Author + information
- Received May 2, 2009
- Revision received September 9, 2009
- Accepted September 14, 2009
- Published online February 23, 2010.
- Roberto Violini, MD*,
- Carmine Musto, MD, PhD*,* (, )
- Francesco De Felice, MD*,
- Marco Stefano Nazzaro, MD, PhD*,
- Alberta Cifarelli, MD*,
- Tommasangelo Petitti, MD† and
- Rosario Fiorilli, MD*
- ↵*Reprint requests and correspondence:
Dr. Carmine Musto, Division of Interventional Cardiology, San Camillo Hospital, Via Circumvallazione Gianicolense n.87, 00100 Rome, Italy
Objectives 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.
- Received May 2, 2009.
- Revision received September 9, 2009.
- Accepted September 14, 2009.
- American College of Cardiology Foundation