Maintenance of long-term clinical benefit with sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction 3-year results of the SESAMI (sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction) trial.
OBJECTIVE
The aim of this study was to investigate whether the reported favorable 1-year outcome of the sirolimus-eluting stent (SES) versus the bare-metal stent (BMS) in the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) trial, in the setting of ST-segment elevation myocardial infarction (STEMI), is maintained at 3-year follow-up.


BACKGROUND
At present, only long-term registry data, but not randomized trials, on the safety and effectiveness of SES in STEMI patients are available.


METHODS
Overall, 320 STEMI patients were randomized to receive SES or BMS. The primary end point was the incidence of major adverse cardiovascular events (MACE), at 3-year follow-up. The secondary end points were the rate of target lesion revascularization (TLR) and target vessel revascularization (TVR) and target vessel failure (TVF). The incidence of late events, starting from clopidogrel withdrawal, was also investigated.


RESULTS
The 3-year incidence of MACE was lower in the SES group compared with the BMS group (12.7% vs. 21%, p = 0.034), as were TLR (7% vs. 13.5%, p = 0.048), TVR (8% vs. 16%, p = 0.027), and TVF (11.5% vs. 20.5%, p = 0.028) rates. The 3-year survival rate free from MACE, TLR, and TVF was significantly higher in the SES group than in the BMS group (87%, 93%, and 89.5% vs. 79%, 86.5%, and 79.5%, respectively, p < 0.05). The lower incidence of adverse events in the SES group was driven by TLR reduction and achieved in the first year of follow-up. The cumulative incidence of death and recurrent myocardial infarction, starting from clopidogrel discontinuation, was comparable in the 2 groups.


CONCLUSIONS
The clinical benefits of SES have been shown to be greater than those of BMS at 3-year follow-up.
Violini
Roberto
R
Interventional Cardiology Department, San Camillo Hospital, Rome, Italy.
Musto
Carmine
C
De Felice
Francesco
F
Nazzaro
Marco Stefano
MS
Cifarelli
Alberta
A
Petitti
Tommasangelo
T
Fiorilli
Rosario
R
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000628:therapy*; D020123:Sirolimus / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus