CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

March 25th, 2012

Study Supports PCI Without On-Site Surgical Backup

Here’s a great example of genuine medical progress: 10% of the first 50 patients who received balloon angioplasty from the procedure’s developer, Andreas Grüntzig, required emergency bypass surgery. By 2002 only 0.15% of PCI patients required emergency surgery, leading many to believe that surgical backup was no longer necessary.

Now a large new study provides strong evidence that PCI can, in fact, be performed safely and effectively at hospitals without surgical backup. In a presentation at the American College of Cardiology and published simultaneously in the New England Journal of Medicine, Thomas Aversano and colleagues in the Cardiovascular Patient Outcomes Research Team (C-PORT) report  the results of a trial that randomized 18,867 patients to undergo PCI at hospitals with or without surgical backup.

  • The 6-week mortality rate was 0.9% at hospitals without surgical backup versus 1.0% at hospitals with surgical backup, which was well within the predefined margin of noninferiority of a 0.4% difference in risk (P=0.004).
  • The 9-month composite rate of death, Q-wave MI, or target-vessel revascularization was 12.1% and 11.2%, respectively, which met the predefined margin of noninferiority of a 1.8% difference in risk (P=0.05).

The authors noted that high-risk patients were excluded from the study, raising the possibility that the study population may differ from the general PCI population. “The study shows that under certain circumstances, non-primary angioplasty can be performed safely and effectively at hospitals without on-site cardiac surgery,” said Aversano, in an ACC press release.

Categories: Cardiac Surgery
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3 Responses to “Study Supports PCI Without On-Site Surgical Backup”

  1. Larry Husten, PHD says:
    March 25, 2012 at 11:17 am

    At an ACC press conference, Aversano discussed the potential impact of the study and warned against interpreting the study as an open invitation to implement PCI without surgical backup:

    “It doesn’t say you ought to go out and do this and expand it willy nilly, that was not the purpose of this project… These hospitals did not simply buy stents and start doing angioplasty. They went through a formal development program.”

  2. Richard A. Lange, MD, MBA says:
    March 26, 2012 at 8:13 pm

    If you asked most young interventionalists (i.e., whippersnappers) what they consider to be the most important benefit of stents over POBA they would probably answer the reduction in restenosis rates. Us “oldtimers” would tell you that it’s the virtual disappearance of acute coronary dissection that often resulted in emergent CABG. Without stenting, C-PORT would not be possible.

    The C-PORT study unequivocally shows that with proper training and oversight, elective PCI can be safely performed without surgical backup in patients who are not high risk when the cath lab has participated in a formal training and oversight program.

    Now the hard part….how to turn this “system approach” into a “real world” experience? Will hospitals voluntarily adopt the same rigorous training and oversight process, or will it only happen after payors refuse to reimburse institutions that do anything less?

  3. David May, MD, PhD says:
    March 29, 2012 at 11:16 pm

    And now the fun begins. If 200 a year is good, surely 100 a year is better! In fact, I can hear it now…” Our system does 600 a year (in 18 hospitals), and our outcomes are ….? Maybe high volume operators can do PCI in small, low volume centers; maybe low volume operators are acceptable in high volume centers. But do we really want low volume operators in low volume centers with inexperienced low volume staff doing PCI today? As financial pressures increase on hospital systems, we will see the mentality of ” do it here” increase. This tendency must be resisted if professionalism is to be our cloak.