http://www.theheart.org/web_slides/1225253.do A PRECOMBAT trial Premier of randomized comparison of bypass surgery vs angioplasty using sirolimus-eluting stent in patients with left main coronary artery disease

1. PRECOMBAT

2. PRECOMBAT
SJ Park (Asan Medical Center, Seoul, Korea)
American College of Cardiology 2011 Scientific Sessions
• Premier of randomized comparison of bypass surgery vs angioplasty using
sirolimus-eluting stent in patients with left main coronary artery disease
• Population and treatment:
300 patients with unprotected left main coronary artery stenosis (>50% of the
diameter) diagnosed with stable angina, unstable angina, silent ischemia, or
non-STEMI and eligible for PCI or surgery
Randomized to PCI with a sirolimus-eluting stent or to CABG surgery
• Primary outcome:
A composite of major adverse cardiac or cerebrovascular events (MACCE),
including death from any cause, MI, stroke, and ischemia-driven target vessel
revascularization at one year

3. PRECOMBAT: Results
• One-year MACCE rate met the statistical criteria for noninferiority
Occurred in 26 patients with PCI and 20 patients with surgery (cumulative event
rate of 8.7% and 6.7%, respectively [p=0.01])
• At two years, the rate of MACCE was 12.2% with PCI and 8.1% with surgery
(statistically nonsignificant)
• Secondary end points:
Composite of death, MI, or stroke occurred in 3.3% of PCI patients at one year
and 4.0% of CABG patients (not statistically significant at two years)
Ischemia-driven target vessel revascularization was reduced significantly with
surgery vs PCI at two years (9.0% and 4.2%; HR 2.18; 95% CI 1.10–4.32)

4. PRECOMBAT: Commentary*
"Overall, this trial is a modest advance on what we already recognize from the
existing—and limited—randomized data and, more broadly, the observational data
of left main PCI."
- Dr David Kandzari
"What you can take away from trials like PRECOMBAT are measurements of
estimates of risk and benefit. You can turn it into a story of the number needed to
treat. . . . We can say to a patient your risk of death, myocardial infarction, or stroke
is very similar, but we would need to treat 20 patients with bypass surgery to avoid
one additional revascularization."
- Dr Gregg Stone
*All comments from PRECOMBAT: PCI noninferior to CABG for left main disease, but questions linger
(http://www.theheart.org/article/1204263.do)

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