CPORT-E: PCI Outcomes Similar Regardless of On-Site Cardiac Surgery
CHICAGO, IL—Elective percutaneous coronary intervention (PCI) performed at hospitals without on-site cardiac surgery is noninferior to similar procedures performed at hospitals with surgical capabilities, according to study results presented March 25, 2012, at the annual American College of Cardiology/i2 Scientific Session.
The study was published simultaneously online in the New England Journal of Medicine.
For the CPORT-E trial, Thomas Aversano, MD, of Johns Hopkins University (Baltimore, MD), and colleagues randomized 18,867 patients with stable CAD or ACS to undergo non-emergency PCI at a hospital with (n = 4,718) or without (n = 14,149) on-site cardiac surgery from April 2006 to March 2011. Participating centers were required to have primary PCI programs available 24 hours per day, 7 days a week, and to be capable of performing 200 PCI procedures annually.
From 6 Weeks to 9 Months
Six-week data reported in November 2011 at the American Heart Association Scientific Sessions showed that 0.9% of patients at hospitals without surgical backup (n = 132) and 1.0% of patients at hospitals with surgical capabilities (n = 46) died (95% CI -0.31 to 0.23; P = 0.004 for noninferiority).
Newly presented 9-month data showed that PCI at hospitals without surgical backup was noninferior to PCI at hospitals with on-site surgery with regard to the primary endpoint of MACE, though no differences were detected in all-cause mortality or MI (table 1).
Table 1. Nine-Month Outcomes (Intention to Treat Population)
|
|
No On-Site Surgery |
On-Site Surgery |
P Value |
|
Death |
3.2% |
3.2% |
- |
|
TVR |
6.5% |
5.4% |
0.01a |
|
MI |
3.1% |
3.1% |
- |
|
MACE (Primary Endpoint) |
12.1% |
11.2% |
0.01b |
aFor superiority; bFor noninferiority.
In an exploratory analysis, if CABG was not considered to qualify as TVR when it was performed as an initial procedure, the rates of MACE at 9 months among participants at hospitals without and those with on-site surgery were 11.9% and 10.5% (P = 0.21 for noninferiority) respectively. In a per-protocol analysis, the death rates at 6 weeks were 0.9% and 0.8%, respectively (P = 0.03 for noninferiority), and the rates of MACE at 9 months were 12.0% and 10.4%, respectively (P = 0.42 for noninferiority).
CABG was performed more frequently at hospitals with surgical backup vs. without. The incidence of unplanned catheterization at 6 weeks and 9 months and the incidence of any subsequent revascularization at 9 months were higher at hospitals without on-site surgery.
TVR Consistently Higher
In all analyses, hospitals without surgery on-site consistently had higher rates of TVR. Dr. Aversano and colleagues note that while the reasons behind this are unclear, it “may reflect a lower initial success rate and a more conservative approach by interventionalists practicing at relatively inexperienced centers that began PCI programs only as part of the CPORT-E trial.”
Going forward, for hospitals without on-site surgery to achieve results similar to those with surgical back-up, the authors write that “it may be necessary for such centers to participate in a formal PCI development program and for interventionalists who perform the procedures to meet the criteria for competency developed by the ACC, AHA, and SCAI.”
Dr. Aversano said that the “study was not undertaken with the express idea of the expansion of angioplasty protocols,” but rather to answer the questions of safety and feasibility in performing the procedure in hospitals without on-site surgery. He added that the majority of participating institutions without on-site surgery were close to a tertiary hospital with it, but there were a select few rural institutions that were not.
Study Details
There was a higher incidence of prior PCI in participants randomly assigned to hospitals without on-site cardiac surgery (P < 0.001). In addition, the rate of emergency catheterizations was higher, and the rate of urgent catheterizations lower, among participants assigned to hospitals with on-site surgery.
More PCIs were staged at hospitals with on-site surgery vs. without (P < 0.001), likely because of the need for transfer. Hence, cath lab visits and DES use were also higher at hospitals with surgery (P < 0.001; P = 0.03, respectively).
Source:
Aversano T, Lemmon CC, Liu L, et al. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2012;Epub ahead of print.
Disclosures:
Dr. Aversano reports no relevant conflicts of interest.
Related Stories:
Comments