March 25, 2012 (Chicago, Illinois) — Nine-month clinical outcomes from a randomized trial comparing elective PCI at centers without vs with on-site cardiac surgery suggest, like the previously reported six-week mortality results, that patients fare about the same regardless of whether PCI has the surgical safety net .
The composite rates of death from any cause, Q-wave MI (QMI), and target-vessel revascularization (TVR) at nine months were 12.1% without on-site surgery and 11.2% with backup surgery in the noninferiority trial, called Cardiovascular Patient Outcomes Research Team Non-Primary PCI (C-PORT E). Previously reported six-week mortality had been 0.9% and 1.0% respectively, which also met the trial's criterion for noninferiority.
The C-PORT-E trial with its six-week and nine-month outcomes, which were co–primary end points, was published online in the New England Journal of Medicine today to coincide with presentation of the nine-month results here at the American College of Cardiology 2012 Scientific Sessions by Dr Thomas Aversano (Johns Hopkins University, Baltimore, MD). He had presented the six-week mortality results last November at the American Heart Association 2011 Scientific Sessions, as reported at the time by heartwire .
The overall findings support recently updated ACC/AHA guidelines that gave a qualified thumbs-up to elective PCI at non–cardiac-surgery centers (gaining a class 2b recommendation: "may be considered"). Emergency PCI at such centers had already been acceptable to the guidelines.
And the practice apparently has broad support in the cardiology community. In a survey conducted jointly last year by theheart.org and US News & World Report, two-thirds of respondents said that elective angioplasty at centers without cardiothoracic surgery on-site can be done safely and effectively, although many had caveats such as limiting such procedures to "well-qualified" and/or higher-volume PCI operators.
Importantly, the non–cardiac-surgery centers in C-PORT E were required to meet certain volume thresholds, including >200 PCIs per year (recently established programs were allowed to have done >100/year in their first year).
As previously reported for C-PORT E, 18 867 patients were randomized 1:3 to undergo PCI at centers with (n=4718) or without (n=14 149) on-site cardiac surgery.
Complete Primary Outcomes and Selected Secondary Outcomes of the C-PORT E Trial
|End point||Without surgery on-site (%), n=14149||With surgery on-site (%), n=4718||p|
|6-wk all-cause mortalitya||0.9||1.0||0.004 for noninferiority|
|9-mo major adverse eventsa, b||12.1||11.2||0.05 for noninferiority|
|9-mo all-cause mortality||3.2||3.2||NS|
|Emergency CABG at index procedure||0.1||0.2||NS|
a. Primary end points
b. Major adverse events=all-cause mortality, QMI, or TVR
Aversano et al note that the C-PORT E population specifically excluded high-risk patients. "It is possible that the population studied is different from the general population requiring PCI, although a comparison of baseline characteristics with those reported in the National Cardiovascular Data Registry suggests that this is not the case," they write.
heartwire will update the story with commentary later in the day.
C-PORT E was funded by the sites participating in the trial. Aversano reports no conflicts of interest; disclosures for the coauthors are listed at www.nejm.org .
Heartwire from Medscape © 2012 Medscape, LLC
Cite this: C-PORT E Nine-Month Results: Elective PCI Doesn't Need Surgery Safety Net - Medscape - Mar 25, 2012.