Retraction

Male Paclitaxel Coronary Myocardial Infarction 610 Kaplan-Meier Estimate Coronary Angiography Disease-Free Survival Follow-Up Studie Immunosuppressive Agent Electrocardiography 03 medical and health sciences 0302 clinical medicine Tubulin Modulator Physiology (medical) Stent Drug-Eluting Stent Humans Sirolimu Angioplasty, Balloon, Coronary Aged Sirolimus Metal Incidence Angioplasty Drug-Eluting Stents Middle Aged Tubulin Modulators 3. Good health Angioplasty, Myocardial infarction, Stents; Aged, Coronary Angiography, Disease-Free Survival, Electrocardiography, Female; Follow-Up Studies, Humans, Immunosuppressive Agents, Incidence, Kaplan-Meier Estimate, Male, Metals, Middle Aged, Myocardial Infarction, Paclitaxel, Sirolimus, Treatment Outcome, Tubulin Modulators, Angioplasty, Balloon, Coronary, Drug-Eluting Stents, Physiology (medical), Cardiology and Cardiovascular Medicine Myocardial infarction Treatment Outcome Metals Female Cardiology and Cardiovascular Medicine Balloon Immunosuppressive Agents Human Follow-Up Studies
DOI: 10.1161/circulationaha.108.830372 Publication Date: 2009-09-01T01:55:31Z
ABSTRACT
Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty.Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization.This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.
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