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Dual therapy with dabigatran and clopidogrel preferred after PCI for patients with AF (RE-DUAL PCI)
Clinical Question
What is the best approach to antithrombotic therapy for patients with atrial fibrillation after undergoing percutaneous coronary intervention?
Bottom line
Among patients with atrial fibrillation who had undergone percutaneous coronary intervention, dual therapy with dabigatran and clopidogrel caused fewer major bleeding events than triple therapy with warfarin, aspirin, and clopidogrel. Either dose of dual therapy with dabigatran was superior to warfarin triple therapy with respect to bleeding events, and was noninferior with respect to thromboembolic prevention. The higher dose may be more appropriate for patients at high risk of thromboembolism, and the lower dose for those at higher risk of bleeding. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (any)
Synopsis
These researchers recruited adults with nonvalvular atrial fibrillation who had undergone PCI including stent placement within the previous 5 days. The 2725 participants were randomized receive to 1 of 3 antithrombotic strategies: (1) dabigatran 110 mg twice daily plus clopidogrel 75 mg daily, (2) dabigatran 150 mg twice daily plus clopidogrel, or (3) triple therapy with warfarin to an international normalized ratio of 2 to 3 plus low-dose aspirin plus clopidogrel. Approximately 10% of patients received ticagrelor instead of clopidogrel. Participants had a mean age of 70 years. Randomization was stratified by age and location; dabigatran is not approved in the 150-mg dose for patients older than 80 years in some countries, so there were fewer patients in that treatment group than in the other 2 groups. This was a noninferiority trial for the comparison of the 2 dual therapy dabigatran groups with the current guideline-recommended triple therapy. Groups were balanced at the start of the trial (other than by age, as noted above) and analysis was by intention to treat. Between 0.5% and 4% of patients in each group were lost to follow-up or withdrew consent, and 13.0% to 16.6% stopped taking the study drugs during the trial period. Patients were treated for a mean of 12 months, and followed up for a total of 14 months. Major bleeding was less common in both of the dabigatran dual therapy groups than in the triple therapy group (5.0% vs 9.0% for the 110-mg dose; P < .001; number needed to treat [NNT] = 25, and 5.6% vs 9.0% for the 150-mg dose; P = .02; NNT = 29). Regarding the combined outcome of myocardial infarction, stroke, systemic embolism, death, or unplanned revascularization, the authors report that both of the dabigatran regimens were noninferior to triple therapy with warfarin. Although statistically "noninferior," the likelihood of this combined efficacy outcome was 11.8% in the 150-mg dabigatran group, 13.4% in the triple therapy group, and 15.2% in the 110-mg dabigatran group.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Good poem
ASA
Did they.ook at dabigstran and ASAas dual Antiplatelet therapy
This is useful evidence for family physicians, hospitals and other who assume care of these patients after discharge. The mean age is 70. The lower dose of dabigatran, 110 mg, must be used after the age of 80. I suspect the frail elderly, who are a greater bleeding risk, we're not included in the study.
Not sure whether to check I am dissatisfied or there is a problem with the presentation of the info. This is a general comment actually. There seems to be a systematic reluctance to provide any kind of conclusion in most of these POEMS. This one is a good example. The results are presented but that's it. Nothing about the quality of the paper, the implications of the paper or any comment about whether this should change practice. In any journal type club I go to these things are always discussed so I find it frustrating that these reviews aren't closed off in this way. They frequently feel incomplete and thus not as useful as they could be. It seems like it is editorial policy not to provide any kind of discussion of the results. I think this should be changed. I may not agree with the conclusions of the reviewer but I at least feel that to be complete some kind of discussion or conclusion should be included.
no mention of costs as most of the patients are elderly and in this category of patients a high number can not afford extra costs for medication
Why such a high drop-out rate in the trial groups? The authors might have commented on reasons given
I am not the one organising this therapy for patients, but I see people who are on it. It can get confusing for the GP and the patients.
Warfarin is frought with issues when managed in standard outpatient practises - it is just hard to get it right in many cases.
Dabigatran is sort of falling out of favour as the evidence seems to push people to use the other NOACs.
I am not too sure how relevant this information will be in general practise.
It is nice to see that we might be able to hold off the DAPT as it does increase bleeding.
Will this change or challenge the guidelines?
the number of drop outs from the study was very high, and the reasons for drop outs not discussed in the article, when the drop out rate approaches 15 percent one wonders if this affects the validity of the study and will this translate into a very high non compliance rate in the real world! I will wait until there is more study into this combination before I proceed with this line of management