Status of anticoagulation therapy in 2016: Is there a need for venous revascularization?

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1 Status of anticoagulation therapy in 2016: Is there a need for venous revascularization? Rupert M. Bauersachs Dept. of Vascular Medicine, Darmstadt Center of Thrombosis Hemostasis, Mainz

2 Status of anticoagulation in 2016: Need for venous revascularization? Disclosures Research support / Principal Investigator : Bayer, BMS, Boehringer, Daiichi-Sankyo, Leo, Pfizer, Portola Consultant & Speakers Bureau: Bayer, BMS, Boehringer, Daiichi-Sankyo, Pfizer Rupert M. Bauersachs Dept. of Vascular Medicine, Darmstadt Center of Thrombosis Hemostasis, Mainz

3 Status of anticoagulation in 2016: Need for venous revascularization? Guidelines, State of the Art Current Evidence for Anticoagulation Need for Revascularization? Current Evidence

4 Guidelines, State of the Art Vasa European Journal of Vascular Medicine Supplement S/90 Interdisziplinäre S2 Leitlinie Diagnostik und Therapie der Venenthrombose und der Lungenembolie Kardiologe : S2k-Leitlinie: Nr VASA 2016;45(S 90): in press. ACCP-Guidelines 2016 Chest. 2016;148(1): in press In proximal DVT we recommend long-term anticoagulant therapy over no such therapy (1B). we suggest dabigatran, rivaroxaban, apixaban or edoxaban over VKA therapy (all 2B). NOAC Meta-analyses: significant reduction in major bleeding 40% Significantly reduced intracranial and fatal bleedings and CR-NMB. Results consistent for several sub-groups, e.g. Body weight > 100 kg; GFR <60 ml/min; age > 75 y; cancer

5 Evidence: Which concepts have been studied? Standard-Therapy LMWH /VKA Heparin VKA Single-drug approach VTE MB CRB Rivaroxaban (Xarelto ) Single-drug 2x15 mg 3 wks 1x20 Rivaroxaban VTE MB CRB Apixaban (Eliquis ) Single-drug 2x10mg 1wk 2x5 mg Apixaban Dabigatran (Pradaxa ) LMWH Acute treatment Switching Parenteral AC 5d Dabigatran 2x 150 mg VTE MB CRB Edoxaban (Lixiana ) LMWH Acute treatment Parenteral AC 5d Edoxaban 1x60 mg VTE MB CRB Day 1 Day 5 11 Week 3

6 Evidence: Which concepts have been studied? Standard-Therapy LMWH /VKA Heparin VKA DVT PE Single-drug approach Rivaroxaban (Xarelto ) Single-drug 2x15 mg 3 wks 1x20 Rivaroxaban DVT PE Apixaban (Eliquis ) Single-drug 2x10mg 1wk 2x5 mg Apixaban DVT PE Dabigatran (Pradaxa ) LMWH Acute treatment Switching Parenteral AC 5d Dabigatran 2x 150 mg DVT PE Edoxaban (Lixiana ) LMWH Acute treatment Parenteral AC 5d Edoxaban 1x60 mg DVT PE Day 1 Day 5 11 Week

7 Evidence: Which concepts have been studied? Standard-Therapy LMWH /VKA Heparin VKA DVT PE Recurrent VTE RCT NOACs PE PE DVT Major Bleeding Es N, et al Blood Sep 18;124(12):

8 Evidence: Which concepts have been studied? Standard-Therapy LMWH /VKA Heparin VKA DVT PE RCT NOACs DVT PE PE RCT CDT PE with PTS as an endpoint

9 Revascularization Treatment N=90 CDT + Standard R 24 mts FU Rekanalisation 100% CDT Standard N=99 Standard 60 PTA Stents Aspiration Caval Filter Inclusion Iliofemoral vein thrombosis: common iliac vein combined iliofemoral segment upper half of the thigh 75% 50% 25% 0% Partial Complete Score >5 (6Mo) <5 = No PTS 5-9 = mild PTS = moderate PTS 15 = severe PTS severe PTS Ulcer Enden T, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM. Longterm outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis the CaVenT study): a randomised controlled trial. Lancet 2012;6736:

10 Revascularization Treatment R N=90 CDT + Standard 24 mts FU Rekanalisation 100% Quality of life CDT Standard N=99 Standard 1 75% 50% 25% 0% Partial Complete 0,8 0,6 0,4 0,2 0 EQ-5D (6 Mo) EQ-5D (24 Mo) Enden T, Wik HS, Kvam AK, Haig Y, Klow NE, Sandset PM. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open. 2013;3(8):e

11 Revascularization Treatment bleeding complications CDT N=90 *abdominal wall haematoma req. transfusion, compartment syndrome req. surgery puncture site haematoma Standard n=99 Total 22% 0 Severe* 3.3% 0 clin. relevant 5.6% 0 Peripheral neurolog. deficit Infection Puncture site ,8 0,6 0,4 0,2 0 Quality of life CDT Standard EQ-5D (6 Mo) EQ-5D (24 Mo) Enden T, Wik HS, Kvam AK, Haig Y, Klow NE, Sandset PM. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open. 2013;3(8):e

