Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).

Abstract

OBJECTIVES:

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).

• Authors: Maurizio Menichelli, Antonio Parma, Edoardo Pucci, Rosario Fiorilli, Francesco De Felice, Marco Nazzaro, Alessia Giulivi, Domenico Alborino, Arianna Azzellino, Roberto Violini
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 49 Issue 19 Pg. 1924-30 (May 15 2007) ISSN: 1558-3597 [Electronic] United States
• PMID: 17498576 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Immunosuppressive Agents
• Sirolimus

Topics

• Aged
• Angioplasty, Balloon, Coronary
• Equipment Design
• Female
• Follow-Up Studies
• Graft Occlusion, Vascular (epidemiology)
• Humans
• Immunosuppressive Agents (administration & dosage)
• Incidence
• Male
• Middle Aged
• Myocardial Infarction (diagnostic imaging, therapy)
• Radiography
• Sirolimus (administration & dosage)
• Stents