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Published on: August 12, 2014
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.
Background:
Late adverse events after percutaneous coronary intervention continue to occur beyond the first year with last-generation drug-eluting stents (DES). The coronary bioadaptor marks a new approach with an uncaging beginning at approximately 6 months after implantation. We conducted a pairwise meta-analysis of bioadaptor versus DES in randomised trials with complementary single-arm 6-12 and 6-24 landmark analyses.
Methods:
The systematic review and meta-analysis was conducted according to PRISMA 2020 Guidelines. PubMed, Embase, CENTRAL and Google Scholar were searched for studies reporting clinical outcomes after bioadaptor implantation. The primary outcome was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularisation at 1 year. Secondary outcomes were TLF and individual components at landmark intervals 6-12 and 6-24 months. Single-arm pooled event rates and pairwise comparisons were estimated using generalised linear mixed-effects models.
Results:
Three randomised trials (n = 2892; 1448 bioadaptor, 1444 DES) were included in pairwise analyses. 1-year TLF showed no significant difference between bioadaptor and DES (OR 0.81, 95% CI 0.51-1.31, I2 = 0.0%, p = 0.3943). Likewise, individual components of TLF and device thrombosis did not differ between groups. Ten studies (1753 patients; 1900 lesions) were included in single-arm analyses. Landmark TLF was 0.57% (95% CI 0.07-4.29; I2 = 4.6%) from 6 to 12 months and 2.01% (95% CI 0.81-4.92; I2 = 74.2%) from 6 to 24 months. Event rates for other endpoints were generally low.
Conclusions:
No significant differences in safety and efficacy outcomes were observed between bioadaptor and DES. Complementary single-arm landmark analyses suggested low late event rates, but these findings should be interpreted as exploratory. Further randomised trials are warranted.
