Outcomes of PCI at Hospitals With or Without On-Site Cardiac Surgery
What are the outcomes of percutaneous coronary intervention (PCI) performed at hospitals without and those with on-site cardiac surgery?
The investigators randomly assigned participants to undergo PCI at a hospital with or without on-site cardiac surgery. Patients requiring primary PCI were excluded. The trial had two primary endpoints: 6-week mortality and 9-month incidence of major adverse cardiac events (MACE) (the composite of death, Q-wave myocardial infarction, or target vessel revascularization). Noninferiority margins for the risk difference were 0.4% for mortality at 6 weeks and 1.8% for MACE at 9 months.
A total of 18,867 patients were randomly assigned in a 3:1 ratio to undergo PCI at a hospital without on-site cardiac surgery (14,149 patients) or with on-site cardiac surgery (4,718 patients). The 6-week mortality rate was 0.9% at hospitals without on-site surgery versus 1.0% at those with on-site surgery (difference, −0.04 percentage points; 95% confidence interval [CI], −0.31 to 0.23; p = 0.004 for noninferiority). The 9-month rates of MACE were 12.1% and 11.2% at hospitals without and those with on-site surgery, respectively (difference, 0.92 percentage points; 95% CI, 0.04-1.80; p = 0.05 for noninferiority). The rate of target vessel revascularization was higher in hospitals without on-site surgery (6.5% vs. 5.4%, p = 0.01).
The authors concluded that PCI performed at hospitals without on-site cardiac surgery was noninferior to PCI performed at hospitals with on-site cardiac surgery.
This study reports that PCI performed at hospitals without on-site cardiac surgery was noninferior to PCI performed at hospitals with on-site cardiac surgery with respect to mortality at 6 weeks and MACE at 9 months. Although there were no significant differences between the two study groups with respect to rates of death or Q-wave myocardial infarction, trial participants treated at hospitals without on-site cardiac surgery more frequently required target vessel revascularization. For outcomes of PCI at hospitals without on-site cardiac surgery to be similar to those at hospitals with on-site cardiac surgery, it may be helpful for such centers to participate in a formal PCI development program and for interventionalists who perform the procedures to meet the criteria for competency developed by the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions.
Keywords: Outcome Assessment (Health Care), Myocardial Infarction, Research Personnel, Cardiology, Disclosure, Confidence Intervals, Cardiac Surgical Procedures, United States, Percutaneous Coronary Intervention
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