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2013 Update on Venous Thromboembolism

1. 2. 3. 4. 5. 2013 Update on Venous Thromboembolism. Stephan Moll, MD University of North Carolina Chapel Hill, NC Advocate Lutheran General Hospital; Park Ride, IL, March 2 nd , 2013. Disclosures. Consultant : Janssen, Boehringer-Ingelheim , Daiichi Speaker bureau : n one.

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2013 Update on Venous Thromboembolism

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  1. 1 2 3 4 5 2013 Update on Venous Thromboembolism Stephan Moll, MD University of North Carolina Chapel Hill, NC Advocate Lutheran General Hospital; Park Ride, IL, March 2nd, 2013

  2. Disclosures Consultant: Janssen, Boehringer-Ingelheim, Daiichi Speaker bureau: none

  3. The 3 Major Developments in 2012 Publication of ACCP Guidelines 2012 I Approval of Rivaroxaban for VTE II Approval of Apixaban for atrial fibrillation III

  4. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient?

  5. Case - PE HPI • 63 year old man, quite healthy • 4 days h/o moderate CP + SOB; now SOB with 1 flight of stairs. • No leg symptoms • No preceding trauma, immobility, surgery, long-distance travel FH PMH • Negative for VTE • Arthroscopic knee surg 2 yrs ago • HTN; Obesity (BMI 32.3) • No h/o cancer; no h/o bleeding

  6. Case Physical Exam • BP 135/87; P 92 / min • RR at rest 16 min, not SOB when talking; O2 on RA 93 % • BMI 32.3; lungs clear; legs R=L CTA chest • RUL segmental PE, L UL and LL subsegmental PE

  7. Question – Outpatient vs. Inpatient? Diagnosis • Unprovoked PE. VTE risk factors: (a) obesity. How to manage this patient? Outpatient? Admit?

  8. ACCP 2012 Acute Treatment • Recommend home treatment for DVT (1B) and early d/c for low-risk PE. (2B). [Kearon C et al. Chest 2012;141(2)(Suppl):e419S-e494S]

  9. Outpatient vs. Inpatient – HESTIA Criteria [Zondag W et al. J Thromb Haemost 2013(Jan 6th )ePub] [Zondag W et al. J Thromb Haemost 2011;9:1500-7]

  10. PESI = Pulmonary Embolism Severity Index [Aujesky D et al. Am J RespirCrit Care Med 2005;15;172(8):1041-6]

  11. Outpatient vs. Inpatient – HESTIA Score Teaching point #1 • Outpatient PE management • Suitable for, may be, 50 % of PE patients; • HESTIA criteria can be useful for decision making.

  12. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q2: Thrombolytics?

  13. Thrombolytics? • For PE, with hypotension or high risk for hypotension: suggest thrombolytics, systemically.2C • For DVT, suggest anticoagulant therapy alone over thrombolysis(catheter-directed or systemic). 2C [Kearon C et al. Chest 2012;141(2)(Suppl):e419S-e494S]

  14. PE: Indicators of Poor Outcome ESC criteria (based on consensus; lack of validation) [Torbicki A et al. Eur Heart J 2008;2276-315]

  15. Thrombolytics? • PEITHO trial: 1,006 patients with RV stain PLUS pos. troponin: thrombolytics versus placebo; results spring 2013. • ATTRACT trial392/692 patients enrolled as of Jan 8th, 2013. [http://clinicaltrials.gov/ct2/show/NCT00639743?term=peitho&rank=1] [http://clinicaltrials.gov/ct2/show/NCT00790335?term=ATTRACT&rank=1]

  16. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q2: Thrombolytics? Q3: LMWH/warfarin or rivaroxaban?

