Long-term efficacy and safety of sirolimus-eluting vs bare-metal stents.
BACKGROUND
Although previous studies have documented persistent clinical benefit of sirolimus-eluting stents (SES)in reducing the need for target vessel revascularization without an increase in myocardial infarction (MI) or mortality, the long-term safety and efficacy of CYPHER stent use in routine clinical practice, including off-label stent implantation, remains uncertain.


METHODS
We compared long-term clinical outcomes in 2,550 patients treated with one or more SES with 1,022 patients treated with one or more bare metal or heparin-coated stents (BMS). The study groups included 1,058 SES patients (41.5%) and 488 BMS patients (47.7%) with off-label indications. A propensity-score method was utilized to adjust for differences in baseline characteristics. Patients were followed for up to five years for the occurrence of all-cause mortality, MI and repeat target vessel revascularization.


RESULTS
Compared to BMS patients, SES patients demonstrated significantly improved event-free survival with respect to all-cause mortality (RR, 1.39; 95% CI, 1.07 to 1.80, P = 0.014) and repeat target vessel revascularization (RR, 2.72; 95% CI, 1.99 to 3.73, P < 0.001), with no significant difference in the incidence of cumulative MI. A landmark analysis, examining composite adverse events occurring six months after stent implantation in the two study groups, demonstrated no increased late hazard associated with SES use (relative risk, 1.08; 95% CI, 0.80 to 1.46).


CONCLUSIONS
Use of SES in routine clinical practice, including off-label indications, is associated with improved long-term mortality, reduced need for repeat target vessel revascularization and no increase in MI compared to BMS.
McKay
Raymond G
RG
Division of Interventional Cardiology, Hartford Hospital Cardiac Laboratory, 80 Seymour Street, Hartford CT 06115, USA. rmckay@harthosp.org
Murphy
Deborah J
DJ
Cloutier
Jill
J
Mather
Jeffrey F
JF
Mennett
Roger A
RA
Dada
Marcin R
MR
Shah
Anuj R
AR
Kiernan
Francis J
FJ
D003327:Coronary Disease / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
D020123:Sirolimus