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A Comprehensive Meta-Analysis of Bioadaptor Versus Drug-Eluting Stents in Randomised Trials With Exploratory
Simon Wölbert1, Stephanie Kühne1, Andrea Patrignani2,3
1Department of Internal Medicine I, Cardiology, University Hospital Augsburg, University of Augsburg, Augsburg, Germany.
European Journal of Clinical Investigation
|May 6, 2026
Summary
This study found no significant differences in safety or efficacy between coronary bioadaptors and drug-eluting stents (DES) in percutaneous coronary intervention. Late adverse event rates were low for bioadaptors, suggesting potential for future research.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Late adverse events persist beyond one year with current drug-eluting stents (DES).
- Coronary bioadaptors offer a novel approach with delayed uncaging around six months post-implantation.
- This study evaluates bioadaptors against DES using meta-analysis and landmark analyses.
Purpose of the Study:
- To compare the safety and efficacy of coronary bioadaptors versus last-generation DES.
- To assess target-lesion failure (TLF) at one year and landmark intervals (6-12, 6-24 months).
- To analyze late adverse event rates using single-arm and pairwise meta-analyses.
Main Methods:
- Systematic review and meta-analysis adhering to PRISMA 2020 guidelines.
- Searched PubMed, Embase, CENTRAL, and Google Scholar for relevant randomized trials.
- Employed generalized linear mixed-effects models for pooled event rates and pairwise comparisons.
Main Results:
- Pairwise meta-analysis of three trials (n=2892) showed no significant difference in 1-year TLF between bioadaptors and DES (OR 0.81, p=0.3943).
- No significant differences were found in individual TLF components or device thrombosis.
- Single-arm landmark analyses indicated low event rates from 6-12 months (0.57%) and 6-24 months (2.01%).
Conclusions:
- Coronary bioadaptors demonstrate comparable safety and efficacy to DES.
- Exploratory landmark analyses suggest low late event rates for bioadaptors.
- Further randomized trials are recommended to confirm these findings.
