I NOACs nelle trombosi venose rare

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Basilio Boni
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1 I NOACs nelle trombosi venose rare Bologna, 5 novembre 2015 Guido Finazzi USS Malattie Mieloproliferative Croniche, USC Ematologia Ospedale Papa Giovanni XXIII, Bergamo

2 Thromb Haemost 2013; 110: 626

Hepatology 2014; 60: 425 Acute portal and mesenteric vein thrombosis in a 50- year-old patient with liver cirrhosis (CTP class A) and several comorbidities.

3 Hepatology 2014; 60: 425 Acute portal and mesenteric vein thrombosis in a 50- year-old patient with liver cirrhosis (CTP class A) and several comorbidities. Treated with UFH with subsequent transition to rivaroxaban 20 mg per day. After 6-month, complete resolution of the clot (CT scan). During the follow-up, the patient did not report any adverse events including bleeding.

4 Intagliata et al. Hepatology 2015; 61: 738

5 The lack of reliable reversal agents for newer anticoagulants could be disastrous during variceal bleedings Monitoring anticoagulation intensity, and its reversal, is vastly superior with warfarin, compared to NOACs Several cases of probable rivaroxaban-induced liver injury have been reported. Theoretically, there is an increased risk of bleeding in patients with impaired hepatic synthesis and metabolism Simonetto et al. Hepatology 2015; 61: 738

6 Report of 14 cases of rivaroxaban-induced liver injury Russmann et al. J Hepatol 2014; 61: 293

7 Report of 14 cases of rivaroxaban-induced liver injury Russmann et al. J Hepatol 2014; 61: 293 There may be a signal, and there may even be an alert. But is it really an alarm? Moore et al. J Hepatol 2014; 61: 198

8 DOACs remain contraindicated in patients with acute or chronic severe liver impairment as a result of their partial metabolism through the cytochrome P450 3A4 system Blood 2014; 124: 3685

DOACs remain contraindicated in patients with acute or chronic severe liver impairment as a result of their partial metabolism through the cytochrome P450 3A4 system Blood 2014; 124: 3685 Using

9 DOACs remain contraindicated in patients with acute or chronic severe liver impairment as a result of their partial metabolism through the cytochrome P450 3A4 system Blood 2014; 124: 3685 Using thrombomodulin-modified thrombin generation testing, we showed that the in vitro anticoagulant potency of Apixaban and Rivaroxaban is substantially reduced in patients with moderate and advanced cirrhosis. These results suggest that anticoagulant treatment with these drugs will likely not result in overanticoagulation, with a potentially increased bleeding risk. Potze et al. Hepatology 2015; 61: 1435

We report the case of BCS development in young Russian male with primary APS. The patient underwent orthotopic liver transplantation on August 26, 2012.

10 We report the case of BCS development in young Russian male with primary APS. The patient underwent orthotopic liver transplantation on August 26, At present time his state is good, the blood flow in the liver restored and its function is not impaired. We report about the first time the successful use of dabigatran etexilate for prolonged anticoagulation therapy in APS patient with BCS. In addition patient is managed with immunosuppressive drugs. World J Hepatol 2015 ; 7: 2229

11 Elevated serum erythropoietin in a patient with polycythaemia vera presenting with Budd-Chiari syndrome. Jones C, Levy Y, Tong AW In this case report, the patient had a positive response to cytoreductive therapy (hydroxyurea 500 mg daily), phlebotomy (750 ml over three phlebotomies) and rivaroxaban Jones et al. BMJ Case Rep 2014 Dec 1; 2014

12 Clinical data for the use of DOACs in MPN patients and in oncologic patients in general are very limited to date. Only 2.5-6% of all patients enrolled in the VTE therapy trials with DOACs were oncologic patients not further characterised in the publications. For these reasons, DOACs should restrictedly used in patients with MPN Kreher et al. Ann Hematol 2014; 93: 1953

13 Studi in corso Studio prospettico a singola coorte su rivaroxaban nei pazienti con trombosi splancniche (W. Ageno) Studio retrospettivo sul trattamento delle trombosi venose nei pazienti con MPN (T. Barbui)

14 2014;45: Sixteen patients were included: 7 treated with rivaroxaban and 9 with VKA (after a median of 5 days on heparin). Overall outcome was excellent in 93.8%, and all patients showed at least partial recanalization. No statistical significant differences were found between the groups. One patient in the VKA and 2 patients in the factor Xa inhibitor group had minor bleeding within the median follow-up of 8 months (5 26).

Eighteen patients were admitted for cerebral vein thrombosis. Dabigatran was started in 11 patients (after a median of 13 days on heparin) and warfarin was started in 7.

15 Eighteen patients were admitted for cerebral vein thrombosis. Dabigatran was started in 11 patients (after a median of 13 days on heparin) and warfarin was started in 7. Four patients on warfarin were switched to dabigatran because of instable INR in 3 and menorrhagia in 1. A total of 15 patients were treated with dabigatran with median follow-up time of 19 months. Gastrointestinal adverse effects were noted in 3/15 patients and alopecia in 2/15. Excellent outcome was observed in 87% of patients and recanalization in 80%. Int J Stroke 2015; 10: 1115

16 Novel oral anticoagulants in the treatment of cerebral venous thrombosis The aim of our work was to review the available evidence for NOACs in the treatment of CVT. Based on our literature search there is insufficient evidence to support the use of NOACs in CVT, although case series with rivaroxaban and dabigatran have showed promising results. Feher et al. Int. Angiol May 21 [EPUB ahead of print]

17 Studio in programma Studio randomizzato internazionale con endpoint composito: recidive + emorragie maggiori. Numerosità stimata: pazienti. Inizio studio: entro giugno (JM Ferro, F Dentali)

18 First presentation During VKA therapy After 4 weeks of Rivaroxaban After 6 weeks of Rivaroxaban Thromb Haemost 2013; 109: 583

reports, piccole serie di pazienti) Ci sono dubbi

19 NOACs nelle TV rare: perchè NO Non c è sufficiente evidenza di efficacia dagli studi pubblicati (case reports, piccole serie di pazienti) Ci sono dubbi sulla sicurezza nei pazienti con epatopatia acuta o cronica severa

20 NOACs nelle TV rare: perchè SI Per quanto limitata, la casistica finora trattata ha dimostrato una buona efficacia e tollerabilità dei NOACs. Non ci sono ragioni fisiopatologiche per pensare ad una diversa attività dei NOACs nelle TV in sedi frequenti o rare. E improbabile che clinical trials con un adeguato numero di pazienti possano essere eseguiti in queste forme rare

una diversa attività dei NOACs nelle TV in sedi

E improbabile che clinical trials con un adeguato

21 NOACs nelle TV rare: perchè SI Per quanto limitata, la casistica finora trattata ha dimostrato una buona efficacia e tollerabilità dei NOACs. Non ci sono ragioni fisiopatologiche per pensare ad una diversa attività dei NOACs nelle TV in sedi frequenti o rare. E improbabile che clinical trials con un adeguato numero di pazienti possano essere eseguiti in queste forme rare INSERIRE I PAZIENTI IN STUDI OSSERVAZIONALI

22 Un ruolo per la FCSA? Indagine conoscitiva dei pazienti con trombosi in sedi rare trattati con NOACs nei Centri FCSA Consensus statement della FCSA sull uso attuale dei NOACs in queste trombosi.

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