ACC takes on DOAC use with new scientific statement
The American College of Cardiology (ACC) has issued a new scientific statement on the use of direct oral anticoagulant (DOAC) therapy for the primary and secondary prevention of thrombotic events.
DOACs have transformed the prevention and treatment of thromboembolic disease because they offer predictable pharmacokinetics, fewer drug interactions and improved safety compared to vitamin K antagonists such as warfarin. However, the ACC said gaps remain in their optimal implementation across multiple clinical scenarios; DOACs continue to be underutilized and sometimes inappropriately dosed. This is particularly a problem in patients at elevated thrombotic risk and in populations historically underrepresented in randomized trials.
"This statement is intended to complement existing clinical practice guidelines by synthesizing evolving data, clarifying areas of uncertainty, and supporting individualized, patient-centered decision making," according to writing committee chair Dharam J. Kumbhani, MD, and colleagues. "By addressing both evidence and implementation challenges, this document aims to improve the appropriate and equitable use of DOACs across the spectrum of thrombotic disease."
The statement covers numerous areas of DOAC use for anticoagulation. These include sections on:
• Anticoagulation in atrial fibrillation (AFib).
• Acute and extended treatment of venous thromboembolism (VTE) and stroke.
• Periprocedural anticoagulation.
• Antithrombotic strategies following stroke, left atrial appendage closure, and catheter ablation.
• DOACs for primary prevention of VTE and stroke.
• Changes in the 2023 ACC/AHA/Multisociety Guideline for Management of AFib.
• Primary prevention of VTE in patients undergoing surgery.
• Duration of anticoagulation in clinical scenarios.
• Use in valvular heart disease.
• Secondary prevention of thrombotic events in patients with atherosclerotic cardiovascular disease.
• Comparison of bleeding risk models.
• Secondary prevention indications, duration and dosing.
• Thrombophilic states, including coagulation inhibitor deficiency and APS.
• Use of DOACs in chronic kidney disease (CKD) and liver disease patients.
• Considerations when using DOACs in obese patients.
• Use in cancer patients with VTE.
• Treatments for central venous catheter DVT and left ventricular thrombus.
• Management of anticoagulation during noncardiac surgery.
• Best practices for managing special populations, including patients with chronic kidney disease, liver dysfunction, cancer, obesity, frailty, prior bleeding, and valvular heart disease.
• Practical considerations such as drug selection, dosing strategies, duration of therapy, bleeding risk assessment, management of anticoagulant-related bleeding, drug–drug interactions, adherence, and cost-related barriers to care.
Recommendations for DOAC monitoring and follow-up
According to the new statement, patients receiving DOAC therapy should undergo periodic reassessments of bleeding risk, renal and hepatic function, concomitant medications and adherence. Closer attention should be paid to patients who face a higher risk for bleeding or drug accumulation.
Bleeding risk scores might be used to identify patients who need more frequent follow-up, but should not be used in isolation to withhold anticoagulation. Instead, the authors wrote, clinicians should focus on mitigating modifiable bleeding risk factors and reinforcing patient education on signs and symptoms of bleeding.
Barriers to use
Cost remains a significant barrier to the wider use of DOACs. Many cost-effectiveness analyses demonstrate DOACs are economically favorable in the long term because of reduced stroke and bleeding events. However, the higher upfront drug cost remains a practical obstacle for individual patients. Out-of-pocket costs of more than $100 are often related to patients abandoning their prescriptions. The document calls for greater efforts to make DOACs more affordable.
The authors found several other reasons why DOACs are not more widely used. While the safety profile of DOACs is very good, for example, concerns about bleeding remain one of the biggest limitations of DOAC use.
A new strategy
One novel anticoagulant strategy is the use of factor XI agents, which have the potential for reduced bleeding risk while preserving antithrombotic efficacy. Several classes of agent have been developed or are under consideration to target factor XI and/or factor XIa, including antisense oligonucleotides, monoclonal antibodies, small molecules, natural inhibitors, aptamers, and small interfering RNAs. Some of these agents can eliminate daily dosing and allow administration every two to four weeks.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]