Clopidogrel After Surgery for Coronary Artery Disease - CASCADE

Dec 19, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Physicians' Services Incorporated Foundation, Boston Scientific Inc., and Bristol-Myers Squibb Sanofi-Aventis Canada partnership
Date Presented:
01/01/2009
Date Published:
01/01/2010
Date Updated:
12/19/2010
Original Posted Date:
12/19/2010
References

Description:

The goal of this trial was to compare treatment with aspirin and clopidogrel compared with aspirin and placebo after coronary artery bypass surgery (CABG).

Hypothesis:

Aspirin and clopidogrel would be superior in preventing saphenous vein graft intimal hyperplasia.

Study Design

  • Parallel
  • Placebo Controlled
  • Randomized

Patients Screened: 126
Patients Enrolled: 113
Mean Follow Up: 1 year
Mean Patient Age: 65 years
Female: 9%

Patient Populations:

  • Patients undergoing multivessel CABG that involves at least two saphenous vein grafts

Primary Endpoints:

  • Saphenous vein graft intimal area by intravascular ultrasound

Secondary Endpoints:

  • Saphenous vein graft patency
  • Major adverse cardiac events
  • Bleeding

Drug/Procedures Used:

After CABG involving at least two saphenous vein grafts, patients were randomized to aspirin and clopidogrel (n = 56) versus aspirin and placebo (n = 57).

Principal Findings:

Overall, 113 patients were randomized. There was no difference in baseline characteristics between the groups. In the aspirin and clopidogrel group, the mean age was 65 years, 9% were women, 25% were diabetics, off-pump CABG was performed in 5.4%, and the mean number of bypasses received was 3.6 per patient.

The primary outcome, vein graft intimal area at 1 year, was 4.1 mm2 with aspirin and clopidogrel versus 4.5 mm2 with aspirin and placebo (p = 0.44). Overall graft patency was 95.2% versus 95.5% (p = 1.0), internal mammary artery patency was 96.6% versus 100% (p = 0.90), and saphenous vein graft patency was 94.3% versus 93.2% (p = 0.69), respectively.

Major adverse cardiac events were 7.1% versus 8.8% (p = 1.0), all-cause death was 0% versus 1.8% (p = 1.0), myocardial infarction was 7.1% versus 1.8% (p = 0.21), and major bleeding was 1.8% versus 0% (p = 0.50), respectively.

Interpretation:

After CABG, the addition of clopidogrel to aspirin is not superior to aspirin alone. Clopidogrel did not reduce saphenous vein graft intimal hyperplasia at 1 year, nor did it improve graft patency or reduce major adverse cardiac events. Major bleeding appeared to be the same in both groups. It is unknown if clopidogrel or a newer antiplatelet agent (prasugrel or ticagrelor) would have produced benefit if it were studied in more patients with longer duration of follow-up.

References:

Kulik A, Le May MR, Voisine P, et al. Aspirin plus clopidogrel versus aspirin alone after coronary artery bypass grafting: the Clopidogrel After Surgery for Coronary Artery Disease (CASCADE) trial. Circulation 2010;122:2680-7.

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

Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Saphenous Vein, Mammary Arteries, Coronary Artery Bypass, Off-Pump, Coronary Disease, Ticlopidine, Piperazines, Hyperplasia, Diabetes Mellitus


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