Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses.
Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.
Schampaert
Erick
E
Cardiology Division, Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada. erick.schampaert.hsc@ssss.gouv.qc.ca
Moses
Jeffrey W
JW
Schofer
Joachim
J
Schlüter
Michael
M
Gershlick
Anthony H
AH
Cohen
Eric A
EA
Palisaitis
Donald A
DA
Breithardt
Günter
G
Donohoe
Dennis J
DJ
Wang
Hong
H
Popma
Jeffrey J
JJ
Kuntz
Richard E
RE
Leon
Martin B
MB
D003324:Coronary Artery Disease / Q000188:drug therapy / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus