This article is more than 5 years old. Information may no longer be current.
CPORT-E: Safe, successful PCI possible without onsite cardiac surgery unit
Click Here to Manage Email Alerts
CHICAGO — Final results from the CPORT-E trial indicate that community hospitals without onsite cardiac surgery units can perform elective percutaneous coronary intervention as safely and as effectively as hospitals with onsite cardiac surgery units.
“Our motivations for studying nonprimary angioplasty in hospitals without onsite cardiac surgery include sustaining standalone PCI programs; improving access to PCI services; reducing pressure to develop cardiac surgery programs created primarily for angioplasty backup; and because additional research is needed to inform future health care policy decisions,” Thomas Aversano, MD, associate professor of cardiology at Johns Hopkins University, said during a presentation at the American College of Cardiology’s 61st Scientific Sessions.
The Cardiovascular Patient Outcomes Research Team Trial (CPORT-E) researchers conducted a noninferiority trial comparing outcomes of 18,867 patients who were randomly assigned in a 3:1 ratio to undergo nonprimary PCI at a hospital with or without an onsite cardiac surgery unit. The 60 participating centers without onsite cardiac surgery units were required to complete a PCI development program; have primary PCI programs available 24 hours per day, 7 days per week; and had to be capable of performing 200 PCI procedures per year.
Six-week mortality was 0.9% at hospitals without onsite surgery and 1% at those with onsite surgery (P=.004 for noninferiority). Similarly, 9-month rates of major adverse cardiac events, defined as a composite of death, Q-wave MI or target vessel revascularization, were 12.1% and 11.2%, respectively (P=.05 for noninferiority). Rate of target vessel revascularization was slightly higher in hospitals without onsite cardiac surgery units compared with those with onsite cardiac surgery units (6.5% vs. 5.4%; P=.01), Aversano said, but rates of other adverse events such as stroke, renal failure, bleeding and the need for vascular surgery were comparable for all hospitals.
Until a recent guideline change by the ACC and American Heart Association, community hospitals without cardiac surgery units performed only emergency angioplasties. Patients needing elective angioplasty were transferred to facilities with on-site cardiac surgery units.
“Up until November 2011, elective PCI was class 3 in the ACC and AHA guidelines, meaning that we should not do elective angioplasty,” Ralph G. Brindis, MD, MPH, FACC, FSCAI, immediate past-president of the ACC, said during a press conference. “While updating the guidelines, we upgraded it to 2b, which means it seems this is something we could possibly do.”
He noted, however, that this decision was based on observational studies.
“[CPORT-E] is a true randomized controlled trial showing safety and efficacy, which is an important finding for us all,” said Brindis, who is senior advisor for cardiovascular diseases at Northern California Kaiser Permanente and clinical professor of medicine at the University of California, San Francisco. – by Melissa Foster
For more information:
- Aversano T. Late-breaking clinical trials II. Presented at: the American College of Cardiology 61st Scientific Sessions & Expo; March 24-27, 2012; Chicago.
- Aversano T. N Engl J Med. 2012; 10.1056/NEJMoa1114540.
Disclosure: Dr. Aversano reports consulting for Science First and his institution has received a CMS Innovation Grant.
This trial was long awaited. Such practices exist in the United States as well as elsewhere. These are very commonly asked questions that are being asked: Is it safe? Is it appropriate? Is it a good thing to do? Unless one conducted a study such as this, which is a randomized study, these very reasonable questions could not be answered. Right now, we know that if you pay enough attention and follow a strict pathway of quality control, it is very safe to perform angioplasty without surgical backup, even in elective patients. I think the sample size of hospitals and patients that were studied is very reassuring.
– George Dangas, MD, PhD
Professor of Medicine
Mount Sinai School of Medicine