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Rivaroxaban safe, effective alternative for unprovoked VTE
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Rivaroxaban conferred lower risk for recurrent deep vein thrombosis and pulmonary embolism than standard treatment in patients with unprovoked venous thromboembolism, according to results from a propensity-matched nationwide cohort study.
“Recurrence of VTE is a major clinical concern — overall recurrence rates have been as high as 10% per year, and are higher for unprovoked VTE than for provoked VTE,” Torben B. Larsen, MD, from the department of cardiology at Aalborg University Hospital in Denmark, and colleagues wrote. “Anticoagulant therapy reduces the risk [for] recurrence, but must be balanced against the associated increased risk of bleeding.”
Limited studies have assessed the safety and efficacy of rivaroxaban (Xarelto, Janssen), an indirect Factor Xa inhibitor, for the treatment of VTE in routine clinical practice.
Larsen and colleagues linked three nationwide Danish health registries to compare the safety and efficacy of rivaroxaban (n = 1,751) with warfarin (n = 2,945) in propensity-matched patients with unprovoked VTE naive to treatment with an oral anticoagulant.
Recurrent VTE served as the primary clinical efficiency outcome, and bleeding served as the primary safety outcome.
Recurrent VTE events occurred in 250 patients within 6 months.
Patients who received rivaroxaban demonstrated lower rates of recurrent VTE than those who received standard of care at 3 months (21.8 vs. 16.4 events per 100 person-years; HR = 0.75; 95% CI, 0.56-1.01) 6 months (13.1 vs. 9.9 events per 100 person-years; HR = 0.74; 95% CI, 0.56–0.96)
Bleeding events occurred in 47 patients within 6 months.
More bleeding events occurred after 6 months in those who received rivaroxaban than warfarin (2.4 vs. 2 incidents per 100 person-years). Patients assigned rivaroxaban demonstrated comparable bleeding rates at 3 months (HR = 0.99; 95% CI, 0.47–2.07) and 6 months (HR = 1.19; 95% CI, 0.66–2.13).
In total, 125 patients died during the study. The two treatment arms demonstrated similar mortality rates at the 6-month follow-up (5.7 vs. 5.5 events per 100 person-years).
“As a single-drug oral treatment, rivaroxaban provides a safe alternative to warfarin with fewer drug interactions and a more predictable pharmacology, which minimizes the need for laboratory monitoring of the anticoagulant effect and frequent dose adjustments,” Larsen and colleagues wrote.
Studies based on administrative health registries may create valuable scientific contributions but may require attention to potential limitations, Søren Paaske Johnsen, MD, PhD, from the department of clinical epidemiology at Aarhus University Hospital in Denmark, wrote in an accompanying editorial.
“The study demonstrates the value of using administrative health data for research but also emphasizes the need for additional studies on the same topic, taking complimentary sets of strengths and limitations into account when interpreting study findings,” Johnsen wrote. “In addition, making use of readily available guidelines for the reporting and assessment of studies based on administrative health data is strongly recommended.” – by Kristie L. Kahl
Disclosure: Larsen reports investigator roles with Boehringer Ingelheim and Janssen Scientific Affairs and speaker roles with Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Roche Diagnostics and Takeda Pharma. Please see the full study for a list of all other researchers’ relevant financial disclosures. Johnsen reports advisory/consultant roles with Bayer, Bristol-Myers Squibb and Pfizer; research grants from Bristol-Myers Squibb and Pfizer; and speaker roles with Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Pfizer.
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