Duration anticoagulation VTE. Clinical case WGA april 2017 Dr Borgoens

Transcription

1 Duration anticoagulation VTE Clinical case WGA april 2017 Dr Borgoens

2 Clinical case 70 y old, sedentary computer engineer 1 st episode intermediate high risk pulmonaryembolism(rv dysfunction, positives cardiac biomarkers) No surgery, trauma or immobilisation 24h ICU LWMH followed Xarelto Medical history: Excess weight Diabetes(glucose intolerance) Hypertension Inactive spondylarthritis HLA B27 Medication: Metformine Coaprovel Cardioaspirine

3 Clinical case Blood test: mild inflammatory syndrome, hypoxemia hypocapnia, Nt Pro BNP 4475pg/ml, USTroponin 50pg/ml ( ), GFR 56ml/min, PSA 8,17ug/l Whole leg US: acute DVT left popliteal vein

4 Clinical case Abdominal CT: no tumoral mass or venous thrombosis Urologic examination and US: normal prostatic volume, no explanation for PSA, -> check 6 weeks later

5 Clinical case Abdominal CT: no tumoral mass or venous thrombosis Urologic examination and US: normal prostatic volume, no explanation for PSA, -> check 6 weeks later -> 6 weeks later, PSA -> biospy: adenocarcinoma Gleason 6 -> total radical prostatectomy

6 Follow up 6 m post prostatectomy Xarelto 20mg od 6 m post total radical prostatectomy Urology: no additional chemotherapy or radiotherapy, persistent negative PSA Good clinicalimprovement, no residual dyspnea, no PTS Echocardiography: no CTEPH signs Legduplex US: no residual thrombus or reflux but subpopliteal veins retraction

7 Clinical question 6 m post prostatectomyand anticoagulation. Whatdo youdecide? 1 Discontinue anticoagulation 2 Continue anticoagulation 3 D dimer level 4 Discontinue anticoagulation ->aspirin

8 Clinical question 6 m post prostatectomyand anticoagulation. Whatdo youdecide? 1 Discontinue anticoagulation 2 Continue anticoaguation 3 D dimer level 4 Discontinue anticoagulation ->aspirin

9 Clinical question 6 m post prostatectomyand anticoagulation. Whatdo youdecide? 1 Discontinue anticoagulation 2 Continue anticoaguation 3 D dimer level850ng/ml 4 Discontinue anticoagulation ->aspirin

10 VTE CANCER, epidemiology 10% patients with cancer 20% VTE patients have cancer 4->6 fold risk VTE High risk: pancreas, colon, gastric, bowel, lung, ovarian and bladder s cancer, lymphoma, adenocarcinoma > epidermoid during chemotherapy cancer surgery catheter High risk recurrence in spite of treatment bleeding risk

11 VTE CANCER recurrence risk

12 Prostate cancer VTE Danish registry-base cohort study prostate cancer patients vs men matched age and comorbidities 3x 1st y VTE risk5 y followup Age, metastases, high Gleasonscore, D Amico high risk group, after surgery

13 Prostate cancer VTE Danish registry-base cohort study 3x 1st y Prostate cancer prostate cancer patients vs men matched age and comorbidities weakriskfactor VTE VTE risk5 y followup Age, metastases, high Gleasonscore, D Amico high risk group, after surgery

14 Prostate cancer VTE Danish registry-base cohort study 3x 1st y Prostate cancer prostate cancer patients vs men matched age and comorbidities weakriskfactor VTE VTE risk5 y followup Age, metastases, high Gleasonscore, D Amico high risk group, after surgery Prostate cancer couldn t be consideredas onlyresponsibleof VTE in thiscase

15 Recurrence risk VTE in this case Prostate cancer remission No major trigger for VTE ConsiderunprovokedVTE

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17 Abnormal Ddimer (1month): +2points Age<50y: +1point Sex, male: +1point Hormone associated VTE: -2 points DASH SCORE 1 LOW RISK: stop anticoagulation? DASH SCORE >1 HIGH RISK: continuation anticoagulation?

18 HER D OO model for womenunprovokedvte HER under VKA D O O If 2 high risk recurrence for women Male -> high risk

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20 Clinical decision Consider high risk recurrence for PE and indication long term anticoagulation Which anticoagulant and which dose? 1) Therapeuticdose Noac(Xarelto, Pradaxa, Eliquis, Lixiana) 2) VKA INR 2-3 3) Prophylactic dose Xarelto 10mg od or Eliquis 2,5mg bid

21 Clinical decision Consider high risk recurrence for PE and indication long term anticoagulation Which anticoagulant and which dose? 1) Therapeuticdose Noac(Xarelto, Pradaxa, Eliquis, Lixiana) 2) VKA INR 2-3 3) Prophylactic dose Xarelto 10mg od or Eliquis 2,5mg bid

22 VTE EXTENSION EINSTEIN EXT AMPLIFY EXT RE MEDY RE SONATE N 1196 pts 2482 pts 2856pts 1353 pts Duration 6-12 month 12 month 6-36month 6 month treatment +12month FUp Dose 20mg Rivaroxaban od, placebo Apixaban 2,5mg bid, 5mg bid, placebo Dabigatran 150bid vs Warfarine Age 58 y 56 y 55y 56 y Dabigatran 150mg bid vs placebo DVT/PE 65/35% 65/35% 65/35% 63/37% % unprovoked 73% 93%

23 VTE EXTENSION EINSTEIN EXT AMPLIFY EXT RE MEDY RE SONATE Recurrent VTE/placebo 1,3%/7,1% 1,7% 2,5mg bid 1,7% 5mg bid 8,8% placebo Vs warfarine 1,8%/1,3% Non inferior 0,4%/5,6% Major bleeding/placebo 0,7%/0% 0,2% 2,5mg bid 0,1% 5mg bid 0,5% placebo Vs warfarine 0,9%/1,8% p<0,001 0,3%/0% Total bleeding/ placebo 6%/1,2% 3,2%2,5mg bid 4,3% 5mg bid 2,1% placebo Vs warfarine 5,6/10,2% p<0,001 5,3%/1,8% Total mortality/ placebo 0,2%/0,3% 0,8% 2,5mg bid 0,5% 5mg bid 1,7% placebo Vs warfarine 1,2/1,3%

24 EINSTEIN CHOICE Long-Term Secondary VTE Prevention Study Official study title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism Objective: efficacy and safety of reduced-dosed rivaroxaban, standard-dosed rivaroxaban versus ASA for the long-term secondary prevention of recurrent symptomatic VTE in patients with symptomatic DVT and/or PE Rivaroxaban 20 mg od Population: DVT and/or PE after 6 12 months of anticoagulation* N~2,850 Day 1 R n~950 Rivaroxaban 10 mg od n~950 ASA 100 mg od n~ month treatment duration 1 month observation period Short design: Multicentre, randomized, doubleblind, double-dummy, active-comparator, eventdriven, superiority study *Completed 6 12 months (±1 month) with interruption of anticoagulation 1 week at randomization

25 3396 patients Equipoise regarding the need for continued anticoagulation Primary efficacy outcome: symptomatic fatal or non fatal VTE Principal safety outcome: major bleeding

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27 EFFICACY

28 SAFETY

29 3396 patients Equipoise regardingthe need for continued anticoagulation Rivaroxaban20mg odor 10mg odiseffective and more effective than aspirin without major bleeding