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Providing optimal care for

our DVT/PE patients: the


role of Non vit K oral anticoagulants
Some Definitions
 Thrombus: is formation of blood clot that is adherent to
the internal wall of a blood vessel in a given location
 Embolus: Any intravascular mass, air, fat, or thrombus that
travels in the blood and capable of clogging small calibre
blood vessels
 Thromboembolism: transport of a thrombus detached
from a vessel wall to another location (within the
circulation) where it causes partial or complete blockade of
the vessel.
 Thrombophilia: Defined as a genetically determined
increased likelihood of thrombosis
Objectives and Principles of Antithrombotic
Treatment
The objectives of treatment in patients with established venous
thromboembolism are to
prevent death from pulmonary embolism,
prevent morbidity from recurrent venous thrombosis or pulmonary
embolism, and
prevent or minimize the postthrombotic syndrome.
For most patients, the first two objectives are achieved by
providing adequate anticoagulant treatment.
Thrombolytic therapy is indicated in selected patients with
pulmonary embolism
Use of an inferior vena cava filter is indicated to prevent death
from pulmonary embolism in patients in whom anticoagulant
treatment is absolutely contraindicated
Contraindication to Anticoagulant therapy
Absolute contraindications to anticoagulant treatment include
intracranial bleeding,
severe active bleeding,
recent brain, eye, or spinal cord surgery, and
malignant hypertension.
Relative contraindications include
recent major surgery,
recent cerebrovascular accident,
active gastrointestinal tract bleeding,
severe hypertension,
severe renal or hepatic failure, and
severe thrombocytopenia (platelets <50,000/l).
VTE requires acute treatment and prevention of recurrence

INITIAL SECONDARY EXTENDED


MANAGEMENT PROPHYLAXIS PROPHYLAXIS
1 week 3–6 months Years

UFH or LMWH
or fondaparinux

Thrombolysis
(+ parenteral AC)

Vitamin K antagonist

Direct thrombin inhibitor or Factor Xa inhibitor


(± UFH/LMWH)

LMWH, low molecular weight heparin; UFH, unfractionated heparin 6


Heparin Vs LMWH
 Initial therapy with continuous intravenous heparin has
been the standard approach to treatment of deep vein
thrombosis or pulmonary embolism for more than 30 years.
 During the 1990s, LMW heparin given by subcutaneous
injection once or twice daily was evaluated by clinical trials
and shown to be as
effective and
safe as continuous intravenous heparin
 for the initial treatment of patients with proximal deep vein
thrombosis and submassive pulmonary embolism.34,35
Heparin Vs LMWH
 The advantage of LMW heparin is that it does
not require anticoagulant monitoring (grade 1A).
 LMW heparin enables outpatient therapy for
many patients with uncomplicated proximal vein
thrombosis.
 Intravenous unfractionated heparin remains the
preferred approach for initial anticoagulant
therapy in patients with severe renal failure
(grade 1A).34
The Low Molecular weight Heparins
Drug Dose Comment
Enoxaparin 1.0 mg/kg bid A once-daily regimen of 1.5 mg/kg can be used
but probably is less effective in patients at high
risk of recurrence, such as those with cancer

Dalteparin 200 IU/kg After 1 month, can be followed by 150 IU/kg once
once daily daily as an alternative to an oral vitamin K
antagonist for long-term treatment
Tinzaparin 175 IU/kg This regimen can also be used for long-term
once daily treatment as an alternative to an oral vitamin K
antagonist
Nadroparin 6150 IU bid 4100 IU bid if patient weighs <50 kg or 9200 IU
for 50–70 kg bid if patient weighs >70kg.
Reviparin 4200 IU bid 3500 IU bid if patient weighs 35–45 kg or 6300 IU
for 46–60 kg bid if patient weighs >60 kg.
Fondaparinux 7.5 mg once daily Synthetic pentasaccharide. 5 mg once daily if
for 50–100 kg patient weighs <50 kg or 10 mg once daily if
patient weighs >100 kg.
The oral anticoagulant

 Long-term anticoagulant therapy is required to prevent


 a high frequency (15–25%) of symptomatic extension of thrombosis
 and/or recurrent venous thromboembolic events.
 Oral anticoagulant treatment using a vitamin K antagonist (e.g.,
sodium warfarin) until recently is the preferred approach for
long-term treatment in most patients (grade 1A).
Warfarin is associated with numerous disadvantages that
the NOACs were designed to overcome

