209scularization Medicine 11 (2010) 199–215

Does reloading clopidogrel for patients with unstable angina who are

on chronic clopidogrel therapy and undergoing percutaneous coronaryintervention impact outcome?Asmir I. Syed, Yanlin Li, Itsik Ben-Dor, Gabriel Maluenda,Manuel A. Gonzalez, Cedric Delhaye, Kohei Wakabayashi, Loic Belle,Nicholas Hanna, Sara D. Collins, Rebecca Torguson, Michael A. Gaglia Jr,Zhenyi Xue, William O. Suddath, Nelson Bernardo, Kenneth M. Kent, LowellF. Satler, Augusto D. Pichard, Joseph Lindsay, Ron WaksmanWashington Hospital Center, Washington, DC, USA

Background: Previous data suggests that patients presenting with acutecoronary syndrome (ACS) who are on chronic clopidogrel have a poorprognosis possibly due to low response to clopidogrel. This study aimed toevaluate whether there is additional benefit for reloading with clopidogrel onpatients with unstable angina who are already on chronic clopidogrel therapy.Methods: A cohort of 1499 patients on chronic clopidogrel therapy(N30 days) who presented with ACS without elevation of cardiac biomarkerswere identified and were followed clinically till hospital discharge. Of these,952 patients were reloaded and 547 patients were not reloaded and continuedwith chronic clopidogrel treatment of 75 mg/day. Clinical events wererecorded and compared between the two groups. Patients with acutemyocardial infarction (MI) were excluded. The decision to reload as well astiming and dosage of the reload was at the discretion of the operator.Results: The baseline characteristics of the groups were similar except higherhistory of coronary artery bypass graft surgery (CABG) and chronic renalinsufficiency in the no-reload group. The no-reload group had higher usage ofunfractionated heparin. Overall angiographic success was lower in the no-reloadgroup, which also experienced higher bleeding rates and longer hospital stays.The in-hospital stent thrombosis rates and the major in-hospital complications(death, Q-wave MI, and CABG) rates were similar in both groups.Conclusions: Patients on chronic clopidogrel therapy who present withunstable angina have similar in-hospital outcomes regardless of clopidogrelreloading. Clopidogrel reloading, although safe, does not impact on clinicalevents and is not required in patients presenting with unstable angina whoare already on chronic clopidogrel therapy.

Special Feature / Cardiovascular Reva

Baseline characteristics(n=1499)

No reload(n=547)

Reload (n=952) P value

Previous renal insufficiency

106/546 (19.4%) 115/948 (12.1%) b.001 Previous CABG 216/544 (39.7%) 317/947 (33.5%) .016 Average duration of

chronic clopidogreltherapy (months)

7.33±11.63

6.93±11.38 .656

Procedural characteristics(lesions=2452)

No reload(lesions=879)

Reload(lesions=1573)

P value

Length of hospitalstay (days)

2.54±2.72

2.22±2.44 .021

Bivalirudin

440/547 (80.4%) 819/952 (86.0%) .004 Unfractionated heparin 75/547 (13.7%) 81/952 (8.5%) .001 Angiographic success 839/870 (96.4%) 1543/1570 (98.3%) .004 DES use 497/861 (57.7%) 1088/1567 (69.4%) b.001 In-hospital outcomes Major in-hospital

complications (death,QWMI, CABG)

2/547 (0.4%)

3/952 (0.3%) 1.000

Major bleeding(GI bleeding,Hct drop N15,hematoma N4 cm)

15/546 (2.7%)

6/952 (0.6%) b.001

Minor bleeding(Hct drop 10–15)

5/542 (0.9%)

17/935 (1.79%) .176

Subacute stent thrombosis

0 0 –

doi:10.1016/j.carrev.2010.03.060

Complex coronary intervention

Deleterious impact of diabetes mellitus on early and mid-term resultsafter stent implantation in left main coronary diseaseJosé F Díaz a, Carlos Sanchez-Gonzaleza, Juan C. Fernandez-Guerrerob,Manuel Jimenez c, Rosa Cardenala, Juan Herradorb, Jose M. Hernandezc,Ana Serradora, Manuel Guzmanb, Juan Alonso c

aJuan Ramon Jimenez Hospital, Huelva, SpainbHospital General de Jaen, Jaen, SpaincHospital Virgen de la Victoria, Malaga, Spain

