1/12/2016. What s in a name? What s in a name? NO.Anti-Coagulation. DOACs in clinical practice. Practical aspects of using

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1 What s in a name? Practical aspects of using DOACs (Direct Oral Anticoagulants) James L. Sebastian, MD, MACP Professor of Medicine (GIM) Medical College of Wisconsin February 5, 2016 DOAC NOAC NOAC ODI SODA TSOAC Direct oral anticoagulant Non-VKA oral anticoagulant Novel/new oral anticoagulant Oral direct inhibitors Specific oral direct anticoagulant Target specific oral anticoagulant J Thromb Haemost 2015; 13: What s in a name? DOAC DO.Anti-Coagulate NOAC NO.Anti-Coagulation J Thromb Haemost 2015; 13: Outline of today s talk Practical aspects of using DOACs in clinical practice General overview Patient selection Warfarin vs. DOAC Monitoring treatment Bridging and peri-procedural management Managing serious DOAC-related bleeding Reversal agents 1

2 Coagulation Cascade General overview Am Fam Physician 2001; 64: Dabigatran Rivaroxaban Apixaban Edoxaban Target Thrombin Factor Xa Factor Xa Factor Xa Peak Effect(h) Half-life (h) Bioavailability 3-7% % ~50% 62% Dosing Frequency Twice daily Daily* Twice daily Daily Clearance DOAC Pharmacokinetics 80% Renal 20% Biliary 66% Renal 33% Biliary 25% Renal 75% Biliary 34% Renal 66% Biliary Eur J Clin Pharm 2013; 69: 1617 Advantages of DOACs compared to Warfarin Rapid onset Rapid offset (short half-life) Predictable pharmacokinetics Fewer drug interactions Lack of need for routine monitoring DM Siegel. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 25, 2015 Disadvantages of DOACs compared to Warfarin Difficult to monitor compliance No reliable, clinically available blood test to determine drug levels Drug accumulates with renal impairment No specific antidote to reverse anticoagulant effect DM Siegel. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 25, 2015 Patient selection Which patients who require longterm anticoagulation should be treated with a DOAC? 2

3 Current FDA-approved indications DOAC vs. Warfarin Stroke or Systemic Embolism DOAC VTE prevention VTE treatment ACS Dabigatran X X - X Rivaroxaban X X - X Apixaban X X - X Edoxaban - X - X AF JW Eikelboom. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 24, 2015 Lancet 2014; 383: DOAC vs. Warfarin Major Bleeding Events DOAC Trials: Pooled Analysis Efficacy and Safety RR (95% CI) P Ischemic stroke 0.92 ( ).10 Hemorrhagic stroke 0.49 ( ) <.0001 All-cause mortality 0.90 ( ).0003 ICH 0.48 ( ) <.0001 Lancet. 2014; 383: Lancet. 2014; 383: Patients who should NOT be treated with a DOAC Dosing and Therapeutic Compliance Averaged from 76 studies using electronic monitoring Dosing Took Most Doses Took Doses on Time Problems with adherence Kidney disease Mechanical heart valves 1 time daily 79% 74% 2 times daily 69% 58% 3 times daily 65% 46% 4 times daily 51% 40% Am J Cardiol 2010; 105:

4 Using DOACs in patients with chronic kidney disease DOACs should NOT be used in pts with mechanical heart valves Creatinine clearance < 30 ml/min DOACs should generally be avoided. Creatinine clearance between ml/min Preference for factor Xa inhibitors over direct thrombin inhibitors (dabigatran) Creatinine clearance > 95 ml/min Black box warning cautions against use of edoxaban due to reduced efficacy Ann Intern Med 2015; 163; Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and no patients in the warfarin group. N Engl J Med 2013; 369: DOACs should NOT be used in pts with mechanical heart valves Poorly studied patient groups All patients with major bleeding had pericardial bleeding Children Very elderly Pregnancy Cancer patients N Engl J Med 2013; 369: JW Eikelboom. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 24, 2015 Monitoring treatment Do patients receiving DOACS need to be monitored? 4

5 How to monitor patients receiving DOACs Ann Intern Med 2015; 163: How to monitor patients receiving DOACs Adherence with DOAC therapy One or more missed doses in an average week Bleeding risk assessment Does not imply that DOAC should be discontinued Creatinine clearance GFR less than 50 ml/min Use of diuretics or recent dehydrating illness Ann Intern Med 2015; 163: How to monitor patients receiving DOACs Drug interactions Concomitant use of ASA, anti-platelets, NSAIDS Examination (physical exam) Blood pressure (too high or too low) Gait impairment, assessment of fall risk Follow-up education and counseling Dosing for scheduled procedures/surgeries Ann Intern Med 2015; 163: Laboratory measurement in patients receiving DOACs Dabigatran Normal thrombin time (TT) likely excludes clinically relevant drug levels. Normal aptt likely excludes excess drug levels. A Cuker. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 24, 2015 Laboratory measurement in patients receiving DOACs Factor Xa Inhibitors Normal anti-xa level likely excludes clinically relevant drug levels. Normal PT likely excludes excess drug levels of rivaroxaban and edoxaban but not apixaban. A Cuker. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 24,

6 BRIDGE Trial- Results Bridging and peri-procedural management N Engl J Med 2015; 373: Example of a pre-operative management strategy for patients receiving Rivaroxaban Minor surgery/procedure (Low bleeding risk) CrCl > 50 ml/min Hold 1 day before - 1 dose CrCl < 50 ml/min Hold 1-2 days before 1-2 doses Major surgery/(high bleeding risk) CrCl > 50 ml/min Hold 1-2 days before 1-2 doses CrCl < 50 ml/min Hold 2-3 days before 2-3 doses May not be applicable to all patients including those undergoing neuraxial anesthesia Example of a post-operative management strategy for patients receiving Rivaroxaban Minor surgery/procedure (Low bleeding risk) Resume hours after procedure once adequate hemostasis has been achieved Major surgery/(high bleeding risk) Resume hours after procedure once adequate hemostasis has been achieved Major bleeding case fatality rates Warfarin DOAC Managing serious DOACrelated bleeding N % N % Rivaroxaban 55/386 14% 27/395 7% Dabigatran 53/407* 13% 57/627* 9% Apixaban 55/462 12% 34/327 10% Edoxaban 59/524 11% 32/418 21/254 8% 8% DM Siegel. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 25,

7 Case Fatality Rates in Patients with Major Bleeding Warfarin vs. DOAC Dabigatran Rivaroxaban Abixaban Edoxaban Warfarin DOAC Approach to patients with DOAC-related major bleeding Initial assessment Hemodynamic stability Source of bleeding Time elapsed since last dose ** Renal function ** Baseline coagulation testing J Thromb Thrombolysis 2013; 35: Approach to patients with DOAC-related major bleeding Potential Role of Pro-Hemostatic Agents in DOAC-Associated Bleeding General measures Anticoagulant withdrawal Mechanical compression of bleeding site Monitor hemodynamic status Volume replacement Definitive interventions Oral charcoal if dabigatran ingestion < 2 hrs.* J Thromb Thrombolysis 2013; 35: What s on the horizon? Reversal strategies DM Siegel. Anticoagulation Forum s 13 th National Conference on Anticoagulant Therapy - Washington DC - April 25,

8 Idarucizumab Idarucizumab for Dabigatran Reversal Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes. N Engl J Med 2015; 373; Andexanet Alfa for reversal of Factor Xa Inhibitor Activity (NEJM.org 11/11/15) Resources Anticoagulation Forum s Centers of Excellence - Resource Center excellence.acforum.org Anticoagulation Forum s Centers of Excellence - Resource Center Drug therapy management Disease state management Transition and coordination of care Service operational performance Patient and family education Comprehensive toolkit Apps for practitioner Additional resources 8

9 New/Novel Oral Anticoagulants (NOACS): Management of Bleeding Milwaukee Journal Sentinel 08/02/15 August 7, 2015 New/Novel Oral Anticoagulants (NOACS): Coagulation Tests New/Novel Oral Anticoagulants (NOACS): Peri-operative Management 9

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