noacs in vte drug selection according to patient’s risk ... · noacs in vte drug selection...
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João Morais
Head of Cardiology Division and Research Centre
Leiria Hospital Centre
Portugal
NOACs in VTEdrug selection according to patient’s risk profile and duration of therapy
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Disclosures
João Morais
On the last year JM received honoraria for consultant activities and invited speaker for pharmaceutical and device’s companies
Astra Zeneca
Bayer Healthcare
BMS / Pfizer
Boehringher Ingelheim
Boston Scientific
Daiichi Sankyo
Merck Sharp and Dhome
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Goals of VTE treatment
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New concepts in anticoagulation therapy
Conventional therapy
•Heparin plus VKA
New therapy
•Single drug approach
•Higher initial dose
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Individualized therapy
Based on the clinical setting
Based on patient’s characteristics
Based on the individual prognosis
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Classification of lower limb DVT
Proximal DVTPopliteal FemoralDeep femoralCommon femoralIliac
Distal DVTGastrocnemiusTibial (ant/post)Soleus Peroneal
Superficial veinGreat saphenous
Chest 2012;141:e419S-e494S
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Classification of lower limb DVT
Proximal DVTPopliteal FemoralDeep femoralCommon femoralIliac
Distal DVTGastrocnemiusTibial (ant/post)Soleus Peroneal
Superficial veinGreat saphenous
Early treatmentAnticoagulantsAgressiveParenterall Rx
Chest 2012;141:e419S-e494S
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Classification of lower limb DVT
Proximal DVTPopliteal FemoralDeep femoralCommon femoralIliac
Distal DVTGastrocnemiusTibial (ant/post)Soleus Peroneal
Superficial veinGreat saphenous
Early treatmentAnticoagulantsAgressiveParenterall Rx
Conservative treatmentDelayed orall Rx
Chest 2012;141:e419S-e494S
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Classification of lower limb DVT
Proximal DVTPopliteal FemoralDeep femoralCommon femoralIliac
Distal DVTGastrocnemiusTibial (ant/post)Soleus Peroneal
Superficial veinGreat saphenous
Early treatmentAnticoagulantsAgressiveParenterall Rx
Conservative treatmentDelayed orall Rx
Prophylatic treatmentChest 2012;141:e419S-e494S
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Clinical trigger
UnprovokedDVT or PE in patients with no recently occurring major clinical risk factors for
venous embolism or
patients with active cancer, thrombophilia or family history of DVT
ProvokedDVT or PE in patients with recent occurrence of major clinical risk
factor for venous embolismsuch as surgery, trauma, immobilization, pregnancy,
oral contraceptive use or hormone replacement therapy
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Bleeding risk assessment
Low risk0 risk factors
Moderate risk1 risk factor
High risk> 2 risk factors
Chest 2012;141:e419S-e494S
Risk factors
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Bleeding risk assessment
Chest 2012;141:e419S-e494S
Anticoagulation 0 - 3 months
Anticoagulation after 3 months
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Targets for anticoagulants
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LMWH orFonda s.c.
VKA
Day 1 Day 5 - 11 At least 3 months
Current standard of care
RE-COVER (dabigatran)
HOKUSAI-VTE (edoxaban)
EINSTEIN-DVT/PE(rivaroxaban)
AMPLIFY (apixaban)
LMWH sc Dabigatran bid/Edoxaban od
Rivaroxaban 15 mg bid 3 weeks, then 20 od
Apixaban 10 mg bid 1 week, then 5 bid
Day 1 Day 5 - 11 At least 3 months
Day 1 At least 3 months
Switching
Single oral drug
Konstantinides S and Goldhaber Z Eur Heart J 2012 doi:10.1093/eurheartj/ehs258
Current and evolving anticoagulant regimen
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RECOVER EINSTEIN
AMPLIFY HOKUSAI
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European Journal of Vascular and Endovascular Surgery (2014), http://dx.doi.org/10.1016/j.ejvs.2014.05.001
NOACs and DVT
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Major bleeding
Net clinical benefit
European Journal of Vascular and Endovascular Surgery (2014), http://dx.doi.org/10.1016/j.ejvs.2014.05.001
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REMEDY: efficacy and safety of long-term treatment
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VTE trials: proportions of patients with PE
Extensive pulmonary embolism> 25% of entire pulmonary vasculature
EINSTEIN-PE 24.7% rivarox group23.9% control group
AMPLIFY 38.4 % apixa group36.0% control group
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VTE extension studies
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NOACs in cancer patients (limitations)
Paucity of clinical trial data
(< 10% of the populations in RCTs)
No comparison with LMWH
Patients were not representative of cancer patients
Drug interaction may be clinically relevant
Liver and renal dysfunction are common in cancer patients
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NOACs in cancer patients
Meta-analysis N = 1952
Efficacy data
Safety data
Int J Cardiol doi:10.1016/j.ijcard.2016.12.168
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NOACs in fragile patients
EINSTEIN pooled analysis
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Key messages
• The paradigm of DVT treatment is rapidly changing. The evidence for NOACs is strong enough to spread the use of these drugs instead of VKAs
• A single drug approach is very attractive and very useful for an outpatient management of patients with DVT
• More data is needed in patients with massive pulmonary embolism (after lytics ?)
• Extended treatment is the rule for unprovoked DVT/PE but no firm recommendations about when to stop
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João Morais
Head of Cardiology Division and Research Centre
Leiria Hospital Centre
Portugal
NOACs in VTEdrug selection according to patient’s risk profile and duration of therapy