Urban, Philip; Meredith, Ian T; Abizaid, Alexandre; Pocock, Stuart J; Carrié, Didier; Naber, Christoph; Lipiecki, Janusz; Richardt, Gert; Iñiguez, Andres; Brunel, Philippe; +13 more... Valdes-Chavarri, Mariano; Garot, Philippe; Talwar, Suneel; Berland, Jacques; Abdellaoui, Mohamed; Eberli, Franz; Oldroyd, Keith; Zambahari, Robaayah; Gregson, John; Greene, Samantha; Stoll, Hans-Peter; Morice, Marie-Claude; LEADERS FREE Investigators; (2015) Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. The New England journal of medicine, 373 (21). pp. 2038-2047. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa1503943
Permanent Identifier
Use this Digital Object Identifier when citing or linking to this resource.
Abstract
BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).
Item Type | Article |
---|---|
Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Medical Statistics |
PubMed ID | 26466021 |
ISI | 364957700009 |