Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease | Clinical Trial - BEST

Description:

The goal of the trial was to evaluate treatment with multivessel percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) among patients with coronary artery disease.

Contribution to the Literature: The BEST trial showed that long-term adverse cardiovascular events were increased after multivessel PCI with everolimus-eluting stents compared with CABG.


Study Design

  • Parallel
  • Randomized
  • Stratified

Patients with multivessel coronary disease were randomized to PCI with everolimus-eluting stents (n = 438) versus CABG (n = 442).

Patient population:

  • Total number of enrollees: 880
  • Duration of follow-up: median 4.6 years
  • Mean patient age: 64 years
  • Percentage female: 31%
  • Percentage diabetics: 40%

Other salient features:

  • Approximately one-third had a chronic total occlusion
  • Mean SYNTAX score: 24
  • Intravascular ultrasound was performed in 72% of the PCI group
  • Off-pump CABG was performed in 64% of the CABG group
  • Complete revascularization: 50.9% of the PCI group vs. 71.5% of the CABG group

Inclusion criteria:

  • Patients at least 18 years of age with multivessel coronary disease and appropriate for either PCI or CABG

Exclusion criteria:

  • Significant left main disease

Principal Findings:

The study was terminated early in October 2013 due to slow enrollment. At that time, 880 of the planned 1,776 subjects had been enrolled.

The primary outcome of death, myocardial infarction (MI), or target vessel revascularization (TVR) at 2 years occurred in 11.0% of the PCI group versus 7.9% of the CABG group (p = 0.32 for noninferiority), and at 4.6 years, occurred in 15.3% of the PCI group versus 10.6% of the CABG group (p = 0.04). Patients with diabetes appeared to derive more benefit from CABG (p for interaction = 0.06).

Secondary outcomes:

  • Death: 6.6% vs. 5.0% (p = 0.30), respectively, for PCI vs. CABG
  • MI: 4.8% vs. 2.7% (p = 0.11), respectively, for PCI vs. CABG
  • Spontaneous MI: 4.3% vs. 1.6% (p = 0.02), respectively, for PCI vs. CABG
  • TVR: 11.0% vs. 5.4% (p = 0.003), respectively, for PCI vs. CABG
  • Stroke: 2.5% vs. 2.9% (p = 0.72), respectively, for PCI vs. CABG

Interpretation:

Among patients with multivessel coronary disease, PCI was not noninferior to CABG at 2 years and was inferior to CABG with longer follow-up. There was possible enhanced benefit in regard to the primary outcome for diabetics undergoing CABG. The primary outcome was driven by an excess of spontaneous MI and repeat revascularization procedures in the PCI group. While most previous studies have reported excess strokes with CABG, this study found a similar frequency between groups. These findings apply to individuals of Asian descent.

References:

Park SJ, Ahn JM, Kim YH, et al., on behalf of the BEST Trial Investigators. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med 2015;Mar 16:[Epub ahead of print].

Presented by Dr. Seung-Jung Park at ACC.15, San Diego, CA, March 16, 2015.

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

Keywords: ACC Annual Scientific Session, Coronary Artery Bypass, Coronary Angiography, Coronary Artery Disease, Drug-Eluting Stents, Stents, Percutaneous Coronary Intervention, Myocardial Infarction, Cardiac Surgical Procedures, Stroke, Intention to Treat Analysis, Prospective Studies


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