dr eileen merriman - gp cme north/fri_room7_1630... · patients with pe and proximal dvt included...
TRANSCRIPT
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Dr Eileen MerrimanClinical Haematologist & Lead Thrombosis
Clinician Dept of Haematology
Waitemata DHB
16:30 - 17:25 WS #82: Case Studies on Venous Thromboembolism Using Direct Oral Anticoagulants
17:35 - 18:30 WS #94: Case Studies on Venous Thromboembolism Using Direct Oral Anticoagulants
(Repeated)
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CASE STUDIES IN VENOUS
THROMBOEMBOLISM USING DIRECT ORAL
ANTICOAGULANTS
Dr Eileen Merriman
Haematologist
North Shore Hospital
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CA S E 1
Mrs MC, age 76 years
Bilateral extensive unprovoked PE
PHx: Hypertension, GORD
Creatinine clearance 56 ml/min
Weight 49kg
Suggested treatment?
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CASE 1: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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Weitz J. Thromb Haemost 2010; 103:62-70.
WARFARIN – THE END OF AN ERA?
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Adapted from Weitz J. Thromb Haemost 2010; 103:62-70.
IdaracizumabAndexanet alfa † Andexanet alfa†
† Not registered in New Zealand.
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Schulman et al NEJM 2009; 361:2342-52
RECOVER I: Dabigatran versus warfarin for
acute VTE
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The Einstein Investigators, NEJM 2010.
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The Einstein-PE Investigators NEJM 2012
Significant reduction in
major bleeding
in rivaroxaban group; 1.1%
vs 2.2% in standard therapy
(VKA) group
(HR 0.49; 95% CI 0.31-0.79;
p=0.003)
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Connolly et al. NEJM 2009; 361: 1139-51
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CASE 1: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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CA S E 1: TR E A T M E N T
But considering history of GORD…
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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CASE 2
Mr PW, age 85 years
Intracranial haemorrhage one year ago thought secondary to
hypertension
Now presents with idiopathic ileofemoral DVT
Creatinine clearance 45 ml/min
Treatment?
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CASE 2: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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DIRECT ORAL ANTICOAGULANTS AND ICH
Chatterjee et al. JAMA Neurol 2013; 70(12):1486-1490
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DA B IG A T R A N A N D B L E E D IN G
Idaricuzimab (Praxbind): monoclonal antibody, provides immediate reversal of
dabigatran anticoagulant effect
Indicated in setting of life-threatening or uncontrolled bleeding, or when
emergency surgery or urgent procedures are required
Minor bleeding: use local haemostatic measures; delay next dose of dabigatran
or discontinue if appropriate
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Pollack CV et al. NEJM 2017;377:431-41
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RIVAROXABAN AND BLEEDING/REVERSAL
Xandexanet not commercially available in New Zealand
In general, manage as for bleeds on Clexane: reversal not usually
required due to short half life
If prothrombin ratio normal (at least in hospitals around
Auckland), then no/very little residual rivaroxaban
If <24 hours post dose rivaroxaban and critical site
surgery/procedure can also ask for anti-Xa assay to confirm
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RIV A R O X A B A N A N D BL E E D IN G
Can use PCCs (e.g. prothrombinex) or FEIBA for life-threatening
bleeding, bleeding in a critical organ or need for urgent
intervention associated with bleeding
Four-factor PCCs given at approx 25U/kg shown effective in 69% of
patients in one study*
In vitro studies have shown FEIBA to be superior to PCCs in vivo
for restoration of haemostasis
Charcoal can be used if <6 hours post ingestion
Please contact haematologist on call for advice
*Blood. 2017 Oct 12;130(15):1706-1712
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XA N D E X A N E T
Recombinant modified human factor Xa decoy protein
Bolus followed by continuous infusion
Recently published trial: 352 patients with acute major
bleeding within 18 hours after FXa inhibitor
administration
64% of enrolled patients had ICH; 26% GI bleeding
Excellent or good haemostasis in 82%
30-day mortality 14%; 30-day thrombotic events in 10%
(compared with 4.8% at 90 days in REVERSE-AD trial
with idarucizumab)
FDA approved in US with black box warning for
thrombotic events/sudden death
Connolly et al NEJM 2019; 380:1326-1335
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CASE 2: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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CA S E 3
Mrs MK, 93 years old
Bilateral extensive PE
Creatinine 93 micromol/L
Weight 45kg
Treatment?
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CASE 3: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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WHAT IS MRS MK’S CREATININE CLEARANCE?
Using Cockcroft-Gault: 23.73 ml/min
Dabigatran and rivaroxaban can only be used if CreCl ≥ 30 ml/min
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CASE 3: TREATMENT
(a) Warfarin, INR 2-3
(b) Rivaroxaban 15mg BD for 3 weeks, then 20mg daily
(c) LMWH for 5 days then dabigatran 150mg BD
(d)LMWH for 5 days then dabigatran 110mg BD
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WH E N W O U L D N ’T Y O U U S E A DOAC*?
Mechanical heart valve
Antiphospholipid syndrome
Cre Cl <30ml/min
Poor compliance (shorter half-life less forgiving)
*DOAC = direct oral anticoagulant
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CA S E 4
Mrs LM, age 42yr
Breast cancer; for mastectomy
Incidental finding of segmental PE on CT staging scan
Patient is asymptomatic (no shortness of breath or chest pain)
Creatinine clearance 102 ml/min
Treatment?
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CASE 4: TREATMENT
(a) No treatment required as patient as patient is asymptomatic
(b) Clexane 1.5 mg/kg daily for one month then reduce to 1mg/kg
once daily
(c) Rivaroxaban 15mg BD for 3 weeks then 20 mg daily
(d) Warfarin with INR 2-3
(e) LMWH 1.5mg/kg daily for 5 days then dabigatran 150mg BD
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CLOT TRIAL
Lee et al. NEJM 2003; 349(2):146-153
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Lee et al. NEJM 2003; 349(2):146-153
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RIVAROXABAN AND MALIGNANCY
Select-D Trial: multicentre, open-label randomised controlled pilot
trial
Patients with PE and proximal DVT included
Dalteparin 200 IU/kg for one month then 150 IU/kg daily for
months 2-6 versus rivaroxaban 15mg BD for 3 weeks then 20mg
once daily
Primary outcome = VTE recurrence over 6 months
203 assigned to each arm, 58% of whom had metastastic disease
Young et al. J Clin Oncol 36: 2017-2023
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Young et al. J Clin Oncol 36: 2017-2023
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Major bleeding rate at 6 months: 4%(95% CI 2-8%) for dalteparin
versus 6% (95% CI 3-11%) for rivaroxaban
Young et al. J Clin Oncol 36: 2017-2023
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SE L E C T -D: BL E E D IN G
Most major bleeding events gastrointestinal (GI)
No CNS bleeds
Patients with oesophageal or gastro-oesophageal cancer tended to
experience more major bleeds with rivaroxaban than with
dalteparin – 4/11 (36%) versus 1 of 19 (11%)
More CRNMB* with rivaroxaban (13%) versus dalteparin (4%) ;
most GI or urologic
*Clinically relevant non-major bleeding Young et al. J Clin Oncol 36: 2017-2023
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CASE 4: TREATMENT
(a) No treatment required as patient is asymptomatic
(b) Clexane 1.5 mg/kg daily for one month then reduce to 1mg/kg
once daily
(c) Rivaroxaban 15mg BD for 3 weeks then 20 mg daily
(d) Warfarin with INR 2-3
(e) LMWH 1.5mg/kg daily for 5 days then dabigatran 150mg BD
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CASE 5
Mr GJ, age 56 years
Oesophageal cancer, unresectable (stented)
Estimated life expectancy no greater than 3 months
Diagnosed with DVT femoral vein
Creatinine clearance 60 ml/min
Treatment?
