Bioadaptor versus contemporary drug-eluting stents: Meta-analysis of randomized controlled trials
O Kumet, F Saylik, R SarikayaAbstract
Background
Permanent metallic drug-eluting stents (DES) provide effective coronary scaffolding but may impair long-term vessel physiology due to chronic metallic caging. Bioadaptor technology has been developed to allow early mechanical support followed by adaptive vessel restoration. We performed a meta-analysis of randomized controlled trials (RCTs) comparing bioadaptor devices with contemporary DES in patients undergoing PCI.
Methods
A systematic meta-analysis of RCTs comparing bioadaptor versus DES was conducted. The primary endpoints were target lesion failure (TLF) and target vessel failure (TVF). Secondary endpoints included target lesion revascularization (TLR), myocardial infarction (MI), cardiovascular death, all-cause death, and definite/probable device or stent thrombosis. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a random-effects model. Heterogeneity was assessed using the I² statistic. Risk of bias was evaluated using the Cochrane RoB 2 tool.
Results
Three randomized controlled trials with a total of 2886 patients were included. Overall risk of bias was low in the large multicenter RCTs, with some concerns in the small mechanistic trial. Bioadaptor was associated with a numerically lower risk of target lesion failure (RR 0.70, 95% CI 0.40–1.20; I²=9.8%) and target vessel failure (RR 0.59, 95% CI 0.23–1.53; I²=64.2%) compared with DES; however, these differences did not reach statistical significance.Target lesion revascularization showed a favorable trend (RR 0.57, 95% CI 0.31–1.03; I²=0%). There were no significant differences in target-vessel myocardial infarction (RR 0.78, 95% CI 0.41–1.46; I²=0%) or any myocardial infarction (RR 1.32, 95% CI 0.79–2.22; I²=0%). Cardiovascular death (RR 0.54, 95% CI 0.06–4.66; I²=54%) and all-cause death (RR 1.36, 95% CI 0.72–2.56; I²=0%) were similar between groups. Definite or probable device/stent thrombosis was not increased with bioadaptor (RR 1.16, 95% CI 0.43–3.16; I²=0%).
Conclusion
In randomized evidence, bioadaptor technology demonstrates similar safety and efficacy profiles compared with contemporary DES. Although statistical significance was not reached, consistent numerical trends toward reduced lesion-related events were observed without an increased risk of thrombosis. Larger trials with extended follow-up are warranted to determine whether adaptive vessel restoration translates into meaningful long-term clinical benefit.Risk of biasFor image description, please refer to the figure legend and surrounding text.Random-Effects Meta-AnalysisFor image description, please refer to the figure legend and surrounding text.