskof adverse events following PCI.

The National Cardiovascular Database Registry (NCDRCathPCI risk score) has been validated in PCI patients andshould only be used in this context.5

The Society of Thoracic Surgeons (STS) score, and the age,creatinine, and ejection fraction (ACEF) score have been vali-dated in surgical patients, and therefore should only be usedto determine surgical risk.

It is important to acknowledge that no risk score can accuratelypredict events in an individual patient. Moreover, limitations existwith all databases used to build risk models, and differences in defi-nitions and variable content can affect the performance of risk scoreswhen they are applied across different populations. Ultimately riskstratification should be used as a guide, while clinical judgementand multidisciplinary dialogue (Heart Team) remain essential.

4. Process for decision making andpatient information

4.1 Patient informationPatient information needs to be objective and unbiased, patientoriented, evidence based, up-to-date, reliable, understandable,accessible, relevant, and consistent with legal requirements.Informed consent requires transparency, especially if there is con-troversy about the indication for a particular treatment (PCI vs.CABG vs. OMT). Collaborative care requires the preconditionsof communication, comprehension, and trust. It is essential torealize that health care decisions can no longer be based solelyon research results and our appraisal of the patients circum-stances. Patients taking an active role throughout the decisionmaking process have better outcomes. However, most patientsundergoing CABG or PCI have limited understanding of theirdisease and sometimes unreasonable expectations with regard to


the proposed intervention, its complications, or the need for latereintervention, especially after PCI.

Informing patients about treatment choices allows them to reflecton the advantages and disadvantages associated with either strategy.Patients can only weigh this information properly in the light of theirpersonal values and must have the time to reflect on the trade-offsimposed by the estimates. The patient deserves to fully understandthe risks, benefits, and uncertainties associated with the conditionand its treatment. Avoiding incomprehensible jargon, and consistentuse of terminology that the patient understands, are mandatory.Informed medical decision making should consider short-termprocedure-related benefits and risks as well as expected long-termrisks and benefits in terms of survival, relief of angina, quality of life,and the potential need for late reintervention. It is equally importantthat any bias of stakeholders towards various treatment options forCAD is made known to the patient. Specialty bias and self-referralshould not interfere with the decision process. With the exceptionof unstable patients or candidates for ad hoc PCI (Table 4), thepatient should be offered enough time, up to several days as required,between diagnostic catheterization and intervention to reflect onthe results of the diagnostic angiogram, to seek a second opinionas desirable, or to discuss the findings and consequences with hisor her referring cardiologist and/or primary care physician. An

example of a suitable and balanced patient information documentis provided in the Appendix of the online document.

There is growing public demand for transparency regarding siteand operator results. Anonymous treatment should be avoided. Itis the patients right to know who is about to treat him or her andto obtain information on the level of expertise of the operator andthe volume load of the centre. In addition, the patient should beinformed whether all treatment options are available at the siteand whether surgery is offered on site or not. Non-emergent high-risk PCI procedures, including those performed for distal left main(LM) disease, complex bifurcation stenosis involving large sidebranches, single remaining coronary artery, and complex chronictotal occlusion (CTO) recanalization, should be performed by ade-quately experienced operators at centres that have access to circu-latory support and intensive care treatment, and havecardiovascular surgery on site.

For patients with stable CAD and multivessel or LM disease, all rel-evant data should be reviewed by a clinical/non-invasive cardiologist,a cardiac surgeon, and an interventional cardiologist (Heart Team) todetermine the likelihood of safe and effective revascularization witheither PCI or CABG.4 To ensure this review, myocardial revascular-ization should in general not be performed at the time of diagnosticangiography, thereby allowing the Heart Team sufficient time to

Table 3 Recommended risk stratification scores to be used in candidates for percutaneous coronary intervention orcoronary artery bypass grafting

Score CalculationNumber of variables used to

calculate riskValidated outcomes Classa/levelb Ref.c

Clinical Angiographic PCI CABG

EuroSCORE www.euroscore.org/calc.html 17 0 Short- and long-term mortality IIb B I B 2, 3, 6

SYNTAX score

www.syntaxscore.com 0 11 (per lesion)Quantify coronary artery disease complexity

IIa B III B 4

Mayo Clinic Risk Score

(7, 8) 7 0 MACE and procedural death IIb C III C

NCDRCathPCI

(5) 8 0 In-hospital mortality IIb B 5

Parsonnetscore

(9) 16 0 30-day mortality III B 9

STS scoredhttp://209.220.160.181/STSWebRiskCalc261/

40 2

Operative mortality, stroke, renal failure, prolonged ventilation, deep sternal infection, re-operation, morbidity, length of stay 14 days

I B 10

ACEF score[Age/ejection fraction (%)] + 1(if creatinine >2 mg/dL)(11)

2 0 Mortality in elective CABG IIb C

aClass of recommendation.bLevel of evidence.cReferences.dThe STS score is undergoing periodic adjustement which makes longitudinal comparisons difficult.ACEF age, creatinine, ejection fraction; CABG coronary artery bypass grafting; MACE major adverse cardiac event; NCDR National Cardiovascular Database Registry;PCI percutaneous coronary intervention; STS Society of Thoracic Surgeons.


assess all available information, reach a consensus, and clearly explainand discuss the findings with the patient. Standard evidence-basedinterdisciplinary institutional protocols may be used for commoncase scenarios, but complex cases should be discussed individuallyto find the best solution for each patient.

The above obviously pertains to patients in a stable condition whocan make a decision without the constraints of an emergency situ-ation. If potential adverse events are negligible compared with theexpected treatment benefit or there is no viable alternative to emer-gency treatment, informed decision making may not be possible.

Patients considered for revascularization should also be clearlyinformed of the continuing need for OMT including antiplateletagents, statins, b-blockers, and angiotensin-converting enzyme(ACE) inhibitors, as well as other secondary prevention strategies(Section 13).