Background: Diabetes mellitus (DM) plays a major role in the developmentand progression of coronary artery disease and negatively impacts clinicaloutcome in patients undergoing revascularization. Drug-eluting stents (DES)significantly reduce restenosis when compared with bare metal stents. Evenso,most of the series published showa less favorable clinical and angiographicoutcome in diabetics. However, little is known about the outcome of diabeticsundergoing percutaneous coronary intervention (PCI) to treat left maincoronary artery (LMCA) disease. Thus, the aim of our study was to assess theinfluence of diabetes on short- and mid-term outcome of patients undergoingcoronary angioplasty and stent implantation for left main disease.Methods: A total of 334 consecutive patients from three tertiary hospitals whounderwent PCI for de novo lesions in a left main coronary artery, 141 (42.3%)diabetic and 193 (57.7%) nondiabetic, were identified retrospectively andanalyzed.Results: Female gender (29.8% vs. 19.7%, Pb.001), peripheral vasculardisease (29.2% vs. 12.6%, Pb.001), left ventricular ejection fraction (LVEF)(28.5% vs. 17.8%, P=.028), and a high-risk EuroSCORE (63.5% vs. 62.4%,P=.046) were more common in the diabetic group. Both groups did not differsignificantly in the presence of multivessel disease (89.3% vs. 87%, P=NS),DES use (85% vs. 83.8%, P=NS), or completeness of revascularization(46.9% vs. 53.9%, P=NS). In-hospital mortality was low and similar in bothgroups (3.1% vs. 2.1%, P=NS). In a medium follow-up of 22.4 months,cardiac death was higher in the diabetic group (16.2% vs. 7.5%, P=.015),especially in the insulin-dependent subgroup (25.8%). Target lesionrevascularization (6.2% vs. 7.4%, P=NS) and nonfatal myocardial infarction(2.3% vs. 3.2%) were not different between groups, same as total majoradverse cardiac events (23.8% vs. 18.3%, P=NS).Conclusions: Our study shows that diabetic patients who undergo PCIand stent implantation for left main disease present with a worse clinicalprofile that carries along a higher cardiac mortality rate in the medium-term follow-up. Anyhow, our results prove this type of procedure is safeand shows acceptable results in the medium-term follow-up.

doi:10.1016/j.carrev.2010.03.061

Allograft vasculopathy: a 23-year retrospective analysis from theLarge Lifelink Transplant RegistryHammad Khana, Louis Carnendranb, Katheryne Downes a,Catherine Hall a, Mark W. Westonb, Debbie Rinde-Hoffmanb

aUSF College of Medicine, Tampa, FL, USAbLifeLink Foundation, Tampa, FL, USA

Background: Coronary allograft vasculopathy (CAV) is a major cause ofmortality in heart transplantation. Immunosuppressants, coronary riskfactors, and statins may influence its pathogenesis. There are conflictingreports regarding the benefits of drug-eluting stents (DES) over bare metalstents (BMS) in CAV.Methods: We retrospectively analyzed a large, single-center (Lifelink)transplant registry for CAV patients undergoing percutaneous coronaryintervention (PCI) and evaluated different clinical, percutaneous revascu-larization, and outcome variables including time trends.Results: Out of 849 patients who underwent angiography during 1984–2007,78 received PCI (prevalence of obstructive CAV=9.2%) with a mean follow-upof 91.3±68.2months. Eighty-eight percent weremaleswithmean age of 49.7±11years; 84% Caucasians, 70% hypertensives, 70% had dyslipidemia, 38%

210 Special Feature / Cardiovascular Revascula

smokers, 31% diabetics, 54% had pretransplant coronary disease, and 46% hadprior transplant rejection. Ninety-one percent were asymptomatic, 9% had acutecoronary syndrome, 94% were on aspirin, 33% on plavix, 53% on statins, 57%on cyclosporine, 50% on prednisone, 47% on azathioprine, 39% onmycophenolate, 33% on tacrolimus, and 14% on sirolimus. Sixty-eight percentreceived stents (78% DES) and 31.5% plain angioplasty. We observed anincrease in the use of stents, DES, plavix, statins, tacrolimus, and sirolimus, but adecrease in cyclosporine, mycophenolate, azathioprine, and steroids use during1984–2007 (P=NS). Follow-up mortality was 5.9%; nonfatal myocardialinfarction, 6.8%; heart failure, 17%; and coronary bypass surgery, 8%. Repeatculprit vessel PCI was 80%; however, repeat target lesion revascularization(TLR) alone was 37%. There were no significant differences between BMS andDES patients except for a low incidence of repeat culprit vessel PCI in DES(35%) compared to BMS (62%) and angioplasty (60.9%) (P=.128).Conclusions: DES use in CAV showed high procedural success and less repeatTLR. Our findings did not reach statistical significance due to small patientnumber. Large randomized studies are needed to confirmDES efficacy in CAV.

doi:10.1016/j.carrev.2010.03.062

RnCarlos CalderasInstituto de Clinicas Urologia Tamanaco, Caracas, Venezuela

Aims: To compare results of two low doses of paclitaxel (b10 μg) on thepolymer-free, bioabsorbable silica-coated Cobra-P coronary stent.Methods and results: Sixty arteries in 54 subjects were enrolled into thePLUS-ONE Study. COBRA-P stents with bioabsorbable coating containingeither 4 μg/18 mm (n=30) or 8 μg/18 mm (n=30) of paclitaxel were implantedin de novo coronary lesions in native coronary arteries. Visual reference vesseldiameter was≥3.0 and≤3.75 and lesions up to 20mm. The primary end pointwas major adverse cardiac events (MACE) at 4 months defined as cardiacdeath, myocardial infarction (MI) (Q wave and non-Q wave), and ischemia-driven target lesion revascularization (TLR). Secondary end points includedMACE at 30 days and 4 months in-stent and in-segment angiographic late loss(millimeters) by quantitative coronary angiography (QCA). Reference vesseldiameter (RVD)was similar in both groups: 2.58 and 2.57mm. Late lumen losswas similar in both groups: 0.36 (±0.30) mm and 0.34 (±0.27) mm. Volumeobstruction by IVUS at 4 months' follow-up was 13.5% (±9.5) and 10.9%(±7.8). In-stent binary restenosis by QCA at 4 months was 7.1% vs. 0%; in-segment binary restenosis was 10.7% vs. 0%. One MACE (TLR: 3.3%; 1/30)occurred in the low-dose arm for ischemia-driven TLR and one TLR occurredfor non-ischemia-driven operator-perceived binary restenosis (TLR: 3.3%; 1/30) in the high-dose arm resulting in a total of two TLRs (3.3%; 2/60 lesions) inthe study. MACE rate remained unchanged at the 1-year follow-up.Conclusion: Based on the results of this FIM, there were no observeddifferences between the two groups in the PLUS-One Study, thusdemonstrating that low doses of paclitaxel with the Cobra-P stent withbioabsorbable coating are safe and feasible resulting in 4-month MACE rate,in-stent, and in-segment late loss results similar to studies of PES usinghigher doses of paclitaxel having nonbioabsorbable coatings. Confirmationof these FIM results with longer term follow-up is required to confirmcomparable results to the conventional TAXUS system.

