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Dr. William Wijns,
Dr. Tenas Manel Sabate
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Presenter | see Discussant report
Manel Sabate Tenas(Spain)Presentation webcastPresentation slides
List of Authors: Manel Sabate, Angel Cequier, Andres Iñiguez, Antonio Serra, Rosana Hernandez-Antolin, Vicente Mainar, Marco Valgimigli, Maurizio Tespili, Armando Bethencourt, Nicolas Vazquez, Peter den Heijer, Patrick Serruys
Background: The use of drug-eluting stents in the acute phase of ST-segment elevation myocardial infarction (STEMI) is still controversial. First generation drug-eluting stents (DES) have demonstrated to be efficacious and safe in randomized controlled trials with strict inclusion and exclusion criteria. No data have been generated so far by the use of currently available second generation DES in STEMI. The aim of this study is to assess, in a multicenter randomized controlled trial with an “all-comers” design, the safety and performance of the Everolimus-Eluting Stent (EES) versus a cobalt chromium bare metal stent (BMS) in the setting of percutaneous coronary intervention (PCI) for treatment of patients presenting with STEMI. Methods: The Evaluation of Xience-V™ stent in Acute Myocardial INfArcTION (EXAMINATION) trial (NC00828087) randomly assigned (1:1) either EES or BMS to patients fulfilling any of the following inclusion criteria: STEMI <12 hours after the onset of symptoms; rescue PCI after failed thrombolysis; PCI indicated early (<24h) after effective thrombolysis; and, ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms (“latecomers”). The main clinical exclusion criteria were patients suffering from stent thrombosis as a cause of STEMI and patients receiving anti-vitamin K therapy. The only angiographic exclusion criterion was a vessel size <2.25mm or >4.0 mm (visual estimate). The primary endpoint was the composite of all-cause death, any myocardial infarction and any revascularization at 1 year (patient-oriented endpoint according to ARC definitions). Secondary endpoints included the individual components of the primary endpoint, stent thrombosis according to ARC definitions and bleeding. All analysis will be performed on the intention-to-treat population. The sample size calculation is based on a 2-sided type I error rate alpha = 0.05,) and a statistical power of at least 86% to detect approximately 30% reduction in the rate of the primary end point at 1 year. Results: Between December 2008 and May 2010 a total of 1,498 patients have been included in this trial (EES group=751; BMS group=747). This figure represents up to 70% of the total number of patients suffering from STEMI during the recruitment period. Mean age was 61.2±12.4 years; 83% male. Main coronary risk factors included: smoking (72.2%); hypertension (48.4%); diabetes (17.2%); dyslipidemia (43.8%); and, family history (16.4%). Most of patients were included as STEMI <12 hours (84.6%). Rescue PCI involved 6.5% of patients, PCI early after successful thrombolysis 2.3% and, latecomers 6.5%. Most of patients were in Killip class I (89.6%). Target lesion was most often located in the right coronary artery (43.6%), followed by left anterior descending artery (40.6%). Antithrombotic regimen included unfractioned heparin (78%); low molecular weight heparin (9.1%) and bivalirudin (7.1%). Overall, IIb/IIIa inhibitors were administered in 53% of patients. Manual thrombectomy was used in 65.4% of patients. At 1-year clinical follow-up the rate of the primary endpoint was 13.9% for BMS group and 11.9% for the EES group (p=0.3). All cause death rate accounted for 3.5% in each group; any myocardial infarction rate was 2.0% in BMS versus 1.3% in EES (p=0.3). Any revascularization rate was 10.3% in BMS vs. 8.0 in EES (p=0.10). The rates of definitive and definitive/probable stent thrombosis were significantly lower in the EES group (0.5% and 0.9% vs. 1.9% and 2.5%, respectively; both p=0.01). Conclusion: The use of EES in the setting of STEMI resulted in a numerically (not significantly) reduced primary endpoint at the expense of a trend in reduction the repeat revascularization rate. The significant reduction observed in the definite and definite/probable stent thrombosis rates suggest an excellent safety profile of the EES in this high risk patients presenting with STEMI. The results of this “all-comer” randomized trial are highly representative of the real world population.
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William Wijns(Belgium)Presentation webcastPresentation slides
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Hot Line III - Acute coronary syndromes
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