4.2 Multidisciplinary decision making(Heart Team)The process for medical decision making and patient informationis guided by the four principles approach to healthcare ethics:

autonomy, beneficience, non-maleficience, and justice. Theinformed consent process should therefore not be looked atsolely as a necessary legal requirement but should be used asan opportunity to optimize objective decision making. Awarenessthat other factors such as sex, race, availability, technical skills,local results, referral patterns, and patient preference, whichsometimes contradict evidentiary best practice, may have animpact on the decision making process, independently of clinicalfindings, is mandatory. The creation of a Heart Team servesthe purpose of a balanced multidisciplinary decision process.4

Additional input may be needed from general practitioners,anaesthesiologists, geriatricians, or intensivists. Hospital teamswithout a cardiac surgical unit or with interventional cardiologistsworking in an ambulatory setting should refer to standardevidence-based protocols designed in collaboration with anexpert interventional cardiologist and a cardiac surgeon, orseek their opinion for complex cases. Consensus on theoptimal revascularization treatment should be documented. Stan-dard protocols compatible with the current Guidelines may beused to avoid the need for systematic case-by-case review ofall diagnostic angiograms.

Table 4 Multidisciplinary decision pathways, patient informed consent, and timing of intervention

ACS Stable MVDStable with

indication for ad hoc PCIa

Shock STEMI NSTE - ACSb Other ACSc

Multidisciplinary decision making

Not mandatory. Not mandatory. Not required for culprit lesion but required for non-culprit vessel(s).

Required. Required. According to predefined protocols.

Informed consent Oral witnessed informed consent or family consent if possible without delay.

Oral witnessed informed consent may be sufficient unless written consent is legally required.

Written informed consentd (if time permits).

Written informed consentd



Time to revascularization

Emergency:no delay.

Emergency:no delay.

Urgency: within 24 h if possible and no later than 72 h.

Urgency:time constraints apply.

Elective:no time constraints.

Elective:no time constraints.

Procedure Proceed with intervention based on best evidence/availability.

Proceed with intervention based on best evidence/availability.

Proceed with intervention based on best evidence/ availability. Non-culpritlesions treated according to institutionalprotocol.

Proceed with intervention based on best evidence/ availability. Non-culprit lesions treated according to institutional protocol.

Plan most appropriate intervention allowing enough time from diagnostic catheterization to intervention.

Proceed with intervention according to institutionalprotocol defined by local Heart Team.

aPotential indications for ad hoc PCI are listed in Table 5.bSee also Table 12.cOther ACS refers to unstable angina, with the exception of NSTE-ACS.dThis may not apply to countries that legally do not ask for written informed consent. ESC and EACTS strongly advocate documentation of patient consent for all revascularizationprocedures.ACS acute coronary syndrome; MVD multivessel disease; NSTE-ACS non-ST-segment elevation acute coronary syndrome; PCI percutaneous coronary intervention;STEMI ST-segment elevation myocardial infarction.


Ad hoc percutaneous coronary interventionAd hoc PCI is defined as a therapeutic interventional procedure

performed immediately (with the patient still on the catheteriza-tion table) following the diagnostic procedure as opposed to astaged procedure performed during a different session. Ad hocPCI is convenient for the patient, associated with fewer accesssite complications, and often cost-effective. However, in areview of .38 000 patients undergoing ad hoc PCI, 30% ofpatients were in categories that were regarded as potential candi-dates for CABG. Ad hoc PCI is therefore reasonable for manypatients, but not desirable for all, and should not automaticallybe applied as a default approach. Institutional protocols designedby the Heart Team should be used to define specific anatomicalcriteria and clinical subsets that can or cannot be treated ad hoc.Based on resources and settings, geographical differences can beexpected. Table 5 lists potential indications for ad hoc PCI. Allother pathologies in stable patients, including lesions of the LMor proximal left anterior descending (LAD) artery and MVD invol-ving the LAD artery, should be discussed by a Heart Team beforea deferred revascularization procedure (PCI or CABG). Table 6lists the recommendations for decision making and patientinformation.

5. Strategies for pre-interventiondiagnosis and imagingExercise testing and cardiac imaging are used to confirm the diag-nosis of CAD, to document ischaemia in patients with stable

symptoms, to risk stratify patients with stable angina and anacute coronary syndrome (ACS), and to help choose treatmentoptions and evaluate their efficacy. In practice, diagnostic and prog-nostic assessments are conducted in tandem rather than separ-ately, and many of the investigations used for diagnosis also offerprognostic information.12 In elective cases, the pre-test likelihoodof disease is calculated based on symptoms, sex, and risk factors.Patients with an intermediate likelihood of obstructive CAD willundergo exercise testing while patients with a high likelihoodundergo direct invasive examination. Boundaries defining inter-mediate likelihood of CAD are usually set at 1090% or2080%. Because of high availability and low costs, an exercise elec-trocardiogram (ECG) is the most commonly used test to confirmthe anginal nature of the symptoms and to provide objective evi-dence of inducible ischaemia. Its accuracy is limited however,especially in women.12 Many of the patients with an intermediatelikelihood of CAD post-exercise ECG are reclassified into higheror lower likelihood groups after non-invasive functional imaging.

The target of revascularization therapy is myocardial ischaemia,not the epicardial coronary disease itself. Revascularization pro-cedures performed in patients with documented ischaemiareduce total mortality13 through reduction of ischaemicburden.14 Discrepancies between the apparent anatomical severityof a lesion and its functional effects on myocardial blood supply arecommon, especially in stable CAD. Thus, functional assessment,non-invasive or invasive, is essential for intermediate stenoses.Revascularization of lesions without functional significance can bedeferred.15

Another indication for non-invasive imaging before revasculari-zation is the detection of myocardial viability in patients withpoor left ventricle (LV) function. Patients who have viable but dys-functional myocardium are at higher risk if not revascularized,while the prognosis of patients without viable myocardium is notimproved by revascularization.16,17

The current evidence supporting the use of various tests for thedetection of CAD is based on meta-analyses and multicentrestudies (Table 7). Few RCTs have assessed health outcomes for

Table 6 Recommendations for decision making andpatient information

Classa Levelb

It is recommended that patients be adequately informed about the potential benefits and short- and long-term risks of a revascularization procedure. Enough time should be spared for informed decision making.

I C

The appropriate revascularization strategy in patients with MVD should be discussed by the Heart Team.

I C

aClass of recommendation.bLevel of evidence.MVD multivessel disease.

Table 5 Potential indications for ad hoc percutaneouscoronary intervention vs. revascularization at aninterval

Ad hoc PCI

Haemodynamically unstable patients (including cardiogenic shock).

Culprit lesion in STEMI and NSTE-ACS.

Stable low-risk patients with single or double vessel disease (proximal LAD excluded) and favourable morphology (RCA, non-ostial LCx, mid- or distal LAD).

Non-recurrent restenotic lesions.

Revascularization at an interval

Lesions with high-risk morphology.

Chronic heart failure.

Renal failure (creatinine clearance 4 mL/kg.

Stable patients with MVD including LAD involvement.

Stable patients with ostial or complex proximal LAD lesion.

Any clinical or angiographic evidence of higher periprocedural risk with ad hoc PCI.

LAD left anterior descending; LCx left circumflex; MVD multivesseldisease; NSTE-ACS non-ST-segment elevation acute coronary syndrome;PCI percutaneous coronary intervention; RCA right coronary artery;STEMI ST-segment elevation myocardial infarction.


diagnostic testing and the available evidence has been derivedlargely from non-randomized studies. On many occasions thechoice of the test is based on local expertise and availability ofthe test. Although several tests can be used, it is important toavoid unnecessary diagnostic steps.

When considering any test to detect CAD one must also takeinto account the risks associated with the test itself. The risks ofexercise, pharmacological stressors, contrast agents, invasive pro-cedures, and cumulative ionizing radiation must be weighedagainst the risk of disease or delayed diagnosis.

In summary, documentation of ischaemia using functional testingis strongly recommended before elective invasive procedures, pre-ferably using non-invasive testing before invasive angiography.

5.1 Detection of coronary artery diseaseThere are two non-invasive angiographic techniques that candirectly image coronary arteries: multidetector computed tom-ography (MDCT) and magnetic resonance imaging (MRI).

Multidetector computed tomography coronaryangiography

The studies and meta-analyses of MDCT to detect CAD havegenerally shown high negative predictive values (NPVs), suggestingthat MDCT is excellent in excluding significant CAD,18,19 whilepositive predictive values (PPVs) were only moderate. In the twomulticentre trials published, one was consistent with the resultsof prior meta-analyses20 but the other showed only moderateNPV (8389%).21 Only about half of the stenoses classified as

significant by MDCT are associated with ischaemia22 indicatingthat MDCT angiography cannot accurately predict the haemo-dynamic significance of coronary stenosis.

In summary, MDCT is reliable for ruling out significant CAD inpatients with stable and unstable anginal syndromes and in patientswith low to moderate likelihood of CAD. However, MDCT angio-graphy typically overestimates the severity of atheroscleroticobstructions and decisions for patient management requirefurther functional testing.

Magnetic resonance imaging coronary angiographyData suggest that MRI coronary angiography has a lower success

rate and is less accurate than MDCT for the detection of CAD.18

5.2 Detection of ischaemiaThe tests are based on either reduction of perfusion or inductionof ischaemic wall motion abnormalities during exercise or pharma-cological stress. The most well-established stress imaging tech-niques are echocardiography and perfusion scintigraphy. Bothmay be used in combination with either exercise stress or pharma-cological stress. Newer stress imaging techniques also includestress MRI, positron emission tomography (PET) imaging, and com-bined approaches. The term hybrid imaging refers to imagingsystems in which two modalities [MDCT and PET, MDCT andsingle photon emission computed tomography (SPECT)] are com-bined in the same scanner, allowing both studies to be performedin a single imaging session.

Table 7 Indications of different imaging tests for the diagnosis of obstructive coronary artery disease and for theassessment of prognosis in subjects without known coronary artery diseasea

Asymptomatic(screening)

SymptomaticPrognostic

value of positive result a

Prognostic value of negative result a

References

Pretest likelihoodb of obstructive disease

Low Intermediate High

Anatomical test

Invasive angiography III A III A IIb A I A I A I A 12

MDCT angiography III B c IIb B IIa B III B IIb B IIa B 1720

MRI angiography III B III B III B III B III C III C 22

Functional test

Stress echo III A III A I A III A d I A I A 12

Nuclear imaging III A III A I A III A d I A I A 12

Stress MRI III B III C IIa B III B d IIa B IIa B 12, 2325

PET perfusion III B III C IIa B III B d IIa B IIa B 26

aFor the prognostic assessment of known coronary stenosis, functional imaging is similarly indicated.bThe pretest likelihood of disease is calculated based on symptoms, sex, and risk factors.cThis refers to MDCT angiography, not calcium scoring.dIn patients with obstructive CAD documented by angiography, functional testing may be useful in guiding the revascularization strategy based on the extent, severity, andlocalisation of ischaemia.CAD coronary artery disease; MDCT multidetector computed tomography; MRI magnetic resonance imaging; PET positron emission tomography.


Stress imaging techniques have several advantages over conven-tional exercise ECG testing, including superior diagnostic perform-ance,12 the ability to quantify and localize areas of ischaemia, andthe ability to provide diagnostic information in the presence ofresting ECG abnormalities or when the patient is unable to exer-cise. For these reasons, stress imaging techniques are preferred inpatients with previous PCI or CABG. In patients with angiographi-cally confirmed intermediate coronary lesions, evidence of ischae-mia is predictive of future events.

Stress echocardiographyStress echocardiography is an established diagnostic test and is

more accurate than exercise ECG test in the detection ofischaemia.12

The most frequently used method is a physical exercise testtypically using a bicycle ergometer, but pharmacological stressorssuch as dobutamine and less frequently dipyridamole can also beused. The technique requires adequate training and experiencesince it is more user dependent than other imaging techniques.Pooled sensitivity and specificity of exercise echocardiographyare reported as 8085% and 8486%, respectively.12

Recent technical improvements involve the use of contrastagents to facilitate identification of regional wall motion abnormal-ities and to image myocardial perfusion. These agents improve theinterpretability of the images, but the technique of perfusionimaging is not yet established.

Perfusion scintigraphySPECT perfusion is an established diagnostic test. It provides a

more sensitive and specific prediction of the presence of CADthan exercise ECG.12 The reported sensitivity and specificity ofexercise scintigraphy when compared with invasive angiographyrange between 8590% and 7075%, respectively.12

Newer SPECT techniques with ECG gating improve diagnosticaccuracy in various patient populations, including women, dia-betics, and elderly patients.23 Adding information from a simul-taneously performed calcium score using MDCT may furtherincrease the accuracy.24

Cardiovascular magnetic resonance imagingCardiac MRI stress testing with pharmacological stressors can be

used to detect wall motion abnormalities induced by dobutamineinfusion or perfusion abnormalities induced by adenosine.Cardiac MRI has been applied only recently in clinical practiceand therefore fewer data have been published compared withother established non-invasive imaging techniques.12

A recent meta-analysis showed that stress-induced wall motionabnormalities from MRI had a sensitivity of 83% and a specificityof 86% in patient-based analysis, and perfusion imaging demon-strated 91% sensitivity and 81% specificity.25 When evaluatedprospectively at multiple sites, the diagnostic performance ofstress perfusion MRI shows similarly high sensitivity but lowerspecificity.

Multidetector computed tomography perfusionMDCT can be used for perfusion imaging, but data obtained in

clinical settings are scarce.Positron emission tomographyStudies with myocardial perfusion PET have reported excellent

diagnostic capabilities in the detection of CAD. The comparisonsof PET perfusion imaging have also favoured PET over SPECT.26

Meta-analysis of data obtained with PET demonstrated 92% sen-sitivity and 85% specificity for CAD detection, superior to myocar-dial perfusion SPECT. Myocardial blood flow in absolute units (mL/g/min) measured by PET further improves diagnostic accuracy,especially in patients with MVD, and can be used to monitor theeffects of various therapies.

5.3 Hybrid/combined imagingThe combination of anatomical and functional imaging has becomeappealing because the spatial correlation of structural and func-tional information of the fused images may facilitate a comprehen-sive interpretation of coronary lesions and their pathophysiologicalrelevance. This combination can be obtained either with imagecoregistration or with devices that have two modalities combined(MDCT and SPECT, MDCT and PET).

Single-centre studies evaluating the feasibility and accuracy ofcombined imaging have demonstrated that MDCT and perfusionimaging provide independent prognostic information. No large ormulticentre studies are currently available.

5.4 Invasive testsIn common practice, many patients with intermediate or high pretestCAD likelihood are catheterized without prior functional testing.When non-invasive stress imaging is contraindicated, non-diagnostic,or unavailable, the measurement of FFR or coronary flow reserve ishelpful. Even experienced interventional cardiologists cannotpredict accurately the significance of most intermediate stenoseson the basis of visual assessment or quantitative coronary angiogra-phy.27,28 Deferral of PCI15,28 or CABG27 in patients with FFR .0.80is safe and clinical outcome is excellent. Thus, FFR is indicated for theassessment of the functional consequences of moderate coronarystenoses when functional information is lacking.

5.5 Prognostic valueNormal functional imaging results are linked with excellent prog-nosis while documented ischaemia is associated with increasedrisk for MACE. Prognostic information obtained from MDCTimaging is becoming available.

5.6 Detection of myocardial viabilityThe prognosis of patients with chronic ischaemic systolic LV dysfunc-tion is poor, despite advances in various therapies. Non-invasiveassessment of myocardial viability should guide patient management.Multiple imaging techniques including PET, SPECT, and dobutaminestress echocardiography have been extensively evaluated for assess-ment of viability and prediction of clinical outcome after myocardialrevascularization. In general, nuclear imaging techniques have a highsensitivity, whereas techniques evaluating contractile reserve havesomewhat lower sensitivity but higher specificity. MRI has a high diag-nostic accuracy to assess transmural extent of myocardial scar tissue,but its ability to detect viability and predict recovery of wall motion isnot superior to other imaging techniques.16 The differences in per-formance of the various imaging techniques are small, and experi-ence and availability commonly determine which technique is used.Current evidence is mostly based on observational studies ormeta-analyses, with the exception of two RCTs, both relating toPET imaging.17 Patients with a substantial amount of dysfunctionalbut viable myocardium are likely to benefit from myocardial


revascularization and may show improvements in regional and globalcontractile function, symptoms, exercise capacity, and long-termprognosis.16

6. Revascularization for stablecoronary artery diseaseDepending on its symptomatic, functional, and anatomical com-plexity, stable CAD can be treated by OMT only or combinedwith revascularization using PCI or CABG. The main indicationsfor revascularization are persistence of symptoms despite OMTand/or prognosis. Over the last two decades significant advancesin all three treatment modalities have reduced many previoustrials to historic value.

6.1 Evidence basis for revascularizationThe evidence basis for CABG and PCI is derived from RCTs andlarge propensity-matched observational registries; both haveimportant strengths, but also limitations.

By eliminating bias, individual RCTs and their subsequentmeta-analyses2931 constitute the highest hierarchical form ofevidence-based medicine. However, their extrapolation to routineclinical practice is complicated by the fact that their patient popu-lations are often not representative of those encountered in normalclinical practice (e.g. most RCTs of PCI and CABG in multivesselCAD enrolled ,10% of potentially eligible patients, most of whomactually had single or double vessel CAD). Analysis on anintention-to-treat basis is problematic when many patients crossover from medical therapy to revascularization or from PCI toCABG. Limited duration of follow-up (usually,5 years) incompletelydepicts the advantages of CABG, which initially accrue with time butwhich may also eventually be eroded by progressive vein graft failure.

In contrast, by capturing data on all interventions, large observa-tional registries may more accurately reflect routine clinicalpractice. In the absence of randomization, however, their fundamen-tal limitation is that they cannot account for all confounding factors,which may influence both the choice and the outcome of differentinterventions. Propensity matching for both cardiac and non-cardiaccomorbidity can only partially mitigate this problem. Accepting thislimitation, independent registries have consistently reported that aninitial strategy of CABG rather than PCI in propensity-matchedpatients with MVD or LM CAD improved survival over a 3- to5-year period by 5%, accompanied by a four- to seven-foldreduction in the need for reintervention.32 37 The differingpopulations in RCTs and registries may partly explain the apparentdifferences in the respective efficacies of the two procedures, atleast in patients with the most severe CAD.

6.2 Impact of ischaemic burden onprognosisThe adverse impact of demonstrable ischaemia on clinical outcome[death, myocardial infarction (MI), ACS, occurrence of angina] hasbeen well recognized for over two decades.13,38 While sympto-matic patients with no or little evidence of ischaemia have no prog-nostic benefit from revascularization, asymptomatic patients with asignificant mass of ischaemic myocardium do.13,38 Most recently, in

a small nuclear substudy of the COURAGE trial (which reportedno overall survival benefit of PCI over OMT), involving just over300 patients, 100 patients with .10% ischaemic myocardiumhad a lower risk of death or MI with revascularization.14

6.3 Optimal medical therapy vs.percutaneous coronary interventionThe efficacy of PCI (with or without stenting) vs. OMT has beenaddressed in several meta-analyses29,30,39 42 and a large RCT.43

Most meta-analyses reported no mortality benefit, increased non-fatal periprocedural MI, and reduced need for repeat revasculariza-tion with PCI. One meta-analysis41 reported a survival benefit forPCI over OMT (respective mortalities of 7.4% vs. 8.7% at anaverage follow-up of 51 months), but this study included patientswith recent MI and CABG patients in the revascularized group.Another meta-analysis reported reduced mortality for PCI vs.OMT, even after exclusion of MI patients [hazard ratio (HR)0.82, 95% confidence interval (CI) 0.680.99].30

The COURAGE RCT43 randomized 2287 patients with knownsignificant CAD and objective evidence of myocardial ischaemia toOMT alone or to OMT + PCI. At a median follow-up of 4.6 years,there was no significant difference in the composite of death, MI,stroke, or hospitalization for unstable angina. Freedom fromangina was greater by 12% in the PCI group at 1 year but waseroded by 5 years, by which time 21% of the PCI group and 33%of the OMT group had received additional revascularization (P,0.001). The authors concluded that an initial strategy of PCI instable CAD did not reduce the risk of death, MI, or MACE whenadded to OMT. The severity of CAD in COURAGE was, at most,moderate, with the relative proportions of one-, two- and three-vessel CAD being 31%, 39%, and 30%, while only 31% of patientshad proximal LAD disease. Furthermore, patients with LM diseasewere excluded and most patients had normal LV function.

6.4 Percutaneous coronary interventionwith drug-eluting stents vs. bare metalstentsBrophy et al.,44 in an analysis of 29 trials involving 9918 patients,reported no difference between bare metal stent (BMS) andballoon angioplasty in terms of death, MI, or the need forCABG, but an 5% absolute reduction in restenosis with stenting.Subsequent meta-analyses45 of RCTs comparing DES with BMSreported similar rates of death, cardiac death, and non-fatal MI,but a significant reduction in the need for subsequent or repeattarget vessel revascularization (TVR) with DES. In contrast,Kirtane et al.,46 in an unadjusted analysis of 182 901 patients in34 observational studies of BMS and DES, reported a significantreduction in mortality (HR 0.78, 95% CI 0.710.86) and MI (HR0.87, 95% CI 0.780.97) with DES. After multivariable adjustment,the benefits of DES were significantly attenuated and the possibilitythat at least some of the clinical benefit of DES might be due toconcomitant dual antiplatelet therapy (DAPT) could not beexcluded. In a network meta-analysis restricted to patients withnon-acute CAD, sequential advances in PCI techniques were notassociated with incremental mortality benefit in comparison withOMT.42


6.5 Coronary artery bypass grafting vs.medical therapyThe superiority of CABG to medical therapy in the management ofspecific subsets of CAD was firmly established in a meta-analysis ofseven RCTs,31 which is still the major foundation for contempor-ary CABG. It demonstrated a survival benefit of CABG in patientswith LM or three-vessel CAD, particularly when the proximal LADcoronary artery was involved. Benefits were greater in those withsevere symptoms, early positive exercise tests, and impaired LVfunction. The relevance of these findings to current practice isincreasingly challenged as medical therapy used in the trials wassubstantially inferior to current OMT. However, a recentmeta-analysis reported a reduction in the HR for death withCABG vs. OMT (HR 0.62, 95% CI 0.500.77).30 In addition, thebenefits of CABG might actually be underestimated because:

most patients in the trials had a relatively low severity of CAD; analysis was conducted on an intention-to-treat basis (even

though 40% of the medical group crossed over to CABG); only 10% of CABG patients received an internal thoracic artery

(ITA); however the most important prognostic component ofCABG is the use of one47,48 or preferably two49 ITAs.

6.6 Percutaneous coronary interventionvs. coronary artery bypass grafting

Isolated proximal left anterior descending arterydiseaseThere are two meta-analyses of .190050 and .120051 patients,

both of which reported no significant difference in mortality, MI, orcerebrovascular accident (CVA), but a three-fold increase in recur-rent angina and a five-fold increase in repeat TVR with PCI at up to5 years of follow-up.

Multivessel disease (including SYNTAX trial)There have been .15 RCTs of PCI vs. CABG in MVD52 but

only one of OMT vs. PCI vs. CABG (MASS II).53 Most patients inthese RCTs actually had normal LV function with single ordouble vessel CAD and without proximal LAD disease.Meta-analyses of these RCTs reported that CABG resulted in upto a five-fold reduction in the need for reintervention, witheither no or a modest survival benefit or a survival benefit onlyin patients .65 years old (HR 0.82) and those with diabetes(HR 0.7).29 The 5-year follow-up of the MASS II53 study of 611patients (underpowered) reported that the composite primaryendpoint (total mortality, Q-wave MI, or refractory angina requir-ing revascularization) occurred in 36% of OMT, 33% of PCI and21% of CABG patients (P 0.003), with respective subsequentrevascularization rates of 9%, 11% and 4% (P 0.02).

