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Randomized Controlled Trial
. 2022 Jan:34:3-10.
doi: 10.1016/j.carrev.2021.02.008. Epub 2021 Feb 25.

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

Juan F Iglesias  1 , Dik Heg  2 , Marco Roffi  1 , Sophie Degrauwe  1 , David Tüller  3 , Olivier Muller  4 , Miriam Brinkert  5 , Stéphane Cook  6 , Daniel Weilenmann  7 , Christoph Kaiser  8 , Florim Cuculi  9 , Marco Valgimigli  10 , Peter Jüni  11 , Stephan Windecker  10 , Thomas Pilgrim  12
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Free article
Randomized Controlled Trial

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

Juan F Iglesias et al. Cardiovasc Revasc Med. 2022 Jan.
Free article

Abstract

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.

Keywords: Acute coronary syndrome; Biodegradable polymer; Clinical outcomes; Drug-eluting stent.

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Conflict of interest statement

Declaration of competing interest JI reports institutional research grants from Biotronik, Abbott Vascular and Astra Zeneca, personal fees from Biotronik, Philips Volcano, Astra Zeneca, Terumo, Medtronic and Cardinal Health, outside the submitted work. DH is affiliated with Clinical Trials Unit Bern (CTU Bern), University of Bern (Bern, Switzerland), which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organisations. In particular, pharmacetical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern's conflicts of interest see www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. MR reports institutional research grants from Terumo, Boston Scientific, Medtronic, Abbott Vascular, and Biotronik, outside the submitted work. PJ serves as an unpaid member of the steering group of trials funded by AstraZeneca, Biotronik, Biosensors, St Jude Medical, and The Medicines Company, and received research grants to their institution from AstraZeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company, and honoraria to their institution for participation in advisory boards from Amgen, but has not received personal payments by any pharmaceutical company or device manufacturer. PJ is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases. MV reports grants and personal fees from Abbott, Terumo, and AstraZeneca, personal fees from Bayer, Dalichi Sankyo, Amgen, Alvimedica, Idorsia, Coreflow, Vifor, Bristol-Myers Squibb, and iVascular, and grants from Medicure, ouside the submitted work. SW received research grants to his institution from Abbott, Amgen, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, Medicines Company, and St Jude. TP received research grants to his institution from Biotronik, Boston Scientific and Edwards Lifesciences, and speaker fees from Biotronik and Boston Scientific Consultancy from HighLIFE SAife SASSAS. The other authors report no conflicts.

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