Dual therapy reduces risk for bleeding better than triple therapy for patients with atrial fibrillation

March 16, 2020

Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. Dual therapy reduces risk for bleeding better than triple therapy for patients with atrial fibrillation undergoing PCI

Abstract: http://annals.org/aim/article/doi/10.7326/M19-3763
Editorial: http://annals.org/aim/article/doi/10.7326/M20-0572
URL goes live when the embargo lifts

Use of dual therapy with a direct oral anticoagulant (DOAC) plus P2Y12 inhibitor was associated with reduced risk for major bleeding compared with triple therapy with a vitamin K antagonist (VKA) plus aspirin and P2Y12 inhibitor for patients with nonvalvular atrial fibrillation after percutaneous coronary intervention (PCI). Findings from a systematic review and meta-analysis are published in Annals of Internal Medicine.

Patients with ischemic heart disease and atrial fibrillation undergoing PCI create a clinical conundrum. It is not clear which antithrombotic regimen is most appropriate for preventing major adverse cardiovascular events in such patients. Evidence has favored DOAC over VKA for these patients for their atrial fibrillation management, but when antiplatelet therapy is also needed following PCI, recent trials have studied an alternative approach - dual therapy consisting of a DOAC and a P2Y12 inhibitor versus triple therapy comprising a VKA and DAPT (dual antiplatelet therapy). Theoretically, the cardiovascular benefits gained by using triple therapy could be offset by higher risk for bleeding, whereas withdrawal of aspirin might lead to higher rates of stent thrombosis and ischemic events with dual therapy.

Researchers from West Virginia University and Johns Hopkins University reviewed 4 trials encompassing nearly 8,000 patients to examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with atrial fibrillation after PCI. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy. Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality, cardiovascular mortality, myocardial infarction, stent thrombosis, and stroke. Results including sensitivity analyses, however, were compatible with a possible increased risk for ischemic end points with use of dual versus triple therapy.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Safi U. Khan, MD, please contact Cassie Thomas at cassie.thomas@hsc.wvu.edu.

2. Conflicts of interest should be considered when evaluating health-related claims of CBD studies
The majority of cannabidiol studies with cannabidiol-related industry funding, conflicts of interest, or author employment have positive conclusions

Abstract: http://annals.org/aim/article/doi/10.7326/M19-3650
URL goes live when the embargo lifts

Conflicts of interest should be taken into account when evaluating studies investigating the health effects of cannabidiol (CBD), a chemical compound in cannabis. Researchers found that studies with cannabidiol-related industry funding, disclosed conflicts of interests, or author employment had conclusions that were supportive of cannabidiol. Findings from a brief research report are published in Annals of Internal Medicine.

Currently, only one CBD-derived drug has received approval from the U.S. Food and Drug Administration (FDA), and that drug is approved to treat a rare form of epilepsy. Regardless, companies continue to market and sell CBD products claiming that they prevent, cure, or treat various conditions. Given the growing number of companies invested in CBD's commercial success, along with previous evidence demonstrating associations between authors' conflicts of interest (COIs) and pro-industry conclusions, it is necessary to evaluate what research is being done on CBD and the industry's potential role in disseminating evidence to patients and physicians through the published literature.

Researchers from Yale School of Public health identified 417 articles published between 2014 and 2019 that discussed the characteristics, use, or therapeutic effect of CBD. Of these, 99 were human studies and 318 were animal studies, basic science studies, nonsystematic reviews, editorials, or commentaries. Among all 417 articles, approximately one fifth disclosed any CBD-related industry funding, and half of them received support from the same company. Of the 99 human studies, more than 60 percent of them had a CBD-related COIs (i.e. industry funding, COI disclosure, or author employment). Conclusions supportive of CBD were found in 110 studies with any CBD-related funding, COI disclosure, or author employment (110/149; 73.8%) compared to 164 studies without such conflicts (164/268; 61.2%). The authors suggest that given the potential for industry bias, sponsorship, and author affiliations, conflicts should be taken into account when evaluating the legitimacy of health-related claims from CBD studies.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Joshua D. Wallach, MS, please contact him directly at joshua.wallach@yale.edu or 203-785-5551.

Also new in this issue:

Early Detection of Sporadic Pancreatic Ductal Adenocarcinoma: Problems, Promise, and Prospects
Suresh T. Chari, MD; Ayush Sharma, MBBS; Anirban Maitra, MBBS

Ideas and Opinions

Abstract: http://annals.org/aim/article/doi/10.7326/M19-2336

Annals Understanding Clinical Research: Studies Using Randomized Trial Data to Compare Nonrandomized Exposures
Catharine B. Stack, PhD; Anne R. Meibohm, PhD; Joshua M. Liao, MD, MSc; and Eliseo Guallar, MD, DrPH

Understanding Clinical Research

Abstract: http://annals.org/aim/article/doi/10.7326/M20-0071

American College of Physicians

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