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CHEST Guidelines 2012 Update

CHEST Guidelines 2012 Update. Betsy Bryant Shilliday, Pharm.D ., CDE, CPP Bart Scott, MPAS, PA-C Brittain Fish Erickson, MHS, PA-C Carrie Palmer, MSN, RN, ANP-BC, CDE April 4, 2012. http://chestjournal.chestpubs.org/content/141/2_suppl. Objectives.

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CHEST Guidelines 2012 Update

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  1. CHEST Guidelines2012 Update Betsy Bryant Shilliday, Pharm.D., CDE, CPP Bart Scott, MPAS, PA-C Brittain Fish Erickson, MHS, PA-C Carrie Palmer, MSN, RN, ANP-BC, CDE April 4, 2012 http://chestjournal.chestpubs.org/content/141/2_suppl

  2. Objectives • Review recently FDA approved oral anticoagulants • Highlight some of the changes from the 2008 (AT8) to the 2012 (AT9) CHEST Guidelines

  3. Grading System

  4. New Oral Agents

  5. Clotting Cascade System Rivaroxaban Apixaban Dabigatran

  6. Dabigatran (Pradaxa®) • Indications: • Atrial fibrillation • Dosage: • 150 mg BID • Adjustments based upon CrCl • CrCl 15-30 ml/min: 75 mg BID • CrCl <15 ml/min: Not recommended • Dosage Forms: • Capsules: 75, 150 mg • Must store in original container & use w/in 4 months

  7. Dabigatran (Pradaxa®) • Drug Interactions • P-glycoprotein inducers or inhibitors Pradaxa® package insert

  8. Switching between Dabigatran & other anticoagulants

  9. Rivaroxaban (Xarelto®) • Indications: • Atrial Fibrillation • Prophylaxis (DVT in patients undergoing knee or hip replacement surgery • Hip replacement: duration of 35 days • Knee replacement: duration of 12 days Xarelto® package insert

  10. Rivaroxaban (Xarelto®) • Dosage • NonvalvularAtrial Fibrillation: • CrCl >50: 20 mg PO once daily with evening meal • CrCl 15-50: 15 mg PO once daily with evening meal • CrCl <15: avoid use • Prophylaxis of DVT: • 10 mg PO once daily with or without food • Take initial dose at least 6-10 hrs after surgery once hemostasis has been established. • Hepatic Impairment: • Avoid use in pts with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any degree of hepatic disease associated with coagulopathy • Dosage Forms: 10, 15, 20 mg tablets Xarelto® package insert

  11. Rivaroxaban (Xarelto®) • Drug Interactions • CYP 3A4, 3A5 • CYP 2J2 • P-Glycoprotein transporters • ATP-binding cassette G2 (ABCG2) transporters • Avoid concomitant use with combined P-gp and strong CYP3A4 inhibitors/inducers Xarelto® package insert

  12. Apixaban • Still in late-stage clinical development • Proposed indications • Prevention and treatment of thromboembolic events • Proposed dosing • 5, 10, 20 mg once daily • 2.5, 5, 10, 20 mg BID • Adverse effects: ? LFT elevation • Drug Interactions: 3A4

  13. Comparison of Anticoagulants J Thromb Haemost. 2011 Jul;9 Suppl 1:12-9

  14. Management of Anticoagulant Therapy

  15. Dosing of Warfarin • Sufficiently healthy patients to be treated as outpatients, we suggest initiating warfarin 10mg daily for first 2 days followed by dosing based on INR rather than starting with the estimated maintenance dose (2C) • Patients w/ previously stable therapeutic INRs who present w/ single out-of-range INR of ≤ 0.5 below or above therapeutic, continue current dose & repeat INR w/in 1-2 wks (2C); recommend against bridging (2C)

  16. Frequency of INR Monitoringin patients on Warfarin • 3.1. For patients taking VKA therapy with consistently stable INRs, we suggest an INR testing frequency of up to 12 weeks rather than every 4 weeks (Grade 2B)

  17. Schulman et al • Purpose: Investigate whether assessment of warfarin dosing q 12 wks is as safe as q 4 wk • Design: randomized, noninferiority trial • Patients: 250 patients receiving long-term warfarin therapy, whose dose was unchanged for at least 6 months • 226 completed study Schulman S, et al. Ann Intern Med 2011; 155:653-59.

  18. Outcomes • Primary outcome: TTR • Secondary outcomes: • number of extreme INRs • changes in maintenance dose • major bleeding events • objectively verified VTE and death Schulman S, et al. Ann Intern Med 2011; 155:653-59.

  19. Results • %TTR: • 74.1% (SD, 18.8%) 4 wk vs 71.6% (SD,20%) 12 wk (absolute difference, 2.5 percentage pts; noninferior p=0.020) • Dose changes: • fewer dose changes in 12 wk grp (37.1% vs 55.6%); absolute difference, 18.5 percentage pts; p=0.004 • Secondary outcomes: no difference Schulman S, et al. Ann Intern Med 2011; 155:653-59.