Slow onset of action Slow offset of action Unpredictable response

Routine coagulation Narrow therapeutic


Frequent dose adjustments
monitoring window

Food–drug interactions Drug–drug interactions Warfarin resistance

PARADOXICAL THROMBOSIS
Ansell et al. Chest 2008; Umer Usman et al. J Interv Card Electrophysiol 2008; Nutescu et al. Cardiol Clin 2008;
Turpie. Eur Heart J 2008; Khoo et al. Int J Clin Pract 2009; Pradaxa ®: EU SPC, 2015 11
The New oral anticoagulants (NOAC)
NOAC Mechanism of FDA Approvals manufacturer Warfarin Non-
Action Inferior Studies
Edoxaban Anti Xa January 8, 2015 Daiichi Sankyo https://
Inc. clinicaltrials.gov/
show/
NCT00986154
Apixaban Anti Xa Dec. 28, 2012 Eliquis, Bristol- Apixaban
Compared with Warfarin in
Myers Patients With Atrial Fibrillati
on and
Squibb/Pfizer Valvular
Heart Disease: Findings Fro
m the ARISTOTLE Trial.
Circulation. 2015 Jun 23.
pii:
CIRCULATIONAHA.114.0148
07. [Epub ahead of print]
PMID: 26106009
Rivaroxaban Anti Xa November 4, Bayer/Johnson Oral rivaroxaban
 for symptomatic venous thr
2011 & Johnson omboembolism.
EINSTEIN Investigator
N Engl J Med. 2010 Dec
23;363(26):2499-510. doi:
10.1056/NEJMoa1007903.
Epub 2010 Dec 3.
.

Dabigatran Anti IIa Sept. 20, 2010 Boehringer Connolly SJ, Ezekowitz MD,


Yusuf S, et al. Dabigatran
Ingelheim versus warfarin in patients
with atrial fibrillation. N
Engl J Medicine 2009;
DOI:10.1056.NEJM0a09055
61. Available at: 
http://www.nejm.org.
.
Acute treatment: NOACs have been compared with
warfarin in multiple trials

RE-COVER™/
EINSTEIN DVT3 EINSTEIN PE4 AMPLIFY5 Hokusai-VTE6,7
RE-COVER™ II1,2
(Rivaroxaban) (Rivaroxaban) (Apixaban) (Edoxaban)
(Dabigatran)
Patients, N 5107 3449 4832 5395 8292
Mean age (years) 55 56 58 57 56
Female (%) 40 43 47 41 43

CrCl <50 mL/min


NR 7 8 6 7
(%)

DVT only (%) 69 99 – 65 59


PE±DVT (%) 31 0.7 100 34 40
Unprovoked (%) NR 62 65 90 65
Cancer (%) 4 6 5 3 9*
Previous VTE (%) 22 19 20 16 18

*History of cancer; active cancer was observed in 2.4% of patients overall


NR, not reported
1. Schulman et al. N Engl J Med 2009; 2. Schulman et al. Circulation 2014; 3. EINSTEIN Investigators. N Engl J Med 2010;
4. EINSTEIN–PE Investigators. N Engl J Med 2012; 5. Agnelli et al. N Engl J Med 2013;
6. Hokusai-VTE Investigators. N Engl J Med 2013; 7. Raskob et al. Presented at ASH 2013. Abstract number 211. 13
Is a NOAC a treatment option in this patient?
What do the guidelines say?

PE without shock or hypotension


(intermediate or low risk)

As an alternative to VKA treatment:


dabigatran is recommended following
acute-phase parenteral anticoagulation
edoxaban* is recommended following
acute-phase parenteral anticoagulation

As an alternative to combination of
parenteral anticoagulation with VKA:
rivaroxaban is recommended apixaban
is recommended

*Was not approved for this indication at the time of publication of the guidelines
Konstantinides et al. Eur Heart J 2014 14
Supportive evidence slides
VTE requires acute treatment and prevention of recurrence

INITIAL SECONDARY EXTENDED


MANAGEMENT PROPHYLAXIS PROPHYLAXIS
1 week 3–6 months Years

UFH or LMWH
or fondaparinux

Thrombolysis
(+ parenteral AC)

Vitamin K antagonist

Direct thrombin inhibitor or Factor Xa inhibitor


(± UFH/LMWH)

