Hybrid Revascularization for Multivessel Coronary Artery Disease - HYBRID

Description:

The goal of the trial was to evaluate a strategy of hybrid revascularization (left internal mammary artery [LIMA] to left anterior descending artery [LAD], plus percutaneous coronary intervention [PCI]) compared with standard surgical revascularization (all surgical bypass grafts) among patients with multivessel coronary artery disease.

Hypothesis:

Hybrid revascularization will improve outcomes.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients ≥18 years of age with multivessel coronary artery disease involving the LAD and at least one other vessel suitable for PCI or CABG

    Number of enrollees: 200
    Duration of follow-up: 12 months
    Mean patient age: 63 years
    Percentage female: 20%

Exclusions:

  • Congestive heart failure (New York Heart Association III or IV)
  • Prior open heart surgery
  • Prior stroke
  • Bleeding abnormality, including thrombocytopenia
  • More than one chronic total occlusion
  • Left ventricular ejection fraction <35%
  • Left main stenosis
  • ST-segment elevation MI within 72 hours
  • Planned additional cardiac surgical procedure
  • Intolerance to aspirin and/or clopidogrel
  • Limited life span
  • Suspected pregnancy
  • Enrollment in another clinical trial

Primary Endpoints:

  • Feasibility; defined as percentage of patients with complete hybrid procedure and percentage of patients with conversion to standard surgical revascularization
  • Safety; defined as occurrence of death, MI, stroke, target vessel revascularization, or major bleeding

Drug/Procedures Used:

Patients with multivessel coronary artery disease were randomized to hybrid revascularization (n = 98) versus standard surgical revascularization (n = 102).

Patients randomized to hybrid revascularization underwent minimally invasive direct coronary artery bypass surgery (CABG) with grafting of LIMA to LAD (stage 1), followed by PCI with drug-eluting stents within 36 hours if minimal chest tube drainage (stage 2). Patients were loaded with clopidogrel 300-600 mg prior to PCI.

Principal Findings:

Overall, 200 patients were randomized. The mean age was 63 years, 20% were women, mean body mass index was 28 kg/m2, 26% had diabetes, 53% had prior myocardial infarction (MI), mean number of lesions was four, and mean left ventricular ejection fraction was 50%. The mean number of grafts was 1.2 per patient in the hybrid group versus 2.6 per patient in the standard surgical group. Duration of surgery was 2.5 hours in the hybrid group versus 3.7 hours in the standard surgical group (p = 0.001).

In the hybrid group, 93.9% of patients completed the hybrid revascularization procedure and 6.1% converted to standard surgical revascularization.

- Death: 2.0% vs. 2.9%, respectively, for hybrid vs. standard revascularization

- MI: 6.1% vs. 3.9%, respectively

- Stroke: 0 vs. 0

- Target vessel revascularization: 2% vs. 0, respectively

- Major bleeding: 2.0% vs. 2.0%

Interpretation:

Among patients with multivessel coronary artery disease, hybrid revascularization is feasible. This approach resulted in shorter duration of surgery without increasing major bleeding. This strategy deserves further evaluation.

References:

Presented by Dr. Michal Hawranek at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 31, 2013.

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

Keywords: Stroke, Myocardial Infarction, Coronary Artery Disease, Follow-Up Studies, Drug-Eluting Stents, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention, Body Mass Index, Drainage, Stroke Volume, Chest Tubes, Internal Mammary-Coronary Artery Anastomosis, Coronary Artery Bypass, Diabetes Mellitus


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