title: Nonemergency PCI at hospitals with or without on-site cardiac surgery.
abstract: BACKGROUND
  Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain.
  
  
  METHODS
  We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness).
  
  
  RESULTS
  A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point.
  
  
  CONCLUSIONS
  Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).
authors.affiliation: Boston University School of Medicine, Cardiovascular Medicine, Department of Medicine, Boston Medical Center, Boston, MA 02118, USA. alice.jacobs@bmc.org
authors.forename: Alice K
authors.initials: AK
authors.lastname: Jacobs
authors.forename: Sharon-Lise T
authors.initials: SL
authors.lastname: Normand
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Carrozza
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Marks
authors.forename: Nancy
authors.initials: N
authors.lastname: Murphy
authors.forename: Iyah K
authors.initials: IK
authors.lastname: Romm
authors.forename: Madeleine
authors.initials: M
authors.lastname: Biondolillo
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods / Q000592:standards; D016507:Cardiology Service, Hospital / Q000592:standards / Q000706:statistics & numerical data*; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D019233:Retreatment; D012306:Risk