Long-Term Cardiac and Neurocognitive Outcome After Off-Pump CABG Versus PCI - OCTOPUS — Presented at AHA 2009

Nov 16, 2009
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Trial Sponsor:
The Netherlands Health Insurance Council
Date Presented:
01/01/2009
Date Updated:
11/16/2009
Original Posted Date:
11/16/2009
References

Description:

The goal of this trial was to determine long-term cardiac and neurocognitive outcomes after off-pump coronary artery bypass grafting (CABG) compared with percutaneous coronary intervention (PCI).

Hypothesis:

Off-pump CABG would be associated with improved long-term cardiac and neurocognitive outcomes.

Study Design

Study Design:

Patients Screened: 2,263
Patients Enrolled: 280
Mean Follow Up: 7.5 years
Mean Patient Age: 59 years
Female: 28%
Mean Ejection Fraction: 79% had normal left ventricular ejection fraction

Patient Populations:

  • Obstructive coronary artery disease
  • Normal or mild left ventricular systolic dysfunction

Primary Endpoints:

  • Composite cardiac outcome: death, myocardial infarction, stroke, repeat revascularization
  • Cognitive outcome: nine validated neuropsychological tests and seven domains of cognition

Drug/Procedures Used:

Patients with coronary artery disease were randomized to off-pump CABG (n = 142) versus PCI with bare-metal stents (n = 138).

Principal Findings:

Overall, 280 patients were randomized. There was no difference in baseline characteristics between the groups. In the off-pump CABG arm, the mean age was 59 years, 28% were women, 7% had a history of stroke or transient ischemic attack, one-vessel coronary disease was present in 74%, and 79% had a normal ejection fraction.

The primary cardiac outcome at 7.5 years—death, myocardial infarction, stroke, or repeat revascularization—occurred in 31.0% of the off-pump CABG group versus 39.9% of the PCI group (p = 0.12). Death, myocardial infarction, or stroke was 19.7% versus 17.4% (p = 0.62), death was 13.4% versus 8.7% (p = 0.21), myocardial infarction was 5.6% versus 8.0% (p = 0.44), stroke was 0.7% versus 0.7%, and repeat revascularization was 11.3% versus 21.7% (p = 0.02), respectively.

Neurocognitive testing was performed in a subset of 200 patients. Across seven cognitive domains, off-pump CABG appeared to be superior (p < 0.01).

Interpretation:

Among patients with coronary artery disease, there were differences in cardiac and neurocognitive outcomes after off-pump CABG versus PCI. Composite cardiac outcomes were similar; however, repeat revascularization occurred more frequently in the PCI group. Off-pump CABG was associated with better long-term cognitive function compared with PCI.

These results should be interpreted cautiously for the following reasons: 1) small sample size; 2) drug-eluting stents were not used, which may have reduced the need for repeat procedures among PCI patients; 3) there were more patients who did not have neurocognitive testing in the PCI group (25% vs. 13%); 4) baseline neurocognitive function was not performed; and 5) the findings contrast to the much larger ROOBY trial, which showed similar cognitive outcomes for off-pump versus on-pump CABG.

References:

Presented by Dr. Jakub Regieli at the American Heart Association Scientific Sessions, Orlando, FL, November 16, 2009.

Keywords: Cognition, Coronary Artery Disease, Myocardial Infarction, Stroke, Ischemic Attack, Transient, Metals, Drug-Eluting Stents, Coronary Artery Bypass, Off-Pump, Angioplasty, Balloon, Coronary


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