title: Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials.
abstract: OBJECTIVE
  The aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI).
  
  
  RESULTS
  Individual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35, 95% CI: 0.16-0.74) and any TLR (OR 0.34, 95% CI: 0.21-0.54).
  
  
  CONCLUSIONS
  Killip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00962416. The EXAMINATION trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00828087.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taniwaki
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbæk
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
authors.forename: Miodrag
authors.initials: M
authors.lastname: Ostoijic
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernandez-Antolin
authors.forename: Andreas
authors.initials: A
authors.lastname: Baumbach
authors.forename: Stefan
authors.initials: S
authors.lastname: Blöchlinger
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Vicente
authors.initials: V
authors.lastname: Mainar
authors.forename: Manel
authors.initials: M
authors.lastname: Sabate
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D065840:Protective Factors; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome