Real-world data on direct oral anticoagulants generally mirror phase III clinical trial results, showing comparable or superior efficacy and safety compared to warfarin.
Real-world evidence confirms the favorable risk-benefit profile of DOACs observed in clinical trials, while highlighting the need for appropriate patient selection, dosing, and management of bleeding complications in routine practice.
The group of new oral anticoagulants or NOACs, now termed direct oral anticoagulants or DOACs, with their favourable results from large scale phase III clinical trials, represent a major advancement and expanded armamentarium in antithrombotic therapy. Dabigatran, rivaroxaban, apixaban and edoxaban are now in clinical routine use for prevention and treatment of arterial and venous thrombotic diseases as addressed in their clinical trials. Usage of the DOACs is expected to increase as clinicians gain more experience and reassurance with data from the real world studies which are generally consistent with that from clinical trials. Development of specific antidotes in management of bleeding complications and development of coagulation assays for their plasma levels will further boost the confidence in the DOACs. Nonetheless, there are still limitations associated with the DOACs. Many patients in need of anticoagulant therapy for indications not studied in the clinical trials will not be eligible for treatment with a DOAC. Conditions where more data is required include DOACs use in the paediatric age group, patients with atrial fibrillation and valvular heart disease, thrombosis associated with the anti-phospholipid syndrome and cancer associated thrombosis. The affordability and access to these drugs may pose an issue for many patients under healthcare systems not providing for these medications. With four new anticoagulants coming onboard very quickly, the focus has shifted to the practical approach and management in real life as many clinicians are not yet familiar with the DOACs. Clinicians need to be educated on how to manage this new class for drugs, from choosing the appropriate drug to prevention and managing bleeding complications as a lack of knowledge and understanding in these drugs will lead to inappropriate use and compromise on patient safety.
Lai Heng Lee (Sat,) conducted a review in Atrial fibrillation and venous thromboembolism. Direct oral anticoagulants (DOACs) vs. Vitamin K antagonists (warfarin) or standard of care was evaluated. Real-world data on direct oral anticoagulants generally mirror phase III clinical trial results, showing comparable or superior efficacy and safety compared to warfarin.