1. In patients with left main coronary artery stenosis, angioplasty with sirolimus-eluting stents was noninferior to coronary artery bypass grafting in preventing subsequent cardiac and cerebrovascular events
2. PCI patients experienced a significantly higher incidence of ischemia-driven target vessel revascularization compared to CABG patients
3. Because of low event rates, the study was underpowered
Original Date of Publication: May 2011
Study Rundown: The Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial compared percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with left main coronary artery stenosis. Prior to this study, some evidence suggested that PCI may be an acceptable alternative to CABG in certain patients with left main disease, though outcomes had never been assessed in a large, randomized trial. In the PRECOMBAT trial, patients with left main coronary artery stenosis were treated with PCI with a sirolimus-eluting stent or CABG and were followed for 2 years after randomization. PCI with sirolimus-eluting stents was found to be non-inferior to CABG for left main coronary artery stenosis at 12 months with respect to the primary outcome. At 2 years, the rates of major coronary events, cerebrovascular events, and all-cause mortality were similar in patients being treated with PCI or CABG. Of note, patients treated with PCI experienced significantly higher rates of ischemia-driven target vessel revascularization when compared with CABG patients at the 2 year mark (HR 2.18; 95%CI 1.10-4.32).
In summary, this study demonstrates that PCI was noninferior to CABG in treating left main coronary artery stenosis with regards to the primary composite endpoint (i.e., major adverse cardiac or cerebrovascular events). As a result of low event rates, however, the study was underpowered and the study authors have noted that these findings should not be clinically directive.
In-Depth [randomized, controlled trial]: This trial was conducted at 13 centers across South Korea. Patients were eligible for the study if they were ≥18 years of age and had received a diagnosis of stable angina, unstable angina, silent ischemia, or non–ST-elevation myocardial infarction (NSTEMI), with more than 50% stenosis of the left main coronary artery. Eligible patients also needed to be candidates for CABG or PCI as determined by their treating physicians and surgeons. The primary endpoint was a composite of death from any cause, myocardial infarction, stroke, and ischemia-driven target vessel revascularization in the 12 months following randomization.
A total of 600 patients were enrolled and randomized as part of the trial. At 12 months, 8.7% of patients in the PCI group and 6.7% of patients in the CABG group experienced primary endpoints (absolute risk difference 2.0%; 95%CI -1.6-5.6%; p=0.01 for non-inferiority). At 24 months, there were no significant differences between the two groups with regards to the primary endpoint (HR 1.50; 95%CI 0.90-2.52). Ischemia-driven target vessel revascularization (i.e., repeat revascularization with stenosis of 50% and ischemic signs/symptoms or 70% without ischemic signs/symptoms) was significantly higher in the PCI group at 24 months (HR 2.18; 95%CI 1.10-4.32).
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