Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials
Manel Sabaté, Lorenz Räber, Dik Heg, Salvatore Brugaletta, Henning Kelbaek, Angel Cequier, Miodrag Ostojic, Andrés Iñiguez, David Tüller, Antonio Serra, Andreas Baumbach, Clemens von Birgelen, Rosana Hernandez-Antolin, Marco Roffi, Vicente Mainar, Marco Valgimigli, Patrick W Serruys, Peter Jüni, Stephan Windecker, Manel Sabaté, Lorenz Räber, Dik Heg, Salvatore Brugaletta, Henning Kelbaek, Angel Cequier, Miodrag Ostojic, Andrés Iñiguez, David Tüller, Antonio Serra, Andreas Baumbach, Clemens von Birgelen, Rosana Hernandez-Antolin, Marco Roffi, Vicente Mainar, Marco Valgimigli, Patrick W Serruys, Peter Jüni, Stephan Windecker
Abstract
Objectives: This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI).
Background: Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES.
Methods: Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year.
Results: Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS.
Conclusions: Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.
Keywords: BES; BMS; CI; DES; DOCE; EES; HR; POCE; RR; ST-segment elevation myocardial infarction; STEMI; bare-metal stent(s); biolimus A9–eluting stent(s); confidence interval; device-oriented composite endpoint; drug-eluting stent(s); everolimus-eluting stent(s); hazard ratio; patient-oriented composite endpoint; relative risk; stent thrombosis.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed