Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).
OBJECTIVE
To confirm whether sirolimus-eluting stents (SES) safely reduce the incidence of restenosis in patients with ST-segment elevation acute myocardial infarction compared with bare-metal stents (BMS).


BACKGROUND
In the setting of primary angioplasty, stent restenosis occurs in up to 27% of patients. The introduction of drug-eluting stents has drastically reduced the incidence of restenosis in clinically stable patients.


METHODS
We conducted a randomized trial of 320 patients with acute ST-segment elevation myocardial infarction assigned to receive SES or BMS. The primary end point was binary restenosis at 1-year angiographic follow-up.


RESULTS
At 1 year, the incidence of binary restenosis was lower in the SES group than in the BMS group (9.3% vs. 21.3%, respectively; p = 0.032), as were the rates of target lesion revascularization (4.3% vs. 11.2%; p = 0.02), target vessel revascularization (5% vs. 13.1; p = 0.015), major adverse cardiac events (6.8% vs. 16.8%; p = 0.005), and target vessel failure (8.7% vs. 18.7%; p = 0.007). The incidence of angiographically documented stent thrombosis was 1.2% (n = 2) in the SES group and 0.6% (n = 1) in the BMS group.


CONCLUSIONS
In patients with acute myocardial infarction, SES are superior to BMS, reducing the incidence of binary restenosis by 56%, target lesion revascularization by 61%, target vessel revascularization by 62%, adverse cardiac events by 59%, and target vessel failure by 53% at 1 year. (Sirolimus Eluting Stenting in Acute Myocardial Infarction; http://www.clinicaltrials.gov/ct/show/NCT00288210; NCT00288210).
Menichelli
Maurizio
M
Division of Interventional Cardiology, San Camillo Hospital, Rome, Italy. menichelli747@yahoo.com
Parma
Antonio
A
Pucci
Edoardo
E
Fiorilli
Rosario
R
De Felice
Francesco
F
Nazzaro
Marco
M
Giulivi
Alessia
A
Alborino
Domenico
D
Azzellino
Arianna
A
Violini
Roberto
R
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D011859:Radiography; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
D007166:Immunosuppressive Agents; D020123:Sirolimus