anticoagulation therapy for liver disease: a panacea
TRANSCRIPT
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Anticoagulation Therapy for
Liver Disease: A Panacea ?
Dominique-Charles Valla
Hépatologie, Hôpital Beaujon,
AP-HP, Université Paris-Diderot, and Inserm UMR 773
Clichy, France
Nothing to disclose
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Acute or Chronic Liver Disease
Portal hypertension
Liver dysfunction
Bleeding Sepsis Multiorgan failure
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Anticoagulation Therapy for Liver Disease
• Vascular diseases of the liver
• Parenchymal diseases of the liver
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Vascular Liver Diseases
Hepatic veins thrombosis (BCS)
Portal vein thrombosis
SOS/VOD
IPH/OPV/NRH
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Risk Factors for Venous Thrombosis in Patients with Splanchnic Vein Thrombosis
• At least one 84% 67%
• Multiple 46% 18%
• Local factor 5% 21%
Murad. Ann Intern Med 2009. N = 163. Plessier. Hepatology 2010. N = 102
HVT PVT
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Prothrombotic Diseases in HVT & PVT
Myeloproliferative neoplasms %
Antiphospholipid syndrome %
Inherited disorders %
Others (PNH, Behcet, IBD, …) %
50 35
15 15
35 35
10 10
HVT PVT
Hirschberg J Hepatol 2000. Janssen, Blood 2000. Denninger, Hepatology 2000.
Primignani, Hepatology 2006. Murad, Ann Intern Med 2009. Plessier, Hepatology 2010.
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Vascular Liver Diseases
Hepatic veins thrombosis (BCS)
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Primary BCS – Natural History
100
50
0
1 5 3
Su
rviv
al %
1960-1970
Ascites with emaciation
GI bleeding due to PHT
Liver failure
Adapted from Tavill.
Gastroenterology 1975
years
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BCS : Improved Survival Over 3 Decades
Copyright ©2008 BMJ Publishing Group Ltd. Valla, D-C Gut 2008;57:1469-1478
1960-1970
Anticoagulation
Zeitoun, Hepatology 1999
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Manifestations No Anticoagulation
Anticoagulation
Medical therapy
TIPS
Transplantation
Angioplasty
Thrombolysis
Stenting
Yes
J Hepatol 2015
EASL CPG and Baveno VI Recommendations, 2015
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EN-Vie cohort. Seijo. Hepatology 2013
BCS - Current Survival
26% Died
13% LTx
39% TIPS
27% Med. Rx.
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N Deaths
Permanent anticoagulation 139 89%
Bleeding 24 17% 3 2%
Portal hypertension 14 2
Intracranial 3 1
Other 7 0
Seijo. Hepatology 2013
BCS - Major Bleeding on Anticoagulation Therapy
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Anticoagulation for BCS
• Acceptable pathophysiological rationale.
• Circumstancial clinical evidence for a favorable
benefit:risk ratio.
• Still high incidence of adverse events related to
anticoagulation therapy.
• Solid evidence unlikely to appear soon due to
rarity. Solid expert consensus.
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Vascular Liver Diseases
Hepatic veins thrombosis (BCS)
Portal vein thrombosis
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Portal Vein Thrombosis
Bleeding Ascites MOF
Intestinal Ischemia
Uncomplicated Acute PVT
Abdominal Pain SIRS
Chronic PVT
Bleeding Encephalopathy Cholangiopathy
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Non-cirrhotic, non-malignant PVT
Treatment
Preventing potentially lethal complications
- Intestinal infarction
- Recurrent thrombosis
- Portal hypertension
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N
Recent PVT. Anticoagulation in 95 Patients
0
*Limited intestinal resection. Both survived. **Malignancy 1. Sepsis 1
100
2
Death**
2
Intestinal Infarction*
Plessier. Hepatology 2010. Hmoud, J Clin Exp Hepatol 2014
Expected ~ 25 ~ 12
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Non-cirrhotic, non-malignant PVT
Treatment
Preventing potentially lethal complications
- Intestinal infarction
- Recurrent thrombosis
- Portal hypertension
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PVT – Anticoagulation and thrombosis
Condat, Gastroenterology 2001
New thrombosis
6.0
+ - Anticoagulation
1.2
% Pt-yr p = 0.015
1
Orr, CGH 2007
3
HR 0.2, p = 0.1 Spaander, JTH 2013
2 New thrombosis
Survival
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Non-cirrhotic, non-malignant PVT
Treatment
Preventing potentially lethal complications
- Intestinal infarction
- Recurrent thrombosis
- Portal hypertension
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Anticoagulation for recent (acute) PVT
Anticoagulation No
anticoagulation
Complete recanalization
Partial recanalization
Recanalization
38.3% 14.0% << 17%
Hall. World J Surg 2011
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Portal
Splenic
Sup. mesenteric
EN-Vie Cohort: 95 anticoagulated patients
Plessier. Hepatology 2011.
