BACKGROUND: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. METHODS: We randomly assigned 3687 patients at 66 U.S. sites to receiveeverolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). RESULTS:Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). CONCLUSIONS:Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.) 2010 Massachusetts Medical Society
RCT Entities:
BACKGROUND: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. METHODS: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). RESULTS:Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). CONCLUSIONS:Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.) 2010 Massachusetts Medical Society
Authors: Yuan Xu; Ryo Nakazato; Sean Hayes; Rory Hachamovitch; Victor Y Cheng; Heidi Gransar; Romalisa Miranda-Peats; Mark Hyun; Leslee J Shaw; John Friedman; Guido Germano; Daniel S Berman; Piotr J Slomka Journal: J Nucl Cardiol Date: 2011-09-20 Impact factor: 5.952
Authors: Carlos L Alviar; Armando Tellez; Michael Wang; Pamela Potts; Doug Smith; Manus Tsui; Wladyslaw Budzynski; Albert E Raizner; Neal S Kleiman; Eli I Lev; Juan F Granada; Greg L Kaluza Journal: J Thromb Thrombolysis Date: 2012-07 Impact factor: 2.300
Authors: Christopher R Kelly; Paul S Teirstein; Ian T Meredith; Bruno Farah; Christophe L Dubois; Robert L Feldman; Joseph Dens; Nobuhisa Hagiwara; Abram Rabinowitz; Didier Carrié; Vincent Pompili; Alain Bouchard; Shigeru Saito; Dominic J Allocco; Keith D Dawkins; Gregg W Stone Journal: JACC Cardiovasc Interv Date: 2017-12-11 Impact factor: 11.195
Authors: Tobias Härle; Uwe Zeymer; Arne Kristian Schwarz; Claus Lüers; Matthias Hochadel; Harald Darius; Wolfgang Kasper; Karl Eugen Hauptmann; Dietrich Andresen; Albrecht Elsässer Journal: Clin Res Cardiol Date: 2014-01-17 Impact factor: 5.460
Authors: Nicolas W Shammas; Gail A Shammas; Elie Nader; Michael Jerin; Luay Mrad; Nicholas Ehrecke; Waheeb J Shammas; Cara M Voelliger; Alexander Hafez; Ryan Kelly; Emily Reynolds Journal: Int J Angiol Date: 2013-09