Direct oral anticoagulants lack trial evidence in patients with severe renal impairment, as these patients were systematically excluded from seminal trials despite high risks of thrombosis and bleeding.
Patients with severe renal impairment have high risks of both thrombosis and bleeding but were systematically excluded from seminal DOAC trials, highlighting a critical evidence gap.
Chronic kidney disease (CKD) is common and increasing, affecting � 10% of the global adult population, with an estimated 4.5 million individuals requiring renal replacement therapy (RRT) 1,2. Severe renal impairment (defined as creatinine clearance CrCl ≤ 29 mL/min with or without RRT for the purpose of this commentary) is associated with an increased risk of atrial fibrillation (AF) and venous thromboembolism (VTE) 3,4. Thus, consideration of anticoagulation is frequently required. Additionally, the risk of both thrombotic and bleeding outcomes increases with greater severity of CKD, with rates of bleeding exceeding thrombotic events 5,6. Despite a clear need for trials to guide optimal care, patients with severe renal impairment were systematically excluded from the seminal trials of direct oral anticoagulants (DOACs) 7–9. Consequently
Byrne et al. (Sun,) conducted a editorial in Severe renal impairment. Direct oral anticoagulants was evaluated. Direct oral anticoagulants lack trial evidence in patients with severe renal impairment, as these patients were systematically excluded from seminal trials despite high risks of thrombosis and bleeding.