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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Maurizio Menichelli, MD^_*,_*, Antonio Parma, MD^_*, Edoardo Pucci, MD^_*, Rosario Fiorilli, MD^_*, Francesco De Felice, MD^_*, Marco Nazzaro, MD^_*, Alessia Giulivi, MD^_*, Domenico Alborino, MD^_*, Arianna Azzellino, PhD and Roberto Violini, MD^_*

^_* Division of Interventional Cardiology, San Camillo Hospital, Rome, Italy
Politecnico Milano, Milan, Italy

Manuscript received October 31, 2006; revised manuscript received January 11, 2007, accepted January 16, 2007.

^_* Reprint requests and correspondence: Dr. Maurizio Menichelli, Department of Cardiology, San Camillo Hospital, Circ. Gianicolense 187, 00100 Rome, Italy. (Email: menichelli747{at}yahoo.com).

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 [ClinicalTrials.gov] )

Abbreviations and Acronyms   BMS = bare-metal stents   MACE = major adverse cardiovascular events   MI = myocardial infarction   PCI = percutaneous coronary intervention   SES = sirolimus-eluting stents   TIMI = Thrombolysis In Myocardial Infarction   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization

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