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5. Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE- ABSORB randomised clinical trial

Author

Yoshinobu Onuma, Robert-Jan van Geuns, Nick E.J. West, Giovanni Esposito, Adrian Wlodarczak, Giuseppe Tarantini, Tommaso Gori, Dariusz Dudek, Bernard Chevalier, Stephan Achenbach, Javier Escaned, Jan G.P. Tijssen, Marie-Claude Morice, Mohamed Abdel-Wahab, Emanuele Barbato, Chun Chin Chang, Viktor Kočka, Pieter C. Smits, Cardiology, Amsterdam Cardiovascular Sciences, ACS - Heart failure & arrhythmias, Smits, P. C., Chang, C. C., Chevalier, B., West, N. E. J., Gori, T., Barbato, E., Tarantin, G., Kocka, V., Achenbach, S., Dudek, D., Escaned, J., Wlodarczak, A., Abdel-Wahab, M., Esposito, G., Tijssen, J. G. P., Morice, M. -C., Onuma, Y., and Van Geuns, R. J.

Subjects
Bioresorbable scaffold, medicine.medical_specialty, Stent thrombosi, Stent thrombosis, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Prosthesis Design, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Percutaneous Coronary Intervention, Restenosis, Tissue Scaffold, Absorbable Implant, Internal medicine, Absorbable Implants, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, Myocardial infarction, Prospective Studies, Prospective cohort study, Tissue Scaffolds, business.industry, Hazard ratio, Stent, Drug-Eluting Stents, medicine.disease, Thrombosis, Prospective Studie, Treatment Outcome, Drug-eluting stent, Cardiology, Cardiology and Cardiovascular Medicine, business, Human
Abstract

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

Published
2020

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