1. Stop the Clot ™ www.stoptheclot.org David Henry and Tom Hogan Cardiovascular and Renal Drugs Advisory Committee U.S. Food and Drug Administration Adelphi, MD March19, 2009

2. Stop the Clot ™ www.stoptheclot.org NATT Community-based, patient led, science driven volunteer organization Committed to prevention and quality treatment of blood clots and clotting disorders

3. Stop the Clot ™ www.stoptheclot.org NATT’s Mission... To prevent, diagnose and treat thrombosis and thrombophilia through research, education, support and advocacy

4. Stop the Clot ™ www.stoptheclot.org NATT-CDC COOPERATIVE AGREEMENT 2007-2009 Patient Education and Support Health Professional Education Website Development Development of Nationwide Chapter Network

5. Stop the Clot ™ www.stoptheclot.org SURGEON GENERAL’S CALL TO ACTION TO PREVENT DVT/PE Issued September 2008 Spotlights public health urgency posed by DVT/PE

6. Stop the Clot ™ www.stoptheclot.org CALL TO ACTION PUBLIC HEALTH THREAT Surgeon General’s Report 350,000-600,000 Americans have blood clots every year 100,000 deaths Blood clots are a leading cause of death!

7. Stop the Clot ™ www.stoptheclot.org MAYO CLINIC DATA (Heit et al) 900,000 Americans have blood clots every year 300,000 deaths Blood clots are a leading cause of death!

8. Stop the Clot ™ www.stoptheclot.org PRIORITY - REINFORCE EVIDENCE-BASED PREVENTION Majority of at-risk patients with confirmed DVT were not prophylaxed, despite risk, and availability of evidence-based guidelines

9. Stop the Clot ™ www.stoptheclot.org SURGEON GENERAL RECOMMENDATIONS Encourage development of new pharmaceutical agents with fewer adverse effects of existing agents: Faster onset Wider therapeutic range Fewer food or drug interactions

10. Stop the Clot ™ www.stoptheclot.org SURGEON GENERAL RECOMMENDATIONS Conduct further research on anticoagulants: Best or optimal choice for designated populations Safest dosing

11. HIP/KNEE REPLACEMENT TRENDS 2005< 1 Million 2009Nearly 1.2 Million Future Aging Baby Boomers Stop the Clot ™

12. Stop the Clot ™ www.stoptheclot.org NEED TO REINFORCE ESTABLISHED GUIDELINES Reluctance of orthopedists to implement prophylaxis on patients with knee and hip replacement Major Concern: BLEEDING A clot is an act of God, whereas bleeding is surgical error

13. Tom Hogan Stop the Clot ™

14. Stop the Clot ™ www.stoptheclot.org POTENTIAL BENEFITS OF NEW ORAL MEDICATION No INR monitoring Pill instead of injection Minimal diet concerns (e.g. vitamin K) Minimal worry about interaction with other medication Quick action and rapid elimination (onset-offset)

15. Stop the Clot ™ www.stoptheclot.org If potential benefits are realized… Close to optimal care + Reduced risks for complications = Increased acceptance/use for TKR/THR + Reduced morbidity and mortality

16. Stop the Clot ™ www.stoptheclot.org NATT SUMMARY Supports Surgeon General Call to Action Appreciates the safety and efficacy review that will be done by committee If approval is recommended, urges expeditious consideration by FDA