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TRG HARVARD MEDICAL SCHOOL TEACHING AFFILIATE Thrombosis Research - - PDF document

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BRIGHAM AND WOMENS HOSPITAL With All the New Drugs, This is How I Treat Acute DVT and Superficial Phlebitis Gregory Piazza, MD, MS Division of Cardiovascular Medicine Brigham and Womens Hospital April 20, 2018 TRG HARVARD MEDICAL

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Thrombosis Research Group

HARVARD MEDICAL SCHOOL TEACHING AFFILIATE

BRIGHAM AND WOMEN’S HOSPITAL

With All the New Drugs, This is How I Treat Acute DVT and Superficial Phlebitis

Gregory Piazza, MD, MS Division of Cardiovascular Medicine Brigham and Women’s Hospital April 20, 2018

TRG

Thrombosis Research Group

Disclosures

  • BMS- grant/research support
  • Daichii-Sankyo- grant/research support
  • BTG/EKOS- grant/research support
  • Janssen- grant/research support
  • Bayer- scientific advisory panel
  • Portola- scientific advisory panel
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Thrombosis Research Group

A 55-year-old woman with acute left leg swelling and pain

  • She recently underwent left knee arthroscopy for

a partial medial meniscus tear.

  • She initially noted left knee swelling and pain but

subsequently found the symptoms extended to her ankle.

  • She suspected it was typical for knee surgery

and self-prescribed bed rest.

TRG

Thrombosis Research Group

A 55-year-old woman with acute left leg swelling and pain

  • Her medical history was remarkable for obesity,

type 2 diabetes, hypertension, hyperlipidemia, GERD, and obstructive sleep apnea.

  • Her medications included metformin, lisinopril,

atorvastatin, omeprazole, and ibuprofen.

  • She was a 1-pack-per-day smoker and worked

as a telemarketer.

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Thrombosis Research Group

A 55-year-old woman with acute left leg swelling and pain

  • On physical examination, she was

afebrile with a blood pressure of 128/72 mmHg, heart rate of 77 bpm, and oxygen saturation of 99% on RA.

  • She had 2+ pitting edema from her

left ankle to lower thigh and trace edema on the right.

  • Her left leg was slightly

erythematous and tender to palpation.

TRG

Thrombosis Research Group

A 55-year-old woman with acute left leg swelling and pain

  • Because of the high

suspicion for DVT, the patient was referred directly for venous ultrasound.

  • Venous ultrasound

demonstrated left femoral and popliteal DVT.

L FV

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Thrombosis Research Group

Risk Stratification for Acute DVT

Acute DVT Iliofemoral DVT Non‐iliofemoral DVT Consider catheter‐ assisted fibrinolysis “Pharmacomechanical Therapy” Therapeutic anticoagulation and compression stockings

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Thrombosis Research Group

Which Anticoagulant to Use in Acute DVT

  • Preferred in patients undergoing

fibrinolysis, surgical or catheter thrombectomy, or IVC filter insertion

Unfractionated Heparin

  • Preferred in patients who require
  • nly anticoagulation

Injectables or Direct Oral Anticoagulants

  • Used in patients with suspected or

confirmed heparin-induced thrombocytopenia (HIT)

Direct Thrombin Inhibitors

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Efficacy of DOACs for VTE Treatment: Meta-Analysis

van der Hulle T, et al. J Thromb Haemost. 2014;12:320

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Thrombosis Research Group

Safety of DOACs for VTE Treatment: Meta-Analysis

van der Hulle T, et al. J Thromb Haemost. 2014;12:320

Relative Risk

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Thrombosis Research Group

Anticoagulation Strategy in Evolution

Overlapping

LMWH/Warfarin Bridge UFH/Warfarin Bridge

Switching

LMWH to Dabigatran (RE-COVER) LMWH to Edoxaban (HOKUSAI-VTE)

Oral Monotherapy

Rivaroxaban (15 mg 2x/d for 3 wks, then 20 mg/d) (EINSTEIN) Apixaban (10 mg 2x/d for 1 wk, then 5 mg 2x/d) (AMPLIFY)

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Thrombosis Research Group

Optimal Anticoagulation for Acute VTE: 2016 CHEST Guideline Update

  • In patients with DVT of the leg or PE

and no cancer, as long-term (first 3 months) anticoagulant therapy, we suggest dabigatran, rivaroxaban, apixaban or edoxaban over VKA therapy (all Grade 2B).

Kearon C, et al. CHEST 2016 ;149:315

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Thrombosis Research Group

Contraindication Checklist for Home-Therapy of Acute DVT

High Thrombotic Load

  • Massive DVT (iliofemoral)
  • Concomitant PE

Increased Risk of Bleeding

  • Active bleeding or bleeding disorder (thrombocytopenia)
  • Advanced renal or liver disease

Special Populations

  • Body weight <45 kg or >100 kg
  • Advanced elderly, pediatric patients, or pregnant women

Symptom Control

  • Pain
  • Difficulty ambulating

Concomitant Medical Disorder Requiring Admission

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Thrombosis Research Group

Beware May-Thurner Syndrome

  • Compression of the left

common iliac vein by the right common iliac artery

  • Most common in young

women

  • May present as a

iliofemoral DVT or as chronic venous insufficiency

Fazel R, et al. N Engl J Med 2007; 357:53

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Thrombosis Research Group

Duration of Anticoagulation

Acute DVT Indeterminate Provoked Unprovoked (idiopathic) Treat with 3-6 months of anticoagulation Assess individual risk of VTE recurrence Consider indefinite duration anticoagulation if low bleeding risk Clinical risk factors:

  • Past/family history of VTE
  • Male gender
  • Thrombophilia
  • Chronic medical conditions (COPD, heart failure,

inflammatory disorders)

  • Obesity
  • Chronic immobilization

Cancer Consider prolonged anticoagulation as long as cancer is active

Goldhaber SZ and Piazza G. Circulation 2011;123:664

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Thrombosis Research Group

Prevention of Recurrent Unprovoked VTE

Study Intervention Recurrent VTE** PREVENT Warfarin, INR 1.5-2

  • vs. placebo

↓64% ELATE Warfarin, INR 2-3

  • vs. INR 1.5-2

↓63% THRIVE III Ximelagatran vs. placebo ↓84% EINSTEIN- DVT Rivaroxaban vs. placebo ↓82% AMPLIFY-EXT Apixaban vs. placebo ↓81% RE-SONATE Dabigatran vs. placebo ↓93% RE-MEDY Dabigatran vs. warfarin, INR 2-3 Non-inferior

**Regardless of thrombophilia status

Prandoni P, et al. Haematologica 2007;92:199 Goldhaber SZ and Piazza G. Circulation 2011;123:664

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Extended Secondary Prevention for All VTE: EINSTEIN CHOICE

Weitz JI, et al. N Engl J Med 2017;376:1211

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Thrombosis Research Group

Selecting the Optimal Agent for Extended Therapy

Increased Risk of Recurrent VTE after Standard Therapy No Cancer Non-High Bleeding Risk and Willing to Continue Anticoagulation DOAC OR Low- or Conventional- Intensity Warfarin High Bleeding Risk OR Not Willing to Continue Anticoagulation Low-Dose Aspirin OR Low-Dose Apixaban or Rivaroxaban Cancer LMWH Monotherapy

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Thrombosis Research Group

n = 676

CLOT Trial: Dalteparin Monotherapy vs. Warfarin

Lee AYY, et al. N Engl J Med 2003;349:146

52%

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Thrombosis Research Group

DOACs in Cancer Patients with VTE: HOKUSAI VTE CANCER

p = 0.09 p = 0.04

Raskob GE, et al. N Engl J Med. 2018; 378:615

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Thrombosis Research Group

A 55-year-old woman with acute left proximal DVT provoked by surgery

  • The patient was discharged from the office on
  • ral rivaroxaban 15 mg twice daily for 3 weeks

and then 20 mg daily for a total of 6 months.

  • She was recommended to use compression

stockings, 30-40 mmHg, thigh-high.

  • In follow-up, her symptoms resolved quickly and

she had no further venous thromboembolic events.

TRG

Thrombosis Research Group

A 62-year-old man with varicose veins and leg pain

  • The patient had long-standing varicose vein

bilaterally but never thought to seek medical attention.

  • He noted a tender firm “cord-like” mass behind

his left knee that felt warm to the touch.

  • His medical history was only significant for

hypertension for which he took HCTZ.

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Thrombosis Research Group

A 62-year-old man with varicose veins and leg pain

  • On physical examination, the

patient had a tender, erythematous cord extending superficially through his popliteal fossa.

  • He had numerous severe varicose

veins bilaterally.

  • A venous ultrasound confirmed

superficial vein thrombosis and no DVT.

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Thrombosis Research Group

Algorithm for Superficial Vein Thrombosis

Severe Symptom Treatment

Fondaparinux 2.5 mg QD Enoxaparin 1 mg/kg QD

Assess Symptom Severity

Severe Non-Severe

Superficial Vein Thrombosis

Isolated With DVT or Cancer

If concomitant DVT or cancer, treat with full-dose anticoagulation, otherwise… If non-severe, treat conservatively with analgesia, otherwise…

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CALISTO: Fondaparinux for Superficial Vein Thrombosis

Decousus H, et al. N Engl J Med. 2010;363:1222

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Thrombosis Research Group

CALISTO: Fondaparinux for Superficial Vein Thrombosis

Decousus H, et al. N Engl J Med. 2010;363:1222

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Rivaroxaban vs. Fondaparinux for Superficial Vein Thrombosis: SURPRISE

  • Prospective, randomized, open-label, non-inferiority trial
  • f superficial vein thrombosis to evaluate the efficacy

and safety of 10 mg rivaroxaban daily compared to fondaparinux 2.5 mg once daily for 45 days.

  • A combined efficacy endpoint will evaluate thrombus

progression, SVT recurrence, DVT, PE and death.

  • Safety end point will focus on major and clinically-

relevant non-major bleeding.

Clinicaltrials.gov: NCT01499953

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Thrombosis Research Group

A 62-year-old man with varicose veins and superficial vein thrombosis

  • The patient was prescribed 45 days of low-dose

fondaparinux 2.5 mg daily with excellent relief of symptoms and no recurrent events.

  • He was also prescribed compression stockings thigh-

high, 30-40 mmHg but found them difficult to wear.

  • He was eventually referred for consideration of

endovenous laser ablation given his episode of superficial vein thrombosis.

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Take-Home Points

  • The DOACs offer enhanced safety and similar efficacy

compared with warfarin for acute treatment of DVT as well as long-term secondary prevention.

  • The DOACs have facilitated home treatment of non-high

risk acute DVT.

  • The role of the DOACs in treatment of superficial vein

thrombosis has yet to be defined.