The following are key points to remember from a state-of-the-art review about when direct oral anticoagulants (DOACs) should not be standard treatment:

1. Therapy with a DOAC has demonstrated efficacy and safety in the following scenarios:
   • Stroke prevention in atrial fibrillation (AF).
   • AF in patients with acute coronary syndrome or recent percutaneous coronary intervention.
   • AF in patients with heart valve disease other than rheumatic heart disease or mechanical valves.
   • Acute management of venous thromboembolism (VTE) and the secondary prevention of VTE.
   • Patients with stable atherosclerotic cardiovascular disease and patients after recent peripheral artery revascularization.
2. Randomized controlled trials have shown that therapy with a DOAC might be less efficacious or safe, or not confer net benefit compared with standard of care, in the following scenarios:
   • Mechanical heart valves (compared to a vitamin K antagonist).
   • Rheumatic AF (AF plus echocardiographically proven rheumatic heart disease, compared to a vitamin K antagonist).
   • Thrombotic antiphospholipid syndrome (compared to a vitamin K antagonist).
   • Following transcatheter aortic valve replacement (TAVR) in patients in sinus rhythm (DOAC with or without aspirin compared to dual antiplatelet therapy [DAPT]).
   • Embolic stroke of undetermined source (compared to aspirin).
   • Left ventricular (LV) assist device (compared to a vitamin K antagonist plus aspirin).
   • Heart failure with reduced LV systolic function without AF (compared to placebo).
3. The safety and/or efficacy of DOACs is uncertain in the following scenarios owing to uncertain indications:
   • Prevention of LV thrombus after anterior myocardial infarction (DOAC plus DAPT compared to DAPT).
   • Primary prevention of catheter-associated deep vein thrombosis (compared to placebo).
   • Splanchnic vein thrombosis in non-cirrhotic patients with no active bleeding (compared to placebo).
   • Cerebral venous sinus thrombosis (compared to a vitamin K antagonist).
4. The safety and/or efficacy of DOACs is uncertain in the following scenarios owing to uncertain evidence:
   • End-stage renal disease (ESRD) for the treatment of AF or VTE (dose-reduced DOAC instead of a vitamin K antagonist).
   • Pregnancy or during breast-feeding.
   • Adult congenital heart disease for the treatment of AF (instead of a vitamin K antagonist).
   • Chronic thromboembolic pulmonary hypertension (instead of a vitamin K antagonist).
   • Patients with body mass index >45 kg/m² or following bariatric surgery.
   • Heparin-induced thrombocytopenia and thrombosis.
5. The following are other considerations in the use of DOACs:
   • Safety concerns with DOACs related to drug-drug interactions (most DOAC trials excluded patients on medications with known interactions) or in patients with advanced liver disease.
   • Limitations in the ability to monitor DOAC plasma levels, and incomplete understanding of the correlation between plasma levels and clinical effects.
6. The following represent knowledge gaps and potential future considerations related to DOAC use:
   • Why are DOACs less safe or less efficacious compared to standard of care in certain clinical scenarios, such as mechanical heart valves, thrombotic antiphospholipid syndrome, embolic stroke of undetermined source, and following TAVR.
   • The safety and efficacy of DOACs in certain subgroups, such as women who are pregnant or breast-feeding; and patients with ESRD, adult congenital heart disease, or chronic thromboembolic pulmonary hypertension.
   • The potential role of factor XIa inhibitors.

Clinical Topics: Anticoagulation Management, Prevention

Keywords: Anticoagulants, Secondary Prevention

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