The SYNTAX trialIn contrast to the highly selective patient populations of previous

RCTs, SYNTAX is a 5-year all comers trial of patients with themost severe CAD, including those with LM and/or three-vesselCAD, who were entered into either the trial or a parallel nestedregistry if ineligible for randomization.4 By having two components,SYNTAX therefore captured real treatment decisions in a trial of1800 patients randomized to PCI or CABG and in a registry of1077 CABG patients (whose complexity of CAD was deemed to

be ineligible for PCI) and 198 PCI patients (considered to be atexcessive surgical risk). At 1 year, 12.4% of CABG and 17.8% ofPCI patients reached the respective primary composite endpoint(P, 0.002) of death (3.5% vs. 4.4%; P 0.37), MI (3.3% vs. 4.8%;P 0.11), CVA (2.2% vs. 0.6%; P 0.003), or repeat revasculariza-tion (5.9% vs. 13.5%; P, 0.001).4 Unpublished data at 2 yearsshowed major adverse cardiac and cerebral event (MACCE)rates of 16.3% vs. 23.4% in favour of CABG (P, 0.001). BecausePCI failed to reach the pre-specified criteria for non-inferiority,the authors concluded at both 14 and 2 years that CABGremains the standard of care for patients with three-vessel orLM CAD although the difference in the composite primary end-point was largely driven by repeat revascularization. Whetherthe excess of CVA in the CABG group in the first year waspurely periprocedural or also due to lower use of secondary pre-ventive medication (DAPT, statins, antihypertensive agents, andACE inhibitors) is not known.

Failure to reach criteria for non-inferiority therefore means thatall other findings are observational, sensitive to the play of chance,and hypothesis generating. Nevertheless, in 1095 patients withthree-vessel CAD, the MACCE rates were 14.4% vs. 23.8% infavour of CABG (P, 0.001). Only in the tercile of patients withthe lowest SYNTAX scores (,23) was there no significant differ-ence in MACCE between the two groups. It is also noteworthythat the mortality and repeat revascularization rates were similarin the 1077 CABG registry patients, even though these patientshad more complex CAD.

Taking together all 1665 patients with three-vessel CAD (1095in the RCT and 570 in the registry), it appears that CABG offerssignificantly better outcomes at 1 and 2 years in patients withSYNTAX scores .22 (79% of all patients with three-vesselCAD). These results are consistent with previous registries32 37

reporting a survival advantage and a marked reduction in theneed for repeat intervention with CABG in comparison with PCIin patients with more severe CAD.

Left main stenosisCABG is still conventionally regarded as the standard of care for

significant LM disease in patients eligible for surgery, and the CASSregistry reported a median survival advantage of 7 years in 912patients treated with CABG rather than medically.54 While ESCguidelines on PCI state that Stenting for unprotected LM diseaseshould only be considered in the absence of other revasculariza-tion options,55 emerging evidence, discussed below, suggeststhat PCI provides at least equivalent if not superior results toCABG for lower severity LM lesions at least at 2 years of follow-upand can justify some easing of PCI restrictions. However, theimportance of confirming that these results remain durable withlonger term follow-up (at least 5 years) is vital.

While LM stenosis is a potentially attractive target for PCIbecause of its large diameter and proximal position in the coronarycirculation, two important pathophysiological features may mitigateagainst the success of PCI: (i) up to 80% of LM disease involves thebifurcation known to be at particularly high risk of restenosis; and(ii) up to 80% of LM patients also have multivessel CAD whereCABG, as already discussed, may already offer a survival advantage.

The most definitive current account of treatment of LM diseaseby CABG or PCI is from the hypothesis-generating subgroup


analysis of the SYNTAX trial. In 705 randomized LM patients, the1-year rate of death (4.4% vs. 4.2%; P 0.88), CVA (2.7% vs. 0.3%;P 0.009), MI (4.1% vs. 4.3%; P 0.97), repeat revascularization(6.7% vs. 12.0%; P 0.02) and MACCE (13.6% vs. 15.8%; P 0.44) only favoured CABG for repeat revascularization, but at ahigher risk of CVA.

By SYNTAX score terciles, MACCE rates were 13.0% vs. 7.7%(P 0.19), 15.5% vs. 12.6% (P 0.54), and 12.9% vs. 25.3% (P 0.08) for CABG vs. PCI in the lower (022), intermediate (2332), and high (33) terciles, respectively. Unpublished data at 2years show respective mortalities of 7.9% and 2.7% (P 0.02)and repeat revascularization rates of 11.4% and 14.3% (P 0.44)in the two lower terciles, implying that PCI may be superior toCABG at 2 years. Of note, among the 1212 patients with LM ste-nosis included in the registry or in the RCTs, 65% had SYNTAXscores 33.

Support for the potential of PCI at least in lower risk LM lesionscomes from several other sources. In a meta-analysis of 10 studies,including two RCTs and the large MAIN-COMPARE registry, of3773 patients with LM stenosis, Naik et al.56 reported that therewas no difference between PCI and CABG in mortality or in thecomposite endpoint of death, MI, and CVA up to 3 years, but upto a four-fold increase in repeat revascularization with PCI.These results were confirmed at 5 years in the MAIN-COMPAREregistry.57

6.7 RecommendationsThe two issues to be addressed are:

(i) the appropriateness of revascularization (Table 8);(ii) the relative merits of CABG and PCI in differing patterns of

CAD (Table 9).

Current best evidence shows that revascularization can bereadily justified:

(i) on symptomatic grounds in patients with persistent limitingsymptoms (angina or angina equivalent) despite OMT and/or

(ii) on prognostic grounds in certain anatomical patterns of diseaseor a proven significant ischaemic territory (even in asympto-matic patients). Significant LM stenosis, and significant proximalLAD disease, especially in the presence of multivessel CAD, arestrong indications for revascularization. In the most severe pat-terns of CAD, CABG appears to offer a survival advantage aswell as a marked reduction in the need for repeat revasculariza-tion, albeit at a higher risk of CVA, especially in LM disease.

Recognizing that visual attempts to estimate the severity of ste-noses on angiography may either under- or overestimate theseverity of lesions, the increasing use of FFR measurements toidentify functionally more important lesions is a significant develop-ment (Section 5.4).

It is not feasible to provide specific recommendations for the pre-ferred method of revascularization for every possible clinical scen-ario. Indeed it has been estimated that there are .4000 possibleclinical and anatomical permutations. Nevertheless, in comparingoutcomes between PCI and CABG, Tables 8 and 9 should formthe basis of recommendations by the Heart Team in informing

patients and guiding the approach to informed consent. However,these recommendations must be interpreted according to individualpatient preferences and clinical characteristics. For example, even if apatient has a typical prognostic indication for CABG, this should bemodified according to individual clinical circumstances such as veryadvanced age or significant concomitant comorbidity.

7. Revascularization in non-ST-segment elevation acute coronarysyndromesNSTE-ACS is the most frequent manifestation of ACS and rep-resents the largest group of patients undergoing PCI. Despiteadvances in medical and interventional treatments, the mortalityand morbidity remain high and equivalent to that of patientswith STEMI after the initial month. However, patients withNSTE-ACS constitute a very heterogeneous group of patientswith a highly variable prognosis. Therefore, early risk stratificationis essential for selection of medical as well as interventional treat-ment strategies. The ultimate goals of coronary angiography andrevascularization are mainly two-fold: symptom relief, andimprovement of prognosis in the short and long term. Overallquality of life, duration of hospital stay, and potential risks

Table 8 Indications for revascularization in stableangina or silent ischaemia

Subset of CAD by anatomy Classa Levelb Ref.c

For prognosis

Left main >50%d I A30, 31,

54

Any proximal LAD >50%d I A 3037

2VD or 3VD with impaired LV functiond

I B 3037

Proven large area of ischaemia(>10% LV)

I B13, 14,

38

Single remaining patent vessel>50% stenosisd

I C

1VD without proximal LAD and without >10% ischaemia III A

39, 40, 53

For symptoms

Any stenosis >50% with limiting angina or angina equivalent, unresponsive to OMT

I A30, 31,

14, 38

3943

Dyspnoea/CHF and >10% LV ischaemia/viability supplied by>50% stenotic artery

IIa B

No limiting symptoms with OMT III C

aClass of recommendation.bLevel of evidence.cReferences.dWith documented ischaemia or FFR ,0.80 for angiographic diameter stenoses5090%.CAD coronary artery disease; CHF chronic heart failure; FFR fractionalflow reserve; LAD left anterior descending; LV left ventricle; OMT optimalmedical therapy; VD vessel disease.


associated with invasive and pharmacological treatments shouldalso be considered when deciding on treatment strategy.

7.1 Intended early invasive orconservative strategiesRCTs have shown that an early invasive strategy reduces ischaemicendpoints mainly by reducing severe recurrent ischaemia and theclinical need for rehospitalization and revascularization. Thesetrials have also shown a clear reduction in mortality and MI inthe medium term, while the reduction in mortality in the longterm has been moderate and MI rates during the initial hospitalstay have increased (early hazard).58 The most recent meta-analysisconfirms that an early invasive strategy reduces cardiovasculardeath and MI at up to 5 years of follow-up.59

7.2 Risk stratificationConsidering the large number of patients and the heterogeneity ofNSTE-ACS, early risk stratification is important to identify patientsat high immediate and long-term risk of death and cardiovascularevents, in whom an early invasive strategy with its adjunctive

medical therapy may reduce that risk. It is equally important,however, to identify patients at low risk in whom potentially hazar-dous and costly invasive and medical treatments provide littlebenefit or in fact may cause harm.

Risk should be evaluated considering different clinical character-istics, ECG changes, and biochemical markers. Risk score modelshave therefore been developed. The ESC Guidelines forNSTE-ACS recommend the GRACE risk score (http://www.outcomes-umassmed.org/grace) as the preferred classification toapply on admission and at discharge in daily clinical practice.60

The GRACE risk score was originally constructed for predictionof hospital mortality but has been extended for prediction of long-term outcome across the spectrum of ACS and for prediction ofbenefit with invasive procedures.61

A substantial benefit with an early invasive strategy has onlybeen proved in patients at high risk. The recently publishedmeta-analysis59 including the FRISC II,62 the ICTUS,63 and theRITA III64 trials showed a direct relationship between risk, evalu-ated by a set of risk indicators including age, diabetes, hypotension,ST depression, and body mass index (BMI), and benefit from anearly invasive approach.

Troponin elevation and ST depression at baseline appear to beamong the most powerful individual predictors of benefit frominvasive treatment. The role of high sensitivity troponin measure-ments has yet to be defined.

7.3 Timing of angiography andinterventionThe issue of the timing of invasive investigation has been a subjectof discussion. A very early invasive strategy, as opposed to adelayed invasive strategy, has been tested in five prospectiveRCTs (Table 10).

A wealth of data supports a primary early invasive strategy overa conservative strategy. There is no evidence that any particulartime of delay to intervention with upstream pharmacological treat-ment, including intensive antithrombotic agents, would be superiorto providing adequate medical treatment and performing angiogra-phy as early as possible.65 Ischaemic events as well as bleedingcomplications tend to be lower and hospital stay can be shortenedwith an early as opposed to a later invasive strategy. In high-riskpatients with a GRACE risk score .140, urgent angiographyshould be performed within 24 h if possible.66

Patients at very high risk were excluded from all RCTs so thatlife-saving therapy was not withheld. Accordingly, patients withongoing symptoms and marked ST depression in anterior leads(particularly in combination with troponin elevation) probablysuffer from posterior transmural ischaemia and should undergoemergency coronary angiography (Table 11). Moreover, patientswith a high thrombotic risk or high risk of progression to MIshould be investigated with angiography without delay.

In lower risk subsets of NSTE-ACS patients, angiography andsubsequent revascularization can be delayed without increasedrisk but should be performed during the same hospital stay, prefer-ably within 72 h of admission.

Table 9 Indications for coronary artery bypassgrafting vs. percutaneous coronary intervention instable patients with lesions suitable for both proceduresand low predicted surgical mortality

Subset of CAD by anatomy

Favours CABG

Favours PCI

Ref.

1VD or 2VD - non-proximal LAD

IIb C I C

1VD or 2VD - proximal LAD I A IIa B30, 31, 50,

51

3VD simple lesions, full functional revascularization achievable with PCI, SYNTAX score 22

I A III A 4, 3037, 53

Left main (isolated or 1VD, ostium/shaft)

I A IIa B 4, 54

Left main (isolated or 1VD, distal bifurcation)

I A IIb B 4, 54

Left main + 2VD or 3VD,SYNTAX score 140 or at

least one high-risk criterion. recurrent symptoms. inducible ischaemia at stress test.

I A64,

6870

An early invasive strategy (140 or multiple other high-risk criteria.

I A63, 64,

66, 7072

A late invasive strategy (within 72 h) is indicated in patients with GRACE score

585% of patients with STEMI undergo primary PCI, a wide rangethat reflects the variability or allocation of local resources andcapabilities.82 Even with an optimal network organization, transferdelays may be unacceptably long before primary PCI is performed,especially in patients living in mountain or rural areas or presentingto non-PCI centres. The incremental benefit of primary PCI, overtimely fibrinolysis, is jeopardized when PCI-related delay exceeds60120 min, depending on age, duration of symptoms, andinfarct location.83,84

Facilitated PCI, or pharmaco-mechanical reperfusion, is definedas elective use of reduced or normal-dose fibrinolysis combinedwith glycoprotein IIbIIIa (GPIIbIIIa) inhibitors or other antiplate-let agents. In patients undergoing PCI 90120 min after FMC, facili-tated PCI has shown no significant advantages over primary PCI.The use of tenecteplase and aspirin as facilitating therapy wasshown to be detrimental compared with primary PCI, withincreased ischaemic and bleeding events, and a trend towardsexcess mortality.85 The combination of half-dose lytics with

GPIIbIIIa inhibitors showed a non-significant reduction inadverse events at the price of excess bleeding.86

Pre-hospital full-dose fibrinolysis has been tested in the CAPTIMtrial,81 using an emergency medical service (EMS) able to performpre-hospital diagnosis and fibrinolysis, with equivalent outcome toprimary PCI at 30 days and 5 years. Following pre-hospital fibrino-lysis, the ambulance should transport the patient to a 24 h a day/7days a week PCI facility.

8.1.3 Delayed percutaneous coronary interventionIn cases of persistent ST-segment elevation after fibrinolysis,defined as more than half of the maximal initial elevation in theworst ECG lead, and/or persistent ischaemic chest pain, rapidtransfer to a PCI centre for rescue angioplasty should be con-sidered.80,87 Re-administration of a second dose of fibrinolysiswas not shown to be beneficial.

In the case of successful fibrinolysis, patients are referred within24 h for angiography and revascularization as required.77 79

Symptoms of STEMI

GP/cardiologist

Immediate transfer to Cath Lab

Transfer to ICU of PCI-capable centre

Self-referralEMS

Pre-hospital diagnosis & care

Ambulanceto Cath

Private transportation

Immediatefibrinolysis

Successfulfibrinolysis?

Primary PCI-capable centre

NO

YES

Non-primary PCI-capable centre

Primary PCI

Rescue PCI

Coronary angiography 3 24 h after FMC

Delayed PCI as required

NOYES

PCI possible in

Patients presenting between 12 and 24 h and possibly up to 60 hfrom symptom onset, even if pain free and with stable haemody-namics, may still benefit from early coronary angiography and poss-ibly PCI.88,89 Patients without ongoing chest pain or inducibleischaemia, presenting between 3 and 28 days with persistent cor-onary artery occlusion, did not benefit from PCI.90,91 Thus, inpatients presenting days after the acute event with a fullydeveloped Q-wave MI, only patients with recurrent angina and/or documented residual ischaemia and proven viability in alarge myocardial territory are candidates for mechanicalrevascularization.

8.1.4 Coronary artery bypass graftingEmergent coronary artery bypass graftingIn cases of unfavourable anatomy for PCI or PCI failure, emer-

gency CABG in evolving STEMI should only be considered whena very large myocardial area is in jeopardy and surgical revascular-ization can be completed before this area becomes necrotic (i.e. inthe initial 34 h).

Urgent coronary artery bypass graftingCurrent evidence points to an inverse relationship between sur-

gical mortality and time elapsed since STEMI. When possible, in theabsence of persistent pain or haemodynamic deterioration, awaiting period of 37 days appears to be the best compromise.92

Patients with MVD receiving primary PCI or urgent post-fibrinolysis PCI on the culprit artery will need risk stratificationand further mechanical revascularization with PCI or surgery.Older age, impaired LV function, and comorbidity are associatedwith a higher surgical risk.

8.2 Cardiogenic shock and mechanicalcomplications8.2.1 Cardiogenic shockCardiogenic shock is the leading cause of in-hospital death for MIpatients. Optimal treatment demands early reperfusion as well ashaemodynamic support to prevent end-organ failure and death.Definitions of cardiogenic shock, the diagnostic procedures aswell as the medical, interventional, and surgical treatment are dis-cussed in previous ESC Guidelines.93,94 No time limit should be setbetween onset of symptoms and invasive diagnosis and revascular-ization in patients with cardiogenic shock, whether or not theypreviously received fibrinolytic treatment. In these patients, com-plete revascularization has been recommended, with PCI per-formed in all critically stenosed large epicardial coronary arteries.95

8.2.2 Mechanical complicationsEchocardiography should always be performed in acute heartfailure (AHF) to assess LV function and to rule out life-threateningmechanical complications that may require surgery such as acutemitral regurgitation (MR) secondary to papillary muscle rupture,ventricular septal defect (VSD), free wall rupture, or cardiac tam-ponade. The natural history of these conditions is characterized bya rapid downhill course and medical treatment alone results inclose to 100% mortality.

Free wall rupture requires prompt recognition and immediatepericardial drainage at the bedside. The incidence of post-MI

VSD is 0.2%. With persistent haemodynamic deteriorationdespite the presence of an intra-aortic balloon pump (IABP),surgery should be performed as soon as possible.92 Other thanfeasibility, there is limited evidence to support percutaneousattempts at defect closure either transiently using balloons ordurably with implantation of closure devices. Acute MR due topapillary muscle rupture usually results in acute pulmonaryoedema and should be treated by immediate surgery.

Whenever possible, pre-operative coronary angiography isrecommended. Achieving complete revascularization in additionto correcting the mechanical defect improves the clinicaloutcome.

8.2.3. Circulatory assistanceThe use of an IABP is recommended only in the presence ofhaemodynamic impairment.96,97 The IABP should be insertedbefore angiography in patients with haemodynamic instability (par-ticularly those in cardiogenic shock and with mechanical compli-cations).92 The benefits of an IABP should be balanced aga