LMWH, low molecular weight heparin; UFH, unfractionated heparin 16


Dabigatran trials in VTE mirrored clinical practice

Confirmed
DVT and/or PE Initial parenteral therapy

Acute treatment
RE-COVER™
D150 vs warfarin

>9 000 patients studied


RE-COVER™ II
D150 vs warfarin

Prevention of recurrence
PRETREATMENT RE-MEDY™*
3–12 months* D150 vs warfarin

PRETREATMENT RE-SONATE™
6–18 months* D150 vs placebo

Time (months) 6 12 18 24 30 48
*RE-MEDY™ original protocol, 3–6 months of pretreatment, then 18 months on study drug; amendment allowed 3–12
months of pretreatment, then up to 36 months on study drug
Schulman et al. New Engl J Med 2009; Schulman et al. N Engl J Med 2013; Schulman et al. Circulation 2014;
Pradaxa® EU SPC, 2015 17
Acute treatment: dabigatran non-inferior to warfarin for
prevention of recurrent DVT/PE in Phase III trials

HR: 1.09
(95% CI: 0.76–1.57) NOAC Warfarin
3
Patients (%)

2
2.4% 2.2%

0
RE-COVER™/
RE-COVER™ II*
Dabigatran

*Pooled analysis
Schulman et al. Circulation 2014 18
Acute treatment: rivaroxaban non-inferior to warfarin for
prevention of recurrent DVT/PE in Phase III trials

HR: 0.89
(95% CI: 0.66–1.19) NOAC Warfarin
3
Patients (%)

2
2.3%
2.1%

0
EINSTEIN-DVT/
EINSTEIN-PE*
Rivaroxaban

. Prins et al. Thromb J 2013 19


Acute treatment: apixaban non-inferior to warfarin for
prevention of recurrent DVT/PE in Phase III trials

HR: 0.84
(95% CI: 0.60–1.18)
NOAC Warfarin
3
Patients (%)

2.7%
2
2.3%

0
AMPLIFY

Apixaban

Agnelli et al. N Engl J Med 2013; 20


Acute treatment: edoxaban non-inferior to warfarin for
prevention of recurrent DVT/PE in Phase III trials

HR: 0.82 NOAC Warfarin


(95% CI: 0.60–1.14)
3
Patients (%)

1.9%
1.6%
1

0
Hokusai-VTE†

Edoxaban4
On treatment

The Hokusai-VTE Investigators et al. N Engl J Med 2013


21
Acute treatment: dabigatran associated with less major
bleeding versus warfarin in Phase III trials

NOAC Warfarin

3 HR: 0.60
(95% CI: 0.36–0.99)
Patients (%)

1.6%
1
1.0%

0
RE-COVER™/
RE-COVER™ II*
Dabigatran1

*Pooled analysis
Schulman et al. Circulation 2014; 22
Acute treatment: rivaroxaban associated with less major
bleeding versus warfarin in Phase III trials

NOAC Warfarin

3
HR: 0.54
(95% CI: 0.37–0.79)
Patients (%)

1.7%
1
1.0%

0
EINSTEIN-DVT/
EINSTEIN-PE*
Rivaroxaban

Prins et al. Thromb J 2013 23


Acute treatment: apixaban associated with less major
bleeding versus warfarin in Phase III trials

NOAC Warfarin

3 HR: 0.31
(95% CI: 0.17–0.55)
Patients (%)

1.8%
1

5
0.6%
0
AMPLIFY

Apixaban

Agnelli et al. N Engl J Med 2013 24


Acute treatment: edoxaban non-inferior to warfarin for
major bleeding in Phase III trials

NOAC Warfarin
3
HR: 0.84
(95% CI: 0.59–1.21)
Patients (%)

1.4% 1.6%
1

0
Hokusai-VTE†

Edoxaban4


On treatment
The Hokusai-VTE Investigators et al. N Engl J Med 2013 25
RE-COVER™/RE-COVER™ II assessed dabigatran vs
warfarin in the acute phase of treatment
Warfarin or a placebo that looked identical to warfarin was generally started on the day of random
assignment and was adjusted to achieve an INR of 2.0 to 3.0 on a point-of-care coagulometer that was
programmed, in conjunction with the randomization schedule, to yield either a true INR or a sham INR
(“singledummy phase”).

