Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry).
Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.
Roy
Probal
P
Division of Cardiology, Washington Hospital Center, Washington, DC, USA.
Bonello
Laurent
L
de Labriolle
Axel
A
Okabe
Teruo
T
Pinto Slottow
Tina L
TL
Steinberg
Daniel H
DH
Torguson
Rebecca
R
Smith
Kimberly
K
Xue
Zhenyi
Z
Satler
Lowell F
LF
Kent
Kenneth M
KM
Suddath
William O
WO
Pichard
Augusto D
AD
Waksman
Ron
R
D000368:Aged; D003327:Coronary Disease / Q000150:complications / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D017239:Paclitaxel; D020123:Sirolimus