  20. Conclusion • Limitations: 12 wk grp had testing and contact with staff q 4 wks, single center and surrogate outcomes • Conclusion: 12 wk monitoring safe and noninferior to q 4 wk • “A comparison of INR testing, patient contact, and warfarin dose assessment q 12 wks vs q 4 wks is necessary before INR testing every 12 wks can be routinely recommended for practice” Schulman S, et al. Ann Intern Med 2011; 155:653-59.

  21. Who may be a candidate for q 12 wk monitoring??? • Stable patients on same dose of warfarin for at least 6 months • Well-educated • Empowered patient who is an active participant of their care

  22. Prevention of VTE

  23. Non-orthopedic Surgery General, Abdominal and Pelvic surgeries

  24. Cardiothoracic Surgeries

  25. Orthopedic Surgery

  26. Perioperative Management • Coronary stents on dual therapy: recommend deferring surgery for at least 6 weeks after placement of bare-metal stent and at least 6 months after drug-eluting stent (1C) • If surgery is required in this time frame, recommend continuing dual antiplatelet instead of stopping (2C) • If receiving IV UFH, stop 4-6 hrs before surgery rather than closer to surgery (2C) • If receiving sc LMWH – last dose 24 hrs before surgeryinstead of 12 hr before surgery (2C) • Resumption of LMWH – in high risk bleeding surgery, suggest resuming 48-72 hrs after surgery instead of resuming 24 hrs after surgery (2C)

  27. Diagnosis of DVT

  28. Dx of Suspected 1st LE DVT • Low pretest probability – initial testing: D-dimer, compression ultrasound (CUS) of proximal veins [UNC lab performs combined modality whole-leg US w/ compression & Doppler from greater saphenous vein up], venography or whole-leg ultrasound (US). *D-dimer > proximal CUS (initial) [Grade 2B] • Neg = don’t treat, pos = treat • Moderate pretest probability – same as above however, I mention CUS as 9th Chest recommends repeat CUS in 1 week if initial is negative • Neg proximal CUS/ pos D-dimer = repeat CUS in 1 week (2B). • High pretest probability – ultrasound or venography for initial screening (no D-dimer alone) (1B). Neg CUS, then D-dimer or whole-leg or repeat CUS 1 week (1B) or venography (2B). Neg CUS and pos D-dimer, then whole-leg or repeat prox CUS 1 (1B) week or venography (2B).

  29. Dx of Suspected 1st LE DVT • If isolated distal DVT is detected on whole-leg US, suggest serial testing to rule out proximal extension over treatment (2C). • Remarks: Patients with abnormal isolated distal DVT findings on US who place a high value on avoiding the inconvenience of repeat testing and a low value on avoiding treatment of false-positive results are likely to choose treatment over repeat US. Patients with severe symptoms and risk factors for extension as outlined in 9th ed are more likely to benefit from treatment over repeat US.

  30. Antithrombotic Therapy for VTE • Acute isolated distal DVT w/outsxs or risk factors for extension – suggest serial imaging for 2 weeks over initial anticoagulation (2C). • Remarks: Patients at high risk for bleeding are more likely to benefit from serial imaging. Patients who place a high value on avoiding the inconvenience of repeat imaging and a low value on the inconvenience of treatment and on the potential for bleeding are likely to choose initial anticoagulation over serial imaging. • Withsxs or risk factors for extension in isolated distal DVT – treat (over serial imaging) [2C]. • Distal DVT managed by serial imaging – recommend no anticoagulation if no extension (1B), suggest anticoagulation if extension but confined to distal veins (2C), recommend anticoagulation if extension into proximal veins (1B).

  31. Duration/Choice of Anticoagulation • DVT/PE and cancer - w/out high bleeding risk, recommend extended anticoagulation therapy over 3 months of therapy (1B); with high bleed risk, suggest extended anticoagulant therapy (2B). • DVT/PE and cancer not treated w/ LMWH (2B recommendation LMWH over VKA), suggest VKA over dabigatran or rivaroxaban for long-term therapy(2B). Remarks: when these guidelines were being prepared (Oct 2011), postmarketing studies of safety were not available. Given the paucity of currently available data and that new data are rapidly emerging, we give a weak recommendation in favor of VKA and LMWH therapy over dabigatran and rivaroxaban, and we have not made any recommendations in favor of one of the new agents over the other.

  32. Duration of Anticoagulation • PE/DVTprovoked by surgery or non-surgical transient risk factor – recommend 3 months of anticoagulation over (1) treatent of longer period (6-12 mo) [1B], (2) extended tx (1B). • Unprovoked PE/DVT – at least 3 months then evaluate risk-benefit ratio of extended therapy (2B).

