DOACs in SPECIAL POPULATIONS

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1 DOACs in SPECIAL POPULATIONS Ann K Wittkowsky PharmD, CACP, FASHP, FCCP Clinical Professor University of Washington School of Pharmacy Director, Anticoagulation Services UWMedicine Department of Pharmacy Seattle WA USA

2 CONFLICTS OF INTEREST Consultant: Research support: Speaker s bureau: Honoraria: Ownership interest: Other: none none none none none none

3 OBJECTIVES Following this presentation, the participant should be able to assess and consider the role of DOACs for treatment of VTE associated with the following conditions: 1. Antiphospholipid syndrome 2. Malignancy

4 CASE #1 ID: Larry F, a 63 year old male with a history of recurrent VTE in the setting of antiphospholipid syndrome (+ LA) Thrombosis history: 1) LLE DVT 1973: warfarin x 3 months 2) LLE DVT 1981: chronic warfarin, goal INR 2-3 3) RLE DVT 1982: increase goal INR to ) RLE DVT 1990: increase goal INR to 3-4 5) LLE DVT/PE 2001: switched to CFX monitoring 6) LLE DVT 2004: switched to long term LMWH

5 REVISED CLASSIFICATION CRITERIA FOR ANTIPHOSPHOLIPID SYNDROME APA = at least 1 clinical criterion and 1 laboratory criterion VASCULAR THROMBOSIS PREGNANCY MORBIDITY LABORATORY CRITERIA 1 or more clinical episodes of arterial, venous or small vessel thrombosis 1 or more unexplained death of normal fetus > 10 weeks gestation 1 or more premature delivery of normal fetus < 34 weeks gestation because of eclampsia or pre-eclampsia, or because of placental insufficiency 3 or more unexplained consecutive miscarriages < 10 weeks gestation Presence of antiphospholipid antibodies on 2 or more occasions, at least 12 weeks apart and no more than 5 years prior to clinical manifestations lupus anticoagulant anticardiolipin IgG or IgM anti-b2 glycoprotein IgG or IgM Miyakis S et al. J Thromb Haemost 2006; 4:

6 13 th International Congress on Antiphospholipid Antibodies Evidence-based recommendations for secondary thromboprophylaxis Definite APS and 1st venous thrombosis Definite APS and arterial thrombosis Recurrent thrombosis or fluctuating INRs VKA with goal INR 2-3 VKA with goal INR > 3 OR VKA with goal INR 2-3 plus antiplatelet therapy LMWH VKA with goal INR > 3 VKA with CFX 35%-25% 1B 1C Non-graded Not included Ruiz-Irastorza G et al. Lupus 2011; 20:206-18

7 VTE TREATMENT WITH DOACs RANDOMIZED TRIALS DOAC ACUTE TX TRIAL Enrolled Unprovoked VTE Known Thrombophilia DOAC Std Tx DOAC Std Tx DOAC Std Tx Apixaban AMPLIFY % 89.8% 2.8% 2.2% Dabigatran RECOVER NR NR NR 8.2% RECOVER II NR NR NR Edoxaban HOSUKAI-VTE % 65.4% NR NR Rivaroxaban EINSTEIN-DVT % 63% 6.2% 6.8% EINSTEIN-PE % 64.3% 5.7% 5.0% TOTAL 13,512 > 7,748 > 529 DOAC EXT TX TRIAL Enrolled Unprovoked VTE Known Thrombophilia DOAC Comp DOAC Comp DOAC Comp Apixaban AMPLIFY-EXT (P) 92% 91.1% (P) NR NR Dabigatran REMEDY (W) NR NR 18.3% 18.4% (W) Rivaroxaban EINSTEIN-EXT (P) 73.1% 74.2% (P) 8.1% 8.1% (P) TOTAL 3,685 > 1,961 > 311

8 TREATMENT OF VTE WITH DABIGATRAN IN PATIENTS WITH THROMBOPHILIA Post-hoc subgroup analysis of pooled data from RE-COVER, RE-COVER II and RE-MEDY Goldhaber SZ et al. Vasc Med 2016; 21:

9 VTE CUMMULATIVE EVENT RATES IN PATIENTS WITH AND WITHOUT THROMBOPHILIA RE-COVER + RE-COVER II RE-MEDY D 1% vs W 3% HR % CI D 1.5% vs W 2.3% HR % CI D 3% vs W 3% HR % CI D 2.3% vs W 0.7% HR % CI Goldhaber SZ et al. Vasc Med 2016; 21:

10 DABIGATRAN VS WARFARIN IN APS SUBGROUP Pooled data from patients with APS enrolled in RE-COVER, RE-COVER II and RE-MEDY Number of patients VTE and VTE-related deaths Dabigatran Warfarin HR (95% CI) 3 (4.2%) 4 (5.0%) 0.43 (0.08, 2.38) Major bleeding 1/70 (1.4%) 2/77 (2.6%) 0.46 (0.04, 5.43) Major bleeding and Clinically relevant bleeding 6/70 (8.6%) 14/77 (18.2%) 0.53 (0.20, 1.41) Any bleeding 14/70 (20%) 31/77 (40.3%) 0.50 (0.26, 0.95) Goldhaber SZ et al. Vasc Med 2016; 21:

