The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent in Patients at High Risk of Restenosis: The COMPARE-ABSORB Randomized Clinical Trial

DOI: 10.4244/EIJ-D-19-01079

1. Department of Cardiology, Maastad Hospital, Rotterdam, the Netherlands, Netherlands
2. Thoraxcenter, Erasmus University Medical Center, the Netherlands. Division of cardiology, department of medicine, Taipei Veterans General Hospital, Taipei, Taiwan
3. Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France
4. Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, UK
5. Center of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz and DZHK Standort Rhein-Main, Mainz, Germany
6. Cardiovascular Research Center OLV Hospital, Aalst, Belgium & Department of Advanced Biomedical Science, University Federico II, Naples, Italy
7. Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
8. Cardiocenter, Third Faculty of Medicine, University Hospital Kralovske Vinohrady, Charles University, Prague, Czech Republic
9. Department of Cardiology, Universitätsklinikum Erlangen, Erlangen, Germany
10. 2nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
11. Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain
12. Department of Cardiology, Miedziowe Centrum Zdrowia, Lubin, Poland
13. Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. Heart Center Leipzig at the University of Leipzig, Leipzig, Germany
14. Cattedra di Cardiologia, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli “Federico II”, Napoli, Italy
15. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
16. Cardiovascular European Research Center, Massy, France
17. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Cardialysis B.V., Rotterdam, Netherlands
18. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Department of Cardiology, Radboud UMC, Nijmegen, the Netherlands

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Aims:The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS). 

Methods and results: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomized study. Patients at high risk of restenosis were randomly assigned to receive either BVS or 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 revascularization at 1 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 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than 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 1 year. BVS carried a higher risk of device thrombosis and TVMI than EES.

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