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Potential conflicts of interest
Speaker’s name: Sjoerd Hofma I have the following potential conflicts of interest to report: 1
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On behalf of all principal COMPARE II investigators:
COMPARE II trial: 1-Year Clinical Data for the Treatment of Small Vessels (<2.75 mm) Sjoerd Hofma On behalf of all principal COMPARE II investigators: Pieter Cornelis Smits, Ad van Boven, Jean-Jaques Goy, Peter den Heyer, Antonio Serra, Ton Slagboom, Mario Togni, Ramiro Trillo Nouche, Mariano Valdés, Andre Vuillomenet, Jose Vázquez, Vassilis Voudris 2
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Biolimus Eluring Stent (BES) Everolimus Eluting Stent (EES)
COMPARE II trial a large scale, multicenter, prospective, randomized (2:1) study, N=2707 Biolimus Eluring Stent (BES) N=1795 Everolimus Eluting Stent (EES) N=912 abluminal, biodegradable polymer biolimus-eluting stent durable polymer everolimus-eluting stent ClinicalTrials.gov Identifier: NCT
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Endpoints Primary endpoint Major secondary endpoints COMPARE II trial
Composite of cardiac death, non-fatal myocardial infarction and target vessel revascularization Major secondary endpoints Composite of cardiac death, non-fatal myocardial infarction and clinically indicated target lesion revascularization Stent thrombosis (def/prob) according to ARC Dual antiplatelet therapy was 12 months for each treatment arm The primary hypothesis was non-inferiority of BES vs EES. Data were independently monitored and adverse events were adjudicated by an independent clinical event committee.
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COMPARATORS Xience / Promus Nobori COMPARE II trial
Everolimus 1.0 µg/mm2 Fluoropolymer Vision multilinkTM Nobori Biolimus 15,6 µg/mm Poly-lactic acid S-StentTM
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COMPARE II trial Small Vessels Subgroup
BACKGROUND AND AIM Small coronary vessels (reference ø < 2.75 mm) are often associated with diabetic and female patients and remain an important challenge in interventional cardiology. We performed a pre-specified substudy on outcome in patients with small vessel treatment within the all-comer COMPARE II trial.
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Methodology BES 1282 patients EES 659 patients Small vessels
COMPARE II trial Small Vessels Subgroup Methodology Total: 2707 patients BES 1282 patients EES 659 patients Small vessels < 2.75 mm Xience/ Promus EES Nobori BES Total: 766 253 513
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Baseline Characteristics
COMPARE II trial Small Vessels Subgroup Baseline Characteristics Baseline demographics BES 513 pts EES 253 pts P-value Age (mean ± SD) 64.31 ± 10.74 63.61 ± 11.23 NS Female, % 26.5 24.9 Cardiovascular history Previous MI, % 23.4 21.1 Previous PTCA, % 18.7 19.0 Previous CABG, % 6.2 5.9 Previous stroke, % 3.9 4.4 Peripheral artery disease, % 8.6 7.1
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Baseline Characteristics
COMPARE II trial Small Vessels Subgroup Baseline Characteristics Risk Factors BES 513 pts EES 253 pts P-value Smoker, % 27.5 23.7 NS Hypertension, % 57.1 59.3 Diabetes, % 25.7 27.7 Renal Failure, % 4.1 6.1 Liver insufficiency, % 0.79 0.80 COPD, % 9.27 7.57
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COMPARE II trial Small Vessels Subgroup
Anginal Status BES EES
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Lesion Characteristics
COMPARE II trial Small Vessels Subgroup Lesion Characteristics BES (983 lesions) EES (518 lesions) p Mean ± SD Lesion length 16.35 ± 9.45 17.44 ± 9.91 0.02 Nb of lesions treated / patient 1.92 ± 0.99 2.05 ± 1.15 NS Stents / lesion 1.39 ± 0.76 1.34 ± 0.63 RVD, pre* 2.67 ± 0.41 2.66 ± 0.45 * All lesions per patient, not only lesions in small vessels
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Lesion Characteristics
COMPARE II trial Small Vessels Subgroup Lesion Characteristics BES EES P=NS Type A Type B1 Type B2 Type C
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Cardiac Death, MI, Clinically Indicated TVR
COMPARE II trial Small Vessels Subgroup Primary Endpoint Cardiac Death, MI, Clinically Indicated TVR P = NS
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Cardiac Death, MI, Clinically Indicated TLR
COMPARE II trial Small Vessels Subgroup Secondary Endpoint Cardiac Death, MI, Clinically Indicated TLR P = NS
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Stent Thrombosis (ARC)
COMPARE II trial Small Vessels Subgroup Stent Thrombosis (ARC) P = NS Definite/Probable ST, ARC
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COMPARE II trial Small Vessels Subgroup
Conclusions In an all-comer population, treatment of small coronary vessels with the Nobori, DES with biodegradable polymer, showed similar outcomes compared to the Xience/Promus DES with biocompatile, permanent polymer Both types of stent demonstrated excellent results up to 1-year follow-up Our study add further evidence about the performance of contemporary limus drug eluting stents in this challenging lesion subset
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