Direct oral anticoagulants to prevent VTE recurrence: full or reduced dosage? MA Sevestre CHU Amiens

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1 Direct oral anticoagulants to prevent VTE recurrence: full or reduced dosage? MA Sevestre CHU Amiens

2 Faculty disclosure Marie Antoinette Sevestre I disclose the following financial relationships: Paid speaker for Bayer SA, BMS Pfizer, Leo Pharma, Aspen Slides from Francis Couturaud (not financial but thank you Francis)

3 Duration of treatment When VTE is provoked by major transient risk factors, recurrence is very low : 3 months treatment is safe When VTE is unprovoked: treatment is undefinite

4 Primary Outcome Secondary Outcomes Secondary Outcomes 6 vs 24 months after unprovoked DVT or PE PADIS Study Design 371 First Unprovoked PE 18 mo. study treatment 24 mo. follow-up 18 months WARFARIN First Unprovoked VTE 6 mo. VKA R 104 First Unprovoked proximal DVT 18 months PLACEBO Couturaud F et al, JAMA 2015;314:31 40 Couturaud F et al, ISTH, Berlin 2017

5 Recurrent VTE in PADIS-PE trial HR 0.67 ( ) HR 0.11 ( ) Couturaud F et al, JAMA 2015;314:31 40

6 Recurrent VTE in PADIS-DVT trial HR 0.72 ( ) HR 0.03 ( ) Couturaud F et al, ISTH, Berlin 2017

7 Rational Impact of different durations of anticoagulation on the risk of recurrent VTE: No impact Only two choices: 3 to 6 months or indefinite Risk factors for recurrent VTE? Major transient risk factors (i.e.; major therapeutic implication) - Surgery in the past 3 months - Trauma of lower limbs in the past 3 months - Hospitalization + prolonged bed rest (72h) in the past 3 months - estro-progestative contraception, HRT, and pregnancy Major persistent risk factor: - active cancer, - chronic inflammatory disease, - major thrombophilia Patients at high risk of recurrence eligible to indefinite anticoagulation: Unprovoked VTE (no major transient risk factors) VTE associated with persistent risk factors Multiple VTE ( 2) Others? (High risk PE, phlegmatia cerulae, etc) 7

8 Recurrent VTE after stopping anticoagulation Recurrences 15% RECURRENT UNPROVOKED VTE 9 % 3 % INDEFINITE 3-6 Months Persistent factors 1 st UNPROVOKED VTE Minor transient factors Threeshold 5% 1 st PROVOKED VTE (by major transient factor) 0 1 year

9 Case-fatality rate of recurrent VTE after stopping anticoagulation Presentation of index VTE Presentation of recurrence LAFIT WODIT PE-DVT PADIS PE-DVT Unprovoked EP As EP 75% 60% 78% Unprovoked 100% 85% 87% Case-fatality rate 15% 10% 8% Unprovoked DVT As TVP 90% 81% 93% Unprovoked 100% 100% 97% Case-fatality rate 0% 0% 3% Kearon 1999; Agnelli 2001; Agnelli 2003; Couturaud 2015

10 Frequency of fatal events (%) For a similar frequency of recurrence of 9%/year after PE or DVT, what is the frequency of death due to: - recurrent VTE after stopping anticoagulation - major bleeding during anticoagulation 2% 1.5 % 1% 0.5 % Rate of death caused by recurrent VTE after stopping anticoagulation for: Unprovoked PE Unprovoked DVT Rate of death caused by major bleeding during anticoagulation with: VKA (INR 2-3) 1 y. 2 y. 3 y. Time of follow-up (years) Le Mao R, Tromeur C, Couturaud F. Press Med 2017

11 Frequency of fatal events (%) For a similar frequency of recurrence of 9%/year after PE or DVT, what is the frequency of death due to: - recurrent VTE after stopping anticoagulation - major bleeding during anticoagulation 2% 1.5 % 1% 0.5 % Rate of death caused by recurrent VTE after stopping anticoagulation for: Unprovoked PE Unprovoked DVT Rate of death caused by major bleeding during anticoagulation with: VKA (INR 2-3) DOAC (100% dose) DOAC (50% dose) 1 y. 2 y. 3 y. Time of follow-up (years) Le Mao R, Tromeur C, Couturaud F. Press Med 2017

12 Extended treatment in patients at equipoise with low-dose DOACs? Amplify-Ext Study N~2,488 Apixaban 5 mg bid n~813 PE and/or DVT initially treated 6 months R Apixaban 2.5 mg bid n~840 PLACEBO od N~ mois (post-study) 12 months of treatment Design: Multicentre, randomized, double-blind, superiority study AMPLIFY-EXT-investigators, NEJM 2013;368(8):

13 Extended treatment in patients at equipoise with low-dose Apixaban (Amplify-Ext Study) Arms Api.5 Api.2.5 Plac. Recurrent VTE 1.7* 1.7* 8.8* Major Bleeding CRNM Bleeding 4.2** ** M+CRNM bleeding Deaths Primary end point of recurrent or fatal VTE or unexplained death *Non-inferiority p<0.001 **Superiority <0.05 Superiority NS Not powered to evaluate IN HIGH RISK PATIENTS: - non-inferiority for efficacy of low / full-dose Apixaban - superiority on safety of low / full-dose Apixaban AMPLIFY-EXT-investigators, NEJM 2013;368(8):

14 Recommendations for extended phase of treatment ACCP 2016, Chest 2016 ACCP comments on extension studies : - moderate quality evidence - heterogeneous populations - short follow-up 6 to 12 months - limited implications

15 Extended treatment in patients at equipoise with low-dose DOACs? Amplify-Ext Study N~2,488 Apixaban 5 mg bid n~813 Einstein-Choice Study N~3,396 Rivaroxaban 20 mg od N=1121 PE and/or DVT initially treated 6 months R Apixaban 2.5 mg bid n~840 PLACEBO od N~ mois (post-study) 12 months of treatment Rivaroxaban 10 mg od R N=1136 ASPIRIN od N= mois (post-study) 12 months of treatment Design: Multicentre, randomized, double-blind, superiority study AMPLIFY-EXT-investigators, NEJM 2013;368(8): Design: Multicentre, randomized, double-blind, superiority study Weitz et al. N Engl J Med Mar 30;376(13):

16 Cumulative incidence (%) Extended treatment in patients at equipoise with low-dose Rivaroxaban (Einstein-Choice Study) 5 4 ASA 100 mg od Arms Riva. 20 Riva.10 Asp Rivaroxaban 20 mg od Rivaroxaban 10 mg od Days Primary end point of recurrent or fatal VTE or unexplained death Recurrent VTE 1.5* 1.2* 4.4* Major Bleeding 0.5** 0.4** 0.3** CRNM Bleeding M+CRNM bleeding 3.3** 2.4** 2.0** Deaths *Non-inferiority p<0.001 **Superiority <NS Not powered to evaluate IN HIGH RISK PATIENTS: - non-inferiority for efficacy of low / full-dose Rivaroxaban - superiority on safety of low / full-dose Rivaroxaban Weitz et al. N Engl J Med Mar 30;376(13):

17 Rational Prolonged use of warfarin (INR 2-3): highly effective but high risk of bleeding. The risk of bleeding (frequency, case-fatality rate) while on anticoagulation may offset the risk of recurrent VTE (frequency, case-fatality rate) after stopping anticoagulation. What alternatives to warfarin (INR 2-3): Warfarin INR 1.5-2: NO Aspirin: NO DOAC? There is evidence that DOACs at full dose are as effective as and safer than warfarin (INR 2-3) based on randomized trials on initial treatment of VTE But there is no evidence that a reduced dose of DOAC would be as effective as and safer than full dose of DOAC in high-risk patients Studies not powered to demonstrate this objective Study populations were not at high risk of recurrence Consequently, a randomized trial comparing low-dose DOAC with full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified RENOVE study. 17

18 Conclusion DOACs are as effective as warfarin to prevent VTE recurrence There is evidence that reduced dosage might avoid recurrence without increased bleeding The choice between reduced dosage and full dose needs to be established in high risk population

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