• PCR Edu Online: How to treat patients with undilatable/calcified coronary artery lesions

• InCathlab Live Case: a safe plaque modification at Bournemouth Hospital

Learning with clinical case:

• Master plaque modification to treat diffused calcified lesions with IVUS support

• EuroPCR 2017 Symposium: The SYNERGY™ Stent: complete revascularization solutions in complex PCI

• EuroPCR 2017 Symposium: LOTUS™ Valve: expanding treatment options in real-world practice

• Boston Scientific has closed Symetis Acquisition

LM Left Main

Vessel

AMI Acute Myocardial

Infarction

CTO Chronic Total

Occlusion

SV Small Vessel

PM Plaque

Modification

X Crossing

SVG SaphenousVein Graft

EDU Education& Training

MVDMultivessel

Disease

CARDIOLOGY NEWSLETTER

Congress and Events

Educational Corner

Clinical Studies

• New data from the EWOLUTION 1 year registry: WATCHMAN™ LAAC Device is effective in reducing the risk of stroke

• SCAAR Registry from EuroPCR 2017: SYNERGY™ Stents presents very low definite ST rates

• Latest updates from EuroPCR 2017: the EVOLVE II Diabetes Substudy

• LOTUS™ Valve: REPRISE III 1 Year data from EuroPCR 2017

• Join the Complex PCI community

• WATCHMAN™: think outside the pill box Featured Content

Congress and Events

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Congresses and Events

EuroPCR 2017 SymposiumThe SYNERGY™ Stent: complete revascularization solutions in complex PCI

Procedure:Two-stage evaluation: objective performance criteria benchmarking and large-scale randomized trial with clinical endpoint evaluation.

Objectives:• To discuss the potential benefits of bioabsorbable polymer DES in high-bleeding risk patients • To understand how PCI guidance can optimise coronary procedures • To learn how the SYNERGY™ stent is being used in complex patient subsets

The SYNERGY™ Stent offers complete revascularization solutions in complex PCI. In this webcast from EuroPCR 2017, a panel of experts discuss about the recommended requirement for use of DES in clinical practice.

Lectures: F.J. Neuman; G.G. Stefanini; R. Byrne; J. Escaned; S. Walsh; M. Lesiak; A. Banning

IC-476301-AA MAY 2017

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Congresses and Events

EuroPCR 2017 SymposiumLOTUS™ Valve: expanding treatment options in real-world practice

Objectives:• To understand the current LOTUS™ Valve clinical evidence and latest clinical data• To learn how paravalvular leak can be minimized despite anatomical complexities• To discuss real-world experience with the LOTUS™ Valve System

LOTUS™ Valve expands treatment options in real-world practice. From EuroPCR 2017, a webcast dedicated to the LOTUS™ program, reviewing a range topics from our trial data to some really good clinical examples.

Speakers: T. Feldman, M. Götberg, D. Mylotte, J.M. Sinning, L. Sondergaard, D. Tchétché

Caution: The LOTUS™ Valve Platofrm may only be used in countries where it is approved for use. The LOTUS™ Valve Platform is not available for sale in the European Economic Area. For educational purposes only. SH-475605 -AA MAY2017

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Congresses and Events

Boston Scientific Corporation has announced the close of its acquisition for $435 million in cash of Symetis SA, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices.

The ACURATE™ valves are designed to treat patients suffering from severe and symptomatic aortic valve stenosis, who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via a transcatheter percutaneous delivery system. Boston Scientific expects to continue the development of the ACURATE neo/AS next generation valve system that is currently in a clinical trial intended to support a future CE mark application.

Boston Scientific has closed Symetis Acquisition

With the completion of the acquisition, Boston Scientific will immediately begin selling the ACURATE TA™ and ACURATE neo™/TF™ valve systems, expanding its Structural Heart Portfolio and increasing the Offerings for the treatment of Patients with Valvular Heart Disease.

LOTUSTM Valve Platform ACURATE TATM

Boston Scientific‘s portfolio

“Adding the ACURATE family of valve products to our structural heart portfolio presents us with the opportunity to provide two distinctly different but complementary TAVI platforms enabling implanting physicians and hospitals to treat the broadest range of patients and aortic valve anatomies,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific.

Ian Meredith, M.D., Executive Vice President and Global Chief Medical Officer of Boston Scientific.

