5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents.
OBJECTIVE
Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials.


BACKGROUND
A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents.


METHODS
In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870).


RESULTS
At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001).


CONCLUSIONS
In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144).
Caixeta
Adriano
A
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
Leon
Martin B
MB
Lansky
Alexandra J
AJ
Nikolsky
Eugenia
E
Aoki
Jiro
J
Moses
Jeffrey W
JW
Schofer
Joachim
J
Morice
Marie-Claude
MC
Schampaert
Erick
E
Kirtane
Ajay J
AJ
Popma
Jeffrey J
JJ
Parise
Helen
H
Fahy
Martin
M
Mehran
Roxana
R
D000368:Aged; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000401:mortality; D009204:Myocardial Revascularization; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
D008670:Metals; D020123:Sirolimus