Duration anticoagulation VTE. Clinical case WGA april 2017 Dr Borgoens

Duration anticoagulation VTE Clinical case WGA april 2017 Dr Borgoens

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

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

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

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

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

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

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

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

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

VTE CANCER recurrence risk

Prostate cancer VTE Danish registry-base cohort study 44035 prostate cancer patients vs 213810 men matched age and comorbidities 3x 1st y VTE risk5 y followup Age, metastases, high Gleasonscore, D Amico high risk group, after surgery

Prostate cancer VTE Danish registry-base cohort study 3x 1st y Prostate cancer 44035 prostate cancer patients vs 213810 men matched age and comorbidities weakriskfactor VTE VTE risk5 y followup Age, metastases, high Gleasonscore, D Amico high risk group, after surgery

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

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?

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

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

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%

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%

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~950 12-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 www.clinicaltrials.gov/ct2/show/nct02064439

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

EFFICACY

SAFETY

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