German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients - GOPCABE

Description:

Despite initial enthusiasm for off-pump coronary artery bypass grafting (OPCAB), results of two large trials, ROOBY and CORONARY, did not demonstrate superior outcomes with OPCAB over on-pump CABG. The current trial sought to study the efficacy of OPCAB in higher-risk patients.

Hypothesis:

OPCAB would be superior to on-pump CABG for patients older than 75 years of age.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Isolated first-time CABG
  • Age ≥75 years

    Number of screened applicants: 4,355
    Number of enrollees: 2,539
    Duration of follow-up: 12 months
    Mean patient age: 78.5 years
    Percentage female: 31%
    Ejection fraction: <30% (3%), 30-50% (29%), >50% (68%)

Exclusions:

  • Need for concomitant cardiac surgery
  • Previous pericardiotomy
  • Emergent surgery (within 24 hours of admission)
  • Planned minimally invasive direct CABG

Primary Endpoints:

  • Composite of death, MI, stroke, repeat revascularization, new renal replacement therapy within 30 days and 12 months of surgery

Secondary Endpoints:

  • Operative time
  • Duration of mechanical ventilation
  • Length of stay in intensive care unit
  • Length of hospital stay
  • Transfusion requirements

Drug/Procedures Used:

Patients undergoing CABG were randomized in a 1:1 fashion to either OPCAB or routine on-pump CABG. Study surgeons were nominated by participating sites, and were required to be experts in either technique. Technical details were at the discretion of the surgeon.

Principal Findings:

A total of 2,539 patients were randomized at 12 German centers, 1,271 to OPCAB and 1,268 to on-pump CABG. Baseline characteristics were fairly similar between the two arms. Approximately 14% had insulin-dependent diabetes mellitus, 10% had chronic obstructive pulmonary disease, 9% had prior stroke, 2% had creatinine >2.2 mg/dl, and 22% had undergone prior percutaneous coronary intervention (PCI). The majority of patients had three-vessel disease (60%), followed by left main trunk disease (29%) and two-vessel (9%). The median logistic EuroSCORE at baseline was 8.3. The mean number of coronary anastomoses was lower in the OPCAB arm compared with the on-pump CABG arm (2.7 vs. 2.8, p < 0.001). Crossover rates were nearly twice as high in the OPCAB arm (9.7% vs. 5.1%).

Mean operative times were similar between the OPCAB and on-pump CABG arms (170 vs. 168 minutes). Postoperative intensive care unit and in-hospital length of stay were similar as well. The primary composite endpoint was similar between the OPCAB and off-pump CABG arms at 30 days (7.8% vs. 8.2%, hazard ratio 0.95, 95% confidence interval 0.71-1.28; p = 0.74). Individual endpoints including all-cause mortality (2.6% vs. 2.8%, p = 0.75), myocardial infarction (MI) (1.5% vs. 1.7%, p = 0.79), and stroke (2.2% vs. 2.7%, p = 0.47) were similar; need for repeat revascularization at 30 days was higher in the OPCAB arm (1.3% vs. 0.4%, p = 0.04).

At 12 months, the composite endpoint was still similar between the two arms (13.1% vs. 14.0%, p = 0.48). Stroke (3.5% vs. 4.4%, p = 0.26) and repeat revascularization (3.1% vs. 2.0%, p = 0.11) were also similar.

Interpretation:

The results of the GOPCABE trial indicate that in high-risk elderly patients undergoing first-time CABG, OPCAB (even when performed by highly skilled operators) was not superior to on-pump surgery for ischemic or neurological outcomes up to 1 year of follow-up. There may be a slightly higher risk of crossover and short-term need for repeat revascularization with OPCAB. These results are very similar to those noted in the ROOBY and CORONARY trials. These results are reflected in the current guidelines, which indicate that either strategy is acceptable, depending on local expertise.

References:

Presented by Dr. Anno Diegeler at ACC.13, San Francisco, March 11, 2013.

Diegeler A, Börgermann J, Kappert U, et al., on behalf of the GOPCABE Study Group. Off-pump versus on-pump coronary-artery bypass grafting in elderly patients. N Engl J Med 2013;Mar 11:[Epub ahead of print].

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

Keywords: Operative Time, Pulmonary Disease, Chronic Obstructive, Myocardial Infarction, Stroke, Coronary Artery Bypass, Off-Pump, Cardiopulmonary Bypass, Creatinine, Diabetes Mellitus, Type 1, Percutaneous Coronary Intervention, Length of Stay


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