Reduced-dosed Rivaroxaban in the long-term prevention of recurrent symptomatic DVT The Einstein-Choice trial

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1 Reduced-dosed Rivaroxaban in the long-term prevention of recurrent symptomatic DVT The Einstein-Choice trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich

2 Disclosure Speaker name: Thomas Stadlbauer I have the following potential conflicts of interest to report: Study-Investigator: Lecturer: Travel grant: Bayer Bayer, Daiichi Sankyo, Bristol Myer Squibb, Pfizer Bristol Myers Squibb, Pfizer, Daiichi Sankyo xxx

3 Direct Factor Xa Inhibitors are the new gold standard treating acute venous thromboembolism EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S

4 Direct Factor X Inhibitors are the new gold standard treating acute venous thromboembolism Acute DVT Einstein Study was designed as an eventdriven, noninferiority study

5 Direct Factor X Inhibitors are the new gold standard treating acute venous thromboembolism Primary efficacy outcome: recurrent thromboembolism 3, 6 oder 12 months of therapy

6 Direct Factor X Inhibitors are the new gold standard treating acute venous thromboembolism Primary safety outcome: major bleeding / CRNMB

7 Challenge: Kumulative Inzidenz von VTE- VTE recurrence rates after cessation of anticoagulation 45 Rezidiven über die Zeit VTE recurrence rates in % Kumulative Inzidenz von VTE-Rezidiven [%] Prandoni et al. Hematologica 2007;92: , Zeit nach dem ersten Ereignis [Jahre] years

8 Challenge: VTE recurrence rates after cessation of anticoagulation RRR 82% Challenge Bleeding: Thus, 34 recurrent events were prevented, at the cost of 4 major bleeding events. However, the incidence of clinically relevant nonmajor bleeding was increased from 1.2% in the placebo group to 5.4% with rivaroxaban.

9 Challenge: VTE recurrence rates after cessation of anticoagulation

10 Challenge: VTE recurrence rates after cessation of anticoagulation

11 Challenge: VTE recurrence rates after cessation of anticoagulation

12 Challenge: VTE recurrence rates after cessation of anticoagulation

13 Challenge: VTE recurrence rates after cessation of anticoagulation RRR 82%

14 Challenge: VTE recurrence rates after cessation of anticoagulation

15 Challenge: EINSTEIN-CHOICE recurrence rates after cessation of anticoagulation

16 Challenge: EINSTEIN-CHOISE VTE recurrence rates after cessation of anticoagulation Primary efficacy outcome: symptomatic recurrent venous thromboembolism Principal safety outcome: major bleeding (fatal / symptomatic critical organ / Hb < 2 mg% or transfusion)

17 Challenge: EINSTEIN-CHOISE VTE recurrence rates after cessation of anticoagulation RRR 74%

18 Challenge: EINSTEIN-CHOISE VTE recurrence rates after cessation of anticoagulation

19 Limitations: Einstein-Choise 1. Patients requiring extended treatment are excluded => it remains unknown whether 10 mg rivaroxaban is sufficient to prevent recurrence in these patients 2. Patients were only treated prolonged for 12 months => additional studies are needed to determine the utility of continuing treatment for longer periods 3. The study was not powered to show the non-inferiority of the 10 mg dose versus 20 mg dose of rivaroxaban

20 Perspectives: Prolonged anticoagulation after venous thromboembolism? Is there a catch-up phenomenon?

21 Perspectives: Prolonged anticoagulation after venous thromboembolism? Is there a catch-up phenomenon?? Does prolonged therapy reduce VTE recurrence rates?

22 Perspectives: How long should we extend Prolonged anticoagulation after venous thromboembolism? Is there a catch-up phenomenon?

23 Perspectives: How long should we extend Prolonged anticoagulation after venous thromboembolism? Is there a catch-up phenomenon?

24 Perspectives: How long should we extend Prolonged anticoagulation after venous thromboembolism? Is there a catch-up phenomenon? 10.7% 5.6% 6.9% 0.4%

25 Take Home Messages: Einstein-Choise In patients with venous thromboembolism continued anticoagulation with 10 or 20 mg rivaroxaban a.) reduced the risk of VTE recurrence compared with aspirin b.) without significantly increasing the bleeding rates There is indirect evidence that prolong anticoagulation after DVT may reduce VTE recurrence rates on the long run

26 NN Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich