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Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents vs thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial

The Lancet Aug 31, 2018

Pilgrim T, et al. - Given that ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents vs thin-strut, durable-polymer, everolimus-eluting stents have shown non-inferiority or superiority in terms of 1 year safety and effectiveness outcomes in the BIOSCIENCE trial, researchers evaluated the final 5-year clinical outcomes of the BIOSCIENCE trial with regards to a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization in patients with chronic stable coronary artery disease or acute coronary syndromes. They found that, among all-comer patients undergoing percutaneous coronary intervention, implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents resulted in a similar 5-year risk of target lesion failure. They also noted that patients treated with biodegradable-polymer stents eluting sirolimus vs those treated with durable-polymer stents eluting everolimus had a higher incidence of all-cause and non-cardiovascular mortality.

Methods

  • Researchers compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes in the randomized, single-blind, multicenter, non-inferiority BIOSCIENCE trial.
  • In this study, they evaluated the final 5-year clinical outcomes of BIOSCIENCE with regards 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.
  • By intention to treat, primary analysis was performed.

Results

  • Five years of follow-up was completed by 2008 (95%) of 2,119 patients recruited between March 1, 2012 and May 31, 2013.
  • The occurrence of target lesion failure was reported 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% CI 0.88–1.31; p=0.487).
  • Patients treated with biodegradable-polymer sirolimus-eluting stents vs those treated with durable-polymer everolimus-eluting stents had significantly higher all-cause mortality (14.1% vs 10.3%; RR 1.36, 95% CI 1.06–1.75; p=0.017), driven by a difference in non-cardiovascular deaths.
  • The cumulative incidence of definite stent thrombosis at 5 years was not different between groups (1.6% in both groups; 1.02, 0.51–2.05; p=0.950).
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