The antithrombotic treatment regimen of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) and P2Y12 inhibitors without aspirin was shown to cause less bleeding without significantly affecting treatment efficacy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) or with concomitant acute coronary syndrome, according to a recent article published in JAMA Cardiology.

The study investigators sought to simplify the variety in antithrombotic treatments for high-risk patients with AF and coronary artery disease. The researchers performed a Bayesian network meta-analysis with data from 4 randomized controlled trials (N=10,026) to evaluate the safety and efficacy of 4 antithrombotic treatment regimens for patients with AF undergoing PCI. The treatment regimens compared were VKAs plus dual antiplatelet therapy (DAPT; P2Y12 inhibitor plus aspirin), VKA plus P2Y12 inhibitor, NOACs with DAPT, and NOACs plus P2Y12 inhibitor. For safety, the researchers compared the regimens to the incidence of Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeding events, including trial-defined primary bleeding events, intracranial hemorrhage, and hospitalization. 

NOACs plus P2Y12 inhibitor was least likely to be associated with a TIMI major bleeding event (odds ratio [OR], 0.49; 95% CI, 0.30-0.82) compared with VKA plus DAPT. VKA plus P2Y12 inhibitor had an OR of 0.58 (95% CI, 0.31-1.08), and the OR for NOACs plus DAPT was 0.70 (95% CI, 0.38-1.23).

In assessing the efficacy of the 4 regimens, the ORs were all comparable, ranging from 0.94 to 1.02 for major adverse cardiovascular events. The results built off of a previous meta-analysis performed in 2018 to evaluate the safety and efficacy of aspirin in the antithrombotic regimen.

A recommendation to stray from the standard triple therapy (VKA or NOAC plus DAPT) was made after a 47% reduction in bleeding events, with comparable major adverse cardiovascular event outcomes occurring in patients with AF undergoing PCI when aspirin was omitted from their regimen.

The limitations of this study were with the network meta-analysis statistical analysis. Where network meta-analysis overcomes some limitations, the researcher’s model had limitations with the estimated between-study heterogeneity of the 4 randomized controlled trials. The researchers addressed that their study had between-study heterogeneity, but it was difficult to define whether it was small or large because of the lack of defined boundaries for the parameter.

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In an attempt to provide the safest but still efficacious antithrombotic treatment, the investigators recommend a regimen of NOAC plus P2Y12 inhibitor for patients with AF undergoing PCI, as it was associated with fewer bleeding events when compared with VKA plus DAPT without significant differences in ischemic events. In addition, the researchers recommend omitting aspirin from the treatment regimen for these high-risk patients, similar results were also shown.

Disclosure: Multiple authors disclose relationships with the pharmaceutical industry. Please refer to the reference for a complete list of authors’ disclosures.

Reference

Lopes RD, Hong H, Harskamp RE, et al. Safety and efficacy of antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention: a network meta-analysis of randomized controlled trials [published online June 19, 2019]. JAMA Cardiol. doi:10.1001/jamacardio.2019.1880