Spirito, Alessandro; Valgimigli, Marco; Cao, Davide; Baber, Usman; Mehta, Shamir R; Gibson, C Michael; Steg, Gabriel P; Sharma, Samin K; Goel, Ridhima; Huber, Kurt; +20 more... Kunadian, Vijay; Escaned, Javier; Franzone, Anna; Yaling, Han; Collier, Timothy; Kaul, Upendra; Kornowski, Ran; Krucoff, Mitchell; Moliterno, David; Sartori, Samantha; Owen, Ruth; Zhang, Zhongjie; Dangas, George D; Kastrati, Adnan; Angiolillo, Dominick J; Cohen, David J; Vranckx, Pascal; Windecker, Stephan; Pocock, Stuart; Mehran, Roxana; (2023) Biolimus-eluting vs. other limus-eluting stents in NSTE-ACS: A pooled analysis of GLASSY and TWILIGHT. International journal of cardiology, 383. pp. 24-32. ISSN 0167-5273 DOI: https://doi.org/10.1016/j.ijcard.2023.04.027
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Abstract
BACKGROUND: Biodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting stents (LES). AIMS: To compare BP-BES with other current-generation LES in ACS patients undergoing PCI. METHODS: We pooled individual data of Non-ST-segment elevation (NSTE)-ACS patients from two large randomized controlled trials (GLASSY and TWILIGHT). The BP-BES groups consisted mostly of GLASSY patients, while the control group (other current-generation LES) included exclusively TWILIGHT patients. The primary outcome was major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, or stent thrombosis; the key secondary outcome was target-vessel failure (TVF). To account for trial design differences, outcomes were assessed at 3 months (short-term) and between 3 and 12 months (long-term) after PCI and subsequently pooled to estimate the 12-month hazards. RESULTS: Of 7107 and 6053 NSTE-ACS patients included in the short- and long-term analysis, 32.7% and 36.5% received a BP-BES, respectively. Risk of MACE associated with BP-BES versus other LES was similar at short-term (1.1% vs 1.3%, adjusted HR 0.86, 95%CI 0.53-1.38), lower at long-term (1.7% vs 3.1%, adjusted HR 0.49, 95%CI 0.34-0.72), and lower in the entire 12-month period (pooled adjusted HR 0.61, 95%CI 0.45-0.82). The cumulative 12-month risk of TVF was reduced with BP-BES (adjusted HR 0.52, 95%CI 0.38-0.70). CONCLUSION: BP-BES was associated with lower 12-month risks of MACE and TVF compared to other current generation LES among NSTE-ACS patients treated with abbreviated or standard ticagrelor-based DAPT. These non-randomized findings are hypothesis-generating. CONDENSED ABSTRACT: Differences in clinical outcomes may exist between biodegradable polymer biolimus-eluting stents (BP-BES) and other current-generation limus-eluting stent (LES) in patients with acute coronary syndrome (ACS). We pooled individual data of about 7000 Non-ST-segment elevation ACS patients undergoing PCI and treated with ticagrelor with or without aspirin from two large randomized controlled trials (GLASSY and TWILIGHT). BP-BES patients derived very largely from GLASSY and other LES patients from TWILIGHT. In this population, BP-BES compared to other current generation LES, were associated with a lower 12-month risk of major adverse cardiovascular events and target-vessel failure.
Item Type | Article |
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Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Medical Statistics |
Research Centre | Clinical Trials Unit |
PubMed ID | 37080466 |
Elements ID | 202665 |
Official URL | http://dx.doi.org/10.1016/j.ijcard.2023.04.027 |
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