ORLANDO, FL—Percutaneous coronary intervention (PCI) on a nonemergency basis is safe in carefully selected centers that do not have on-site cardiac surgery facilities, according to findings from the CPORT-E trial presented during a late breaking clinical trial session on Monday, November 14, 2011, at the American Heart Association Scientific Sessions.

Researchers led by Thomas Aversano, MD, of Johns Hopkins Medical Institutions (Baltimore, MD), screened 18,867 patients who had undergone diagnostic catheterization at a center without on-site surgery and who still required PCI. These patients were randomly assigned on a 3:1 basis to have PCI at the initial institution or to be transferred to a hospital with surgical backup. A total of 13,981 patients ended up receiving PCI at a center without surgical backup compared with 4,515 who underwent PCI at a hospital with on-site cardiac surgery. To be included, the patients could not be judged at high risk, have unprotected left main disease, or EF less than 20%.

Success of PCI

The vast majority of PCI procedures were completed successfully at both types of centers. When assessed on a per-patient basis, 90.8% were completely successful and 5.7% were partially successful at centers without on-site surgery, while only 3.4% failed in these centers. In institutions with such facilities, 91.9% were completely successful and 5.5% were partially successful; only 2.5% failed.

When evaluated on a per-lesion basis, 93.4% of PCI procedures were successful at centers without cardiac surgical capabilities and 94.1% were successful at centers with such facilities. PCI success was defined as 20% residual stenosis or less and TIMI 3 flow.

Less than 1% of patients died: 0.91% in centers without on-site surgery and 0.93% in centers with such facilities (P = 0.94). Other adverse events were also similar at 6 weeks (table 1).

Table 1. Adverse Events at 6 Weeks

 
Emergency CABG was more frequent in centers with on-site surgery, while subsequent unplanned catheterization and PCI were more frequent in centers without such facilities (table 2).

Table 2. Unplanned Procedures

 
The initial findings from the CPORT-E trial are encouraging but narrow, said discussant Loren F. Hiratzka, MD, of TriHealth and Bethesda North and Good Samaritan Hospitals (Cincinnati, OH). “In a carefully selected subset of patients, the presence or absence of on-site cardiac surgery does not affect the 6-week outcomes of patients undergoing primary PCI when performed by experienced interventionalists in hospitals with a defined minimum annual PCI volume,” he said. “The central question is, can these results be reproduced in a general community practice?”

Even if positive outcomes can be achieved in the general community, the potential exists that a proliferation of community programs will end up causing per-center PCI volumes to fall. “There has to be major concern about surgical programs when volumes are in the neighborhood of or in some cases less than 100 cases a year [because programs have been] designed strictly to support PCI programs,” Dr. Hiratzka said.

“One of the main reasons for doing this study,” Dr. Aversano noted, “was that [states’ certificate of need] co-location requirements tended to spur on that kind of metastasis of surgical programs just to back up angioplasty. So if there is evidence you can separate those two, it doesn’t mean ‘let’s have more angioplasty programs.’ It means we don’t have to have them co-located necessarily.”

Study Details

Data on 9-month quality outcomes for the CPORT-E study will be reported in early 2012.

Centers without on-site cardiac surgery were included in this study if they had completed a formal PCI development program, adhered to CPORT participation requirements, and monitored outcomes. The centers had to be capable of performing at least 200 elective and primary PCI procedures per year, had 24/7 primary PCI coverage, and had interventionalists who met AHA/ACC competency criteria. A total of 60 centers participated in the study. The median annual PCI volume for these centers was 120.

Baseline demographic characteristics for patients treated in centers with and without surgical backup were similar. The mean age was 64 years; the population was equally divided by gender, race, and ethnicity. Risk factors for heart disease, cardiac and renal function were similar.

 

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Source:
Aversano T. CPORT-E trial: Randomized trial comparing medical, economic and quality of life outcomes of non-primary PCI at hospitals with and without on-site cardiac surgery. Presented at: American Heart Association Scientific Sessions 2011; November 14, 2011; Orlando, FL.

 

 

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