Recent PVT: EN-Vie Cohort
Hall. Hepatogastroenterol 2013
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Portal Vein Thrombosis
Ascites MOF
Intestinal Ischemia
Uncomplicated Acute PVT
Abdominal Pain SIRS
Chronic PVT
Bleeding Encephalopathy Cholangiopahy
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PVT – Anticoagulation and bleeding
+ - Anticoagulation
Bleeding
7
17 p = 0.212
Condat, Gastroenterology 2001
1
HR P
GI bleed* 2.1 <.01
Ascites* 2.0 =.01
Anticoagulant 2.1 <.01
Spaander, JTH 2013
2 Bleeding
* At baseline
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PVT - Severity of Bleeding
Hemoglobin (g/dL)
Length of stay (days)
Transfusion (N units)
Condat, Gastroenterology 2001. Spaander, JTH 2013. Christol, ILC 2012
No impact of anticoagulation therapy on
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Noncirrhotic Splanchnic Vein Thrombosis
From Ageno, JAMA Intern Med 2015
Major Thrombotic Events
Major Bleeding Events
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Anticoagulation for PVT without cirrhosis
• Allows recanalization in 40% of patients seen at the acute stage.
• Prevents extension/recurrence of thrombosis.
• May improve long-term outcome in patients with extensive thrombosis.
• Does not appear to increase the severity of PHT-related bleeding.
• Has unclear impact on the risk of bleeding.
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PVT : Unresolved treatment issues
→ Permanent anticoagulation therapy for all?
→ Which criteria for a precision medicine ?
‒ Degree of venous involvement
‒ Causes and risk factors
‒ Personal or familial history
RIPORT A randomized control trial in patients
without highly prothrombotic conditions or previous intestinal ischemia
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Anticoagulation therapy for liver disease
• Vascular diseases of the liver
• Parenchymal diseases of the liver
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Parenchymal Liver Disease
• Coagulation and hepatic fibrogenesis
• Coagulation anomalies in liver disease
• Thrombosis and cirrhosis progression
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Chronic Liver
Disease
Cirrhosis
Decompensated
Cirrhosis
Fibrogenesis Coagulation
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Activated Coagulation
Stellate Cell Activation
Liver Injury Levy. Hepatology 1983.
Neubauer. Gastroenterology 1995
Marsden JCI 2003
Marra. Hepatology 1995 & 1998
Mallat. J Biol Chem 1998
Gaca. J Hepatol 2002
Fiorucci. Hepatology 2004.
Gillibert Duplantier. Gut 2004
Rullier. Am J Physiol GI 2007
Anstee. JTH 2008
Thrombin
PAR1 Fibrin
Murine models
Anstee. Clin Res Hepatol Gastroenterol 2011
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Anstee. J Thromb Haemost 2008
Four weeks High power
Four weeks Low power
C57BL/6
Control
C57BL/6
FVL Mutant
CCl4 Murine Model
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Factor V Leiden OR 3.5 Hepatitis C
Cirrhosis
Decompensated
Cirrhosis
Fibrogenesis Prothrombotic
factor
Wright. Gut 2003
Poujol-Robert. Hepatology 2004
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Anstee. J Thromb Haemost 2008
Four weeks High power
Four weeks Low power
C57BL/6
Warfarin
C57BL/6
Control
C57BL/6
FVL Mutant
CCl4 Murine Model
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Murine model of congestive hepatopathy
Simonetto, Hepatology 2015
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Parenchymal Liver Disease
• Coagulation and fibrogenesis
• Coagulation anomalies in liver disease
• Thrombosis and cirrhosis progression
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Coagulation in Cirrhosis
• Platelet counts decreased
• Factor II, VII, IX and X levels decreased
• Tissue factor levels increased
• Coagulation factor VIII increased
• Von Willebrandt factor increased
• Clearance of activated factors decreased
• Coagulation inhibitors decreased
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Cirrhosis as a Prothrombotic State ?
