Noval Oral Anticoagulants: Life Is Not As Simple as Anticipated

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1 Noval Oral Anticoagulants: Life Is Not As Simple as Anticipated PRESENTED BY VICKI L GROO, PHARMD CLINICAL ASSOCIATE PROFESSOR DEPARTMENTS OF PHARMACY PRACTICE AND CARDIOLOGY UNIVERSITY OF ILLINOIS AT CHICAGO

2 NOACs DOACs Provider Patient

3 Objectives: Review dosing for atrial fibrillation and venous thromboembolism Provide guidance on when to hold NOACs for procedures Review options for reversal Discuss what is on the horizon for new indications and dosing

4 NOAC Dosing

5 NOAC Dosing Renal Impairment: Afib: Renal or patient characteristic dose adjustments Some based on PK modeling only (ie no clinical data) VTE: varies by drug, check prescribing guide Contraindicated for CrCl < 30 ml/min vs renal dose adjustment vs no adjustment Drug interactions PgP inhibitors: Increase exposure (dabigatran and edoxaban) Strong CYP3A4 + PgP inhibitors: Increase exposure (apixaban and rivaroxaban) PgP inducers or PgP + CYP3A4 inducers: Decrease exposure CONTRAINDICATED ALL VTE initial treatment varies Duration LMWH vs oral load

6 NOAC Dosing: Apixaban (Eliquis) XA inhibitor with combined renal (30%) and liver elimination Start when INR < 2.0 if switching from warfarin Use parenteral agent until INR therapeutic if switching to warfarin No Dose adjustments on CrCl alone Non-valvular Afib DVT/PE Most patients 5 mg bid When 2 characteristics present Age 80; Wt 60 kg; SrCr mg bid ESRD on HD If Age 80 OR Wt 60 kg 5 mg bid* 2.5 mg bid* Initial Dose mg bid x 7 days* Maintenance Dose mg bid* Extended Rx to prevent recurrence mg bid* * Based on PK modeling for ESRD on HD

7 NOAC Dosing: Dabigatran (Pradaxa) Direct thrombin inhibitor with 80% renal elimination Dialyzable Start when INR < 2.0 if switching from warfarin If switching to warfarin, overlap with warfarin as follows: CrCl > 50 x 3 days / Cr Cl x 2 days / Cr Cl x 1 day Store original bottle / swallow whole Non-Valvular Afib DVT/PE^ CrCl > 30 ml/min 150 mg bid 150 mg bid Maintenance dose and to reduce risk of recurrence CrCl ml/min 75 mg bid * contraindicated CrCl < 15 ml/min contraindicated contraindicated ^ Treat 1 st with LMWH or UFH x 5-10 days * Based on PK modeling for CrCl

8 NOAC Dosing: Edoxaban (Savaysa) XA inhibitor with 50% renal elimination Start when INR < 2.5 if switching from warfarin If switching to warfarin; reduce dose by 50% then d/c when INR therapeutic or Use parenteral agent until INR therapeutic Non-Valvular Afib DVT/PE^ CrCl > 95 ml/min Contraindicated 60 mg daily CrCl > ml/min 60 mg daily 60 mg daily CrCl ml/min 30 mg daily* 30 mg daily* CrCl < 15 ml/min contraindicated contraindicated Any CrCl with weight 60 kg mg daily ^ Treat 1 st with LMWH or UFH x 5-10 days * Based on PK modeling for CrCl

9 NOAC Dosing: Rivaroxaban (Xarelto) XA inhibitor with combined renal (66%) and liver elimination Start when INR < 3.0 if switching from warfarin Use parenteral agent until INR therapeutic if switching to warfarin Take with food (usually pm meal) Non-valvular Afib DVT/PE Initial Dose mg bid x 21 days Maintenance Dose 20 mg daily 20 mg daily CrCl < 50 ml/min including ESRD on HD 15 mg daily* Extended Rx to prevent recurrence mg daily Contraindicated CrCl < 30 ml/min * Based on PK modeling for CrCl or ESRD on HD

10 NOAC Dosing: The need to get it right NOAC dosing patterns and associated outcomes in patients with Afib and renal impairment 14,865 patients from Optum Data Warehouse (Medicare Advantage enrollees) Started apixaban, dabigatran or rivaroxaban from 10/1/2010 to 9/30/2015 Creatinine available before treatment initiation Outcomes: Ischemic stroke or systemic embolism and major bleeding egfr calculated using CKD-EPI (Sr Cr, age, gender, race) Apixaban if SrCr > 1.5 (sensitivity analysis performed for age > 80) Propensity score matching used to balance baseline characteristics b/t reduced and standard dose patients Yao X, Shah ND, Sangaralingham LR, et al. J Am Coll Cardiol 2017;69:

11 NOAC Dosing: The need to get it right 1473 with indication for dose reduction 79 years GFR 39, CHADSVASc =5 HAS-BLED= 4 43% received standard dose OVERDOSE Apixaban 5x risk of stroke 13,392 no indication for dose reduction 70 years, GFR 73 CHADSVASc = 4 HAS-BLED = % received reduced dose UNDERDOSED Stroke/ 100 pt yrs 2.32S vs 1.85R P=0.48 Bleed/ 100 pt yrs 11.29S vs 5.06R P=0.03 Stroke/ 100 pt yrs 1.43S vs 1.70R P=NS Bleed/ 100 pt yrs 5.03S vs 5.43R P=NS Yao X, Shah ND, Sangaralingham LR, et al. J Am Coll Cardiol 2017;69: , Nielsen PB, Skjoth F, Sogaard M, et al. BMJ 2017;356 doi:

12 Surgical Interruption

13 Surgical Interruption: Estimate thromboembolic risk: Applies to evaluation need for bridging Risk Stratum A Fib VTE Very High CHADSVASC score 6 CVA or TIA within 3 months Rheumatic valvular disease VTE within 3 months Severe thrombophilia* High CHADSVASC score of 4-5 VTE in past 3-12 months Non-severe thrombophilia^ Recurrent VTE Active cancer Moderate CHADSVASC score of 2-3 VTE > 12 months and not other risk factors * Protein C or S deficiency, antithrombin or antiphospholipid antibodies ^ heterozygous factor V Leidein or prothrombin gene mutation Bridging is NOT recommended during therapeutic interruption for NOACs Douketis JD, Spyropoulos AC, Spencer FA, et al. Chest 2012; 141(2 Suppl):e326S, Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69:

14 Surgical Interruption PATIENT BLEED RISK FACTORS HAS-BLED parameters Hypertension SPB > 160mmHg Abnormal renal function dialysis/transplant or Cr > 2.6 Abnormal liver function (cirrhosis, ALT/AST > 3x ULN or bili > 2x ULN) Prior Stroke Bleeding Hx of anemia or predisposition Labile INR (VKA) Elderly > 65 years Antiplatelet or NSAID use Drug or alcohol use > 8 drinks/week Other ICH or other bleed in last 3 months Bleed history with similar procedure Quantitative or qualitative platelet abnormality uremia Bleed history from previous bridging HAS-BLED Scoring 1 point each Score 3 predictive of bleeding events during bridging Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69: Omran H, Bauersachs R, Rubenacker S, et al. Thromb Haemost 2012;108:65-73

15 Surgical Interruption: Surgical Risk Evaluation Minimal Bleeding Risk Minor dermatologic procedures (e.g. excision of basal and squamous skin cancers, actinic keratosis, and premalignant or cancerous skin nevi) Cataract procedures Dental cleanings, fillings Low Bleeding Risk 2 day risk of major bleed < 2% Minor dental procedures (simple dental extractions, restorations, prosthetics, endotonics) Cutaneous/lymph node biopsies Shoulder/foot/hand surgery Coronary angiography EP procedures: ICD implant/ ablations GI scope +/- biopsy Abdominal hysterectomy Hemorrhoidal surgery Bronchoscopy +/- biopsy Epidural injections with INR < 1.2 Pacemaker battery change Arthroscopy High Bleeding Risk 2 day risk of major bleed 2% Cancer surgery Major orthopedic surgery Reconstructive plastic surgery TURP, blader resection or tumor ablation Nephrectomy, kidney biopsy Colonic polyp resection Bowel resection PEG placement or ERCP Cardiac, intracranial, or spinal surgery Surgery in high vascular organs Any major operation > 45 min Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69: Online Appendix for complete list

16 Surgical Interruption Check Creatinine Clearance!!! UIC guide is up to 3 days Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69:

17 Surgical Interruption Resume NOAC 1 day after low bleeding risk procedures 2-3 days after high bleeding risk procedures AND Adequate hemostasis is achieved

18 Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69: Narouze S, Benzon HT, Provenzano DA, et al. Reg Anesth Pain Med 2015;40: Surgical Interruption: Other Considerations Post procedural VTE prophylaxis with AC not needed: Patient is fully anticoagulated Can still consider pneumatic compression if appropriate Can consider prophylactic doses of NOAC, LMWH, or UFH 6-8 hours post procedure until appropriate to increase to full treatment dose. Apixaban 2.5 mg bid Dabigatran 150 mg daily Edoxaban mg daily Rivaroxaban 10 mg daily Neuraxial Anesthesia All have black box warning risk of spinal or epidural hematoma Each PI provides guidance American Society of Regional Anesthesia and Pain Management wait 24 hours after catheter removal

