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Author Spotlight: Enhancing Coronary Artery Revascularization
Published on: September 15, 2023
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.
Background:
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice.
Methods:
We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we 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 1 year. Event rates at 2 years were also compared between the two groups.
Results:
The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).
Conclusions:
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. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).
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