Tripodi, JTH 2011. Rautou J Hepatol 2015
• Maintained thrombin generation potential in plasma in vitro
• In vitro resistance to the anticoagulant action of thrombomodulin (↑ factor VIII, ↓ protein C)
• TAT, D-dimers and TF microparticles increased
• Moderate increase in the risk of DVT
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Parenchymal Liver Disease
• Coagulation and fibrogenesis
• Coagulation anomalies in liver disease
• Thrombosis and cirrhosis progression
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Chronic Liver
Disease
Cirrhosis
Decompensated
Cirrhosis
Thrombosis Prothrombotic
Factors
Fibrogenesis Coagulation
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70% intrahepatic HV thrombosed
Explanted Cirrhotic Livers
Wanless, Hepatology 1995. Shimamatsu, Hepatology 1997
40 % intrahepatic PV thrombosed
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Extrahepatic Portal Vein Thrombosis in Cirrhosis
Partial PVT Occlusive PVT
10% (5-16) 3% (1-4)
Nery, Hepatology 2014. Maruyama, Am J Gastro 2013. Luca, Radiology 2012
Spontaneous regression
40% (31-71)
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Extrahepatic Portal Vein Thrombosis in Cirrhosis
Nery, Hepatology 2014. Maruyama, Am J Gastro 2013. Luca, Radiology 2012
Associated with severity in
cross-sectional studies
Inconsistent impact on
mortality in follow-up studies
Englesbe. Liver Transplant 2010. SRTR 22,291 listed candidates. Occlusive PVT 4.02%
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Advanced
Cirrhosis
PVT
? Advanced
Cirrhosis
PVT
?
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• 1243 patients, Child A-B, median f-up 47 mo
• Baseline features, F.V & F.II Leiden
• Portal vein thrombosis, portal flow velocity,
liver disease progression
THROMBOCIR Study
Progression
N = 355
PVT
N = 118
Both
N = 52
US-Doppler screening for HCC q 3 or 6 mo. Trinchet, Hepatology 2011
Nery, Hepatology 2014
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PVT and severity of cirrhosis
• Time dependent analysis for PVT
→ Severity of liver disease at baseline
Not : progression of liver disease
• Time dependent analysis for progression
→ Age, severity of liver disease at baseline
Not : PVT
Nery, Hepatology 2014
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Advanced
Cirrhosis
Portal vein Thrombosis
Nery. Hepatology 2014
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Advanced
Cirrhosis
Portal vein Thrombosis
?
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PVT Prophylaxis – Cirrhosis (CTP B7-C10)
Villa. Gastroenterology 2012. Enoxaparin 4.000 UI/d, for 12 mo.
N. of patients 36 34
Partial PVT 3 0
Complete PVT 3 0
Control Enoxaparin
Decompensation 19 4
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Villa. Gastroenterology 2012. Enoxaparin 4.000 UI/d, for 48 weeks.
Survival Decompensation
Enoxaparin
Enoxaparin
Control
Control
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Advanced Cirrhosis
Portal Vein Thrombosis
?
Villa, E. et al. Gastroenterology 2012
Nery, F. et al The Liver Meeting 2013. Communication #127
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Anticoagulation therapy (AT) for PVT in cirrhosis
Qi, Eur J Intern Med 2014
Complete recanalization 41.5%
Major AT related complication 3%
AT related death 0
OR for recanalization 4.16 (1.88-9.20)
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Anticoagulation for
Parenchymal Liver Disease (I)
• Detrimental role of coagulation activation in hepatic fibrogenesis.
• Favorable effect of anticoagulation in animal model of hepatic fibrogenesis; to be ascertained in patients.
• Thrombin generation potential normal or increased in patients with cirrhosis.
• Intrahepatic thromboses associated with severe disease.
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• PVT is a marker, but not a direct cause, for progression of liver disease.
• A common determinant to PVT and progression would best explain the findings.
• This common determinant could be targeted by enoxaparin therapy.
• Curative therapy for PVT has not yet been shown to ameliorate outcome
Anticoagulation for
Parenchymal Liver Disease (II)
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In waiting for additional data from randomized controlled trial,
Anticoagulation can be considered in patients with cirrhosis and established portal vein thrombosis when
– in a context of acute intestinal ischemia;
– there is an associated highly prothrombotic condition;
– the patient is a transplant candidate
Anticoagulation for
Parenchymal Liver Disease (III)
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Hôpital Beaujon A. Plessier, PE.Rautou, B. Condat, E. de Raucourt, L. Boudaoud, A. Sibert, V. Vilgrain, D Cazals Hatem,
V. Paradis, P. Bédossa, O. Goria, JJ Kiladjian
Réseau Français des Maladies Vasculaires du Foie
European network for vascular diseases of the liver (VALDIG)
(JC. Garcia-Pagan, H. Janssen)
Collaborations
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Progression of Fibrosis in
Experimental Cirrhosis
• Hypoxia is associated with angiogenesis and the progression of fibrosis
• Hypoxia induces VEGF and Collagen 1 expression in stellate cells
Corpechot Hepatology 2002
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Transjugular Intrahepatic Porto-Systemic Shunt (TIPS)
Hepatic vein
Portal vein
IVC
TIPS