title: 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.
abstract: OBJECTIVE
  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: University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
authors: Manel
authors: M
authors: Sabaté
authors: Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
authors: Lorenz
authors: L
authors: Räber
authors: Department of Clinical Research, Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors: Dik
authors: D
authors: Heg
authors: University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: sabrugal@clinic.ub.es.
authors: Salvatore
authors: S
authors: Brugaletta
authors: Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark.
authors: Henning
authors: H
authors: Kelbaek
authors: University Hospital of Bellvitge, Barcelona, Spain.
authors: Angel
authors: A
authors: Cequier
authors: Clinical Center of Serbia, Belgrade, Serbia.
authors: Miodrag
authors: M
authors: Ostojic
authors: Hospital do Meixoeiro, Vigo, Spain.
authors: Andrés
authors: A
authors: Iñiguez
authors: Cardiology Department, Triemlispital, Zurich, Switzerland.
authors: David
authors: D
authors: Tüller
authors: University Hospital of Sant Pau, Barcelona, Spain.
authors: Antonio
authors: A
authors: Serra
authors: Bristol Heart Institute, Bristol, United Kingdom.
authors: Andreas
authors: A
authors: Baumbach
authors: Thoraxcentrum Twente, Twente University, Enschede, the Netherlands.
authors: Clemens
authors: C
authors: von Birgelen
authors: University Hospital San Carlos, Madrid, Spain.
authors: Rosana
authors: R
authors: Hernandez-Antolin
authors: Cardiocentro, Lugano, Switzerland.
authors: Marco
authors: M
authors: Roffi
authors: Hospital General of Alicante, Alicante, Spain.
authors: Vicente
authors: V
authors: Mainar
authors: University Hospital Ferrara, Ferrara, Italy.
authors: Marco
authors: M
authors: Valgimigli
authors: Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Patrick W
authors: PW
authors: Serruys
authors: Department of Clinical Research, Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors: Peter
authors: P
authors: Jüni
authors: Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
authors: Stephan
authors: S
authors: Windecker
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D000068338:Everolimus; C518022:umirolimus; D020123:Sirolimus
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