SAN FRANCISCO—The rates of major adverse cardiac events at 30 days and 12 months were similar among patients randomized to PCI at Massachusetts hospitals with and without cardiac surgery services. The research was presented March 11 at the American College of Cardiology (ACC) scientific session and published concurrently in the New England Journal of Medicine.
Emergency surgery is rare with PCI. The reported incident rates hover between 0.1 and 0.4 percent; however, researchers have not determined if onsite cardiac surgery services are essential for best possible outcomes, according to Alice K. Jacobs, MD, from Boston University School of Medicine, and colleagues.
Expansion of PCI to hospitals without surgical services is justified as data support PCI for patients presenting with STEMI, she continued. “Controversy exists about expansion due to concerns about the risk to benefit ratio in a setting where timely access to PCI is less important for optimal cardiovascular outcomes,” she explained.
The MASS COMM (Massachusetts Hospitals With Cardiac Surgery On-Site and Community Hospitals Without Cardiac Surgery On-Site) trial was designed to investigate and compare the safety and effectiveness of PCI at Massachusetts hospitals with and without cardiac surgery services.
The researchers randomly assigned 3,691 patients, in a 3:1 ratio stratified by diabetes, to undergo PCI at one of 10 hospitals without onsite cardiac surgery services and one of seven with onsite surgery.
The co-primary endpoints were a composite of all-cause mortality, MI, repeat coronary revascularization or stroke at 30-days (safety) and 12 months (effectiveness).
Hospitals without on-site surgery participating in MASS COMM were required to meet the following criteria:
- Approval from the Massachusetts department of public health (DPH);
- Formal PCI development program;
- Participation in DPH special project for primary PCI;
- Signed collaboration agreement with onsite surgery hospital for 24/7 back-up and patient arrival within 60 minutes; and
- Perform a minimum 300 diagnostic procedures in each of previous two years; 36 primary PCI procedures per year.
Among the 2,774 patients treated in hospitals without cardiac surgery services, the rate of major adverse cardiac events was 9.5 percent at 30 days. The corresponding rate of the 917 patients treated in hospitals with on-site services was 9.4 percent. Rates increased to 17.3 percent and 17.8 percent, respectively, at 12 months.
There were no differences in the groups in terms of age, sex and risk factors. A history of prior MI was reported slightly more often for hospitals without on-site surgery.
“These data suggest that performance of PCI at hospitals without onsite cardiac surgery but with established programs and requisite hospital and operator procedural volume, may be considered an acceptable option for patients presenting to such hospitals for care,” Jacobs concluded.
“Will hospital administrators in surgery onsite hospitals cry SOS,” asked one ACC panelist. The answer is uncertain; however, the panel agreed that translation of MASS COMM requires strict adherence to the model.
Jacobs closed with a final point for hospitals to consider: How will PCI be disseminated? She hinted at a possible conflict between increasing access and duplicating services.