A new study looking at a dual antithrombotic strategy in patients with atrial fibrillation after PCI has bolstered evidence supporting a move away from standard triple therapy with warfarin.
The RE-DUAL PCI study presented at the ESC this week and simultaneously published in the NEJM showed that combining one of two dabigatran (Pradaxa) doses with a P2Y12 inhibitor reduces bleeding without increasing thrombotic events compared to triple therapy with warfarin, a P2Y12 inhibitor, and aspirin.
Dabigatran 110 mg twice daily combined with either clopidogrel or ticagrelor reduced the primary endpoint – major bleeding or clinically relevant non-major bleeding by an absolute 11.5% compared to triple therapy (15.4% vs 26.9%) meeting non-inferiority and superiority criteria against standard therapy.
Meanwhile the 150-mg twice-daily dose of dabigatran reduced the primary endpoint by an absolute 5.5% versus triple therapy (20.2% vs 25.7%), which met non-inferiority criteria.
Speaking to the limbic Professor Ron Dick, Chairman of the Cardiovascular Institute at Epworth Healthcare in Victoria said the findings would be helpful to physicians treating the 20-30% of people who are already on oral coagulation due to AF but who will also need dual antiplatelet therapy as a result of undergoing PCI.
It’s a setting where evidence has been lacking.
“There haven’t been any guidelines for the concurrent use of the NOACs with an antiplatelet therapy until this paper.
With this randomisation between warfarin and dabigatran you can see there is an advantage with decreased bleeds within the dual therapy arms – markedly so with the lower 110mg dose twice daily,” Professor Dick told the limbic.
While the findings add another piece of information on the safety of dual therapy with dabigatran for patients undergoing PCI who already have nonvalvular AF, the question of whether it signals triple therapy with warfarin is on the way out is not yet clear-cut, Professor Dick concedes.
“You could say this study gives us a real basis for just using an antithrombotic like dabigatran, which is a factor II blocker and aspirin or clopidogrel although you have to remember that the other two NOACS [rivaroxaban and apixaban] are factor Xa inhibitors affecting a different part of the pathway so they would need to have independent trials and comparisons.
“This trial doesn’t mean that all NOACs should be treated the same way but it does say that dabigatran and one antiplatelet medication is better than initial triple therapy with a vitamin K antagonist, which is currently guideline recommended.”
Commenting on whether he would drop warfarin in his own practice he added:
“Most of my patients that come in with ischaemic heart disease and AF are still on warfarin therapy and so I will stick to the European guidelines initially but, with this paper, you could consider changing your whole strategy and talking to your patient about moving to a NOAC like dabigatran.”