11 DOAC USE IN PATIENTS WITH APS systematic review 6 case reports + 8 case series = 122 APS patients exposed to DOAC (107 = rivaroxaban) Patient Characteristics (n=122) Number of clinical criteria for APS APS without recurrent thrombosis (n=103) APS with recurrent thrombosis (n=19 [16%]) p value / / Anticardiolipin Ab 68% 94% 0.06 triple positive (LA + acl+anti-b2-gp1) follow-up time (suggestive of time to recurrence) 22% 50% /- 8.5 mo 5.2 +/- 3.2 mo < Dufrost V et al Curr Rheumatol Rep 2016; 18:74-81

12 EFFECT OF WARFARIN vs RIVAROXABAN ON THROMBIN GENERATION 1. Thrombin generation curve 2. Endogenous thrombin potential a. time to peak thrombin generation longer for rivaroxaban b. peak thrombin generation - lower for rivaroxaban c. Inhibition of endogenous thrombin potential - relatively less for rivaroxaban Arachchillage DRJ et al. Thromb Res 2015; 135:388-93

13 EFFECT OF WARFARIN vs RIVAROXABAN ON THROMBIN GENERATION IN APS N = 116 patients with APS on warfarin (goal INR 2-3) for prior VTE at least 3 months prior Randomized 1:1 to continue warfarin or switch to rivaroxaban 20mg daily Outcome: change in endogenous thrombin potential (ETP) at day 42 Interpretation: rivaroxaban inferior to warfarin in suppressing ETP Other parameters: Conclusion: time to peak thrombin generation longer for rivaroxaban peak thrombin generation - lower for rivaroxaban recurrent VTE at day 210 no events in either group no increased thrombotic risk with rivaroxaban Cohen H et al. Lancet 2016; 3:e426-36

14 ONGOING CLINICAL TRIALS ASTRO-APS RAPS TRAPS Apixaban for secondary prevention of VTE in patients with APS (5mg bid vs warfarin) Intermountain Healthcare/Utah NCT Rivaroxaban for APS (20mg daily) St Joseph Healthcare/Hamilton ONT NCT Rivaroxaban for thrombotic APS (20mg daily vs warfarin) University of Pavoda/Italy NCT

15 AUDIENCE RESPONSE QUESTION #1 Have you prescribed, recommended or managed DOACs in patients with APA? A. YES B. NO C. NOT SURE

16 AUDIENCE RESPONSE QUESTION #2 Would you recommend a DOAC for this patient? A. YES B. NO C. NOT SURE ID: Larry F, a 63 year old male with a history of recurrent VTE in the setting of antiphospholipid syndrome (+ LA) Thrombosis history: 1) LLE DVT 1973: warfarin x 3 months 2) LLE DVT 1981: chronic warfarin, goal INR 2-3 3) RLE DVT 1982: increase goal INR to ) RLE DVT 1990: increase goal INR to 3-4 5) LLE DVT/PE 2001: switched to CFX monitoring 6) LLE DVT 2004: switched to long term LMWH

17 CASE #2 ID: Fred G, a 73 year old male with metastatic prostate cancer, on no active treatment. RLE DVT diagnosed 10/3/16 Treatment history: 1) 10/3/16: started on rivaroxaban 15mg bid by PCP 2) 10/6/16: switched to enoxaparin 1mg/kg SQ q12h 3) 12/1/16: bruising at injection sites. My stomach looks like a war zone. Get me off this stuff

18 TREATMENT OF CANCER-ASSOCIATED THROMBOSIS Systematic Review and Meta-Analysis N = 5 RCTs enrolling 1178 pts with active cancer and acute VTE Randomized to LMWH vs conventional therapy (LMWH/VKA) Favors LMWH Favors VKA Carrier M et al. Thromb Res 2014; 124:1214-9

19 TREATMENT OF CANCER-ASSOCIATED THROMBOSIS The CLOT Trial N=672 patients with active cancer and acute VTE Dalteparin 200 U/kg x 1 mo then 150 U/kg daily vs conventional therapy x 6 mo Recurrent Thrombosis 17% of % of 336 Lee AY et al. N Engl J Med. 2003; 349:

20 TREATMENT OF CANCER-ASSOCIATED THROMBOSIS The CATCH Trial N=900 patients with active cancer and acute VTE Tinzaparin 175 U/kg q24h vs conventional therapy x 6 mo 10.5% of % of 449 Lee AYY et al. JAMA 2015; 314:

21

22 LMHW FOR CANCER-ASSOCIATED VTE Expensive Burdensome - injection-site pain - injection-site bruising - injection-site hematoma High discontinuation rates during first 3 months of therapy Van der Wall SJ et al. J Thromb Haemost 2017; 15:74-9