  17. Question –Anticoagulant Choice Outpatient management is chosen. CBC, PT, aPTT normal; Creatinine 0.95; liver enzymes normal. How would you treat? LMWH or fondaparinux / warfarin Rivaroxaban (Xarelto) Dabigatran (Pradaxa) Apixaban (Eliquis)

  18. New Oral Anticoagulants [Garcia D et al. Blood. 2010 Jan 7;115(1):15-20. Review] In clinical development: Edoxaban, Betrixaban (not FDA approved)

  19. A. DVT study Rivaroxaban in Acute DVT and PE B. PE study [Bueller H et al. NEJM 2010;363:2499-510] [Bueller H et al. NEJM 2012;366:1287-97]

  20. Rivaroxaban BLEEDING • Clinically relevant bleeding(composite of major and clinically relevant non-major bleeding): Same. • Major bleeding: Same(DVT study) or less (PE study). [Bueller H et al. NEJM 2010;363:2499-510] [Bueller H et al. NEJM 2012;366:1287-97] Nov 2012

  21. In which patient do I consider rivaroxaban? Rivaroxaban • Acute DVT or PE • All patients treated as outpatients • Mild to moderate DVT; HESTIA criteria for PE • On long-term warfarin • I discuss it with all patients • Fluctuating INRs, high “warfarin hate factor”

  22. In which patient would I NOT use rivaroxaban? Rivaroxaban • Renal impairment: GFR < 30 ml/min (or 40; “buffer zone”) by Cockroft-Gault • Liver disease • Increased bleeding risk; particularly GI bleeding • Acute cerebral vein thrombosis • BMI > 40 or “low” body weight • Cancer • Patient who doesn’t like idea of “no known reversal agent/strategy”.

  23. Things to consider when starting rivaroxaban Rivaroxaban • LABS: CBC, creatinine, AST, ALT, t. bili • GFR > 30 ml/min • Check with insurance carrier ($ 335 / month) • 15 mg bid for 3 weeks, then 20 mg qd • Take with food (AM or PM) • Drug interactions: HIV meds, antifungal, sz drugs, St. John’s wort • F/u with you in 3 weeks and in 3 months, then yearly.

  24. Rivaroxaban Teaching point #2 • Acute or previous VTE: Rivaroxaban is a possible treatment option.

  25. Other Drug Approvals in 2012

  26. Apixaban in Atrial Fibrillation [Granger CB et al. N Engl J Med 2011;365:981-92]

  27. Apixaban in Atrial Fibrillation • Apixaban… • is MORE effective than warfarin • leads to LESS major bleeding. Dec 2012

  28. Dabigatran: Hospital Guide for New Oral Anticoagulants http://www.med.unc.edu/im/staff/clinic/files/Dabigatran%20Management%20-%20PDF%20-%20Updated%20201111.pdf Rivaroxaban: http://professionalsblog.clotconnect.org/wp-content/uploads/2012/05/UNC-Xarelto-2012.pdf Apixaban: http://patientblog.clotconnect.org/wp-content/uploads/2013/02/Apixaban-UNC-2-2013.pdf Teaching Point #3 • Comprehensive management documents: : UNC and rivaroxaban

  29. New Oral Anticoagulants: Cost • Per day: $ 9.20 to $ 11.20 (ca. $ 10.00 /day) • Per month: $ 276.00 to 336.00 (ca. $ 300.00 /mo) [personal communciations: evaluation of Average Wholesale Price (AWP) and inquiry from 3 national pharmacy chains; Jan 28, 2013]

  30. VTE Brochure [http://files.www.clotconnect.org/DVT_and_PE.pdf]

  31. VTE Brochure Teaching point #4 • www.clotconnect.org

  32. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q4: Compression stockings? Q2: Thrombolytics? Q3: LMWH/warfarin or rivaroxaban?

  33. Compression Stockings? SOX trial [Kahn SR;ASH 2012;abstract 393] Teaching point #5 • Compression stockings probably/possibly do not prevent PTS.

  34. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q4: Compression stockings? Q5: D/c anticoagor long-term? Q2: Thrombolytics? Q3: LMWH/warfarin or rivaroxaban?

