SELECT-D
Trial question
What is the effect of rivaroxaban in patients with cancer and VTE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 406
406 patients (192 female, 214 male).
Inclusion criteria: patients with active cancer who had symptomatic PE, incidental PE, or symptomatic lower-extremity proximal DVT.
Key exclusion criteria: a history of VTE, previous treatment dose of anticoagulant or > 75 mg aspirin per day, clinically significant liver disease, bacterial endocarditis, active bleeding or high risk of bleeding, or uncontrolled hypertension.
Interventions
N=203 oral factor Xa inhibitor, rivaroxaban (15 mg BID for 3 weeks, then 20 mg once daily for a total of 6 months).
N=203 LMWH, dalteparin (200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6).
Primary outcome
Rate of VTE recurrence over 6 months
4%
11%
11.0 %
8.3 %
5.5 %
2.8 %
0.0 %
Oral factor Xa inhibitor,
rivaroxaban
Low molecular weight heparin,
dalteparin
Significant
decrease ▼
NNT = 14
Significant decrease in the rate of VTE recurrence over 6 months (4% vs. 11%; HR 0.43, 95% CI 0.19 to 0.99).
Safety outcomes
No significant difference in cumulative major bleeds at 6 months (6% vs. 4%); mostly GI bleeding.
Significant difference in major bleeds in esophageal or gastroesophageal cancer (36% vs. 11%).
Conclusion
In patients with active cancer who had symptomatic PE, incidental PE, or symptomatic lower-extremity proximal DVT, oral factor Xa inhibitor, rivaroxaban was superior to LMWH, dalteparin with respect to the rate of VTE recurrence over 6 months.
Reference
Young AM, Marshall A, Thirlwall J et al. Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism: Results of a Randomized Trial (SELECT-D). J Clin Oncol. 2018 Jul 10;36(20):2017-2023.
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