BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

2nd Department of Cardiology Jagiellonian University Medical College Krakow Poland

3rd Faculty of Medicine Charles University and University Hospital Královske Vinohrady Prague Czech Republic

Amsterdam UMC University of Amsterdam Amsterdam the Netherlands

Cardiology Department Maasstad Hospital Rotterdam the Netherlands

Cardiovascular Research Center OLV Hospital Aalst Belgium

Center of Cardiology Cardiology 1 University Medical Center of the Johannes Gutenberg University Mainz and DZHK Standort Rhein Main Mainz Germany

Department of Cardiology Hospital and University Fribourg Switzerland

Department of Cardiology Universitätsklinikum Erlangen Erlangen Germany

Department of Interventional Cardiology Royal Papworth Hospital UK

Hospital Clinico San Carlos IDISSC Complutense University Madrid Spain

Interventional Cardiology Unit Department of Cardiac Thoracic and Vascular Sciences University of Padua Italy

Ramsay Générale de Santé Hopital Privé Jacques Cartier Massy France

Ramsay Générale de Santé ICPS Hôpital Jacques Cartier Massy France

Thoraxcenter Erasmus University Medical Center Rotterdam the Netherlands; Cardialysis Clinical Trials Management and Core Laboratories Rotterdam the Netherlands

Thoraxcenter Erasmus University Medical Center Rotterdam the Netherlands; Cardiology Department Radboud UMC Nijmegen the Netherlands

Thoraxcenter Erasmus University Medical Center Rotterdam the Netherlands; Division of Cardiology Department of Medicine Taipei Veterans General Hospital Taiwan

Citace poskytuje Crossref.org

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ClinicalTrials.gov
NCT02486068