  35. VTE due to transient risk factor How Long To Treat With Anticoagulation? 3 months Woman with DVT or PE, hormones Woman with DVT, not hormones Strong Thrombophilia - D-dimer + Woman with PE Man with DVT Long-term Man with PE Other risk factors for recurrence: Obesity?; age? Other considerations: Bleeding, fluctuating INRs, lifestyle impact, pt preference

  36. How Long to Treat with Anticoagulation? [Palareti G et al. NEJM 2006;355:1780-9] [Verhovsek M et al. Systematic review on D-dimer to predict recurrent VTE. Ann Int Med 2008;149(7):481‐490]

  37. VTE Recurrence – Risk Assessment Scores HERDOO-2 score [Rodger M et al; CMAJ 2008;179:417-426] DASH score [Tosetto A et al. J Thromb Haemost 2012 Jun;10(6):1019-25]

  38. Women How Long to Treat With Warfarin? - HERDOO-2 • Conclusion: • Women ≤ 1 d/c anticoagulation. • Men, no matter what the score, need to continue anticoagulation. • HERDOO-2 rule • HER = • Hyperpigmentation or • Edema or • Redness • D = D-dimer positivity (on warfarin) • O= obesity, BMI ≥ 30 • O = Older age, ≥ 65 yrs • 2 = score of ≥ 2: continue warfarin [Rodger M et al; CMAJ 2008;179:417-426]

  39. How Long to Treat With Warfarin? - DASH • DASH score • D = D-dimer pos (off warfarin) + 2 • A = age < 50 years + 1 • S = sex (male) + 1 • H = hormone use - 2 • Conclusion: • Score ≤ 1: d/c anticoagulation • Annual VTE recurrence rate: • ≤ 1: 3.1 % • 2: 6.4 % • ≥ 3: 12.3 % [Tosetto A et al. J Thromb Haemost 2012 Jun;10(6):1019-25]

  40. Patient‘s Preference “Coumadin hate factor” 0 10

  41. Conglomerate decision of: VTE: Length of Anticoagulation Risk of recurrent VTE (a)…., (b)…., (c) ….. Risk of Bleeding (a)…., (b)…., (c) ….. Patient preference“Coumadin hate factor”

  42. ACCP 2012 Guidelines: Highlights Treatment beyond Acute Period • Surgery-associated DVT/PE: recommend 3 months. (1B) • Non-surgical transient risk factor: recommend 3 months over 6 or more months. (1B) • Unprovoked DVT/PE and low/intermediate risk for bleeding: suggest extendedanticoagulation (2B). High bleeding risk: 3 months (1B). • Cancer patient with DVT/PE: recommend/suggest extended therapy. LMWH rather than VKA (2C). [Kearon C et al. Chest 2012;141(2)(Suppl):e419S-e494S]

  43. VTE: Length of Anticoagulation Teaching point #6 • How long to treat with anticoagulation? • Risk factors for VTE: (a)…., (b)….., (c)…… • Risk factors for bleeding: (a)…., (b)….., (c)…… • Patient preference

  44. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q4: Compression stockings? Q5: D/c anticoagor long-term? Q2: Thrombolytics? Q6: Warfarin or rivaroxaban? Q3: LMWH/warfarin or rivaroxaban?

  45. VTE extension study Rivaroxaban in VTE, Secondary Prophylaxis [Bueller H et al. NEJM 2010;363:2499-510]

  46. Patient Diagnosis few days later 3 mo any time Q1: Outpatient or inpatient? Q4: Compression stockings? Q5: D/c anticoagor long-term? Q2: Thrombolytics? Q6: Warfarin or rivaroxaban? Q3: LMWH/warfarin or rivaroxaban? Q7: Aspirin vs anticoagulant?

  47. placebo aspirin A. WARFASA study Aspirin and VTE Prevention HR 0.58 95% CI 0.36 to 0.93 p= 0.02 [Becattini C et al; NEJM 2012; 366:1959-1967]

  48. B. ASPIRE study Aspirin and VTE Prevention [Brighton TA, et al. N Engl J Med. 2012 Nov 22;367(21):1979-87]

  49. C. Meta-analysis Aspirin and VTE Prevention – Meta-Analysis [Brighton TA, et al. N Engl J Med. 2012 Nov 22;367(21):1979-87]

  50. ASA and VTE Teaching point #7 • Not clear whether Aspirin prevents recurrent VTE. • But it does lead to a net “vascular benefit” (arterial and venous together).

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