Table 2.
Overview of randomized trials investigating the effectiveness and safety of anticoagulation beyond 6 months treatment in patients with cancer and venous thromboembolism.
| Trial Name | Study Population | Treatment Comparison |
Outcome | |||
|---|---|---|---|---|---|---|
| Recurrent Venous Thrombo-Embolism | Major Bleeding | Clinically Relevant Non-Major Bleeding | Other | |||
| Completed trials | ||||||
| SELECT-D: 12 m | Ninety-two patients with cancer and residual deep vein thrombosis or index pulmonary embolism having completed 6 months of rivaroxaban or dalteparin * | Six months rivaroxaban 20 mg − 1 vs. placebo | 4% vs. 14%, Hazard ratio 0.32 (0.06–1.58) |
5% vs. 0% | 4% vs. 0% | |
| Hokusai VTE Cancer–post hoc analysis | Five hundred and sixty-seven patients with cancer having completed 6 months treatment with either edoxaban or dalteparin ** | Up to 6 months edoxaban 60 mg − 1 versus dalteparin 150 IU/kg *** | 1.4% vs. 2.9%, Hazard ratio 0.48 (0.14–1.63) |
2.4% vs. 1.1%, Hazard ratio 2.23 (0.59–8.46) |
4.8% vs. 4.8%, Hazard ratio 1.02 (0.48–2.16) |
Recurrent VTE or major bleeding: 3.7% vs. 4.0%, Hazard ratio 0.96 (0.42–2.22) |
| Cancer-DACUS **** | Two hundred and forty-two patients with cancer and residual vein thrombosis having completed 6-month treatment for deep vein thrombosis | Six months of nadroparin-75% of full weight-adjusted dosage-vs. no treatment | 4 vs. 18 events | 4 vs. 1 event | Not reported | Not reported |
| Ongoing trials | ||||||
| EVE, NCT03080883 |
Three hundred and seventy patients who have completed 6–12 months of anticoagulation after cancer-associated venous thromboembolism | Twelve months of apixaban 2.5 mg bid vs. 5 mg bid | Yes | Yes–combined | Arterial thrombosis | |
| API-CAT, NCT03692065 |
One thousand seven hundred and twenty-two patients with cancer who have completed 6 months of anticoagulation for proximal deep-vein thrombosis and/or pulmonary embolism | Twelve months of apixaban 2.5 mg bid vs. 5 mg bid | Yes | Yes | Recurrent symptomatic VTE VTE-related death All-cause death Major bleeding |
|
* One hundred and thirty-six patients were eligible for randomization, but 44 patients declined to participate or were advised not to by their clinicians, e.g., due to bleeding risk assessment. ** The decision on treatment continuation beyond 6 months, including choice of anticoagulant, was left to the discretion of the treating physician, and thus not based on randomization. *** The initial randomization dosage was edoxaban 60 mg daily preceded by 5 days of low-molecular-weight heparin (with dose reductions to edoxaban 30 mg daily in patients with low body weight, impaired renal function, or concomitant strong P-gp inhibitors) versus dalteparin 200 IU/kg for 30 days followed by 150 IU/kg thereafter. **** Main results originally reported after 12-month follow-up, but the active treatment period was only 6 months. This table presents only data during the active treatment period.