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ACC: PCI Appears Noninferior to CABG for Stenosis

Found noninferior in terms of adverse events, though noninferiority margin is wide

TUESDAY, April 5 (HealthDay News) -- For the treatment of left main coronary artery stenosis, percutaneous coronary intervention (PCI) with sirolimus-eluting stents appears to be equivalent to coronary artery bypass grafting (CABG) in terms of major adverse cardiac or cerebrovascular events, according to research published online April 4 in the New England Journal of Medicine to coincide with the American College of Cardiology's 60th Annual Scientific Session & Expo, held from April 2 to 5 in New Orleans.

Seung-Jung Park, M.D., of the University of Ulsan College of Medicine in Seoul, South Korea, and colleagues randomized 600 patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). The investigators used a wide margin for noninferiority and compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at one year.

The primary end point occurred in 26 patients who underwent PCI compared with 20 patients who underwent CABG, with a cumulative event rate of 8.7 and 6.7 percent, respectively (P = 0.01 for noninferiority). At two years, the primary end point occurred in 36 patients who had undergone PCI compared to 24 who underwent CABG, with a cumulative event rate of 12.2 and 8.1 percent, respectively (P = 0.12). The investigators also found that the composite rate of death, myocardial infarction, or stroke at two years occurred in 13 patients who underwent PCI compared with 14 patients who underwent CABG, with a cumulative event rate of 4.4 and 4.7 percent, respectively (P = 0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients who underwent PCI compared to 12 patients who underwent CABG, with a cumulative event rate of 9.0 and 4.2 percent, respectively (P = 0.02).

"In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive," the authors write.

Several authors disclosed financial relationships with pharmaceutical and biotechnology companies.

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