12 Revascularization Treatment bleeding complications CDT N=90 *abdominal wall haematoma req. transfusion, compartment syndrome req. surgery puncture site haematoma Standard n=99 Total 22% 0 Severe* 3.3% 0 clin. relevant 5.6% 0 Peripheral neurolog. deficit Infection Puncture site CDT Phlebography Puncture popliteal vein Flouroscopy Several days of bed-rest during Infusion 2nd Phlebography UFH-Infusion APTT monitoring Enden T, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM. Longterm outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis the CaVenT study): a randomised controlled trial. Lancet 2012;6736:

13 Revascularization Treatment bleeding complications CDT N=90 Standard n=99 Total 22% 0 Severe* 3.3% 0 clin. relevant 5.6% 0 Peripheral neurolog. deficit Infection Puncture site *abdominal wall haematoma req. transfusion, compartment syndrome reg. surgery puncture site haematoma CDT Phlebography Puncture popliteal vein Flouroscopy Several days of bed-rest during Infusion 2nd Phlebography UFH-Infusion APTT monitoring Standard..and go home Benefit with CDT (24 Months FU): moderate PTS reduced by 14.4% (55 % => 41 %) Quality of life identical Enden T, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM. Longterm outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis the CaVenT study): a randomised controlled trial. Lancet 2012;6736:

14 Prandoni P, et al Ann Intern Med 2004;141: Revascularization Treatment 24 mts CDT Standard Compression- Tx Within INR- Target 63,3 51,5 65,4 50,0 Subtherapeutic anticoagulation is associated with increased PTS severe mild/moderate OR (95%CI) for PTS INR <2 for >20% of the time 1.9 ( ) 20 INR <2 for >50% of the time 2.7 ( ) 0 Compression Control

15 Revascularization Treatment 24 mts CDT Standard Compression- Tx 63,3 51,5 60 severe mild/moderate Within INR- Target 65,4 50, Subtherapeutic anticoagulation is associated with increased PTS OR (95%CI) for PTS 0 Compression Control Prandoni P, et al Ann Intern Med 2004;141: INR <2 for >20% of the time 1.9 ( ) INR <2 for >50% of the time 2.7 ( ) Benefit with CDT (24 Months FU): moderate PTS reduced by 14.4% (55 % => 41 %) Quality of life identical Enden T, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM. Longterm outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis the CaVenT study): a randomised controlled trial. Lancet 2012;6736:

16 Thrombus regression at 3 wks Rivaroxaban dose - finding studies 80 bid rivaroxaban doses Enox & VKA Rivaroxaban total daily dose (mg) VKA +Enoxaparin 4-point improvement in thrombus burden by CCUS without recurrent VTE Without recurrent VTE Per-protocol population (n=528) Agnelli G et al. Circulation Jul 10;116(2):180-7 Bauersachs RM,et al. N Engl J Med 2010;363(26):

17 PTS- Score > 5 Rivaroxaban Phase III studies Rivaroxaban Enox / VKA 40 N=335 Age (yrs) RR 0.74; ( ). Male 59 % Follow-up 57 mts (48-64) 20 Rivaroxaban/VKA 48 / 52 % Good Compliance 94% (R) vs 75 % (E) ECS 69% (R) vs 80 % (E) 0 Rivaroxaban Enox / VKA Bauersachs RM,et al. N Engl J Med 2010;363(26): Middeldorp S et al JTH 2015, 13 (Suppl. 2)

18 Institutional Volume on Outcome in CDT Hi-Vol Centers 6/y Low-Vol Centers <6/y NOACs n Complication - Period 6 days 6 days 6 months Age (18 97) Intracranial hemorrhage, (%) Blood transfusion, (%) All major: 1.0 GI bleed, (%) GI: 0.4 Pulmonary embolism, (%) Hematoma, (%) IVC filters, (%) Not hospitalized Charges, median, $ th, 75th percentile Jarrett H, Zack CJ, Aggarwal V, Lakhter V, Alkhouli MA, Zhao H, Comerota A, Bove AA, Bashir R. Circulation Sep 22;132(12): /07/23. Merli GJ, et al. Costs of hospital visits among patients with deep vein thrombosis treated with rivaroxaban and LMWH/warfarin. J Med Econ Jan;19(1):84-90.

19 Institutional Volume on Outcome in CDT Hi-Vol Centers 6/y Low-Vol Centers <6/y NOACs n FU 6 days 6 days 6 months Intracranial hemorrhage (%) Blood transfusion (%) All major: 1.0 GI bleed, (%) Pulmonary embolism, (%) Hematoma, (%) IVC filters, (%) Not hospitalized Charges, median, $ Jarrett H, Zack CJ, Aggarwal V, Lakhter V, Alkhouli MA, Zhao H, Comerota A, Bove AA, Bashir R. Circulation Sep 22;132(12): /07/23. Merli GJ, et al. Costs of hospital visits among patients with deep vein thrombosis treated with rivaroxaban and LMWH/warfarin. J Med Econ Jan;19(1):84-90.

20 Treatment satisfaction score 1. Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R. Thromb Haemost Oct;110(4): Prins MH Bamber L, Cano SJ, Wang MY, Erkens P, Bauersachs R, et al. Thromb Res Feb;135(2): Anticoagulation Need for revascularization? Conclusion Abundance of evidence High efficacy (2.0% rec.vte) and high safety (1.1% Major Bleed) High QoL Scores Any proposed additional treatment has to provide evidence that it surpasses the current standard DVT treatment ACTS Burdens* Rivaroxaban Enox/VKA

21 Thank you very much for your attention!

22 Thank you very much for your attention!

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