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More data suggest onsite cardiac surgery may not be necessary for PCI-treated patients
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SAN FRANCISCO — Results from the Massachusetts-based MASS COMM trial suggest that outcomes of nonemergency PCI are not influenced by whether the procedure is performed at a site with or without cardiac surgery.
The results were presented at a late-breaking trial presentation at the American College of Cardiology Scientific Sessions, 1 year after the final results from the CPORT-E trial were presented at the ACC 2012 meeting, which demonstrated that elective PCI was safe and effective at hospitals without onsite surgery units.
Despite these earlier results, Alice K. Jacobs, MD, professor of medicine, Boston University School of Medicine, and trial researcher, said in a presentation, “Controversy exists over the further expansion of nonemergency PCI to hospitals without onsite cardiac surgery, due to concern over the risk-to-benefit ratio in a setting where timely access to PCI is less important for optimal CV outcomes, which is reflected in the Class IIb recommendation in the 2011 PCI guidelines.”
This led to the design of the prospective, multicenter, noninferiority, randomized, controlled MASS COMM trial, which sought to assess the short-term safety and 12-month outcomes of PCI — excluding primary PCI for STEMI — performed at hospitals with vs. without on-site cardiac surgery in Massachusetts. Patients undergoing coronary angiography at hospitals without onsite cardiac surgery were randomly assigned 3:1 to PCI at hospitals without (n=2,774) or with (n=917) onsite surgery. The co-primary endpoints were 30-day (safety) and 12-month (effectiveness) MACE — a composite of all-cause mortality, MI, repeat coronary revascularization or stroke. Baseline characteristics were similar between the groups, with the exception of prior MI, which was higher in the hospitals without onsite surgery (24.1% vs. 20.2%; P=.015).
At 30 days, rates of MACE were nearly identical between groups (no onsite surgery, 9.5% vs. onsite surgery, 9.4%; RR= 1.00; P for noninferiority <.001), which was also the case at 1 year (no onsite surgery, 17.3% vs. onsite surgery, 17.8%; HR=0.98; P for noninferiority <.001). None of the differences between the individual endpoints at either time period reached statistical significance.
Secondary endpoints, including 30-day and 12-month rates of target lesion revascularization, target vessel revascularization and stent thrombosis, were also similar.
“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 said. – by Brian Ellis
For more information:
Jacobs AK. Late-breaking clinical trials IV: General cardiology. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Jacobs AK. N Eng J Med. 2013;doi:10.1056/nejmoa1300610.
Disclosure: Jacobs reports no relevant financial disclosures. The study was funded by Massachusetts Hospitals without on-site cardiac surgery.