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Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

2016; Massachusetts Medical Society; Volume: 375; Issue: 13 Linguagem: Inglês

10.1056/nejmoa1607991

1533-4406

Kaare Harald Bønaa, Jan Mannsverk, Rune Wiseth, Lars Aaberge, Yngvar Myreng, Ottar Nygård, Dennis W Nilsen, Nils‐Einar Kløw, Michael Uchto, Thor Trovik, Bjørn Bendz, Sindre Stavnes, Reidar Bjørnerheim, Alf-Inge Larsen, Morten Slette, Terje K. Steigen, Ole Johan Jakobsen, Øyvind Bleie, Eigil Fossum, Tove Aminda Hanssen, Øystein Dahl-Eriksen, Inger Njølstad, Knut Rasmussen, Tom Wilsgaard, Jan Erik Nordrehaug,

Cardiac Valve Diseases and Treatments

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.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.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.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 .).