title: Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease.
abstract: BACKGROUND
  To assess the influence of therapy crossovers on treatment comparisons and mortality at 5 years in patients with ischemic heart disease and heart failure randomly assigned to medical therapy alone (MED) or to MED and coronary artery bypass graft (CABG) surgery in the Surgical Treatment for Ischemic Heart Failure (STICH) trial.
  
  
  RESULTS
  The influence of early crossover (within the first year after randomization) on 5-year mortality was assessed using time-dependent multivariable Cox models. CABG was performed in 65/602 patients (10.8%) assigned to MED, and 55/610 patients (9.0%) assigned to CABG received MED only. Common reasons for crossover from MED to CABG were progressive symptoms or acute decompensation. MED-assigned patients who underwent CABG had lower 5-year mortality than those who received MED only (25% vs 42%; hazard ratio, 0.50; 95% confidence interval, 0.30-0.85; P=0.008).The main reason for crossover from CABG to MED was patient/family decision. Five patients did not undergo their assigned CABG within a year but died before receiving surgery without status change. They were deemed crossover to MED. The CABG-to-MED crossover population had higher 5-year mortality compared with those treated with CABG per-protocol (59% vs 33%; hazard ratio, 2.01; 95% confidence interval, 1.36-2.96; P<0.001). CABG was associated with lower mortality compared with MED in per-protocol and several time-dependent analyses (all P<0.05).
  
  
  CONCLUSIONS
  CABG reduced mortality in both the per-protocol and crossover STICH patient populations. Crossover from assigned therapy, therefore, diminished the impact of CABG on survival in STICH when analyzed by intention to treat.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.
authors.affiliation: Department of Cardiothoracic Surgery, University of Jena, Jena, Germany. doenst@med.uni-jena.de
authors.forename: Torsten
authors.initials: T
authors.lastname: Doenst
authors.forename: John G F
authors.initials: JG
authors.lastname: Cleland
authors.forename: Jean L
authors.initials: JL
authors.lastname: Rouleau
authors.forename: Lilin
authors.initials: L
authors.lastname: She
authors.forename: Stanislaw
authors.initials: S
authors.lastname: Wos
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: Maria
authors.initials: M
authors.lastname: Krzeminska-Pakula
authors.forename: Balram
authors.initials: B
authors.lastname: Airan
authors.forename: Robert H
authors.initials: RH
authors.lastname: Jones
authors.forename: Matthias
authors.initials: M
authors.lastname: Siepe
authors.forename: George
authors.initials: G
authors.lastname: Sopko
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Velazquez
authors.forename: Normand
authors.initials: N
authors.lastname: Racine
authors.forename: Lars
authors.initials: L
authors.lastname: Gullestad
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Filgueira
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
mesh_terms: D000368:Aged; D015897:Comorbidity; D001026:Coronary Artery Bypass / Q000401:mortality; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000401:mortality* / Q000601:surgery / Q000628:therapy*; D018592:Cross-Over Studies; D018450:Disease Progression; D005260:Female; D054143:Heart Failure, Systolic / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged
keywords: coronary bypass surgery; heart failure; medical therapy