title: On-pump versus off-pump coronary artery bypass surgery in high-risk patients: operative results of a prospective randomized trial (on-off study).
abstract: OBJECTIVE
  To analyze the risk reduction of cardiopulmonary bypass complications between on-pump and off-pump coronary artery bypass grafting in high-risk patients.
  
  
  METHODS
  This multicenter, prospective, randomized, parallel trial enrolled patients for elective or urgent isolated coronary artery bypass grafting with an additive European System for Cardiac Operative Risk Evaluation of 6 or more. The patients in cardiogenic shock were excluded. The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, reoperation for bleeding and adult respiratory distress syndrome within 30 days after surgery. The total sample size was 693 patients, according to a scheduled interim analysis at 400 patients enrolled (α-spending = 0.029, Pocock method).
  
  
  RESULTS
  A total of 411 patients were included in the interim analysis. Randomization assigned 203 patients to on-pump and 208 patients to off-pump treatment. Of the 411 patients, 24 crossed over; thus, 195 patients were actually treated on-pump and 216 off-pump. According to the intention to treat analysis, the rate of the composite primary end point was significantly lower (unadjusted P = .009, adjusted P = .010) in the off-pump group (5.8% vs 13.3%). The risk of experiencing the primary end point was significantly greater for the on-pump group (unadjusted odds ratio, 2.51; 95% confidence interval, 1.23-5.10; P = .011; adjusted odds ratio, 3.07; 95% confidence interval, 1.32-7.14; P = .009).
  
  
  CONCLUSIONS
  Off-pump coronary artery bypass grafting reduces early mortality and morbidity in high-risk patients.
authors.affiliation: Cardiovascular Surgery Department, Luigi Sacco University General Hospital, Milano, Italy. lemma.massimo@hsacco.it
authors.forename: Massimo G
authors.initials: MG
authors.lastname: Lemma
authors.forename: Enrico
authors.initials: E
authors.lastname: Coscioni
authors.forename: Francesco P
authors.initials: FP
authors.lastname: Tritto
authors.forename: Paolo
authors.initials: P
authors.lastname: Centofanti
authors.forename: Corrado
authors.initials: C
authors.lastname: Fondacone
authors.forename: Andrea
authors.initials: A
authors.lastname: Salica
authors.forename: Agnese
authors.initials: A
authors.lastname: Rossi
authors.forename: Tiziana
authors.initials: T
authors.lastname: De Santo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Benedetto
authors.forename: Luigi
authors.initials: L
authors.lastname: Piazza
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Antonio L De Luca Tupputi
authors.initials: AL
authors.lastname: Schinosa
authors.forename: Ruggero
authors.initials: R
authors.lastname: De Paulis
authors.forename: Monica
authors.initials: M
authors.lastname: Contino
authors.forename: Michele
authors.initials: M
authors.lastname: Genoni
mesh_terms: D000368:Aged; D002315:Cardiopulmonary Bypass / Q000009:adverse effects / Q000401:mortality; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality; D047549:Coronary Artery Bypass, Off-Pump / Q000009:adverse effects / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D016017:Odds Ratio; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000601:surgery; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000209:etiology / Q000517:prevention & control; D012086:Reoperation; D012128:Respiratory Distress Syndrome / Q000209:etiology / Q000517:prevention & control; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome