prevention of dvt recurrence. a practical approach...dacus study ultrasound first episode dvt...
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Prevention of DVT Recurrence.
A Practical Approach
Andrew Nicolaides
Emeritus Prof. of Vascular Surgery, Imperial College, London, UK
Honorary Prof. of Surgery,
Nicosia University Medical School, Cyprus
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Disclosures
Received Honoraria for lectures from:
Covidien/Medronic
Servier
Alpha Wasserman
Pierre Fabre
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Recurrent VTE Following Cessation of Anticoagulation
Unprovoked
Provoked
11%
30%
40%
Prandoni et al Haematologica 1997; 82:423
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Are there any markers of recurrence?
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CompressionNo Compression
B-mode Ultrasound
Normal vein
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Residual Vein Thrombus (DACUS study)
Siragusa S et al Blood 2008;112:511-515
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Residual Thrombus(N=180)
No RVT(N=78)
Siragusa S et al Blood 2008; 112:511-515
Residual Thrombus in CF and/or Popliteal Vein and Recurrent DVT
DACUS Study
Ultrasound
First Episode DVT
(N=258)
AnnualRecurrence
0.63% 12.8%
p<0.001
3 Months VKA
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D-dimer and Recurrence of DVT
Idiopathic VTE
(N=619)
Randomized
No Anticoagulation
(N=385)
Normal D-dimer
(N=385)
Elevated D-dimer
(N=227)
Resume Anticoagulation
(N=105)
No Anticoagulation
(N=122)
D-dimer 1 Month after
Anticoagulation Discontinued
15.0%6.2% 2.9%Events at 18 months
(VTE or Bleed)
Palareti G et al NEJM 2006;355:1780
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NEJM 2012; 366:1959
NEJM 2012; 367:1979
WA
RF
AS
AA
SP
IRE
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Brighton TA et al NEJM 2012;367:1979
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Recurrent VTE/Death
Ris
k
Months
p=0.001 p=0.03
11.5%
5.6%
0.4%
7.6%
Extended Use of Dabigatran
Schulman S et al NEJM 2013;368:709
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Any
Bleeding
Months
P<0.003
10.5 %
5.9 %
Extended Use of Dabigatran
Major or
CRNMB
5.3 %
1.8 %
P<0.001
Schulman S et al NEJM 2013;368:709
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Extended Use of Rivaroxaban in VTERecurrent VTE
Major or CRNMB
1.2 %
6.0 %
P<0.001
EINSTEIN Investigators NEJM 2010;363:2499
RRR 75%
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After completion of 6-12 months anticoagulant therapy, 2486 patients
were randomized 1:1:1 to:
(a) Placebo
(b) 2.5mg apixaban
(c) 5.0mg apixaban
for 12 months
Extended Use of Apixaban in VTE(Amplify-Extension Study)
Agnelli G et al NEJM 2013;368:699-708
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RRR = 81%
P<0.001
Recurrent VTE / VTE Death8.8 %
1.7 %
Extended Use of Apixaban in VTE(Amplify-Extension Study)
Agnelli G et al NEJM 2013;368:699-708
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P=NS
4.3 %
3.2 %2.7 %
Extended Use of Apixaban in VTE(Amplify-Extension Study)
Major or CRNMB
Agnelli G et al NEJM 2013;368:699-708
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Sulodexide: Multicenter RCT615 patients with 1st unprovoked VTE after completion of VKA therapy
Efficacy: 54% reduction in VTE Bleeding
No Major bleeding
2 patients in each group had
clinically relevant bleeding
episodes
Andreozzi MA et al. The SURVET Study: Circulation 2015;132:1891-7
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Current Thinking
1. “One approach fits all” is not appropriate
2. Can we balance risk of recurrence vs. risk of bleeding?
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Risk of VTE Recurrence after 1st Episode
High (one or more risk factors)Unprovoked 2 or more VTE Episodes
Iliofemoral DVT
Residual thrombus (>40%)
Active cancer
Serious thrombophilia
D-dimer > 500 1-3 months after stopping
anticoagulation
Life threatening PE
Inflammatory bowel disease
Moderate (one risk factor)Unprovoked isolated calf DVT
Male
Obesity
Low (one transient risk factor)Post major surgery or bed rest for > 4 days.
Post POP or post major trauma
Post estrogen therapy or pregnancy
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Risk of Bleeding during Anticoagulant Therapy
HighHistory of major bleeding
Platelet count < 50,000
Need for double antiplatelet therapy
Portal hypertension (Bleeding esoph.
varices)
History of stroke or cerebral changes
Metastatic Carcinoma
Renal insufficiency
Liver failure
Diabetes
Age > 75
ModerateHistory of clinically relevant non-major
bleeding
One antiplatelet drug
Platelet count 50,000- 100,000
Age 65-75
LowNo history of bleeding
No bleeding during previous antig. Therapy
No associated pro-hemorrhagic drugs
Age < 65
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BLEEDING RISKRefused or
Contraindication
to DOAsLOW MODERATE HIGH
DVT RISK HIGH ≥ 20%
in 2 years
Rivaroxaban or
Apixaban
Apixaban Sulodexide or
Apixaban
Sulodexide
DVT RISK MODERATE
5-20% in 2 years
Rivaroxaban or
Apixaban
Sulodexide or
Apixaban
Sulodexide or
Apixaban
Sulodexide
DVT RISK LOW < 5%
in 2 years
Sulodexide or
Aspirin*
Sulodexide* Sulodexide* Sulodexide or
Aspirin*
* If patient would like to have cover
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The Evidence for DVT Reduction in Cancer Patients
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LMWH vs VKA in Cancer Patients: Efficacy
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LMWH vs VKA in Cancer Patients: Major Bleeding
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DOAC vs LMWH in Cancer Patients: Efficacy
LMWH
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DOAC vs LMWH in Cancer Patients: Major Bleeding
LMWH
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Conclusions
Reduction in recurrent VTE without any increase in bleeding is
now possible; it should contribute to the reduction in PTS
In patients with active cancer:➢ LMWH are more effective than VKA in preventing VTE recurrence
without any increase in bleeding
➢ DOAC are more effective than LMWH in preventing VTE recurrence
but caused more major bleeding (6.5% vs 3.7%).
➢ More studies with DOAC are needed.