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  3. 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
 

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

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BORIS DOI
10.7892/boris.41111
Publisher DOI
10.1016/j.jcin.2013.07.012
PubMed ID
24332419
Description
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.
Date of Publication
2014-01
Publication Type
article
Subject(s)
600 - Technology::610 - Medicine & health
300 - Social sciences, sociology & anthropology::360 - Social problems & social services
Keyword(s)
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
Language(s)
en
Contributor(s)
Sabaté, Manel
Räber, Lorenz
Universitätsklinik für Kardiologie
Heg, Dierik Hansorcid-logo
Departement Klinische Forschung, Core Facility, Clinical Trials Unit (CTU) Bern
Brugaletta, Salvatore
Kelbaek, Henning
Cequier, Angel
Ostojic, Miodrag
Iñiguez, Andrés
Tüller, David
Serra, Antonio
Baumbach, Andreas
von Birgelen, Clemens
Hernandez-Antolin, Rosana
Roffi, Marco
Mainar, Vicente
Valgimigli, Marco
Serruys, Patrick W
Jüni, Peter
Institut für Sozial- und Präventivmedizin (ISPM)
DKF CTU Bern
Windecker, Stephan
Universitätsklinik für Kardiologie
Departement Klinische Forschung, Forschungsgruppe Kardiologie
Additional Credits
Institut für Sozial- und Präventivmedizin (ISPM)
Universitätsklinik für Kardiologie
Departement Klinische Forschung, Core Facility, Clinical Trials Unit (CTU) Bern
Series
JACC. Cardiovascular Interventions
Publisher
Elsevier
ISSN
1876-7605
Access(Rights)
restricted
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