This article is more than 5 years old. Information may no longer be current.
Extended VTE therapy averts recurrence, increases risk for nonmajor clinically relevant bleeding
Click Here to Manage Email Alerts
In patients with unprovoked venous thromboembolism, extending treatment with warfarin and direct oral anticoagulants effectively prevents recurrence without higher risk for major bleeding, according to results from a meta-analysis.
Five studies covering six randomized clinical trials showed, however, that using warfarin and direct oral anticoagulants for the extended treatment of VTE does increase the chances for nonmajor clinically relevant bleeding.
“This emphasizes that extending treatment should be based on consideration of the patient’s individual risk of a recurrent event and risk of bleeding,” the researchers wrote. “It is not possible to conclude whether there is a clinical benefit from using [direct oral anticoagulants] compared to warfarin.”
Caroline Sindet-Pedersen, of the University of Copenhagen and Copenhagen University Hospital Gentofte, Denmark, and colleagues filtered 729 articles on PubMed and Embase and performed the analysis on studies with similar study design and standard for comparison.
Extended use of warfarin and direct oral anticoagulants lowered the risk for recurrent VTE by 83% vs. placebo. The greatest RR reduction was seen with warfarin (RR = 0.03; 95% CI, 0-0.49) and dabigatran (Pradaxa, Boehringer Ingelheim; RR = 0.08; 95% CI, 0.03-0.27), followed by apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) 2.5 mg (RR = 0.19; 95% CI, 0.11-0.33), rivaroxaban (Xarelto, Janssen; RR = 0.19; 95% CI, 0.09-0.4) and apixaban 5 mg (RR = 0.2; 95% CI, 0.11-0.34).
The investigators observed no increased risk for major bleeding with extended treatment vs. placebo (RR = 1.15; 95% CI, 0.4-3.31) but found an overall increased risk for nonmajor clinically relevant bleeding (RR = 2.12; 95% CI, 1.55-2.9). Neither warfarin nor apixaban 2.5 mg were individually linked to heightened risk for nonmajor clinically relevant bleeding.
The researchers highlight one study not included in the meta-analysis that showed dabigatran was noninferior to vitamin K antagonists for preventing recurrent VTE (HR = 1.44; 95% CI, 0.78-2.64) and further lowered nonmajor clinically relevant bleeding risk (RR = 0.58; 95% CI, 0.43-0.77).
“More studies are needed to further investigate this association in extended treatment,” the researchers wrote. “This includes randomized clinical trials examining the efficacy and safety of apixaban and rivaroxaban compared with [vitamin K antagonists] for extended treatment, and cohort studies that assess the safety and efficacy of [direct oral anticoagulants] compared with [vitamin K antagonists] in a real world setting.” – by Allegra Tiver
Disclosure: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts