The Anticoagulation Clinic of the Future

1. The Anticoagulation Clinic of the Future Edith Nutescu, PharmD Clinical Assistant Professor Director Antithrombosis Service The University of Illinois at Chicago College of Pharmacy & Medical Center

2. 1998First commercially available DTI 2001First commercially available synthetic factor Xa inhibitor 1940sHeparin available commercially 1993First commercially available LMWH I N J E C T A B L E A G E N T S 50 Years 1954Warfarin availablecommercially 2005First oral DTI AC Management Services Advances in AC Therapy in the United States 1930 1940 1950 1960 1970 1980 1990 2000 2005 O R A L A G E N T S AC = anticoagulant; DTI = direct thrombin inhibitor; LMWH = low-molecular-weight heparin.

3. AC CLINICS N = 1300 Registered

4. AMS vs. Usual Care Ansell, et al. Chest 2001; 119:22S-38S

5. ACCP 2001: Chapter on AMS • Reviews Models Of Care…Recommends Anticoagulation Clinics Over Usual Medical Care, Grade 1C Ansell, et al. Managing Oral Anticoagulant Therapy. Chest 2001; 119:22S-38S

6. Medicolegal Considerations : AMS “…there is little doubt that practitioners who use the “less effective” system are at higher risk of legal liability…and may be seen by a jury as not having exercised a level of diligence demanded by the risk …to the patient…it will be very difficult to mount a defense sufficient to overcome this charge.” McIntyre K. Chest 2001; 119:342S (also 1998 Chest suppl)

7. Anticoagulation Clinics: Affiliations Ansell et al; AC Forum Survey 2000

8. Anticoagulation Clinics: Duration of Service Ansell et al; AC Forum Survey 2000

9. Anticoagulation Services ATC ACC Warfarin Heparin Antiplatelet Tx LMWH Others: GPIIbIIIa DTIs Pentasaccharide Risk Factor Management - CV Risk Reduction: weight loss, lipids, HTN, DM, smoking cessation

10. Anticoagulation Services

11. Anticoagulation Management Services • Systematic, organized management of anticoagulation • Improved dose regulation • Continuous patient education • Early identification of potential risk factors for thrombotic or hemorrhagic complications • Timely, appropriate intervention to avoid or minimize complications

12. Disease States - Indications • Atrial Fibrillation • Prosthetic Heart Valves • Valvular Heart Disease • VTE: DVT/PE • CVA/TIA • PAD/PVD • CAD/ACS • MI • Surgical: orthopedic, transplant, neurosurgery, general, trauma • Procedures: colonoscopy, dental, eye, etc. • Medical: CHF, cancer, lung disease

13. Anticoagulation Clinics: Referral Indications Ansell et al; AC Forum Survey 2000

14. Patient Volume • Small Volume Clinic • 150-200 active patients • 300 visits/month • Mid Volume Clinic • 400-500 active patients • 750 visits/month • High Volume Clinic • 500-1000 active patients • 1500 visits/month • Staffing: • 1 FTE/200-300 patients

15. Anticoagulation Clinics: Size Ansell et al; AC Forum Survey 2000

16. Anticoagulation Clinics: Staffing Ansell et al; AC Forum Survey 2000

17. Anticoagulation Services: Functions-Roles • Patient education • Treatment initiation/change • LOT, Intensity • AC selection • Dose adjustment • Monitoring; order labs • Refills • Physical assessment • Minimum complications/maximum efficacy: QA • Health care provider education • Research • Formulary, protocols, pathways • Reversal of over-anticoagulation • Peri-procedure management • Patient triage: first line access to healthcare • Administrative

18. Ximelagatran: Potential Initial Indications • Orthopedic Surgery (THR/TKR) • METHRO • PLATINUM • EXPRESS • DVT/PE Treatment • THRIVE • Atrial Fibrillation • SPORTIF

19. ACCP Recommended DVT Prophylaxis Geerts et al, Chest 2001.

20. ACCP Recommended: Treatment of VTE 1992I.V. heparin/warfarin Grade A 1995 I.V. heparin/warfarin Grade A (LMWH used in some centers) --- • I.V./S.C. heparin/warfarin Grade A1 LMWH/warfarin Grade A1 2001 LMWH/warfarin Grade A1 I.V./S.C. heparin/warfarin Grade A1 ACCP, American College of Chest Physicians: 2001

21. Current Recommendations Stroke Prevention in Atrial Fibrillation RISK CATEGORYGOAL INR DURATIONCOMMENT No risk factors None Chronic ASA 325mg qd 1 moderate risk factor 2.0 - 3.0 Chronic or ASA 325mg qd > 1 moderate risk factor 2.0 - 3.0 Chronic or any high risk factor Moderate Risk Factors: Age 65-75 CAD Diabetes High Risk Factors Age > 75 HTN Hx TIA/stroke/TE  LV fxn MV dz valve replacement ACCP Consensus Conference on Antithrombotic Therapy. Chest 2001; 119 (suppl 1):194-206.

22. Impact of PO DTIs Gradual Transition Warfarin Ximelagatran THA/TKA DVT/PE Atrial Fibrillation Other Indications ? Valves, CVA, PVD, MI

23. Impact of PO DTIs On ACC Volume Evaluate your patient mix/indications

24. Nutescu E, et.al 2003.

25. Antithrombosis ServicesRisk Reduction Clinics ATC ACC Warfarin Antithrombotic Therapy UFH LMWH Anti-Xa Antiplatelet Agents PO DTIs Others

26. Will Ximelagatran Eliminate ALL Follow-Up ? • Baseline Education Crucial • Disease state • Importance of compliance • Routine Follow-Up ? • Initially q few weeks (esp DVT/PE) • Long-term: Q 3-6 months • Treatment failures ? • Bleeding complications ? • Special patient circumstances

27. UIC

28. Antithrombosis Services • Expertise in “all” antithrombotic agents • Risk stratification • Patient education • Compliance management • Special patient populations (high risk patients) • Monitoring • Disease management • Overall risk reduction (CV, stroke, etc.) • Guidelines, Pathways, Protocols

29. Will Anticoagulation Clinics Survive ? YES!!! Antithrombosis Risk Reduction Services Warfarin/Coumadin Clinics

30. Thromboembolic Highway AC Management: The Road Ahead Disease Management Warfarin Management