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Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction - SESAMI
Description:
The goal of the trial was to evaluate primary/rescue percutaneous coronary intervention (PCI) using a sirolimus-eluting stent compared with a bare-metal stent among patients with acute myocardial infarction (MI).
Study Design
Study Design:
Patients Enrolled: 320
Mean Follow Up: One year
Mean Patient Age: Median age, 62 years
Female: 20
Patient Populations:
Acute MI to be treated with primary or rescue angioplasty
Exclusions:
Left main disease; saphenous vein grafts; cardiogenic shock; history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; or noncardiac illness associated with a life expectancy of <1 year
Primary Endpoints:
Angiographic binary restenosis at 1 year
Secondary Endpoints:
One-year TLR, TVR, TVF, and MACE
Drug/Procedures Used:
Patients undergoing primary or rescue PCI were randomized to sirolimus-eluting stent (n = 160) or bare-metal stent (n = 160). One-year angiographic follow-up was available in 166 patients.
Principal Findings:
Baseline characteristics were well balanced between groups, with primary PCI performed in 82% of patients and rescue PCI in 18% of patients. The infarct-related artery was the left anterior descending in approximately half of patients. Abciximab was used in either the emergency room or the cath lab in the majority of patients. Post-procedural TIMI grade 3 flow was present in 95% of patients.
The primary endpoint of 1-year binary restenosis on angiography occurred less often in the sirolimus-eluting stent group versus the bare-metal stent group (9.3% vs. 21.3%, relative risk reduction [RRR] 56%, p < 0.05). Likewise, clinically driven restenosis was also lower in the sirolimus-eluting stent group (5.6% vs. 17.2%, RRR 64%, p < 0.05).
Among the secondary endpoints, the sirolimus-eluting stent group had lower rates of target lesion revascularization (TLR) (4.3% vs. 11.2%), target vessel revascularization (TVR) (5% vs. 13.1%), major adverse cardiac events (MACE) (6.8% vs. 16.8%), and target lesion vessel failure (TVF) (8.7% vs. 18.7%; all p < 0.05). There was no difference in acute thrombosis (0.6% each) or acute + subacute thrombosis (3.1% for sirolimus-eluting stent vs. 3.7% for bare-metal stent).
Interpretation:
Among patients with acute MI undergoing primary or rescue PCI, use of a sirolimus-eluting stent was associated with a reduction in binary restenosis at 1 year compared with use of a bare-metal stent.
Results of the present single-center trial are similar to those seen in the multicenter TYPHOON trial, which showed a reduction in TVF at 1 year with sirolimus-eluting stents compared with bare-metal stents in PCI for acute MI, driven primarily by a reduction in TLR. The PASSION trial, however, did not demonstrate a reduction in TLR with paclitaxel-eluting stents over bare-metal stents among STEMI patients. A cost-effectiveness analysis from the present trial is underway.
References:
Menichelli M, Parma A, Pucci E, et al. Randomized Trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol 2007;49:1924-30.
Presented by Dr. Maurizio Menichelli at the EuroPCR meeting, May 2006, Paris, France.
Keywords: Risk, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Immunoglobulin Fab Fragments, Sirolimus, Cyclonic Storms, Emergency Service, Hospital, Angioplasty, Percutaneous Coronary Intervention, Stents, Paclitaxel, Thrombosis
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