title: Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial.
abstract: Compared with bare metal stents, first-generation drug-eluting stents (DES) are associated with an increased risk of late restenosis and stent thrombosis (ST). Whether this risk continues or attenuates during long-term follow-up remains unknown.
  
  
  
  We extended the follow-up of 1012 patients [sirolimus-eluting stent (SES): N = 503 and paclitaxel-eluting stent (PES): N = 509] included in the all-comers, randomized Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) trial to 10 years. Follow-up was complete in 895 patients (88.4%) at 10 years. At 1, 5, and 10 years of follow-up, rates of ischaemia-driven target lesion revascularization (ID-TLR) were 8.1%, 14.6% and 17.7%, respectively, and rates of ST were 1.9%, 4.5% and 5.6%, respectively. The annual risks of ID-TLR and definite ST were significantly higher between 1 and 5 years as compared with the 5- to 10-year period [ID-TLR: 1.8% vs. 0.7%/year, hazard ratio (HR) 0.36, 95% confidence intervals (95% CI) 0.21-0.62, P < 0.001; definite ST: 0.67% vs. 0.23%/year, HR 0.31, 95% CI 0.13-0.75, P = 0.01]. The attenuation of the risk of ID-TLR and ST beyond 5 years was independent of age. Major adverse events (cardiac death, myocardial infarction, and ID-TLR) occurred in 33.7% of SES- and 33.8% of PES-treated patients (P = 0.72).
  
  
  
  During long-term follow-up through 10 years, the annual risks of ID-TLR and definite ST significantly decreased beyond 5 years after first-generation DES implantation. These findings may have important implications for secondary prevention after percutaneous coronary intervention with first-generation DES including long-term antiplatelet therapy.
  
  
  
  http://www.clinicaltrials.gov. Unique identifier: NCT00297661.
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Kyohei
authors: K
authors: Yamaji
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Lorenz
authors: L
authors: Räber
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Thomas
authors: T
authors: Zanchin
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Ernest
authors: E
authors: Spitzer
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Christian
authors: C
authors: Zanchin
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Thomas
authors: T
authors: Pilgrim
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Stefan
authors: S
authors: Stortecky
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Aris
authors: A
authors: Moschovitis
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Michael
authors: M
authors: Billinger
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors: Christa
authors: C
authors: Schönenberger
authors: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors: Franz
authors: F
authors: Eberli
authors: Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
authors: Peter
authors: P
authors: Jüni
authors: Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.
authors: Thomas F
authors: TF
authors: Lüscher
authors: Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
authors: Dik
authors: D
authors: Heg
authors: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland stephan.windecker@insel.ch.
authors: Stephan
authors: S
authors: Windecker
mesh_terms: D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D009203:Myocardial Infarction; D017239:Paclitaxel; D020123:Sirolimus; D015607:Stents; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus
keywords: Coronary artery disease; Drug-eluting stent; Restenosis; Stent; Stent thrombosis