A Meta-Analysis of Randomized Controlled Trials: Newer generation Ultra-thin strut Sirolimus-Eluting Stents Versus Second-generation Everolimus-Eluting Stents for Coronary Artery Disease

Background: Newer-generation ultra-thin strut sirolimus-eluting stents (SES) improve clinical outcomes compared with second-generation everolimus-eluting stents (EES). Randomized controlled trials have shown that variations in stent strut thickness correlate with clinical outcomes. This study aimed to perform an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing clinical outcomes between ultrathin-strut and conventional second-generation EES in the treatment of coronary artery disease. Methods: We pooled individual participant data from 10 randomized clinical trials including 10,328 patients, comparing newer-generation ultrathin strut SES (defined as strut thickness <70 µm) versus thicker strut EES. A one-stage meta-analysis was conducted using a comprehensive meta-analysis software. The prespecified primary outcomes included target lesion failure (TLF), target vessel failure (TVF), myocardial infarction (MI), stent thrombosis (ST), cardiac death, repeat revascularization, cardiac death, and all-cause mortality (including cardiac and non-cardiac death). Results: Ten randomized controlled trials from various regions met the inclusion criteria and contributed individual participant-level data, totalling 10,328 patients. The ultrathin-strut SES evaluated were MSURE-S (59μm), Orsiro (60μm), Supraflex (60μm), MiStent (64μm), and BioMime (65μm), compared against second-generation EES. The mean follow-up period was 36.6 months. The ultrathin-strut SES were associated with a lower risk of TLF and TVF compared to conventional second-generation EES [Odds Ratio 0.75 & 0.77, 95% confidence interval (CI), P=0.017 & P=0.019]. This found an insignificant difference in risk for myocardial infarction and a lower significant risk for stent thrombosis in comparison to conventional second-generation EES [Odds Ratio 1.09 & 0.69, P>0.05, P=0.05]. The ultrathin-strut SES were also associated with a lower risk for repeat revascularization and insignificant risk for mortality in comparison to conventional second-generation EES [Odds Ratio 0.75 & 0.91, 95% confidence interval (CI), P=0.018 & P=0.63]. They also showed a lower risk of cardiac death and non-cardiac death in comparison to conventional second-generation EES and were statistically non-significant [Odds Ratio 0.90 & 1.12, 95% confidence interval (CI), P=0.081 & P=0.63]. Conclusion: In the present meta-analysis of 10 trials randomizing 10,328 patients and with a mean follow-up of 3.5 years, ultrathin-strut sirolimus-eluting stents were associated with a significantly lower risk of TLF, TVF, stent thrombosis, and repeat revascularization compared with conventional second-generation everolimus-eluting stents. There was no significant difference in risks associated with myocardial infarction and mortality.