• Cardiology Clinical Trials
• Interventional Techniques & Devices

Performance of elective percutaneous coronary intervention (PCI) at hospitals with and without on–site open heart surgery backup produces similar rates of mortality and major adverse cardiac events (MACE), according to clinical outcomes from the Cardiovascular Patient Outcomes Research Team (CPORT) Non–Primary PCI Trial [CPORT–E; NCT00549796]. Thomas Aversano, MD, Johns Hopkins University, Baltimore, Maryland, USA, presented findings from the study [Aversano T et al. N Engl J Med 2012].

This first randomized noninferiority trial that was designed to address concerns about the need for emergency cardiac surgery to treat complications that are related to nonprimary PCI, CPORT–E had two primary endpoints: 1) all–cause mortality 6 weeks after the index PCI, and 2) composite of MACE 9 months after the index PCI, including death from all causes, Q–wave myocardial infarction (MI), or target–vessel revascularization (TVR).

Inclusion criteria included patients aged ≥18 years with stable coronary disease or an acute coronary syndrome. Patients with an acute ST–segment elevation MI (STEMI) or an ejection fraction of <20%, patients who required PCI of an unprotected left main coronary artery, and others who were considered to be at too high a risk in the judgment of the treating physician were excluded. A total of 60 centers with an annual mean procedural volume of 150 cases participated in the trial.

CPORT–E randomized a total of 18,867 patients in a 3:1 ratio to undergo PCI at a hospital without on–site cardiac surgery (n=14,149) or with on–site cardiac surgery (n=4718). Noninferiority margins for the risk difference were an absolute increase in risk of no more than 0.4% for mortality at 6 weeks and 1.8% for MACE at 9 months.

The 6–week mortality rates were 0.9% at hospitals without versus 1.0% with on–site surgery (ie, an absolute risk difference of −0.04%; 95% CI, −0.31% to +0.23%; the upper 95% CI was less than the noninferiority margin of 0.4%; p value for noninferiority=0.004; Table 1). The respective 9–month rates of MACE were 12.1% and 11.2% at hospitals without and with on–site surgery (ie, an absolute risk difference of +0.92%; 95% CI, +0.04% to +1.80%; the upper 95% CI was equal to the noninferiority margin of 1.8%; therefore, the one–sided p value for noninferiority=0.05; Table 2). The rate of TVR was significantly higher in hospitals without on–site surgery (6.5% vs 5.4%; p value for superiority of on–site surgery=0.01).

When only patients who were treated per protocol were analyzed (excluding patients who crossed over), the respective 9–month rates of MACE were 12.0% and 10.4% at hospitals without and with on–site surgery (ie, an absolute risk difference of +1.64%; 95% CI, +0.77% to +2.51%); the upper 95% CI was higher than the noninferiority margin of 1.8%; therefore, the one–sided p value for noninferiority was not significant and treatment at non–on–site surgery hospitals were not equivalent to treatment at on–site surgery hospitals.

Six weeks after the index PCI, mortality was similar among hospitals with and without on–site surgery; in addition, the incidence of bleeding, renal failure, and stroke was similar among both kinds of facilities. However, unplanned coronary artery bypass grafting (CABG) surgery, especially emergency CABG, was more frequent among patients who were assigned to hospitals with on–site surgery; yet, unplanned catheterization and PCI procedures were more frequent among patients who were assigned to non–on–site surgery hospitals. The rate of PCI failure was higher among participants who were treated at hospitals without on–site surgery.

Dr. Aversano and colleagues concluded that “nonprimary PCI outcomes at hospitals without on–site cardiac surgery are noninferior to those with on–site cardiac surgery, if the former completes a formal PCI development program, adheres to C–PORT–E participation requirements, and has outcomes monitored.”

However, higher rates of subsequent TVR among patients who were treated at non–on–site surgery hospitals contributed to a 0.92% absolute higher rate of MACE at 9 months, with a 95% upper CI of 1.8% that equaled the noninferiority border. The authors suggested within their manuscript that the reasons for an incomplete initial revascularization were unclear “but may reflect a lower initial success rate and a more conservative approach by interventionalists practicing at relatively inexperienced centers that began PCI programs only as part of the CPORT–E trial.“ Additional studies would be helpful to further clarify the comparison of longer–term results of PCI between these two types of facilities.

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