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PRECOMBAT: Sirolimus-eluting stent non-inferior to CABG in patients with unprotected left main CAD

Issue: May 2011

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American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Data from the PRECOMBAT trial have suggested that angioplasty with a sirolimus-eluting stent was noninferior to CABG in a composite endpoint of major adverse cardiac or cerebrovascular events at 1 year among patients with unprotected left main coronary artery disease.

The Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial included 600 patients who were randomly assigned to either CABG (n=300) or angioplasty with a sirolimus-eluting stent (SES; Cypher, Cordis; n=300). All patients of the prospective, open-label trial had unprotected left main coronary artery (ULMCA) stenosis. The primary outcome was a composite of major adverse cardiac or cerebrovascular events that included all-cause mortality, stroke, MI and ischemia-driven target vessel revascularization (TVR) at 12 months.

According to results, the primary outcome was 8.7% in the CABG arm vs. 6.7% in the SES arm (P=.39), which remained similar at 24 months (SES, 12.2% vs. CABG, 8.1%; P=.12). Rates of death, MI or stroke at 2 years (CABG 4.7% vs. 4.4% SES) did not differ to a statistically significant extent, although ischemia-driven TVR did favor CABG (CABG, 4.2% vs. SES, 9.0%; P=.022).

“We didn’t find any hard endpoint concern in MI, stroke or all-cause death, just a difference in ischemia-driven TVR. The TVR concern is of frequent clinical relevance, however it is not such a strong one,” Seung-Jung Park, MD, PhD, professor of medicine, University of Ulsan College of Medicine, Seoul, Korea and lead study author, told Cardiology Today, later adding that he is anticipating large numbers of upcoming prospective, randomized studies that will give clearer answers on these hard endpoints in percutaneous coronary intervention vs. CABG procedures. – by Brian Ellis

Disclosure: Dr. Park has received consulting fees/honoraria as well as research grants from Cordis.

For more information:

• Park S. LBCT II, Session 3013. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

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