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Educational Corner

Educational objectives:• How to treat undilatable / calcified coronary lesions• What are the essential tools one need to have and the key essential steps for safe usage of Rotational

Atherectomy• How to avoid and manage potential complications

PCR Edu Online: How to treat patients with undilatable/calcified coronary artery lesions

Do you want to learn how to perform successful procedure using ROTABLATOR™ in complex and calcified/undilatable coronary lesions? PCR Edu Online dedicated a Practical Program to those Interventional Cardiologists and cathlab staff who want to discover how to treat patients with undilatable and calcified coronary artery lesions using the Rotational Atherectomy System.

Team: Emanuele Barbato, Adam De Belder, Jean Fajadet, Michael Haude and Flavio Ribichini

What will you learn? Watch the video:

Find out the tips and tricks to treat specific lesions! Join the course on PCR Edu Online:

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Educational Corner

Educational objectives:• Improve rotablation understanding for catheter lab staff and 2nd operators• Step by step procedure for setting up the ROTABLATOR™ system • Discuss pre-procedural and procedural recommendations• Increase confidence in Rotablation for plaque modification • Compare techniques and approach strategies of different experts

Patient History: • 83-year old male patient• Stable Angina and good LV systolic function • Permanent AF on long term anticoagulation (Warfarin)• Coronary Angiography Sept 2016• PCI RCA 14th November 2016 – Rotablation 1.75mm Burr

InCathlab Live Case: a safe plaque modification at Bournemouth Hospital

A Rotational Atherectomy Live Case from Bournemouth Hospital to master a safe plaque modification with a step-by-step procedure: from setting up the system to practical procedural recommendations.

Peter O’kane, MD; Jehangir Din, MD; Sami Omar, MD; Charlotte Carswell, nurse-technician

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KEY TAKEAWAYS:

• Exceptional deliverability of the OPTICROSSTM Coronary Imaging Catheter is the key to assessing vessels with long diffused calcified lesions

• ROTABLATORTM Rotational Atherectomy System was used to modify calcified lesion for optimal stent delivery and implantation

• IVUS confirmed presence of diffused calcified lesion in the LCx and LMCA with a need for stenting a long segment of the vessel

• Then, IVUS helped optimize stent implantation and confirm the final result

Educational Corner

Learning with clinical case: Master plaque modification to treat diffused calcified lesions with IVUS

This case illustrates the need for OPTICROSS™ Coronary Imaging Catheter and ROTABLATOR™ Rotational Atherectomy System to treat long diffused calcified lesions.

Prof. Sławomir Dobrzycki

The Clinic of Invasive Cardiology with Intensive Care and Hemodynamics

University Clinic Hospital in Białystok, Poland

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Clinical Studies

New data from the EWOLUTION 1 year registry: WATCHMAN™ LAAC Device is effective in reducing the risk of stroke

One-year data from the EWOLUTION registry confirmed that the WATCHMAN™ left atrial appendage closure (LAAC) device had a high implant success rate and was effective in stroke reduction for patients with non-valvular atrial fibrillation (AF), including those patients deemed unsuitable for oral anticoagulation. One-year data also found that LAAC with WATCHMAN™ followed by dual antiplatelet therapy (DAPT) significantly reduced the risk of stroke and lowered the risk of major bleeding by more than half as compared to Warfarin use.

The prospective EWOLUTION registry evaluated 1,025 patients1,2 with non-valvular atrial fibrillation (AF) who have a high risk for stroke and systemic embolism. More than 70 % were deemed unsuitable for anticoagulation therapy (OAC) and were not taking any OAC directly after the procedure.

Highlights of the data presented at HRS 20173 and EuroPCR 20174:

• WATCHMAN™ is confirmed to be safe and effective in a high risk population showing:

- 84% reduction in ischemic strokes (annual stroke rate was 1.1%) as compared to no therapy5.

- 48% reduction in major bleeding events (annual major bleeding rate was 2.6% compared to warfarin6. Excluding periprocedural bleeding, reduction in major bleeding events was 54% (annual major bleeding rate excluding procedural was 2.3%)6.

• More than 70% of the patients were deemed unsuitable for any oral anti-coagulation and used only Antiplatelet (Dual or Single) or no medical therapy which didn’t appear to affect the occurrence of stroke or other TE events during F-U.

• Dual antiplatelet therapy (DAPT) post-procedure was used in 60% of patients and including this patient population, WATCHMAN continued to demonstrate low ischemic stroke (annual stroke rate was 1.4%)4 and low major bleeding rates (annual major bleeding rate was 2.5% and 2.1% excluding periprocedural bleeding)4.

