Background: Active cancer places patients at increased risk for VTE. Ambulatory patients can be risk stratified using the validated Khorana score to assess risk for VTE, a complication resulting in significant morbidity, mortality, and health care costs.
Study design: Randomized, placebo-controlled, double-blind clinical trial.
Setting: Ambulatory; Canada.
Synopsis: A total of 1,809 patients were assessed for eligibility, 1,235 were excluded, and 574 with a Khorana score of 2 or higher were randomized to apixaban 2.5 mg twice daily or placebo. Treatment or placebo was given within 24 hours after the initiation of chemotherapy and continued for 180 days. The primary efficacy outcome – first episode of major VTE within 180 days of randomization – occurred in 4.2% of the apixaban group and in 10.2% of the placebo group (hazard ratio, 0.41; 95% confidence interval, 0.26-0.65; P less than .001). Major bleeding in the modified intention-to-treat analysis occurred in 3.5% in the apixaban group and 1.8% in the placebo group (HR, 2.00; 95% CI, 1.01-3.95; P = .046).
There was no significant difference in overall survival, with 87% of deaths were related to cancer or cancer progression.
Bottom line: VTE is significantly lower with the use of apixaban, compared with placebo, in intermediate- to high-risk ambulatory patients with active cancer who are initiating chemotherapy.
Citation: Carrier M et al. Apixaban to prevent venous thromboembolism in patients with cancer. N Engl J Med. 2018 Dec 4. doi: 10.1056/NEJMoa1814468.
Dr. Trammell Velasquez is an associate professor of medicine in the division of general and hospital medicine at UT Health San Antonio and a hospitalist at South Texas Veterans Health Care System.