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1-Year Clinical Data: Treatment of Long Lesions (>20mm)

This study presents the 1-year clinical data of the treatment of long lesions (>20mm) using biolimus-eluting and everolimus-eluting stents. The study confirms the safety and efficacy of both stents for treating long lesions in coronary arteries.

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1-Year Clinical Data: Treatment of Long Lesions (>20mm)

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  1. Pieter Cornelis Smits On behalf of all principal COMPARE II investigators: 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 COMPARE II trial:1-Year Clinical Data of the Treatment of Long Lesions (>20 mm)

  2. Potential conflicts of interest Speaker’s name: Pieter Cornelis Smits  I have the following potential conflicts of interest to report:  Research contracts: Boston Scientific, Abbott Vascular, Terumo  Consulting: Blue Medical  Employment in industry; none  Stockholder of a healthcare company; none  Owner of a healthcare company; none  Other(s): travel and speaking fees from Abbott Vascular

  3. 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: NCT01233453

  4. COMPARE II trial Primary endpoint 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 Endpoints 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.

  5. COMPARE II trialLong Lesion Subgroup BACKGROUND AND AIM Treatment of long lesions (LL) remains a challenge in interventional cardiology, with a high propensity to restenosis. Our aim was to evaluate the clinical outcomes of the patients with long lesions treated with the Nobori biolimus eluting stent (BES) versus patients treated with Xience/Promus everolimus eluting stent (EES) in a real world / all-comer situation as a substudy of the COMPARE II trial.

  6. COMPARE II trial COMPARATORS Xience / Promus Everolimus 1.0 µg/mm2 Vision multilinkTM Fluoropolymer Nobori Biolimus 15,6 µg/mm Poly-lactic acid S-StentTM

  7. COMPARE II trialLong Lesion Subgroup Methodology Total Population: 2.707 patients Randomization 2 : 1 Non Inferiority Design DAPT up to 12 months 12 sites PI: Dr. P. Smits BES n = 1795 EES n = 912 Patients with Long Lesions (>20 mm) treated EES (LL) n =224 BES (LL) n = 403 Clinical Follow-up 0d 30d 3yr 5yr 12mo Primary endpoint at 12 months: Composite ofcardiac death, non-fatal myocardial Infarction and clinically indicated target vessel revascularization

  8. COMPARE II trialLong Lesion Subgroup Baseline Characteristics

  9. COMPARE II trialLong Lesion Subgroup Baseline Characteristics

  10. COMPARE II trialLong Lesion Subgroup Baseline Characteristics

  11. COMPARE II trialLong Lesion Subgroup Lesion Characteristics

  12. COMPARE II trialLong Lesion Subgroup Type A Type B1 Type B2 Type C Lesion Characteristics BES EES P=NS B2/C: 77.2% B2/C: 75.3%

  13. COMPARE II trialLong Lesion Subgroup Primary Endpoint Cardiac Death, MI, Clinically Indicated TVR P = NS

  14. COMPARE II trialLong Lesion Subgroup Secondary Endpoint Cardiac Death, MI, Clinically Indicated TLR P = NS

  15. COMPARE II trialLong Lesion Subgroup Stent Thrombosis (ARC) P = NS Definite/Probable ST, ARC

  16. COMPARE II trialLong Lesion Subgroup Conclusions • Despite high complexity of lesions in the LL subgroup, good clinical outcomes and a low rate of revascularization were observed at 12 months post-procedure with both types of DES. • Stent thrombosis was relatively low despite multiple overlapping stents. Our findings confirm the safety and efficacy of both BES and EES for treatment of patients with LL in coronary arteries.

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