Mid-term outcomes of the Absorb BVS versus second-generation DES: A systematic review and meta-analysis

Cordula M Felix; Victor J van den Berg; Sanne E Hoeks; Jiang Ming Fam; Mattie Lenzen; Eric Boersma; Peter C Smits; Patrick W Serruys; Yoshinobu Onuma; Robert Jan M van Geuns

doi:10.1371/journal.pone.0197119

Mid-term outcomes of the Absorb BVS versus second-generation DES: A systematic review and meta-analysis

PLoS One. 2018 May 9;13(5):e0197119. doi: 10.1371/journal.pone.0197119. eCollection 2018.

Authors

Affiliations

¹ Thorax centre, Erasmus Medical Centre, Rotterdam, the Netherlands.
² Cardiology department, National Heart Centre Singapore, Singapore.
³ Cardiology department, Maasstad Hospital, Rotterdam, the Netherlands.
⁴ Cardiology department, The National Heart and Lung Institute, Imperial College London, London, United Kingdom.
⁵ Cardiology department, Radboud UMC, Nijmegen, the Netherlands.

Abstract

Background: Bioresorbable Vascular Scaffolds (BVS) were introduced to overcome some of the limitations of drug-eluting stent (DES) for PCI. Data regarding the clinical outcomes of the BVS versus DES beyond 2 years are emerging.

Objective: To study mid-term outcomes.

Methods: We searched online databases (PubMed/Medline, Embase, CENTRAL), several websites, meeting presentations and scientific session abstracts until August 8th, 2017 for studies comparing Absorb BVS with second-generation DES. The primary outcome was target lesion failure (TLF). Secondary outcomes were all-cause mortality, myocardial infarction, target lesion revascularization (TLR) and definite/probable device thrombosis. Odds ratios (ORs) with 95% confidence intervals (CIs) were derived using a random effects model.

Results: Ten studies, seven randomized controlled trials and three propensity-matched observational studies, with a total of 7320 patients (BVS n = 4007; DES n = 3313) and a median follow-up duration of 30.5 months, were included. Risk of TLF was increased for BVS-treated patients (OR 1.34 [95% CI: 1.12-1.60], p = 0.001, I2 = 0%). This was also the case for all myocardial infarction (1.58 [95% CI: 1.27-1.96], p<0.001, I2 = 0%), TLR (1.48 [95% CI: 1.19-1.85], p<0.001, I2 = 0%) and definite/probable device thrombosis (of 2.82 (95% CI: 1.86-3.89], p<0.001 and I2 = 40.3%). This did not result in a difference in all-cause mortality (0.78 [95% CI: 0.58-1.04], p = 0.09, I2 = 0%). OR for very late (>1 year) device thrombosis was 6.10 [95% CI: 1.40-26.65], p = 0.02).

Conclusion: At mid-term follow-up, BVS was associated with an increased risk of TLF, MI, TLR and definite/probable device thrombosis, but this did not result in an increased risk of all-cause mortality.

Publication types

Meta-Analysis
Research Support, Non-U.S. Gov't
Review
Systematic Review

MeSH terms

Absorbable Implants / adverse effects
Coronary Thrombosis / drug therapy*
Coronary Thrombosis / pathology
Drug-Eluting Stents*
Everolimus / therapeutic use
Humans
Myocardial Infarction / drug therapy*
Myocardial Infarction / pathology
Percutaneous Coronary Intervention
Risk Factors
Tissue Scaffolds*
Treatment Outcome

Substances

Everolimus

Grants and funding

Prof. Patrick Serruys is member of the international advisory board of Abbott. Prof. Robert Jan van Geuns and Yoshinobu Onuma received research grants and speakers fee from Abbott. Peter Smits received fee from Abbott. All other authors have no conflicts of interest to declare. Funding for local registries was obtained by the Erasmus MC from Abbott Vascular. The funders had no role in this study design, data collection and analysis, decision to publish, or preparation of the manuscript.