Low dose

High dose TAXUS IV

Angiography results at 4 months

In-stent RVD 2.82±0.64 2.61±0.39 2.75±0.46 In-stent minimum lumen diameter 2.24±0.43 2.20±0.39 2.26±0.58 In-stent % diameter stenosis 18.8±15.5 15.6±10.2 17.4±17.7 In-stent late loss 0.36±0.30 0.34±0.27 0.39±0.50 IVUS results at 4 months % Neointimal obstruction 13.5±9.5 10.9±7.8 12.2±12.4

doi:10.1016/j.carrev.2010.03.063

Effectiveness of a new microbial sealant in reducing bacteremia,

puncture site, and sheath contamination after percutaneousinterventions: a single-center randomized studyDimitrios Nikas a, Lamprini Kasselouria, Amalia Kallinterib,Aris Mpechlioulis c, Eugenia Pappaa, Euaggelos Kountourisa,Konstantinos SiogasaaCardiology Department, Ioannina Public Hospital, Ioannina, GreecebMicrobiology Laboratory, Ioannina University Hospital, Ioannina, GreececMichailideion Cardiac Center, Ioannina Medical School, Ioannina, Greece

Aim: To evaluate the effectiveness of the new film-forming cyanoacrylateliquid microbial sealant InteguSEAL⁎ (Kimberly-Clark) to reduce local skinbacteria contamination and bacteremia after percutaneous interventions (PI).Methods: Sixty-three consecutive patients who underwent PI wererandomized using a 1:1 allocation to receive either a standard skinpreparation and application of InteguSEAL [31 patients (49.2%), Group A]or standard skin preparation [32 patients (51.8%), Group B]. All patientsunderwent puncture site skin flora cultures: immediately before and afterskin preparation, prior to intervention conclusion (acute skin contamination),and 24–48 h postprocedure [late skin contamination (LSC)]. Blood cultureswere taken upon procedure conclusion and prior to sheath removal in orderto identify rates of acute bacteremia (AB). In patients with sheath removalN6 h, postprocedure blood cultures were taken prior to late sheath removal[late bacteremia (LB)], while the tip of the sheath was sent for microbialculture in order to identify late sheath contamination (LShC). All patientswere followed up for 48 h and at 30 days postprocedure for the occurrence ofclinical and laboratory signs of local or systemic infections.Results: None of the patients developed clinical or laboratory signs ofinfection up to 30 days of follow-up. Patients in Group A had fewer rates ofLSC [3 patients (9.7%) for Group A vs. 12 (37.5%) for Group B, P=.017).AB was identified in 3 patients (4.7%): 2 (6.5%) in Group A and 1 (3.1%) inGroup B (P=NS). LB was identified in 1 patient (3.1%) in Group B and none(0.0%) in Group A (P=NS). Eight patients (50%) had LShC: 2 (6.5%) inGroup A and 6 (18.7%) in Group B (P=NS). In all cultures, Staphylococcusaureus was identified as the predominant bacterium.Conclusion: PI procedures cause low but not negligible rates of acute and latebacteremia. Presence of sheath for N6 h is associated with high rates of sheathcontamination. The microbial sealant InteguSEAL⁎ (Kimberly-Clark) reducessignificantly the rates of LSC without reducing the rates of AB and LB.

doi:10.1016/j.carrev.2010.03.064

Transradial percutaneous coronary interventions: single-center15-year experienceMohamed Loutfia, Antoine Saugetb, Jean FajadetbaCardiology Department, Faculty of Medicine, Alexandria, EgyptbClinique Pasteur, Toulouse, France

Background: Percutaneous coronary intervention (PCI) via transradialapproach (TRA) has emerged as an alternative and competitive methodcompared with transfemoral approach (TFA) for PCI in simple to complexcoronary disease. TRA is safe and is associated with a reduced rate of accesssite or bleeding complications.Methods: From February 1994 to October 2009, TRA has been attempted in19,151 consecutive procedures (64.4%) of total 29,734 PCI. We report ourexperience using the transradial approach for more than 19,000 interven-tional procedures, its feasibility, safety, and outcome.Results: The transradial approach represented 30% of cases in 1994, 73%in 1999, 66% in 2004, and 74.1% during the current year. Over the last5 years, TRA was used to perform increasingly complex procedures: 88.2%of bifurcation lesion, 82.2% of multivessel, 73.4% of unprotected left main,68.2% of saphenous vein graft PCI. In 297 (2.45%) of these cases,angioplasty could not be performed via the radial route whether due toinability to cannulate the coronary ostium in 1.15% or to advance the

rization Medicine 11 (2010) 199–215