Randomized trial of stents versus bypass surgery for left main coronary artery disease

Seung-Jung Park1, Young-Hak Kim, Duk-Woo Park

  • 1Heart Institute, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. sjpark@amc.seoul.kr

Insights

Percutaneous coronary intervention (PCI) using sirolimus-eluting stents was found to be noninferior to coronary-artery bypass grafting (CABG) for treating unprotected left main coronary artery stenosis. However, the wide noninferiority margin suggests results require cautious interpretation.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Vascular Surgery

Background:

  • Unprotected left main coronary artery stenosis is a critical condition.
  • Coronary-artery bypass grafting (CABG) has been the traditional treatment of choice.
  • Percutaneous coronary intervention (PCI) is an emerging alternative.

Purpose of the Study:

  • To compare the efficacy and safety of PCI with sirolimus-eluting stents versus CABG.
  • To evaluate major adverse cardiac or cerebrovascular events (MACCE) at 1 and 2 years.
  • To determine noninferiority of PCI to CABG in this patient population.

Main Methods:

  • Randomized trial comparing CABG (300 patients) and PCI with sirolimus-eluting stents (300 patients).
  • Primary endpoint: composite of death, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization at 1 year.
  • Secondary endpoint: comparison of event rates at 2 years.

Main Results:

  • Noninferiority for the primary endpoint was met at 1 year (8.7% for PCI vs. 6.7% for CABG; P=0.01).
  • At 2 years, PCI showed a higher rate of the primary endpoint (12.2% vs. 8.1%) and significantly more ischemia-driven target-vessel revascularization (9.0% vs. 4.2%).
  • Composite rates of death, myocardial infarction, or stroke were similar between groups at 2 years (4.4% vs. 4.7%).

Conclusions:

  • PCI with sirolimus-eluting stents demonstrated noninferiority to CABG for major adverse cardiac or cerebrovascular events in unprotected left main stenosis.
  • The wide noninferiority margin and increased revascularization rates with PCI warrant cautious clinical interpretation.
  • Further evaluation is needed to fully establish PCI's role in this complex patient group.
Abstract

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