Less bleeding after PCI when dabigatran replaces aspirin, warfarin in AFib

By Reuters Staff

NEW YORK (Reuters Health) - Adding dabigatran to a P2Y-12 inhibitor after percutaneous coronary intervention (PCI) in people with atrial fibrillation (AF) poses a lower risk of bleeding, without reducing effectiveness, than the three-drug combination of warfarin, aspirin and the P2Y-12 inihibitor, according to a study funded by dabigatran's manufacturer, Boehringer Ingelheim.

Results of the trial, known as RE-DUAL PCI, were reported August 27 at the European Society of Cardiology Congress in Barcelona, Spain, and published online by the New England Journal of Medicine.

The rate of a clinically relevant bleeding event was 15.4% with dual therapy versus 26.9% with triple therapy when the dabigatran dose was 110 milligrams twice daily (P<0.001). At a twice-daily dabigatran dose of 150 mg, the rates were 20.2% and 25.7%, respectively (P<0.001).

Mean follow-up was 14 months, and mean duration of treatment with dabigatran was 12.3 months. All 2,725 trial participants in 41 countries had nonvalvular AF. All were treated within 120 hours after successfully undergoing PCI and receiving a stent. More than 4 in 5 patients received drug-eluting stents.

"Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events," said the research team, led by Dr. Christopher Cannon of the Baim Institute for Clinical Research in Boston.

The composite rates of death, unplanned revascularization, myocardial infarction, stroke, or systemic embolism was 13.7% in the dual-therapy group and 13.4% with triple therapy.

Dabigatran costs about $360 per month, far more than warfarin, although warfarin requires more-frequent monitoring.

The odds of a fatal serious adverse event were 3.9% with 110 mg of dabigatran, 3.2% with 150 mg of the drug, and 4.3% when aspirin and warfarin were used instead.

Clopidogrel and ticagrelor were the P2Y-12 inhibitors used in the trial.

Compared to the rates in the triple-therapy group, when 110 mg of dabigatran was used, the rate of major bleeding was a significant 4.2 percentage points lower and the odds of a major thromboembolic event were a nonsignificant 1.8 percentage points higher.

A similar trend was seen in the 150-mg dabigatran group.

SOURCE: https://bit.ly/2xolVa4

N Engl J Med 2017.

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