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Meta-analysis confirms dual antithrombotic therapy optimal after PCI in AF
A dual antithrombotic therapy regimen consisting of a non-vitamin K antagonist oral anticoagulant and a P2Y12 inhibitor is the best medication strategy after PCI in patients with atrial fibrillation, according to a meta-analysis published in JAMA Cardiology.
Renato D. Lopes, MD, PhD, professor of medicine at Duke University School of Medicine and member of the Duke Clinical Research Institute, and colleagues analyzed 10,026 patients from four studies — WOEST, PIONEER-AF PCI, RE-DUAL PCI and AUGUSTUS — with AF who had PCI and/or ACS (mean age, 70-72 years; 29% women). All patients received one of four antithrombotic therapy regimens after PCI: a vitamin K antagonist plus dual antiplatelet therapy, a non-vitamin K antagonist oral anticoagulant (NOAC) plus DAPT, a vitamin K antagonist plus a P2Y12 inhibitor but no aspirin, or a NOAC plus a P2Y12 inhibitor but no aspirin.
‘Complicated field’
“This is a complicated field,” Lopes told Cardiology Today. “The antithrombotic regimens that exist to treat these patients are numerous. Yet, we only started having randomized trials in this area in the last few years. This is a difficult population to study, and each of these trials were not big enough to answer the question of which antithrombotic regimen should be used to treat these patients. After AUGUSTUS was published in March, we decided it would be nice to combine all these high-quality randomized trials in a meta-analysis to have a larger number of patients help us determine the one or two strategies that are most appropriate.”
The ACS population in each study ranged from 28% to 61%.
The primary safety outcome was TIMI major bleeding. The primary efficacy outcome was trial-defined major adverse CV events.
Compared with patients who received a vitamin K antagonist plus DAPT, the other groups had lower risk for TIMI major bleeding, including vitamin K antagonist plus P2Y12 inhibitor (OR = 0.58; 95% CI, 0.31-1.08), NOAC plus P2Y12 inhibitor (OR = 0.49; 95% CI, 0.3-0.82) and NOAC plus DAPT (OR = 0.7; 95% CI, 0.38-1.23), but only the NOAC plus P2Y12 inhibitor group reached statistical significance.
There were no differences between the groups in risk for major adverse CV events (OR for vitamin K antagonist plus P2Y12 inhibitor vs. vitamin K antagonist plus DAPT = 0.96; 95% CI, 0.6-1.46; OR for NOAC plus P2Y12 inhibitor vs. vitamin K antagonist plus DAPT = 1.02; 95% CI, 0.71-1.47; OR for NOAC plus DAPT vs. vitamin K antagonist plus DAPT = 0.94; 95% CI, 0.6-1.45).
Net clinical benefit
“In light of so many different combinations, we found that using a P2Y12 inhibitor and a NOAC instead of a vitamin K antagonist and without aspirin seems to be the preferred regimen for most patients,” Lopes, who was principal investigator of AUGUSTUS, told Cardiology Today. “This gave us the greatest net clinical benefit, in terms of the best bleeding results without an increase in ischemic events.”
Clinicians should understand that, for these patients, “less is more, and when you pile up drugs, it’s not necessarily a good strategy,” Lopes said in an interview. “We have shown that there are ways to minimize bleeding such as avoiding aspirin and using a NOAC.”
Clinical practice has been shifting toward dropping aspirin and using a NOAC in these patients, “but this analysis is the most comprehensive, complete and largest one to reassure that dropping aspirin is the preferred regimen for most patients,” Lopes said. “Still, we are refining analyses from the individual trials to try to identify subgroups where we might have to use aspirin a little bit longer during initial treatment after ACS or PCI.” – by Erik Swain
For more information:
Renato D. Lopes, MD, PhD, can be reached at renato.lopes@duke.edu.
Disclosure: Lopes reports he received grants and personal fees from Bristol-Myers Squibb
and Pfizer and personal fees from Bayer and Boehringer Ingelheim during the conduct of the study and grants from Amgen, GlaxoSmithKline, Medtronic and Sanofi Aventis outside the submitted work. Please see the study for the other authors’ relevant financial disclosures.