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CA S E 5: TR E A T M E N T
(a) No treatment required as patient is palliative
(b) Clexane 1.5 mg/kg daily for one month then reduce to
1mg/kg once daily
(c) Rivaroxaban 15mg BD for 3 weeks then 20 mg daily
(d) Warfarin with INR 2-3
(e) LMWH 1.5mg/kg daily for 5 days then dabigatran 150mg BD
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CASE 6
Ms ML, age 34 years
Admitted with swollen right leg; also severe vertigo past few days
Known triple positivity APL antibodies: aCL IgG 126 GPL, β2GP
156 G units (found during infertility work-up)
No previous history of thrombosis
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CASE 6
USS right leg: extensive ileofemoral DVT
MRI: small recent infarcts right parietal lobe and cerebellar
hemisphere; white matter changes in right occipital lobe and both
cerebellar hemispheres
Diagnosis: antiphospholipid syndrome with arterial and venous
thrombosis
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CASE 6: TREATMENT
(a) Aspirin 100mg daily
(b) Rivaroxaban 15mg BD for 3 weeks then 20 mg daily
(c) Warfarin with INR 2-3
(d) LMWH 1.5mg/kg daily for 5 days then dabigatran 150mg BD
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Pengo et al Blood 2018; 132: 1365-1371
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CASE 6: TREATMENT
(a) Aspirin 100mg daily
(b) Rivaroxaban 15mg BD for 3 weeks then 20 mg daily
(c) Warfarin with INR 2-3
(d) LMWH 1.5mg/kg daily for 5 days then dabigatran 150mg BD
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CA S E 7
Mr MS, 43 year old, left femoral DVT one week after flight from
London to Auckland
Has now completed six months of treatment with rivaroxaban; still
on 20mg daily
Repeat USS left leg shows small amount residual thrombus
No residual leg symptoms
?Treatment from this point
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CASE 7
(a) Stop treatment as provoked by air line travel
(b) Continue on rivaroxaban 20mg daily
(c) Reduce rivaroxaban to 10mg daily
(d) Refer for catheter directed thrombolysis of residual thrombus
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AIR TRAVEL AND VTE
Risk very small
27 PE per million flights and 0.05% DVT through screening
ultrasounds; most DVT muscular vein (calf vein) thrombosis
Risk significantly increased for flights ≥6-8 hours
Most patients have pre-existing risk factors
Prolonged sitting in cramped quarters, hypoxia, low humidity
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1626 consecutive patients who discontinued anticoagulation
after first episode of symptomatic proximal DVT or PE
Prandoni et al. Haematologica 2007;92:199-205
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DU R A T IO N O F TR E A T M E N T
3-6 months for those with VTE provoked by
transient risk factors
For those with permanent risk factors such as
active cancer: indefinite anticoagulation
For first idiopathic proximal DVT or PE: ACCP
guidelines recommend extended treatment for
those with low to moderate risk of bleeding
Antiphospholipid syndrome and proximal DVT
or PE: indefinite treatment
Kearon et al Chest 2016; 149(2):315-52.
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Primary efficacy outcome
occurred in 1.5% of patients
on 20mg rivaroxaban,
1.2% on 10mg rivaroxaban
and 4.4% on aspirin
NEJM 2017;376:1211-22
Rates of major bleeding
0.5% in 20mg rivaroxaban
group, 0.4% in 10mg riva
group and 0.3% in
aspirin group
EINSTEIN CHOICE
Trial
BCC8661BCC8661
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CASE 7
(a) Stop treatment as provoked by air line travel
(b) Continue on rivaroxaban 20mg daily
(c) Reduce rivaroxaban to 10mg daily
(d) Refer for catheter directed thrombolysis of residual thrombus
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SUMMARY
Venous thromboembolism (idiopathic) is a chronic illness
DOACs are at least as efficacious for VTE treatment/prevention and SPAF, with an improved safety profile
DOACs can be used in selected patients with cancer-associated thrombosis
DOACs contraindicated in patients with mechanical heart valves and antiphospholipid syndrome
Warfarin and dabigatran should be used in patients with significant risk factors for bleeding due to reversibility