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. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
RCT Entities:
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. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Authors: Giuseppe De Luca; Maurits T Dirksen; Christian Spaulding; Henning Kelbæk; Martin Schalij; Leif Thuesen; Bas van der Hoeven; Marteen A Vink; Christoph Kaiser; Carmine Musto; Tania Chechi; Gaia Spaziani; Luis Salvador Diaz de la Llera; Vincenzo Pasceri; Emilio Di Lorenzo; Roberto Violini; Harry Suryapranata; Gregg W Stone Journal: Clin Res Cardiol Date: 2014-04-01 Impact factor: 5.460
Authors: Bruce Brodie; Yashashwi Pokharel; Nathan Fleishman; Adam Bensimhon; Grace Kissling; Charles Hansen; Sally Milks; Michael Cooper; Christopher McAlhany; Tom Stuckey Journal: JACC Cardiovasc Interv Date: 2011-01 Impact factor: 11.195