April 4th, 2011

PRECOMBAT Explores PCI Versus CABG for Left Main Disease

In the PRECOMBAT trial, Korean investigators randomized 600 patients with unprotected left main disease to either PCI with a sirolimus-eluting stent or CABG. The results were presented at the ACC and published simultaneously in the New England Journal of Medicine.

At 1 year, the incidence of the primary composite endpoint – death from any cause, MI, stroke, or ischemia-driven target-vessel revascularization – was 8.7% (26 patients) in the PCI group versus 6.7% (20 patients) in the CABG group, for an absolute risk reduction of 2% (95% CI -1.6 – 5.6, p=0.01 for noninferiority). At 2 years, the incidence was 12.2%  for PCI versus 8.1% for CABG (HR 1.50, 95% CI 0.90 -2.52, p=0.12).

The authors conclude that although the trial “met the prespecified criterion for noninferiority,” their results “cannot be considered to be clinically directive” because “the power of the trial was lower than anticipated and because the noninferiority margin was wide.”

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

2 Responses to “PRECOMBAT Explores PCI Versus CABG for Left Main Disease”

  1. Robin Motz, M.D., Ph.D. says:

    There already have been many arguments over whether or not these results are clinically significant. In experimental physics we have a simple rule: if two physicists have to argue about whether or not experimental results are significant, they they are not.(Of course in observational astrophysics, where the data is relatively sparse,and there are relatively few significant observations, there are arguments over whether or not the data fits a particular theory, such as an expanding universe, the amount of dark matter, etc.)

  2. Great point. So it seems there will remain equipoise on this one — as well as on whether or not the universe is expanding…