title: Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention.
abstract: BACKGROUND
  There is conflicting evidence on the utility of elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI). Observational series have indicated a reduction in major in-hospital adverse events, although randomized trial evidence does not support this. A recent study has suggested a mortality benefit trend early after PCI, but there are currently no long-term outcome data from randomized trials in this setting.
  
  
  RESULTS
  Three hundred one patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8; maximum possible score=12) were randomized to receive PCI with elective IABP support (n=151) or without planned IABP support (n=150). Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland). The groups were balanced in terms of baseline characteristics (left ventricular ejection fraction, 23.6%; BCIS-1 jeopardy score, 10.4) and the amount and type of revascularization performed. Mortality data were available for the entire cohort at a median of 51 months (interquartile range, 41-58) from randomization. All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group (n=42) than in the group that underwent PCI without planned IABP support (n=58) (hazard ratio, 0.66; 95% confidence interval, 0.44-0.98; P=0.039).
  
  
  CONCLUSIONS
  In patients with severe ischemic cardiomyopathy treated with PCI, all-cause mortality was 33% at a median of 51 months. Elective IABP use during PCI was associated with a 34% relative reduction in all-cause mortality compared with unsupported PCI.
  
  
  BACKGROUND
  URL: http://www.isrctn.org. Unique identifier: ISRCTN40553718; and http://www.clinicaltrials.gov. Unique identifier: NCT00910481.
authors.affiliation: Cardiovascular Division, St. Thomas' Hospital Campus, Kings College London, London SE1 7EH, UK. Divaka.Perera@kcl.ac.uk
authors.forename: Divaka
authors.initials: D
authors.lastname: Perera
authors.forename: Rod
authors.initials: R
authors.lastname: Stables
authors.forename: Tim
authors.initials: T
authors.lastname: Clayton
authors.forename: Kalpa
authors.initials: K
authors.lastname: De Silva
authors.forename: Matthew
authors.initials: M
authors.lastname: Lumley
authors.forename: Lucy
authors.initials: L
authors.lastname: Clack
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000401:mortality*; D003131:Combined Modality Therapy / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000401:mortality*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy; D017202:Myocardial Ischemia / Q000401:mortality / Q000628:therapy; D012307:Risk Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000401:mortality / Q000628:therapy