Pieter C. Smits1, MD, PhD; Chun Chin Chang2,3, MD; Bernard Chevalier4, MD; Nick E.J. West5, MD; Tommaso Gori6, MD, PhD; Emanuele Barbato7,8, MD, PhD; Giuseppe Tarantini9, MD, PhD; Viktor Kocka10, MD, PhD; Stephan Achenbach11, MD, PhD; Dariusz Dudek12, MD, PhD; Javier Escaned13, MD, PhD; Adrian Wlodarczak14, MD; Mohamed Abdel-Wahab15,16, MD; Giovanni Esposito17, MD, PhD; Jan G.P. Tijssen18, PhD; Marie-Claude Morice19, MD; Yoshinobu Onuma2,20, MD, PhD; Robert-Jan M. van Geuns2,21; COMPARE-ABSORB trial investigators
1. Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands; 2. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 3. Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; 4. Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France; 5. Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom; 6. Center of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, and DZHK Standort Rhein-Main, Mainz, Germany; 7. Cardiovascular Research Center OLV Hospital, Aalst, Belgium; 8. Department of Advanced Biomedical Science, University Federico II, Naples, Italy; 9. Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy; 10. Cardiocenter, Third Faculty of Medicine, University Hospital Kralovske Vinohrady, Charles University, Prague, Czech Republic; 11. Department of Cardiology, Universitätsklinikum Erlangen, Erlangen, Germany; 12. 2nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 13. Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain; 14. Department of Cardiology, Miedziowe Centrum Zdrowia, Lubin, Poland; 15. Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany; 16. Heart Center Leipzig at the University of Leipzig, Leipzig, Germany; 17. Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli “Federico II”, Naples, Italy; 18. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 19. Cardiovascular European Research Center, Massy, France; 20. Cardialysis B.V., Rotterdam, the Netherlands; 21. Department of Cardiology, Radboud UMC, Nijmegen, the Netherlands
Aims: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS).
Methods and results: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: −1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group.
Conclusions: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.