Five-Year Outcomes With Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute Coronary Syndrome: A Subgroup Analysis of the BIOSCIENCE Trial
Iglesias JF., Heg D., Roffi M., Degrauwe S., Tüller D., Muller O., Brinkert M., Cook S., Weilenmann D., Kaiser C., Cuculi F., Valgimigli M., Jüni P., Windecker S., Pilgrim T.
Background: Thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain. Methods: We performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years. Results: Among 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57–0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78–1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect. Conclusions: In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.