A Comprehensive Meta-Analysis of Bioadaptor Versus Drug-Eluting Stents in Randomised Trials With Exploratory Single-Arm Landmark Analyses.
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.
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.
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.
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.
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.
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.
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.
Authors
Wölbert Wölbert, Kühne Kühne, Patrignani Patrignani, Chiarito Chiarito, von Scheidt von Scheidt, Torzewski Torzewski, Raake Raake, Bongiovanni Bongiovanni
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