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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.
JACC Cardiovasc Interv 2014; 7(1):55-63JC

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.

Authors+Show Affiliations

University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.Department of Clinical Research, Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: sabrugal@clinic.ub.es.Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark.University Hospital of Bellvitge, Barcelona, Spain.Clinical Center of Serbia, Belgrade, Serbia.Hospital do Meixoeiro, Vigo, Spain.Cardiology Department, Triemlispital, Zurich, Switzerland.University Hospital of Sant Pau, Barcelona, Spain.Bristol Heart Institute, Bristol, United Kingdom.Thoraxcentrum Twente, Twente University, Enschede, the Netherlands.University Hospital San Carlos, Madrid, Spain.Cardiocentro, Lugano, Switzerland.Hospital General of Alicante, Alicante, Spain.University Hospital Ferrara, Ferrara, Italy.Erasmus Medical Center, Rotterdam, the Netherlands.Department of Clinical Research, Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.

Pub Type(s)

Journal Article
Meta-Analysis

Language

eng

PubMed ID

24332419

Citation

Sabaté, Manel, et al. "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." JACC. Cardiovascular Interventions, vol. 7, no. 1, 2014, pp. 55-63.
Sabaté M, Räber L, Heg D, et al. 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. JACC Cardiovasc Interv. 2014;7(1):55-63.
Sabaté, M., Räber, L., Heg, D., Brugaletta, S., Kelbaek, H., Cequier, A., ... Windecker, S. (2014). 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. JACC. Cardiovascular Interventions, 7(1), pp. 55-63. doi:10.1016/j.jcin.2013.07.012.
Sabaté M, et al. 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. JACC Cardiovasc Interv. 2014;7(1):55-63. PubMed PMID: 24332419.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sabaté,Manel, AU - Räber,Lorenz, AU - Heg,Dik, AU - Brugaletta,Salvatore, AU - Kelbaek,Henning, AU - Cequier,Angel, AU - Ostojic,Miodrag, AU - Iñiguez,Andrés, AU - Tüller,David, AU - Serra,Antonio, AU - Baumbach,Andreas, AU - von Birgelen,Clemens, AU - Hernandez-Antolin,Rosana, AU - Roffi,Marco, AU - Mainar,Vicente, AU - Valgimigli,Marco, AU - Serruys,Patrick W, AU - Jüni,Peter, AU - Windecker,Stephan, Y1 - 2013/12/11/ PY - 2013/07/01/received PY - 2013/07/17/accepted PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/9/30/medline KW - BES KW - BMS KW - CI KW - DES KW - DOCE KW - EES KW - HR KW - POCE KW - RR KW - ST-segment elevation myocardial infarction KW - STEMI KW - bare-metal stent(s) KW - biolimus A9–eluting stent(s) KW - confidence interval KW - device-oriented composite endpoint KW - drug-eluting stent(s) KW - everolimus-eluting stent(s) KW - hazard ratio KW - patient-oriented composite endpoint KW - relative risk KW - stent thrombosis SP - 55 EP - 63 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 7 IS - 1 N2 - 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. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/24332419/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)01535-5 DB - PRIME DP - Unbound Medicine ER -