  33. Dx of Pregnancy-Related DVT • Suspected DVT in pregnancy – recommend initial testing w/ prox CUS over whole-leg US (2C), D-dimer (1B), or venography (1B). • Initial CUS neg - suggest further testing w/ either serial prox CUS at day 3 and 7 (1B) or D-dimer at time of presentation (2B). • Positive D-dimer - have an additional f/u prox CUS at day 3 and 7 over venography (1B) or whole-leg (2C). • Suspected isolated iliac DVT in pregnancy and no evidence on CUS – suggest further testing w/ either Doppler US (2C), venography (2C) or MRI (2C) over serial CUS.

  34. Miscellaneous • Superficial vein thrombosis of lower limb of at least 5 cm – suggest prophylactic dose fondaparinux or LMWH for 45 days over no anticoagulation (2B). Fondaparinux 2.5mg daily over LMWH (2C). • Catheter associated UEDVT and cancer and catheter is removed – recommend 3 months of anticoagulation over longer duration of therapy (2C). • Acute symptomatic UEDVT, suggest against the use of compression sleeves (2C). However in patients who have PTS of the arm, suggest a trial of compression sleeves (2C).

  35. Miscellaneous • Symptomatic hepatic, portal, mesenteric, and/or splenic vein thromboses – recommend anticoagulation (1B) however incidentally detected thromboses, suggest no anticoagulation over anticoagulation (2C). • Initiating bridge w/ LMWH–suggest once over twice-daily dosing (2C). • Acute VTE – Suggest anticoagulation tx alone over catheter-directed thrombolysis (CDT) and operative venous thrombectomy (2C).

  36. Miscellaneous • Acute PE and hypotension – admit for thrombolytics (2C). • Suspected recurrent ipsilateral DVT and abnl US w/out prior comparison – recommend further testing w/ venography or D-dimer over serial prox CUS (2B). Neg D-dimer - suggest no further testing over venography (2C), positive – suggest venography (if available) over empirical treatment of recurrence (2C). • Remarks: patients who place a high value on avoiding the inconvenience and potential side effects of a venography are likely to choose treatment over venography. • Acute prox DVT or PE and IVC filter as an alternative to anticoagulation – suggest a conventional course of anticoagulation therapy if risk of bleeding resolves (2B). • Remarks: 9th Chest does not consider that a permanent IVC filter, of itself, is an indication for extended anticoagulation.

  37. Antithrombotic Therapy for Atrial Fibrillation

  38. CURRENT USE CHEST Guidelines Chest 2012;141(2):7S-47S

  39. SAFETY DATA Use in the Elderly: RELY Trial Intracranial Bleeding Rates Warfarin Event Rate (%/yr) Dabigatran 150 mg Dabigatran 110 mg Age Extracranial Major Bleeding Rates Event Rate (%/yr) Circulation. 2011;123(21):2363-72. Arch Intern Med. 2011;171(14):1285-6. Age

  40. SAFETY DATA Use in the Elderly: RELY Trial *Statistically significant for interaction Circulation. 2011;123(21):2363-72. Arch Intern Med. 2011;171(14):1285-6.

  41. SAFETY DATA Use in the Elderly: RELY Trial Major Bleeding 150 mg vs. VKA *Statistically significant for interaction Circulation. 2011;123(21):2363-72. Arch Intern Med. 2011;171(14):1285-6.

  42. Antithrombotic and Thrombolytic Therapy for Valvular Disease

  43. Bioprosthetic Valves • Transcatheter aortic bioprosthetic valve • Aspirin (50-100 mg) + clopidogrel (75 mg) over VKA or no therapy for 3 months post surgery (2C) • Aspirin therapy after 3 months (2C)

  44. Mechanical Valves: Language Change • Bridging: • Formerly bridge until INR therapeutic x 2 consecutive days • Now bridge until INR “stable on VKA” (2C) • Concomitant Aspirin: • Formerly “additional risk factors” (AF, low EF, hypercoag, atherosclerosis) • Now “at low risk of bleeding” (1B)

  45. Antithrombotic and Thrombolytic Therapy forIschemic Stroke

  46. Ischemic Stroke • Change in time frame for IV r-tPA • Formerly within 3 hours of symptom onset • Now within 4.5 hours of symptoms onset • Evidence grade within 3 hours: 1A • Evidence grade within 4 hours: 2C • Acute ischemic CVA or TIA • Early aspirin (within 48 hours) preferred over parenteral anticoagulation (1A)

  47. Acute Ischemic Stroke: VTE Prophylaxis • LMWH (prophylactic dose) recommended over UFH (formerly either/or) (2B) • Recommend against compression hose (2B)

  48. Acute Hemorrhagic Stroke: VTE Prophylaxis • LMWH or UFH (prophylactic doses) between days 2-4 (2C) • Suggest against compression hose (2B)

  49. Ischemic Stroke/TIA + AF • Recommend anticoagulation with dabigatran (2B): • Over VKA • Over aspirin + clopidogrel • If unable/unwilling to take anticoagulant • Combination aspirin + clopidogrel (1B)

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