With All the New Drugs, This is How I Treat Acute DVT and Superficial Phlebitis
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1 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 HARVARD MEDICAL SCHOOL TEACHING AFFILIATE 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 1
2 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. 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. 2
3 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. 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. L FV Venous ultrasound demonstrated left femoral and popliteal DVT. 3
4 Risk Stratification for Acute DVT Acute DVT Iliofemoral DVT Non iliofemoral DVT Consider catheterassisted fibrinolysis Pharmacomechanical Therapy Therapeutic anticoagulation and compression stockings Which Anticoagulant to Use in Acute DVT Unfractionated Heparin Preferred in patients undergoing fibrinolysis, surgical or catheter thrombectomy, or IVC filter insertion Injectables or Direct Oral Anticoagulants Preferred in patients who require only anticoagulation Direct Thrombin Inhibitors Used in patients with suspected or confirmed heparin-induced thrombocytopenia (HIT) 4
5 Efficacy of DOACs for VTE Treatment: Meta-Analysis van der Hulle T, et al. J Thromb Haemost. 2014;12:320 Safety of DOACs for VTE Treatment: Meta-Analysis Relative Risk van der Hulle T, et al. J Thromb Haemost. 2014;12:320 5
6 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) 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 6
7 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 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 7
8 Duration of Anticoagulation Acute DVT Provoked Indeterminate Unprovoked (idiopathic) Cancer Treat with 3-6 months of anticoagulation Assess individual risk of VTE recurrence Consider indefinite duration anticoagulation if low bleeding risk Consider prolonged anticoagulation as long as cancer is active Clinical risk factors: Past/family history of VTE Male gender Thrombophilia Chronic medical conditions (COPD, heart failure, inflammatory disorders) Obesity Chronic immobilization Goldhaber SZ and Piazza G. Circulation 2011;123:664 Prevention of Recurrent Unprovoked VTE Study Intervention Recurrent VTE** PREVENT Warfarin, INR vs. placebo ELATE Warfarin, INR 2-3 vs. INR % 63% THRIVE III EINSTEIN- DVT AMPLIFY-EXT RE-SONATE RE-MEDY Ximelagatran vs. placebo Rivaroxaban vs. placebo Apixaban vs. placebo Dabigatran vs. placebo Dabigatran vs. warfarin, INR % 82% 81% 93% Non-inferior **Regardless of thrombophilia status Prandoni P, et al. Haematologica 2007;92:199 Goldhaber SZ and Piazza G. Circulation 2011;123:664 8
9 Extended Secondary Prevention for All VTE: EINSTEIN CHOICE Weitz JI, et al. N Engl J Med 2017;376:1211 Selecting the Optimal Agent for Extended Therapy Increased Risk of Recurrent VTE after Standard Therapy No Cancer Cancer Non-High Bleeding Risk and Willing to Continue Anticoagulation High Bleeding Risk OR Not Willing to Continue Anticoagulation LMWH Monotherapy DOAC OR Low- or Conventional- Intensity Warfarin Low-Dose Aspirin OR Low-Dose Apixaban or Rivaroxaban 9
10 CLOT Trial: Dalteparin Monotherapy vs. Warfarin n = % Lee AYY, et al. N Engl J Med 2003;349:146 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 10
11 A 55-year-old woman with acute left proximal DVT provoked by surgery The patient was discharged from the office on oral 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, mmhg, thigh-high. In follow-up, her symptoms resolved quickly and she had no further venous thromboembolic events. 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. 11
12 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. Algorithm for Superficial Vein Thrombosis Isolated Severe Fondaparinux 2.5 mg QD Superficial Vein Thrombosis Assess Symptom Severity Severe Symptom Treatment With DVT or Cancer If concomitant DVT or cancer, treat with full-dose anticoagulation, otherwise Non-Severe If non-severe, treat conservatively with analgesia, otherwise Enoxaparin 1 mg/kg QD 12
13 CALISTO: Fondaparinux for Superficial Vein Thrombosis Decousus H, et al. N Engl J Med. 2010;363:1222 CALISTO: Fondaparinux for Superficial Vein Thrombosis Decousus H, et al. N Engl J Med. 2010;363:
14 Rivaroxaban vs. Fondaparinux for Superficial Vein Thrombosis: SURPRISE Prospective, randomized, open-label, non-inferiority trial of 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 clinicallyrelevant non-major bleeding. Clinicaltrials.gov: NCT 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 thighhigh, mmhg but found them difficult to wear. He was eventually referred for consideration of endovenous laser ablation given his episode of superficial vein thrombosis. 14
15 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. 15
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