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The safety and effectiveness of nonemergency percutaneous coronary intervention (PCI) at hospitals without on-site cardiac surgery are controversial, partly because of high historical rates of emergency surgery with PCI. In this Massachusetts study, investigators randomized 2774 patients to undergo PCI at 10 hospitals without on-site surgery and 917 to be transferred to 7 hospitals with on-site surgery. Average patient age was 64 years, and average ejection fraction was 55%. Minimum volume requirements were 300 diagnostic coronary catheterizations and 36 primary PCIs per year for sites and 75 PCIs per year for operators.
The rate of the composite endpoint — death, myocardial infarction, repeat revascularization, and stroke — did not differ significantly between patients assigned to sites without on-site surgery and those assigned to sites with on-site surgery, either at 30 days (9.5% vs. 9.4%) or at 12 months (17.3% vs. 17.8%). No individual component of the composite endpoint differed significantly between the groups; however, rates of death and emergency coronary artery bypass surgery were several-fold higher in hospitals without on-site surgery than in those with on-site surgery (0.7% vs. 0.3% and 0.3% vs. 0.1%, respectively). The rate of the composite endpoint also varied considerably across individual sites at both 30 days (by 14%) and 12 months (by 17%).
Jacobs AK et al. Nonemergency PCI at hospitals with or without on-site cardiac surgery. N Engl J Med 2013 Mar 11; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa1300610)
Comment
These results build on the CPORT-E findings (JW Cardiol Mar 25 2012) that early and late outcomes of elective percutaneous coronary intervention by experienced operators in low-risk patients do not differ between hospitals with and without on-site cardiac surgery. However, the substantial between-hospital variability suggests the need for ongoing quality assurance and program monitoring. Although I agree with the authors' conclusion that PCI in this setting may be an acceptable option for patients, I would also point out that this study was not powered to detect noninferiority of the primary endpoint components that are of most concern: death and emergency surgery.