Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice – results from the European Absorb Consortium

Wiebe J, Hofmann FJ, West N, Baumbach A, Carrie D, Bermudez EP, Cayla G, Hernandez FH, De La Torre Hernandez JM, Koning R, Loi B, Moscarella E, Tarantini G, Zaman A, Lober C, Riemer T, Achenbach S, Hamm CW, Nef HM (2021)

Publication Type: Journal article

Publication year: 2021

Journal

DOI: 10.1002/ccd.29932

Abstract

Objectives: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. Background: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. Methods: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. Results: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. Conclusions: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Authors with CRIS profile

Involved external institutions

Clínica Universidad de Navarra Spain (ES) Hospital Clínico Universitario Virgen de la Arrixaca Spain (ES) Brotzu Hospital Italy (IT) Clinique Saint-Hilaire France (FR) Justus-Liebig-Universität Gießen Germany (DE) Queen Mary, University of London United Kingdom (GB) University of Montpellier / Université Montpellier France (FR) IHF GmbH Institut für Herzinfarktforschung Germany (DE) Università degli studi della Campania Luigi Vanvitelli Italy (IT) Newcastle University United Kingdom (GB) Marqués de Valdecilla University Hospital / Hospital Universitario de Marqués de Valdecilla (HUMV) Spain (ES) University of Padua / Universita degli Studi di Padova Italy (IT) Royal Papworth Hospital NHS Foundation Trust United Kingdom (GB) Université Toulouse III - Paul Sabatier France (FR) Deutsches Herzzentrum München Germany (DE)

How to cite

APA:

Wiebe, J., Hofmann, F.J., West, N., Baumbach, A., Carrie, D., Bermudez, E.P.,... Nef, H.M. (2021). Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice – results from the European Absorb Consortium. Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.29932

MLA:

Wiebe, Jens, et al. "Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice – results from the European Absorb Consortium." Catheterization and Cardiovascular Interventions (2021).

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