30-day
Single-dummy Double-dummy period follow-up
period

Warfarin
placebo Dabigatran etexilate 150 mg BID

Warfarin placebo
Objective
confirmation
of VTE 72 hrs
Dabigatran etexilate placebo BID
Warfarin Warfarin (INR 2.0–3.0)
Initial parenteral
therapy

Enrolment R
R Until INR ≥2.0 at two consecutive 6 months
measurements (8–11 days) End of treatment

Active dabigatran and warfarin-like placebo or active warfarin and dabigatran-like


placebo were then given for 6 months (“double-dummy phase”)

R, randomization
Schulman et al. New Engl J Med 2009; Schulman et al. Circulation 2014 26
RE-COVER™/RE-COVER™ II demonstrated benefits of
dabigatran vs warfarin in the acute phase of treatment

Non-inferior
EFFICACY

Superior

similar
40%
VTE OR
RELATED DEATH
SAFTEY*

40%
40% 44%
40% 33%
40%
MAJOR AND CLINICALLY
MAJOR BLEEDING RELEVANT NON-MAJOR ANY BLEEDING
BLEEDING

*Pooled data RE-COVER™ and RE-COVER™ II; oral drug treatment period only; significant reductions with dabigatran vs
warfarin based on upper limit of 95% CI not crossing 1.0
Schulman et al. New Engl J Med 2009; Schulman et al. Circulation 2014 27
Acute treatment: dabigatran non-inferior to warfarin for
prevention of recurrent/fatal VTE

Dabigatran 150 mg BID Warfarin


HR: 1.09 HR: 1.10 HR: 1.08
3 (95% CI: 0.76–1.57) (95% CI: 0.65–1.84) (95% CI: 0.64–1.80)
P<0.001 (non-inferiority) P<0.001 (non-inferiority)

2.4% 2.4% 2.3%


Patients (%)

2 (60/2553) 2.2% (30/1274) 2.2%


2.1% (30/1279)
(55/2554) (28/1289)
(27/1265)

1
1.3%
(18/1426)

0
Pooled data RE-COVER™ RE-COVER™ II
Risk difference: 0.4%
(95% CI: −0.8–1.5) Risk difference: 0.2%
(95% CI: −1.0–1.3)
P<0.001 (non-
inferiority) P<0.001(non-inferiority)

Schulman et al. New Engl J Med 2009; Schulman et al. Circulation 2014 28
Acute treatment: major bleeding significantly lower with
dabigatran versus warfarin

HR: 0.60
(95% CI: 0.36–0.99)
Patients (%)

1.6%
(40/2554)
1
1.0%
(24/2553)

0
Dabigatran etexilate Warfarin
150 mg BID

Pooled data from RE-COVER™ and RE-COVER™ II


Bleeding events from start of oral anticoagulation (double-dummy period)
Significance based on upper limit of 95% CI not crossing 1.0
Schulman et al. Circulation 2014 29
Acute treatment: major and clinically relevant non-major
bleeding significantly lower with dabigatran versus warfarin

HR: 0.56
10 (95% CI: 0.45–0.71)

8
7.7%
Patients (%)

6 (189/2554)

4 4.4%
(109/2553)
2

0
Dabigatran etexilate Warfarin
150 mg BID

Pooled data from RE-COVER™ and RE-COVER™ II


Bleeding events from start of oral anticoagulation (double-dummy period)
Significance based on upper limit of 95% CI not crossing 1.0
Schulman et al. Circulation 2014 30
EU label: identical dosing regimens for SPAF and DVT/PE,
with no dose titration or changes after initiation

150 mg BID Recommended dose of dabigatran

Recommended for patients ≥80 years, and patients


110 mg BID
who receive concomitant verapamil

Individual assessment of thromboembolic and bleeding


risk recommended in:
150 mg BID • Patients 75–80 years
or • Patients with moderate renal impairment
110 mg BID • Patients with gastritis, oesophagitis,
gastro-oesophageal reflux
• Other patients at increased risk of bleeding

Pradaxa®: EU SPC, 2015 31


Which dose would I choose for these patients?