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Clinical Studies

New data from the EWOLUTION 1 year registry: WATCHMAN™ LAAC Device is effective in reducing the risk of stroke

In the DAPT subgroup, the level of stroke risk reduction is similar to that seen in ARISTOTLE (apixaban) in a high-risk population (CHA2DS2-VASc ≥ 3)7.

1. PREVAIL, Holmes, DR et al. JACC 2014;Vol.64, No.12. (2014). Circulatory System Devices Panel:

WATCHMAN® Left Atrial Appendage Closure Therapy Sponsor Presentation. 2014 FDA Circulatory System Devices Panel.

3. EWOLUTION, Boersma L.V.A et al. Eur Heart J. 2016 Aug;37(31):2465-74

Implant success results:98.5% highest implant success rate of all WATCHMAN™ trials1-3:

Implant Success

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2. PREVAIL, Holmes, DR et al. JACC 2014;Vol.64, No.13. (2014). Circulatory System Devices Panel:

WATCHMAN® Left Atrial Appendage Closure Therapy Sponsor Presentation. 2014 FDA Circulatory System Devices Panel.

3. EWOLUTION, Boersma L.V.A et al. Eur Heart J. 2016 Aug;37(31):2465-74

Implant procedure safety: 2,8% Lowest peri-procedural risk of all WATCHMAN™2-4 trials

Serious adverse procedure or device related events (SAE) at 7 days

% o

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Featured Content

Clinical Studies

New data from the EWOLUTION 1 year registry: WATCHMAN™ LAAC Device is effective in reducing the risk of stroke

* Effectiveness in stroke reduction vs. estimated in the absence of therapy for comparable CHA2DS2-VASc scores based on Friberg et al. EHJ 2012

* Effectiveness in bleeding reduction vs. estimated under VKA therapy for comparable HAS-BLED scores based on Lip et al. JACC 2011

References:1.Boersma LV, et al., Catheter Cardiovasc Interv. 2016 Sep;88(3):460-52. Boersma LV, et al., Eur Heart J. 2016 Aug;37(31):2465-743. Boersma LV, et al., Presented at HRS 2017 Congress4. Bergmann MW, et al., Presented at EuroPCR 2017 Congress5. Friberg L, et al., European Heart Journal (2012) 33, 1500–15106. Lip GYK, et al., J Am Coll Cardiol. 2011 Jan 11;57(2):173-807. Lopes LD, et al., Lancet. 2012 Nov 17;380(9855):1749-58

Effectiveness in bleeding reduction3:48% reduction in major bleeding events compared to warfarin* and 54% reduction in major bleeding events if excluding periprocedural bleeding*:

Expected, based on CHA2DS2-VASc*

Expected, based on HAS-BLED*

Observed in EWOLUTION

Observed in EWOLUTION

Effectiveness in ischemic stroke reduction3: 84% reduction in ischemic strokes (annual stroke rate 1.1%) as compared to no therapy*:

12%

10%

8%

6%

4%

2%

0%Ischemic Stroke Ischemic Stroke/TIA/SE

RR85%

RR84%

7.2%

10.1%

1.1% 1.5%

6%

5%

4%

3%

2%

1%

0%Major Bleeding Major Bleeding Excl. Procedural

RR54%

RR48%

5.0% 5.0%

2.6%2.3%

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Clinical Studies

SYNERGY™ Stents presents best in class healing and is associated with low cardiac events in complex high risk indicated patients (CHIP). This is the result of the SCAAR Registry data showed during EuroPCR 2017.

Accordingly to a new publication from the SCAAR team, SYNERGY™ was used in very complex cases in SCAAR (e.g. patients with diabetes, hypertension, prior MI, 3 vessel disease and bifurcation lesions) and demonstrated very low definite ST rates with almost 21000 stents implanted: 0.36% at mean FU of 1.3 years.

SCAAR Registry from EuroPCR 2017: SYNERGY™ Stents presents very low definite ST rates

1 Sarno, Giovanna, et al. “Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).” Catheterization and Cardiovascular Interventions (2017).

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Clinical Studies

Latest updates from EuroPCR 2017: the EVOLVE II Diabetes Substudy

EVOLVE II Diabetes Substudy is a consecutive, multicenter, single-arm, non-randomized study with the SYNERGY™ Stent in medically-treated diabetic patients. While second generation PP-DES failed to improve the results in diabetic patients after PCI, SYNERGY™ BP Stent showed excellent performance as compared to all patients in the EVOLVE II Trial at three years:

*Patients who did not receive a study stent were only followed through 1 year (safety population) presented by M Gilard, PCR 2017.

