VA Study Confirms Safety of PCI Without Surgical Backup
Allowing percutaneous coronary intervention (PCI) at centers without on-site cardiothoracic surgery capabilities can improve patient access without affecting safety, affirmed a study of the Veterans Affairs (VA) system published online September 4, 2014, ahead of print in Circulation. However, the need for subsequent revascularization—particularly repeat PCI—was higher at centers without surgical backup.
|Thomas M. Maddox, MD, MSc, of the VA Eastern Colorado Health Care System (Denver, CO), and colleagues looked at data from 24,387 patients (mean age 63 years; 98.4% male) who underwent PCI at 59 VA facilities from October 2007 to September 2010; 27.1% of patients underwent procedures at 18 facilities without on-site surgical backup. All information was recorded in the VA CART (Clinical Assessment, Reporting, and Tracking) program, which was established when the VA first allowed PCI without surgical backup in 2005.|
Median patient drive time to the nearest PCI facility—a proxy for access—was shortened by 90.8 minutes when centers without surgical backup were included in the scenario, with an even greater reduction for patients undergoing primary PCI for STEMI (96.1 minutes) compared with those with NSTEMI/unstable angina (91.4 minutes) and those having elective procedures (87.2 minutes).
That improvement in access was not accompanied by any signals of harm, with rates of emergent CABG during the procedure and procedural mortality rates of 0.1% or lower, regardless of whether the center had on-site surgical backup.
In addition, the 1-year rate of all-cause mortality or MI hospitalization (primary outcome) was similar at centers with and without on-site surgical backup (8.7% vs 8.4%; P = .51). The lack of difference was consistent for mortality and MI individually, as well as across PCI indications and volumes.
There was, however, a greater risk of subsequent unplanned revascularization in the year following the index procedure at facilities without on-site surgery (15.2% vs 12.7%; adjusted HR 1.21; 95% CI 1.03-1.42), driven by a higher risk of repeat PCI (adjusted HR 1.28; 95% CI 1.07-1.52).
Real World Matches Clinical Trials
The feasibility and safety of performing PCI without on-site surgical backup has been demonstrated in multiple clinical trials and observational studies, Dr. Maddox and colleagues write. Consequently, “current PCI guidelines allow for the procedure at facilities without on-site cardiothoracic surgery, but call for appropriate program development and quality oversight,” they say, noting the higher rate of unplanned revascularization when on-site backup is not available.
“The reasons behind this finding are unclear, but may represent a lower initial PCI success rate and/or a more conservative approach by interventionalists at these facilities,” the authors write. “Regardless of the reasons, this difference in revascularization rates was not accompanied by a safety signal of harm at 1 year.”
The researchers acknowledge that the study findings may not be applicable to female patients or to settings outside of the VA.
“The integrated nature of the VA health care system, the unique aspects of the national VA quality oversight program, and low PCI volumes in the VA may reduce the generalizability of our findings to non-VA settings without these characteristics,” they write. “However, the quality oversight features inherent in the VA CART program can be replicated in non-VA settings, and the national move towards greater health care integration and accountable care organizations may necessitate emulating the VA’s approach.”
Maddox TM, Stanislawski MA, O’Donnell C, et al. Patient access and 1-year outcomes of percutaneous coronary intervention facilities with and without on-site cardiothoracic surgery: insights from the VA CART program. Circulation. 2014;Epub ahead of print.
- Dr. Maddox reports receiving support from the Department of Veterans Affairs Health Services.