Henri François Sylvaine

Dabigatran Dabigatran Dabigatran


150 mg BID 150 mg BID 110 mg BID

• 67 years old • 76 years old • 80 years old


• Previous DVT • Swollen painful calf • Oedema of left lower
• Shortness of breath and • D-dimer = positive limb and shortness of
chest pain • V/Q scan = negative breath
• Chest CT scan shows • Compression ultra sound • Left popliteal vein
bilateral PE shows proximal DVT thrombosis and acute PE

32
How long should anticoagulation be continued?
What do the guidelines say? (1)

Unprovoked PE: oral anticoagulation is


recommended for at least 3 months

Unprovoked PE + low bleeding risk:


extended oral anticoagulation
should be considered

Second unprovoked PE: indefinite oral


anticoagulation is recommended

Konstantinides et al. Eur Heart J 2014 33


How long should anticoagulation be continued?
What do the guidelines say? (2)

Unprovoked VTE*
(low/moderate bleeding risk): suggest
extended anticoagulation

Unprovoked VTE
(high bleeding risk):
recommend 3 months anticoagulation

Second unprovoked VTE


(low/moderate bleeding risk):
recommend/suggest extended
anticoagulation

Second unprovoked VTE


(high bleeding risk):
suggest 3 months anticoagulation

*Unprovoked proximal DVT and unprovoked PE


Adapted from ACCP guidelines. Kearon et al. Chest 2012 34
Prevention of recurrence is long-term: a positive safety
profile is crucial

Fear of bleeding and practical limitations of VKAs may inhibit long-term use

For some patients with


VTE, extended or indefinite
anticoagulation is
recommended1,2

1. Kearon et al. Chest 2012; 2. Konstantinides et al. Eur Heart J 2014 35


RE-MEDY™ assessed dabigatran vs warfarin for the
prevention of recurrence

Screening/ 30-day
baseline Treatment period follow-up

Dabigatran etexilate 150 mg BID

Anticoagulant Warfarin placebo


therapy
3–12 months*
and “increased Dabigatran etexilate placebo BID
risk of recurrence” 0–7 days
until Warfarin (INR 2.0–3.0)
INR ≤2.3

Confirmed Screening RR Up to 36 months*


VTE End of treatment

*Original protocol, 3–6 months pretreatment, 18 months on study drug; amendment allowed 3–12 months pretreatment,
then up to 36 months on study drug
R, randomization
Schulman et al. N Engl J Med 2013 36
RE-MEDY™ demonstrated benefits of dabigatran vs warfarin
for the prevention of recurrence

Non-inferior
EFFICACY

Superior
Not significant

similar
40%
VTE OR
RELATED DEATH

Numerically
SAFTEY*

lower with
dabigatran
48%
40% 46%
40% 29%
40%
MAJOR AND CLINICALLY
MAJOR BLEEDING RELEVANT NON-MAJOR ANY BLEEDING
BLEEDING

*Major bleeding numerically lower with dabigatran vs warfarin; major and clinically relevant non-major bleeding and any
bleeding were significantly lower with dabigatran vs warfarin
Schulman et al. N Engl J Med 2013 37
Prevention of recurrence: dabigatran non-inferior to
warfarin for prevention of recurrent/fatal VTE

Risk difference
at 18 months:
3 0.38%
(95% CI: −0.50–1.25)
HR: 1.44
(95% CI: 0.78–2.64) P<0.001
(non-inferiority)
P=0.014 (non-inferiority)
Patients (%)

1.8%
(26/1430)
1.3%
1
(18/1426)

0
Dabigatran etexilate Warfarin
150 mg BID

RE-MEDY™ study
Schulman et al. N Engl J Med 2013 38
Prevention of recurrence: major bleeding numerically lower
with dabigatran versus warfarin

3
HR: 0.52
(95% CI: 0.27–1.02)

P=0.058
Patients (%)

1.8%
(25/1426)
1
0.9%
(13/1430)

0
Dabigatran etexilate Warfarin
150 mg BID

On-treatment population; RE-MEDY™ study


Schulman et al. N Engl J Med 2013 39
Prevention of recurrence: major or clinically relevant
bleeding significantly lower with dabigatran versus warfarin

14
HR: 0.54
12 (95% CI: 0.41–0.71)

P<0.001
10 46% 10.2%
Patients (%)

RRR
8 (145/1426)

6
5.6%
4 (80/1430)

0
Dabigatran etexilate Warfarin
150 mg BID

On-treatment population; RE-MEDY™ study


Schulman et al. N Engl J Med 2013 40
RE-SONATE™ demonstrated benefits of dabigatran vs
placebo for the prevention of recurrence

Significant
EFFICACY

Not significant

92%
40%
VTE, RELATED DEATH OR
UNEXPLAINED DEATH

Higher with Expected with any


dabigatran anticoagulant vs placebo
SAFTEY

Low incidence
in both groups
40% 40%
MAJOR OR CLINICALLY
RELEVANT BLEEDING
MAJOR BLEEDING
ANY BLEEDING

