West of Scotland Regional Heart and Lung Center

Glasgow, United Kingdom

West of Scotland Regional Heart and Lung Center

Glasgow, United Kingdom
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Carrie D.,Center Hospitalier University | Menown I.,Craigavon Cardiac Center | Oldroyd K.,West of Scotland Regional Heart and Lung Center | Copt S.,Biosensors | And 5 more authors.
JACC: Cardiovascular Interventions | Year: 2017

Objectives The aim of this study was to compare the performance of drug-coated stents (DCS) versus bare-metal stents (BMS) in patients who are candidates for long-term oral anticoagulation (OAC) after percutaneous coronary interventions. Background The randomized controlled LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom™ Stent) trial demonstrated the superior safety and efficacy of a polymer-free biolimus A9 DCS compared with a similar BMS used with 1 month of dual antiplatelet therapy in 2,466 patients at high bleeding risk. Methods The 2 stents were compared in a pre-specified analysis of the 879 LEADERS FREE patients (35.6%) scheduled to remain on OAC after percutaneous coronary intervention. The primary safety endpoint was a composite of cardiac death, myocardial infarction, and stent thrombosis. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularization. Results Baseline characteristics of 448 DCS and 431 BMS recipients were similar, 78.8% had histories of atrial fibrillation, and 21% presented with acute coronary syndromes. Four hundred patients in the DCS group and 376 in the BMS group were discharged on OAC after percutaneous coronary intervention. At 2 years, for the DCS and BMS recipients, respectively, the incidence of clinically driven target lesion revascularization was 7.5% versus 11.2% (hazard ratio: 0.63; 95% confidence interval: 0.40 to 1.01; p = 0.0514), the safety endpoint was reached by 14.4% and 15.0% (p = NS), and the rates of major bleeding events (Bleeding Academic Research Consortium 3 to 5) were 10.7% and 12.9% (p = NS). Conclusions The efficacy advantage of DCS over BMS up to 2 years appears confirmed in patients on long-term OAC. Despite the very short course of dual antiplatelet therapy, both the DCS and BMS groups experienced similarly high rates of major bleeding. (A Randomized Clinical Evaluation of the BioFreedom™ Stent [Leaders Free]; NCT01623180) © 2017 American College of Cardiology Foundation


Murphy A.,University College Cork | Fenwick E.,University of Glasgow | Toff W.D.,University of Leicester | Neilson M.P.,University of Glasgow | And 4 more authors.
International Journal of Technology Assessment in Health Care | Year: 2013

Aortic stenosis (AS) is caused by age-related calcific degeneration of the aortic valve (1). Initially, cases are asymptomatic but, from the point that symptoms first develop, there is rapid progression and if left untreated survival estimates are low (2-3 years) (1). Therefore, managing AS effectively and efficiently is a priority for health systems with increasing healthcare costs and longer life expectancy. Copyright © Cambridge University Press 2013.

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