Kaare H Bønaa1, Jan Mannsverk1, Rune Wiseth1, Lars Aaberge1, Yngvar Myreng1, Ottar Nygård1, Dennis W Nilsen1, Nils-Einar Kløw1, Michael Uchto1, Thor Trovik1, Bjørn Bendz1, Sindre Stavnes1, Reidar Bjørnerheim1, Alf-Inge Larsen1, Morten Slette1, Terje Steigen1, Ole J Jakobsen1, Øyvind Bleie1, Eigil Fossum1, Tove A Hanssen1, Øystein Dahl-Eriksen1, Inger Njølstad1, Knut Rasmussen1, Tom Wilsgaard1, Jan E Nordrehaug1. 1. From the Department of Community Medicine (K.H.B., I.N., T.W.) and the Department of Clinical Medicine (T.S., T.A.H., K.R.), University of Tromsø-the Arctic University of Norway, and the Department of Cardiology, University Hospital of North Norway (J.M., T.T., T.S., T.A.H., Ø.D.-E., K.R.), Tromsø, the Departments of Public Health and General Medicine (K.H.B.) and Circulation and Medical Imaging (R.W.), Norwegian University of Science and Technology, and the Clinic for Heart Disease, St. Olav's University Hospital (K.H.B., R.W., M.S.), Trondheim, the Departments of Cardiology (L.A., B.B., E.F.), Radiology, (N.-E.K.), and Heart Disease (R.B.), Oslo University Hospital, and the Faculty of Medicine, University of Oslo (N.-E.K., B.B.), Oslo, the Department of Cardiology, Feiring Heart Clinic, Feiring (Y.M., S.S.), the Department of Heart Disease, Haukeland University Hospital (O.N., Ø.B.), and the Department of Clinical Science, University of Bergen (O.N., D.W.N., A.-I.L., J.E.N.), Bergen, the Department of Cardiology, Stavanger University Hospital, Stavanger (D.W.N., A.-I.L., J.E.N.), and the Department of Medicine, Sørlandet Hospital, Arendal (M.U., O.J.J.) - all in Norway.
Abstract
BACKGROUND: Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life. METHODS: We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of eithercontemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life. RESULTS: At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups. CONCLUSIONS: In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).
RCT Entities:
BACKGROUND: Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life. METHODS: We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life. RESULTS: At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups. CONCLUSIONS: In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).
Authors: Mehmet H Kural; Juan Wang; Liqiong Gui; Yifan Yuan; Guangxin Li; Katherine L Leiby; Elias Quijano; George Tellides; W Mark Saltzman; Laura E Niklason Journal: Biomaterials Date: 2019-05-07 Impact factor: 12.479