Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease

Study Questions:

What is the safety and efficacy of left main artery stenting compared with coronary artery bypass grafting (CABG)?

Methods:

The PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) investigators randomized 600 patients with unprotected left main artery stenosis to undergo CABG or percutaneous coronary intervention (PCI) using sirolimus-eluting stents. The primary endpoint was a composite of death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization. The study had a noninferiority design.

Results:

The study met the noninferiority endpoint, although the event rates were higher in the PCI arm at 1 year (8.7% vs. 6.7%; p = 0.01 for noninferiority). There was no difference in the rate of death, MI, or stroke at 2 years (4.4% vs. 4.7%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.43%-1.96%; p = 0.83). Ischemia-driven target vessel revascularization was more common with PCI (9.0% vs. 4.2%; HR, 2.18; 95% CI, 1.10-4.32; p = 0.02).

Conclusions:

The authors concluded that among patients with unprotected left main artery stenosis, PCI using the sirolimus-eluting stent was noninferior to CABG.

Perspective:

This study provides further data to support the pre-eminence of CABG over PCI for left main artery stenosis while also confirming the safety and efficacy of PCI. The trial was small with generously wide noninferiority margins and, thus, cannot be used to support change in clinical practice. The study does, however, corroborate earlier small studies that have demonstrated similar intermediate-term hazard of death, MI, and stroke with PCI compared with CABG, while the need for target vessel revascularization has been consistently higher with PCI. The totality of the data would suggest that CABG should remain the preferred revascularization strategy for patients with unprotected left main artery stenosis, although PCI may be appropriate for some patients based on anatomy, comorbidities, and patient and physician preference.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Sirolimus, Coronary Artery Bypass, Angioplasty, Stents, Percutaneous Coronary Intervention


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