title: Off-pump versus on-pump coronary artery bypass grafting surgery in high-risk patients: PRAGUE-6 trial at 30 days and 1 year.
abstract: OBJECTIVE
  Off-pump coronary artery bypass graft surgery (OPCAB) is an established alternative to on-pump surgical revascularization. Previous studies in patients with low or intermediate risk showed no significant differences between off-pump and on-pump surgical revascularization. The aim of this study was to compare the two techniques in patients with high operative risk.
  
  
  METHODS
  PRAGUE-6 is a prospective randomized single-center study of 206 patients, with an additive EuroSCORE ≥ 6, scheduled for isolated coronary surgery: Group A - on-pump (n = 108) versus Group B - off-pump (n = 98). The primary outcome was a combined endpoint of all-cause deaths, stroke, myocardial infarction, or renal failure requiring new hemodialysis, within 30 days and 1 year after randomization. All data were analyzed using the "intention-to-treat" principle.
  
  
  RESULTS
  Early postoperative myocardial infarction was detected in 12.1% (A) vs. 4.1% (B) of patients (P = 0.048, hazard ratio 0.32, 95% CI 0.11-0.99). There was a significantly higher incidence of primary combined end-point in group A (20.6% vs. 9.2%, P = 0.028, HR 0.41, 95% CI 0.19-0.91) in the first 30 days, but not after 1 year (30.8% vs. 21.4%, P = 0.117, HR 0.65, CI 0.37-1.12).
  
  
  CONCLUSIONS
  Off-pump surgical revascularization in patients with high operative risks can significantly reduce the incidence of major postoperative complications during the first 30 days. There was no statistically significant difference in the incidence of these complications after 1 year.
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Hlavicka
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Zbynek
authors.initials: Z
authors.lastname: Straka
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Stepan
authors.initials: S
authors.lastname: Jelinek
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Budera
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Tomas
authors.initials: T
authors.lastname: Vanek
authors.affiliation: National Institute of Public Health, Prague, Czech Republic.
authors.forename: Marek
authors.initials: M
authors.lastname: Maly
authors.affiliation: Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology / Q000401:mortality; D000293:Adolescent; D000328:Adult; D000368:Aged; D001026:Coronary Artery Bypass / Q000379:methods* / Q000401:mortality; D047549:Coronary Artery Bypass, Off-Pump / Q000379:methods / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D009204:Myocardial Revascularization / Q000379:methods / Q000401:mortality; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome; D055815:Young Adult
keywords: cardiopulmonary bypass; high-risk patient; off-pump; revascularization