EVOLVE II Patient Disposition

Diabetic subjects in the SYNERGYTM Stent arm of the EVOLVE II RCT

N=263

No study implanted N=3*

3-year Clinical follow-up95.5% (442/463)

EVOLVE II Diabetes Substudy N=466

Diabetic subjects in the Diabetes single-arm study

N=203

Missed 3-year Visit N=10Withdrew Consent N=5Lost to Follow-up N=5

Other N=1

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Clinical Studies

Latest updates from EuroPCR 2017: the EVOLVE II Diabetes Substudy

Results:

• 1.1% def/Prob Stent Thrombosis at 3 years

• Patients with DM treated with the Synergy™ BP Stent had 0% definite/probable ST after 30 days, suggesting optimal early healing in this complex patient population

SYNERGY™ BP Stent showed exceptional comparable clinical outcomes in patients with DM and EVOLVE II RCT that include a broad range of patient population:

Presented by M.Gilard. PCR 2017.

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LOTUS™ Valve showed superiority to CoreValve® TAVI System Platform in the primary effectiveness endpoint at 1 year and non-inferiority in the primary safety endpoint at 30 days. This is the result of the REPRISE III 1 year data trial presented by Dr. T. Feldman at EuroPCR 2017, which is a multi-center, randomized controlled trial that includes 912 patients from the US, Europe, Canada and Australia.

Clinical Studies

LOTUS™ Valve: REPRISE III 1 Year data from EuroPCR 2017

Watch the animation of the Reprise III Data Highlights:

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Clinical Studies

LOTUS™ Valve: REPRISE III 1 Year data from EuroPCR 2017 Primary EndpointsComposite of all-cause mortality, stroke, life-threatening and major bleeding events, acute kidney injury (stage 2/3) and major vascular complications at 30 days:

Composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (core lab assessment) at 1 year:

Primary Composite Safety Endpoint1year-intent-to-treat

* All-cause mortality, stroke, life-threatening/major bleed, stage 2/3 AKI, major vascular complications at 30 days

‡ Primary analysis set - enrolled patients implanted with the assigned valve

† Upper 1-sided CI and P value are derived from the Farrington-Manning test

Primary Composite Safety Endpoint*Non-inferiority Testing

10.5% prespecified non-inferiority margin

* All-cause mortality, stroke, life-threatening/major bleed, stage 2/3 AKI, major vascular complications

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Clinical Studies

LOTUS™ Valve: REPRISE III 1 Year data from EuroPCR 2017 Secondary Endpoint

Moderate or Greater Paravalvular Leak at 1 Year (Based on Core Lab Assessment):

Paravalvular LEAK AT 1 YearCore Lab Assessment – Intent-to-treat

ConclusionsLotus™ Valve shows:• Non-Inferiority for the 30-day safety endpoint• Superiority for the 1-year primary effectiveness endpoint• Less moderate or greater paravalvular leak• Fewer disabling strokes • Fewer repeat procedures • More valve thrombosis• More new pacemaker implantations • Less TAV-in-TAV deployment and less valve malpositioning

* All-cause mortality, stroke, life-threatening/major bleed, stage 2/3 AKI, major vascular complications at 30 days

‡ Primary analysis set - enrolled patients implanted with the assigned valve

† Upper 1-sided CI and P value are derived from the Farrington-Manning test

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WATCHMAN™: think outside the pill box

Find out the new European Watchman Campaign to learn more about the one-time procedure that may provide a long-term stroke risk reduction in NVAF patients.

Join the Complex PCI CommunityStay up to date with the latest advances for optimizing revascularization.

Join the Complex PCI community to download the Journal of Invasive Cardiology Clinical Article: Initial Experience of Bioabsorbable Polymer Everolimus-Eluting Synergy Stents in High-Risk Patients Undergoing Complex Percutaneous Coronary Intervention With Early Discontinuation of Dual-Antiplatelet Therapy by Rebecca L. Noad, MB, PhD; Colm G. Hanratty, MD; Simon J. Walsh, MD

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See the campaign »

www.bostonscientific.eu

© 2017 Boston Scientific Corporationor its affiliates. All rights reserved.

* Lund experience with the ™ Valve in an all-comers population, Matthias Götberg, EuroPCR 2016

IC-479109-AA JUN 2017 Printed in Germany by medicalvision.

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