For Patients With Provoked VTE and at Least One Ongoing Risk Factor, 12 Months of Apixaban Is Better Than 3 Months

For patients with a provoked episode of venous thromboembolism (VTE) and at least one ongoing risk factor for VTE, is 12 months of apixaban (Eliquis) better than 3 months?

For patients with a provoked VTE and at least one ongoing risk factor (eg, obesity, chronic lung disease, chronic inflammatory disease), 12 months of apixaban, 2.5 mg twice daily reduced recurrent VTE compared with 3 months of treatment (NNT = 11). (Level of Evidence = 1b)

Current guidelines recommend 3 months of anticoagulation with a direct oral anticoagulant for patients with a provoked VTE, defined as a VTE occurring with major surgery, trauma, acute medical illness, or immobility. The safety profile and convenience of direct oral anticoagulants, such as apixaban, are more favorable than warfarin, so it is possible that a longer period of anticoagulation may be beneficial. The researchers of the US industry–sponsored study identified 600 adults with an episode of VTE provoked by major surgery, acute medical illness, or immobility. The patients had at least one ongoing risk factor for VTE, such as body mass index of at least 30 kg/m², chronic inflammatory disease, or chronic lung disease. Patients had been taking anticoagulants for at least 3 months and were randomized to receive apixaban, 2.5 mg twice daily or matching placebo for 12 months. Groups were balanced at baseline with a mean age of 59 years, 58% were female, and 48% had deep venous thrombosis, 23% had pulmonary embolism, and 29% had both. At 1 year, the researchers had 100% follow-up. The likelihood of symptomatic recurrent VTE was significantly lower in the apixaban group (1.3% vs 10.0%; P < .001; number needed to treat = 11). There were reductions in deep venous thrombosis (4 vs 23) and pulmonary embolism (0 vs 11) in the apixaban group. With regard to harm, major bleeding occurred in one patient in the apixaban group and none in the placebo group; clinically relevant nonmajor bleeding was numerically more common with apixaban (4.8% vs 1.7%; P = .06).

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry

Setting: Outpatient (any)

Reference: Piazza G, Bikdeli B, Pandey AK, et al.; HI-PRO Trial Investigators. Apixaban for extended treatment of provoked venous thromboembolism. N Engl J Med. 2025;393(12):1166-1176.

Editor’s Note: Dr. Ebell is deputy editor for evidence-based medicine for AFP.