23 VTE TREATMENT WITH DOACs RANDOMIZED TRIALS DOAC ACUTE TX TRIAL Enrolled Active Cancer DOAC Std Tx DOAC Std Tx Apixaban AMPLIFY Dabigatran RECOVER RECOVER II Edoxaban HOSUKAI-VTE Rivaroxaban EINSTEIN-DVT EINSTEIN-PE TOTAL 13, DOAC EXT TX TRIAL Enrolled Active Cancer DOAC Comparison DOAC Comparison Apixaban AMPLIFY-EXT (P) (P) Dabigatran REMEDY (W) (W) Rivaroxaban EINSTEIN-EXT (P) (P) TOTAL 3,

24 APIXABAN FOR CANCER-ASSOCIATED THROMBOSIS Subgroup Analysis of AMPLIFY trial N = patients with active cancer at baseline Apixaban N LMWH +VKA Recurrent VTE 3 (3.7%) 5 (6.4%) Major bleeding 2 (2.3%) 4 (5%) Major + clinically relevant non-major bleeding 11 (12.6%) 18 (22.5%) Mortality 5 (6%) 6 (7.7%) HR (95% CI) 0.56 ( ) 0.45 ( ) 0.57 ( ) Agnelli G. J Thromb Haemost 2015; 13:

25 RIVAROXABAN FOR CANCER-ASSOCIATED THROMBOSIS Subgroup Analysis of EINSTEIN DVT/EINSTEIN PE N = patients with active cancer at baseline or diagnosed with cancer during treatment Rivaroxaban LMWH +VKA ITT population Safety population Recurrent VTE 16 (5%) 20 (7%) Major bleeding 8 (2%) 15 (5%) Major + clinically relevant non-major bleeding 48 (14%) 49 (16%) Mortality 58 (16%) 53 (18%) HR (95% CI) p value 0.67 ( ) ( ) ( ) ( ) 0.70 Prins HM et al. Lancet Haematol 2014; 1:e37-46

26 DOACs FOR CANCER-ASSOCIATED THROMBOSIS Systematic Review and Meta-Analysis N = 1132 pts with active cancer enrolled in 4 RCTs RECURRENT VTE Carrier M et al. Thromb Res 2014; 124:1214-9

27 DOACs FOR CANCER-ASSOCIATED THROMBOSIS Systematic Review and Meta-Analysis N = 1132 pts with active cancer enrolled in 4 RCTs MAJOR BLEEDING Carrier M et al. Thromb Res 2014; 124:1214-9

28

29 RIVAROXABAN FOR CANCER-ASSOCIATED THROMBOSIS N = 400 consecutive patients with active cancer and acute VTE Treatment a) inpatients (75.5%): LMWH (mean = 5.6 days) then rivaroxaban at discharge b) outpatients (24.5%): rivaroxaban alone LMWH + rivaroxaban Rivaroxaban alone TOTAL N Recurrent VTE 3% 4.1% 3.25% Major bleeding 6.3% 3.2% 5.5% Pignataro BS et al. Clin Appl Thromb Hemost 2016; 14-9

30 RIVAROXABAN FOR CANCER-ASSOCIATED THROMBOSIS N = 296 consecutive registry patients with acute VTE treated with rivaroxaban Mean Followup = /- 0.5 years Minimum duration of treatment = 3 months Active malignancy N No cancer p value Recurrent VTE 3.3% 2.8% 0.53 Major bleeding 2.5% 0% 0.06 Clinically relevant non-major bleeding 3.4% 0.6% 0.08 Minor bleeding 2.5% 1.7% 0.69 Death (none related to VTE) 22% 0 < Bott-Kitslaar DM et al. Am J Med 2016; 129:615-9

31 ONGOING CLINICAL TRIALS CANVAS CONKO-011 COSIMO DOACs vs LMWH +/- warfarin for VTE in Cancer Harvard Partners NCT Rivaroxaban vs LMWH for cancer-associated VTE Charite University/Berlin and Bayer NCT Rivaroxaban vs LMWH for cancer-associated VTE Bayer/Janssen NCT

32 AUDIENCE RESPONSE QUESTION #3 Have you prescribed, recommended or managed DOACs during the first 3-6 months of VTE treatment in patients with malignancy? A. YES B. NO C. NOT SURE

33 AUDIENCE RESPONSE QUESTION #4 Would you recommend a DOAC for this patient? A. YES B. NO C. NOT SURE ID: Fred G, a 73 year old male with metastatic prostate cancer, on no active treatment. RLE DVT diagnosed 10/3/16 Treatment history: 1) 10/3/16: started on rivaroxaban 15mg bid by PCP 2) 10/6/16: switched to enoxaparin 1mg/kg SQ q12h 3) 12/1/16: bruising at injection sites. My stomach looks like a war zone. Get me off this stuff

34 SUMMARY Following this presentation, the participant should be able to assess and consider the role of DOACs for treatment of VTE associated with the following conditions: 1. Antiphospholipid syndrome 2. Malignancy

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