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ACC: Even Very Low Dose Rivaroxaban Prevents Recurrent VTE

— Results from EINSTEIN CHOICE point to new clinical pathway

Ƶ MedicalToday

This article is a collaboration between Ƶ and:

WASHINGTON -- Continuing use of rivaroxaban (Xarelto) at either 20 mg or 10 mg dose appears to reduce the risk of recurrent venous thromboembolism without increasing the risk for bleeding.

"This is a useful and safe clinical pathway for managing these patients," saidof the University of Ottawa, who reported the results from the 3,396-patient EINSTEIN CHOICE study today during a late-breaking clinical trials session at the meeting.

Based on these results, speaking at a press conference Wells said there is "really no role for aspirin in this setting ... I hope these findings will encourage more physicians to prescribe rivaroxaban for these patients."

"Clotting and bleeding have been the focus of so many studies over the years, but those studies are usually focused in the coronary bed, so I am really glad to see these data," said Sandra Lewis, MD, of Oregon Health and Science University in Portland. Lewis, who served as a discussant, added that her patients find it hard to stay on long-term anticoagulation with warfarin due to the need for testing and dietary restrictions.

The decision, she said, often comes down to "equipoise and so we rely on aspirin." The EINSTEIN CHOICE findings suggest that "... we can improve outcome and prevent events in a very safe way."

Patients were randomized to rivaroxaban 20 mg or 10 mg daily or to aspirin 100 mg daily. Prior to study enrollment patients completed 6 to 12 months of anticoagulation therapy and were in equipoise in terms of needing additional anticoagulation.

The study drugs were administered for up to 12 months and the efficacy endpoint was symptomatic recurrent venous thromboembolism (fatal or nonfatal); the safety endpoint was major bleeding.

"We are talking about an area of clinical care that is very challenging," said , who was not involved in the study. "In our own vascular institute we are trying to develop a clinical pathway for this. There are very few guidelines and those that do exist are conflicting," Gardiner, a surgeon, is medical director of Christiana Care's Center for Heart & Vascular Health and executive director of the Value Institute and is a former president of the American Heart Association.

"This looks like it could be the answer, " Gardner said, noting that warfarin is often difficult to manage and "aspirin is just not adequate."

In the U.S. there is a pressing need for a clinical pathway such as Gardner mentioned because recurrent VTE is one of the quality markers used by Medicare.

Wells told Ƶ that using rivaroxaban as described in the current study is a recognized clinical pathway in Canada, but "little was known about the efficacy of the lower (10 mg) dose."

The study was also simultaneously published online by .

Recurrent VTE occurred in 17 of 1,107 patients taking 20 mg rivaroxaban and in 13 of the 1,127 treated with the 10-mg dose. Among 1,131 patients receiving aspirin, there were 50 VTEs reported. These results translated to a hazard ratio of 0.34 for 20 mg rivaroxaban vs aspirin (95% CI 0.20-0.59); for 10 mg of rivaroxaban vs aspirin, HR 0.26 (95% CI 0.14-0.47).

The major bleeding rate were similar in both rivaroxaban doses (0.5% and 0.4% for 20 mg and 10 mg, respectively). The rate was also low, 0.3%, in the aspirin control group. "The rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups," Wells and colleagues wrote.

Disclosures

EINSTEIN-CHOICE was funded by Bayer Pharmaceuticals.

Wells disclosed grant and personal support from Bayer Healthcare, Bristol-Myers Squibb, and Pfizer, as well as personal fees from Janssen and Daiichi-Sankyo outside the submitted work.

Weitz reports receiving consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Ionis Pharmaceuticals, Merck, Novartis, Portola, and Pfizer outside the submitted work.

Crowther reports grant support, personal fees and non-financial support from Bayer , personal fees from Octapharma,

Shinogi, Pfizer, and Alexion, personal fees and non-financial support from Portola, grant support from Leo Pharma,

personal fees from legal firms retained by Bayer for expert testimony outside the submitted work.

Cuker reports grant support from Bayer/Janssen outside the submitted work and reports he is Chair of the forthcoming

American Society of Hematology Clinical Practice Guidelines on Venous Thromboembolism.

Primary Source

The New England Journal of Medicine

Weitz , JI et al, "Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism"Published on March 18,2017, at NEJM.org

Secondary Source

The New England Journal of Medicine

Crowther, MA, and Cuker, A "Reduced-Intensity Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism" Published on March 18,2017, at NEJM.org

Additional Source

ACC.17 66th Annual Scientific and Session & Expo

Weitz, JI "EINSTEIN CHOICE "Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism" Late-breaking clinical trial Saturday, March 18, 2017