Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease | Clinical Trial - PRECOMBAT

Description:

The goal of the trial was to evaluate treatment of unprotected left main coronary artery stenosis with percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG).

Contribution to the Literature: The PRECOMBAT trial showed that PCI with sirolimus-eluting stents was noninferior to CABG among patients with severe left main disease.


Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Korean patients ≥18 years of age with unprotected left main coronary artery stenosis ≥50%
  • Patients had to be suitable candidates for either PCI or CABG
  • Number of enrollees: 600
  • Duration of follow-up: 2 years
  • Mean patient age: 62 years
  • Percentage female: 24%
  • Ejection fraction: 61%

Exclusions:

  • ST-elevation myocardial infarction

Primary Endpoints:

  • Major adverse cardiac or cerebrovascular events, defined as all-cause mortality, myocardial infarction, stroke, or ischemia-driven target vessel revascularization

Secondary Endpoints:

  • Individual components of the primary outcome

Drug/Procedures Used:

Korean patients with unprotected left main coronary artery stenosis were randomized to PCI with sirolimus-eluting stents (n = 300) versus CABG (n = 300).

Principal Findings:

Overall, 600 patients were randomized. In the PCI group, the mean age was 62 years, 24% were women, 34% had diabetes, mean left ventricular ejection fraction was 61%, the mean SYNTAX score was 25, and the mean EuroSCORE was 2.6.

The primary outcome, major adverse cardiac or cerebrovascular events at 1 year, occurred in 8.7% of the PCI group versus 6.7% of the CABG group (p for noninferiority = 0.01). The primary outcome at 2 years occurred in 12.2% versus 8.1% (p = 0.12), respectively. The primary outcome at 5 years occurred in 17.5% versus 14.3% (p = 0.26), respectively, for PCI versus CABG.

Among patients with isolated left main coronary stenosis, the hazard ratio for the primary outcome was 0.39 (p = 0.41), and among patients with left main coronary stenosis and three-vessel coronary artery disease, the hazard ratio for the primary outcome was 3.05 (p = 0.01; however, p for interaction = 0.14), respectively, for PCI versus CABG.

At 2 years, death occurred in 2.4% versus 3.4% (p = 0.45), myocardial infarction occurred in 1.7% versus 1.0 (p = 0.49), stroke occurred in 0.4% versus 0.7% (p = 0.56), ischemia-driven target vessel revascularization occurred in 9.0% versus 4.2% (p = 0.02), and stent thrombosis or symptomatic graft occlusion occurred in 0.3% versus 1.4% (p = 0.25), respectively, for PCI versus CABG.

At 5 years, death occurred in 5.7% versus 7.9% (p = 0.32), myocardial infarction occurred in 2.0% versus 1.7 (p = 0.76), stroke occurred in 0.7% versus 0.7% (p = 0.99), and ischemia-driven target vessel revascularization occurred in 11.4% versus 5.5% (p = 0.012), respectively, for PCI versus CABG.

Interpretation:

Among Korean patients with unprotected left main coronary stenosis, revascularization with sirolimus-eluting stents was noninferior to CABG. Major adverse cardiac and cerebrovascular events were similar between the groups at 5 years. Individual components of the primary outcome were lower than expected and similar between the two groups, except for target vessel revascularization, which occurred more frequently in the PCI group.

SYNTAX score (angiographic severity of coronary disease) and EuroSCORE (clinical risk assessment) were lower in the PRECOMBAT trial than the SYNTAX trial, which could have contributed to a lower than expected event rate in the current trial. This study was conducted exclusively in Koreans and might be less applicable to other populations. While CABG is still considered the standard of care for revascularization of left main coronary stenosis, accumulating data support the use of PCI for select patients.

References:

Park SJ, Kim YH, Park DW, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med 2011;Apr 4:[Epub ahead of print].

Presented by Dr. Seung-Jung Park at the ACC.11/i2 Summit, New Orleans, LA, April 4, 2011.

Ahn JM, Roh JH, Kim YH, et al. Randomized Trial of Stents versus Bypass Surgery for Left Main Coronary Artery Disease: Five-Year Outcomes of the PRECOMBAT Study. J Am Coll Cardiol 2015;Mar 15:[Epub ahead of print].

Presented by Dr. Jung-Min Ahn at ACC.15, San Diego, CA, March 15, 2015.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Stenosis, Thrombosis, Standard of Care, Stroke Volume, Sirolimus, Risk Assessment, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents


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