Thomas Pilgrim1, Olivier Muller2, Dik Heg3, Marco Roffi4, David J Kurz5, Igal Moarof6, Daniel Weilenmann7, Christoph Kaiser8, Maxime Tapponnier9, Sylvain Losdat3, Eric Eeckhout2, Marco Valgimigli1, Peter Jüni10, Stephan Windecker1, Juan F Iglesias11. 1. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. 2. Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. 3. CTU Bern, University of Bern, Bern, Switzerland. 4. Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. 5. Department of Cardiology, Triemli Hospital, Zurich, Switzerland. 6. Department of Cardiology, Kantonsspital, Aarau, Switzerland. 7. Department of Cardiology, Kantonsspital, St. Gallen, Switzerland. 8. Department of Cardiology, Basel University Hospital, Basel, Switzerland. 9. Department of Cardiology, Hôpital du Valais, Sion, Switzerland. 10. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. 11. Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. Electronic address: juanfernando.iglesias@hcuge.ch.
Abstract
OBJECTIVES: The aim of this study was to investigate the safety and efficacy of biodegradable-polymer sirolimus-eluting stents (BP-SES) compared with durable-polymer everolimus-eluting stents (DP-EES) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND:Primary percutaneous coronary intervention (PCI) is an effective treatment for patients with STEMI, and long-term outcomes are determined by the safety and efficacy profile of the newest generation drug-eluting stents. METHODS: BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial using Bayesian methods. Patients with STEMI undergoing primary PCI within 24 h of symptom onset were randomized in a 1:1 ratio to receive BP-SES (n = 649) or DP-EES (n = 651). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial reinfarction, and clinically indicated target lesion revascularization (TLR) at 2 years. RESULTS:Between April 2016 and March 2018, 1,300 patients were included. Baseline characteristics were comparable between the 2 treatment groups. Follow-up through 2 years was complete in 1,221 patients (94%). At 2 years, TLF occurred in 33 patients (5.1%) treated with BP-SES and in 53 patients (8.1%) treated with DP-EES (rate ratio: 0.58; 95% Bayesian credible interval: 0.40 to 0.84; posterior probability of superiority = 0.998). The difference was driven by a lower incidence of clinically indicated TLR in patients treated with BP-SES compared with DP-EES (2.5% vs. 5.1%; rate ratio: 0.52; 95% Bayesian credible interval: 0.30 to 0.87; posterior probability of superiority = 0.993). There were no significant differences in rates of cardiac death, target vessel myocardial reinfarction, and definite stent thrombosis between the 2 treatment arms. CONCLUSIONS: In patients with STEMI undergoing primary PCI, BP-SES were superior to DP-EES with respect to TLF at 2 years. The difference was driven by lower rates of ischemia-driven TLR. (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [BIOSTEMI]; NCT02579031).
RCT Entities:
OBJECTIVES: The aim of this study was to investigate the safety and efficacy of biodegradable-polymersirolimus-eluting stents (BP-SES) compared with durable-polymereverolimus-eluting stents (DP-EES) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Primary percutaneous coronary intervention (PCI) is an effective treatment for patients with STEMI, and long-term outcomes are determined by the safety and efficacy profile of the newest generation drug-eluting stents. METHODS: BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable PolymerSirolimus-Eluting Stent With a Durable PolymerEverolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial using Bayesian methods. Patients with STEMI undergoing primary PCI within 24 h of symptom onset were randomized in a 1:1 ratio to receive BP-SES (n = 649) or DP-EES (n = 651). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial reinfarction, and clinically indicated target lesion revascularization (TLR) at 2 years. RESULTS: Between April 2016 and March 2018, 1,300 patients were included. Baseline characteristics were comparable between the 2 treatment groups. Follow-up through 2 years was complete in 1,221 patients (94%). At 2 years, TLF occurred in 33 patients (5.1%) treated with BP-SES and in 53 patients (8.1%) treated with DP-EES (rate ratio: 0.58; 95% Bayesian credible interval: 0.40 to 0.84; posterior probability of superiority = 0.998). The difference was driven by a lower incidence of clinically indicated TLR in patients treated with BP-SES compared with DP-EES (2.5% vs. 5.1%; rate ratio: 0.52; 95% Bayesian credible interval: 0.30 to 0.87; posterior probability of superiority = 0.993). There were no significant differences in rates of cardiac death, target vessel myocardial reinfarction, and definite stent thrombosis between the 2 treatment arms. CONCLUSIONS: In patients with STEMI undergoing primary PCI, BP-SES were superior to DP-EES with respect to TLF at 2 years. The difference was driven by lower rates of ischemia-driven TLR. (A Comparison of an Ultrathin Strut Biodegradable PolymerSirolimus-Eluting Stent With a Durable PolymerEverolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [BIOSTEMI]; NCT02579031).
Authors: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983