Schulman et al. N Engl J Med 2013 41


RE-SONATE™ showed that the benefit of dabigatran vs
placebo was maintained after discontinuation

Dabigatran
discontinued
12 10.7% 39%
symptomatic recurrent VTE* (%)

Dabigatran RRR
Estimated cumulative risk of

10 Placebo

8 6.9%

0 3 6 9 12 15 18

Time since randomization (months)

*Including DVT, fatal/non-fatal PE, and unexplained death. Extended follow-up completed for 1323 patients who underwent
randomization and received study drug; P=0.001 at 6 months; P=0.006 at 12 months; P=0.03 at 18 months
Schulman et al. N Engl J Med 2013 42
What if Henri has moderate renal impairment?
Similar treatment effect vs warfarin across CrCl groups (1)

Recurrent/fatal VTE Dabigatran 150 mg BID Warfarin

10 HR: 0.61
Interaction (95% CI: 0.37–0.99)*
p value = 0.9998
8 HR: 0.75
(95% CI: 0.31–1.84)*
Incidence (%)

5/123
4
10/539
9/561 48/1838
58/1860
2

0/114
0
30–<50 50–<80 ≥80
CrCl (mL/min)

* Applies to the pooled patient group (RE-COVER™ and RE-COVER™ II) irrespective of assigned treatment
Schulman et al. ASH 2013 43
What if Henri has moderate renal impairment?
Similar treatment effect vs warfarin across CrCl groups (2)

Major bleeding Dabigatran 150 mg BID Warfarin

10 HR: 3.10
Interaction (95% CI: 1.81–5.31)*
p value = 0.5675
8 HR: 6.71
(95% CI: 3.34–13.48)*
Incidence (%)

6 6/106

5/114
4
16/536
9/504
2
19/1783
9/1811
0
30–<50 50–<80 ≥80
CrCl (mL/min)

* Applies to the pooled patient group (RE-COVER™ and RE-COVER™ II) irrespective of assigned treatment
From start of double-dummy period (oral dabigatran or warfarin alone) to the end of the 6-month treatment period
Schulman et al. ASH 2013 44
What if François developed cancer?
Consistent dabigatran efficacy versus warfarin

Dabigatran 150 mg BID Warfarin


HR: 0.63
14
Incidence of recurrent/fatal VTE (%)

(95% CI: 0.20–2.0)

12 13%
(7/55)
10

8
HR: 0.74 8.5%
(95% CI: 0.20–2.7) (5/59)
6

4 4.7% HR: 1.19


(95% CI: 0.79–1.79)
(5/107)
3.5%
2 (4/114) 2.1% 1.8%
(51/2380) (43/2392)
0
Cancer diagnosis Cancer diagnosis No
before randomization during the study cancer diagnosis

Patients who were randomized and received at least one dose of study drug
Pooled data from RE-COVER™ and RE-COVER™ II
Schulman et al. Thromb Haemost 2015 45
Studies in DVT/PE show the non-inferior efficacy and
favourable safety profile of dabigatran vs warfarin

Non-inferior for prevention of VTE/VTE-related death


Acute treatment
Significant reduction in major and major/CR bleeds*

Non-inferior for prevention of VTE/VTE-related death


Prevention of Significant reduction in major/CR bleeds
recurrence Up to 36 months’ follow-up
Only NOAC studied long-term vs warfarin in this setting

*Pooled analysis; data from start of oral drug only period


CR, clinically relevant
Pradaxa®: EU SPC, 2015; Schulman et al. New Engl J Med 2009; Schulman et al. Circulation 2014;
Schulman et al. N Engl J Med 2013 46
Key communication points:
providing optimal care for our DVT/PE patients

1 VTE requires acute treatment and prevention of


recurrence, often needing long-term anticoagulation

2 Studies in DVT/PE support non-inferior efficacy and a


favourable safety profile for dabigatran vs warfarin

Dabigatran is the only NOAC to have been compared


3 with warfarin for long-term anticoagulation in this setting
(up to 36 months)

THANK YOU 47
Introducing our patients, all diagnosed with DVT/PE

Henri François Sylvaine

• 67 years old • 70 years old • 80 years old


• Previous DVT • Swollen painful calf • Oedema of left lower limb
• Shortness of breath and • D-dimer = positive and shortness of breath
chest pain • V/Q scan = negative • Left popliteal vein
• Chest CT scan shows • Compression ultra sound thrombosis and acute PE
bilateral PE shows proximal DVT

48

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