Ticagrelor Compared With Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation - TiCAB

Jun 10, 2019
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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:
Deutsches Herzzentrum München and AstraZeneca
Date Presented:
11/11/2018
Date Published:
05/30/2019
Date Updated:
06/10/2019
Original Posted Date:
11/11/2018
References

Contribution To Literature:

The TiCAB trial failed to show that ticagrelor was superior to aspirin at preventing adverse events after CABG.

Description:

The goal of the trial was to evaluate aspirin monotherapy compared with ticagrelor monotherapy after coronary artery bypass grafting (CABG).



Study Design

  • Randomized
  • Parallel
  • Blinded

Patients who underwent CABG were randomized to aspirin monotherapy 100 mg daily (n = 931) versus ticagrelor monotherapy 90 mg twice daily (n = 928) within 24 hours of surgery.

  • Total number of enrollees: 1,893 (3,760 patients planned; however, recruitment cancelled due to lack of funding from sponsor and recommendation from the Data Safety Monitoring Board to stop the trial)
  • Duration of follow-up: 1 year
  • Mean patient age: 67 years
  • Percentage female: 15%
  • Percentage with diabetes: 36%

Inclusion criteria:

  • Patients ages ≥18 years undergoing CABG for three-vessel disease, left main disease, or two-vessel disease with left ventricular systolic dysfunction
  • Stable ischemic heart disease or acute coronary syndrome

Exclusion criteria:

  • Cardiogenic shock or hemodynamic instability
  • Indication for oral anticoagulation or dual antiplatelet therapy
  • Allergy to aspirin or ticagrelor

Principal Findings:

The primary outcome, major adverse cardiac events (cardiovascular death, myocardial infarction, stroke, or revascularization), occurred in 9.7% of the ticagrelor group compared with 8.2% of the aspirin group (p = 0.28). Results were the same in all tested subgroups.

Secondary outcomes:

  • All-cause mortality: 2.5% in the ticagrelor group vs. 2.6% in the aspirin group (p = 0.89)
  • Cardiovascular mortality: 1.2% in the ticagrelor group vs. 1.4% in the aspirin group (p = 0.68)
  • Target vessel revascularization: 5.0% in the ticagrelor group vs. 3.9% in the aspirin group (p = 0.28)
  • Major bleeding: 3.7% in the ticagrelor group vs. 3.2% in the aspirin group (p = 0.53)

Interpretation:

Among patients undergoing CABG, the use of ticagrelor monotherapy did not reduce major adverse cardiac events compared with aspirin monotherapy. Ticagrelor compared with aspirin was also associated with a similar incidence of individual ischemic outcomes and major bleeding. Unfortunately, this trial experienced a lower than anticipated event rate and ultimately was terminated early at the recommendation of the Data Safety Monitoring Board.

Trials that compared dual antiplatelet therapy versus monotherapy include CASCADE, which found no difference in saphenous vein graft patency at 1 year with aspirin/clopidogrel compared with aspirin/placebo. A single-center study conducted among Chinese patients found no difference in overall graft patency at 3 months with aspirin/ticagrelor compared with aspirin. However, there was possible improvement in saphenous vein graft patency at 3 months for aspirin/ticagrelor compared with aspirin. The DACAB trial investigators found that aspirin/ticagrelor improved saphenous vein graft patency at 1 year compared to aspirin monotherapy.

References:

Schunkert H, Boening A, von Scheidt M, et al. Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial. Eur Heart J 2019;May 30:[Epub ahead of print].

Presented by Dr. Heribert Schunkert at the American Heart Association Annual Scientific Sessions (AHA 2018), Chicago, IL, November 11, 2018.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and ACS, Cardiac Surgery and Arrhythmias, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: AHA Annual Scientific Sessions, AHA18, Acute Coronary Syndrome, Adenosine, Anticoagulants, Aspirin, Cardiac Surgical Procedures, Coronary Artery Bypass, Coronary Artery Disease, Hemorrhage, Myocardial Infarction, Myocardial Revascularization, Primary Prevention, Stroke, Vascular Diseases


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