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5-Year Outcomes of BIOSCIENCE Trial
Study Questions:
What are the 5-year outcomes of the BIOSCIENCE trial comparing efficacy and safety of an ultrathin-strut, biodegradable-polymer, drug-eluting stent with those of a durable-polymer everolimus-eluting stent?
Methods:
The investigators compared biodegradable polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes using a randomized, single-blind, multicenter, noninferiority study, the BIOSCIENCE trial. They report on the final 5-year clinical outcomes of BIOSCIENCE with regard to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization. The primary analysis was done by intention to treat. Time to first event for each outcome, and numbers of patients and Kaplan-Meier estimates of cumulative incidence are reported.
Results:
A total of 2,008 (95%) of 2,119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence, 20.2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18.8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR], 1.07; 95% confidence interval [CI], 0.88–1.31; p = 0.487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14.1% vs. 10.3%; RR, 1.36; 95% CI, 1.06–1.75; p = 0.017), driven by a difference in noncardiovascular deaths. No difference between groups in cumulative incidence of definite stent thrombosis at 5 years was observed (1.6% in both groups; 1.02, 0.51–2.05; p = 0.950).
Conclusions:
The authors concluded that 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents.
Perspective:
This study reports that cumulative incidence of target lesion failure over 5 years of follow-up did not differ between patients treated with biodegradable-polymer sirolimus-eluting stents and those treated with durable-polymer everolimus-eluting stents, and there was no significant interaction between treatment effect and time. All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable polymer everolimus-eluting stents, driven by a difference in noncardiovascular death, which warrants careful observation in ongoing studies. The safety and efficacy of biodegradable-polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) is currently under investigation in the BIOSTEMI trial, and will provide additional insight of safety and efficacy of ultrathin-strut, biodegradable-polymer stents.
Keywords: ESC Congress, ESC18, Acute Coronary Syndrome, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Polymers, Sirolimus, Stents, Thrombosis
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