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Published on: February 28, 2012
Direct oral anticoagulant use in special populations
Michelle C Lamarche1, Eman Alrajhi2, Philip S Wells3
1Department of Medicine, University of Alberta, Clinical Sciences Building, Edmonton, Alberta.
Insights
Direct oral anticoagulants (DOACs) are effective for venous thromboembolism (VTE) and nonvalvular atrial fibrillation (NVAF), even in patients with common comorbidities. Individualized decisions are key for safe and effective anticoagulant therapy.
Area of Science:
- Pharmacology
- Cardiology
- Hematology
Background:
- Direct oral anticoagulants (DOACs) are widely used for venous thromboembolism (VTE) and nonvalvular atrial fibrillation (NVAF).
- Initial trials excluded patients with common comorbidities like obesity, advanced kidney disease, cirrhosis, cancer, and antiphospholipid antibody syndrome.
- Real-world data has emerged on DOAC use in these excluded populations.
Purpose of the Study:
- To review the efficacy and safety of DOACs in patients with common comorbidities typically excluded from pivotal trials.
- To synthesize current evidence on DOAC use in specific high-risk patient groups.
Main Methods:
- Review of retrospective studies, meta-analyses, national databases, and pharmacokinetic data.
- Analysis of DOAC efficacy and safety in patient populations with obesity, advanced chronic kidney disease, cirrhosis, cancer, and antiphospholipid antibody syndrome.
Main Results:
- DOACs demonstrate efficacy and safety in many patients with comorbidities, despite initial trial exclusions.
- Caution or avoidance of DOACs is advised in specific conditions like high-risk antiphospholipid antibody syndrome, advanced cirrhosis, advanced kidney disease, and intact gastrointestinal cancers.
- DOAC use is expanding beyond initial randomized controlled trial criteria.
Conclusions:
- DOACs have transformed anticoagulant management for VTE and NVAF.
- Individualized patient assessment, considering comorbidities and patient preference, is crucial for selecting the appropriate anticoagulant.
- Informed consent is paramount when making decisions about anticoagulant therapy.
Purpose Of Review:
The pivotal phase III trials demonstrating efficacy and safety of direct oral anticoagulants (DOACs) in the treatment of venous thromboembolism (VTE) or nonvalvular atrial fibrillation (NVAF) excluded patients with important and common comorbidities, including obesity, advanced chronic kidney disease, cirrhosis, cancer and antiphospholipid antibody syndrome. Despite the lack of large prospective randomized control trials in these patient populations, the use of DOACs has led to a wealth of efficacy and safety data within these groups.
Recent Findings:
Retrospective studies, meta-analyses, national databases and pharmacokinetic data have shed light on the efficacy and safety of DOACs in these patient populations. Although DOACs should be avoided in those with high-risk triple positive antiphospholipid antibody syndrome, advanced cirrhosis, advanced kidney disease and intact gastrointestinal cancers, and used with caution in genitourinary cancers, their use extends beyond the inclusion criteria of the initial randomized control trials.
Summary:
DOACs have revolutionized anticoagulant management and have become the cornerstone for VTE treatment and stroke prevention in NVAF. The decision to use DOACs must be individualized. Patient preference, underlying comorbidities and informed consent must always be considered when selecting the most appropriate anticoagulant.
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