19 Surgical Interruption Doherty JU, Gluckman TJ, Hucker WJ, et al. J Am Coll Cardiol 2017;69:

20 Reversal

21 Reversal No reversal agents available during landmark clinical trials Management and Outcomes of Major Bleeding: Dabigatran vs Warfarin 27,419 patients treated for 6-36 months in 5 phase III trials 1034 patients (627 dabigatran and 407 warfarin) had 1121 major bleeds Dabigatran patients were older, had lower CrCl, and more often used aspirin or NSAIDS 30 day mortality favors dabigatran (9.1% vs 13%, p=0.057) OR after adjustment 0.66 ( p=0.051) ICU stay favors dabigatran (1.6 vs 2.7 nights, p = 0.01) Dabigatran more likely to receive blood transfusion / warfarin received plasma Who should reversal be considered in? Emergent need for surgery or invasive procedure (4-6 hours) and/or Major bleeding while on antithrombotic therapy Majeed A, Hwang HG, Connoly SF, et al. Circulation 2013;128:

22 NOAC Reversal Agents Agent Idarucizumab Andexanet Alfa Ciraparantag Target Dabigatran only Factor Xa inhibitors* UFH, Factor XA inhibitors, Dabigatran Mechanism Humanized antibody fragment; binds dabigatran with 350x the affinity of thrombin Recombinant modified human factor Xa decoy protein; directly binds target and restores activity of factor Xa Small synthetic molecule; directly binds drug target to block binding to target site Onset < 10 minutes 2 5 minutes 5 20 minutes FDA Approval FDA 2015 Currently delayed by FDA until more data FDA granted fast track review in April 2015 with edoxaban and enoxaparin Currently in Phase 3 studies Administration Data 5 gm total given as 2 consecutive IV bolus or infusion (2.5 gm each) 90 pts (ICH, GI, trauma) / procedure clotting times normalized 88-98% 33/36 normal procedure hemostasis 11.4 hrs to hemostasis in bleeds Dose based on drug and timing of last dose; IV bolus + 2 hour infusion Healthy subjects: AntiXA activity 92-94% ANNEXA 4 ongoing: 67 pts bleeding (GI and ICH) Excellent/good hemostasis 79% IV bolus; future studies may include infusion Healthy volunteer studies with edoxaban and enoxaparin; reverses effect on whole blood clotting time Pollack CV, Reilly PA, Eikelboom J, et al. N Engl J Med 2015;373: Siegal DM Curnutte JT, Connolly SJ, et al. N Engl J Med 2015;373: Connoly SJ, Milling TJ, Eikelboom JW, et al. N Engl J Med 2016;375: ,Milling TJ, Kaatz S. Am J Emerg Med 2016;34:39-45

23 NOAC Reversal Agents Agent Idarucizumab Andexanet Alfa Ciraparantag Target Dabigatran only Factor Xa inhibitors* UFH, Factor XA inhibitors, Dabigatran Mechanism Humanized antibody fragment; binds dabigatran with 350x the affinity of thrombin Recombinant modified human factor Xa decoy protein; directly binds target and restores activity of factor Xa Small synthetic molecule; directly binds drug target to block binding to target site Onset < 10 minutes 2 5 minutes 5 20 minutes FDA Approval FDA 2015 Currently delayed by FDA until more data FDA granted fast track review in April 2015 with edoxaban and enoxaparin Currently in Phase 3 studies Administration Data 5 gm total given as 2 consecutive IV bolus or infusion (2.5 gm each) 51 bleeding pts (ICH, GI, trauma) 39 urgent procedures clotting times normalized 88-98% 33/36 normal procedure hemostasis 11.4 hrs to hemostasis in bleeds Dose based on drug and timing of last dose; IV bolus + 2 hour infusion Healthy subjects: AntiXA activity 92-94% ANNEXA 4 ongoing: 67 pts reported Excellent/good hemostasis 79% IV bolus; future studies may include infusion Healthy volunteer studies with edoxaban and enoxaparin; reverses effect on whole blood clotting time Pollack CV, Reilly PA, Eikelboom J, et al. N Engl J Med 2015;373: Siegal DM Curnutte JT, Connolly SJ, et al. N Engl J Med 2015;373: Connoly SJ, Milling TJ, Eikelboom JW, et al. N Engl J Med 2016;375: ,Milling TJ, Kaatz S. Am J Emerg Med 2016;34:39-45

24 NOAC Reversal: PCCs Use for XA inhibitors 3-factor PCC: (II, IX, X) 50 U/kg IV, may repeat q 12 hours 4-factor PCC: (II, VII IX, X, Protein C and S) 50 U/kg x 1 FEIBA has activated factor VII? Thromboembolic risk KCentra all inactivated factors Dose not based on INR!!! What do we know? Animal models of bleeding; decreased blood loss Healthy subjects; reverses abnormal coagulation values, decreases bleeding, improves hemostasis ICH; 18 pts suggested reduces hemorrhagic complications and hematoma expansion Eikelboom, Merli G. Am J Emerg Med 2016;34:3-8, Nutescu EA, Dager WE, Kalus JS, et al. Am J Health-Syst Pharm 2013;70:e82-97

25 NOAC Reversal Summary XA Inhibitor PCC Major Bleeding or Urgent invasive procedure Dabigatran Idarucizumab Other Considerations: Time of last dose and half-life of drug Dabigatran hours, increases with declining renal fxn Apixaban 8-15 hours Edoxaban hours Rivaroxaban 5-9 hours, increases to hours in elderly Activated charcoal for overdose Dialysis for dabigatran Prevent Bleeding Patient selection Correct Dose Antiplatelet NSAIDs

26 What s New

27 COMPASS 27,395 patients with stable ASCVD Rivaroxaban 2.5 mg bid + ASA 100 mg daily Rivaroxaban 5 mg bid + placebo ASA 100 mg daily + placebo Primary outcome: CV death, stroke or MI Key Inclusion/Exclusion Age < 65 had to have ASCVD in 2 vascular beds or 2 additional risk factors (smoking, DM, egfr < 60 ml/min, heart failure, nonlacunar ischemic stroke > 1 month egfr < 15 ml/min, severe HF, high bleeding risk, DAPT, anticoagulation Population: 68 years, male, 62% white on ACEi or ARB, beta-blocker and lipid lowering agent Outcomes: rivaroxaban 2.5 mg bid + ASA (4.9%) vs ASA (5.4%) HR 0.76, p<0.001 Increased risk of major bleeding with combination: 3.1 vs 1.9%, HR 1.70, p>0.001 Net clinical benefit (1 outcome + fatal/critical organ bleeding) favors combination: 4.7 vs 5.9%, HR 0.8, p<0.001 Eikelboom JW, Connolly SJ, Bosch J, et al. N Engl J Med 2017;377:

28 PIONEER 2124 patients with atrial fibrillation in need of PCI with stent Rivaroxaban 15 mg once daily (10 mg if CrCl ml/min) + P2Y12 inhibitor x 12 months Rivaroxaban 2.5 mg bid + DAPT x 1, 6, or 12 months After 1 or 6 months of triple therapy completed, dose change to mg daily + ASA until 12 months Dose adjusted VKA + DAPT x 1, 6, or 12 months Duration of DAPT specified by investigator prior to randomization Primary outcome: clinical significant bleeding Key exclusion: CrCl < 30 ml/min, Hx of CVA/TIA or GI bleed in last 12 months, Hgb < 10 g/dl Population: 70 years, white, CrCL ml/min (28% < 60 ml/min), clopidogrel, DES 66% Outcomes: Both rivaroxaban groups had lower rates of bleeding than warfarin (HR 0.59 and 0.63, p<0.001) No difference in MACE (HR 1.08, p 0.75 and HR 0.93, p 0.76) Gibson CM, Mehran R, Bode C, et al. N Engl J Med 2016;375:

29 EINSTEIN CHOICE 3365 patients with VTE randomized after 6-12 months of treatment Rivaroxaban 20 mg daily Rivaroxaban 10 mg daily ASA 100 mg daily Primary outcome: symptomatic recurrent VTE Key Inclusion/Exclusion Initial treatment could have been any AC, no more than 7 days interruption prior to randomization CrCl < 30 ml/min or hepatic disease associated with coagulopathy Population: 58 yo, 55% male, 60% provoked, 20% prior VTE Outcomes: rivaroxaban 20 mg (1.5%), 10 mg (1.2%), ASA (4.4%); HR 0.34 and 0.26, p<0.001 Major bleeding: rivaroxaban 20 mg (0.5%), 10 mg (0.4%), ASA 0.3%); HR 1.64, p=0.50 Weitz, JI, Lensing AWA, Prins MH, et al. N Engl J Med 2017;376:

30 Final Thoughts: NOACS SIMPLE Dosing Dosing varies by indication Pay attention to renal function and drug interactions New indications or doses on the horizon (2.5 mg dose of rivaroxaban not currently available) Surgical interruption Based on risk and drug half-life Parenteral bridging is not necessary Bleeding Idaruzimab for dabigatran PCC for XA New agents on the horizon Refer to prescribing guides as needed Create institutional clinical care guidelines and reference documents

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