Strive Teleconf Presentation Sept13 2006

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  • 1. CVD Critical Pathways Group 2006 Teleconferences September 13, 2006 12:00 Noon ET (9:00 AM PT) This activity is supported by an educational grant from the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
  • 2. Faculty Christopher P. Cannon, MD Associate Professor of Medicine Harvard Medical School Senior Investigator, TIMI Study Group Associate Physician, Cardiovascular Division Brigham and Women’s Hospital Boston, Massachusetts
  • 3. The Network for Continuing Medical Education requires that CME faculty disclose, during the planning of an activity, the existence of any personal financial or other relationships they or their spouses/partners have with the commercial supporter of the activity or with the manufacturer of any commercial product or service discussed in the activity. Disclosure Statement
  • 4. Christopher P. Cannon, MD , has received grant/research support from Merck & Co., Inc., AstraZeneca Pharmaceuticals PL, and Merck/Schering Plough Partnership. He has served as a consultant on scientific/advisory boards of AstraZeneca Pharmaceuticals PL, Bristol-Myers Squibb Company, GlaxoSmithKline, Merck & Co., Inc., Merck/Schering Plough Partnership, Pfizer Inc, sanofi-aventis, and Schering-Plough Corporation. He has received honoraria for CME lectures supported by AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Merck & Co., Inc., Millennium Pharmaceuticals, Inc., Pfizer Inc, sanofi-aventis, and Schering-Plough Corporation. The team from University of Texas Health Science Center and College of Pharmacy reports no such relationships. Faculty Disclosure Statement
  • 5. Polling Question #1
    • Given the study results presented at the World Congress of Cardiology 2006, will you continue to recommend drug-eluting stents for ACS?
      • Yes, the new information will not change my practice
      • Yes, but I will also recommend longer-term antiplatelet therapy to reduce the risk of late stent thrombosis
      • No, I will return to using bare-metal stents
      • No, I have not been using drug-eluting stents so this will not change my practice
  • 6. Highlights from the World Congress of Cardiology 2006 Christopher P. Cannon, MD
  • 7. Highlights From WCC 2006
    • PCI ExTRACT-TIMI 25: E no x aparin and T hrombolysis R eperfusion for A cute Myocardial Infar ct ion (PCI in Patients Receiving Enoxaparin or UFH Following Fibrinolytic Therapy for STEMI)
    • Drug-eluting Stents Meta-analyses (2): Results from long-term data
    • FRISC II : F ast R evascularization during I nstability in C oronary Artery Disease (5 Year Results)
    • ICTUS: I nvasive versus C onservative T reatment in U nstable Coronary S yndromes (3-Year Results)
  • 8. PCI in Patients Receiving Enoxaparin or UFH Following Fibrinolytic Therapy for STEMI: PCI ExTRACT-TIMI 25 C. Michael Gibson, Sabina A. Murphy, David A. Morrow, Carolyn H. McCabe, Dietrich C. Gulba, Gilles Montalescot, Servet Cetin, Oscar H. Kracoff, Basil S. Lewis, Nathan Roguin, Elliott M. Antman, Eugene Braunwald, for the ExTRACT-TIMI 25 Investigators Adapted with permission from www.clinicaltrialresults.org. Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain.
  • 9. Background: Main Results ExTRACT-TIMI 25 Primary Endpoint: Death or non-fatal re-MI by 30 days Main Secondary Endpoint: Death, non-fatal re-MI, urgent revascularization by 30 days N Engl J Med. 2006;354:1477-1488. 12.0 9.9 UFH UFH ENOX ENOX 14.5 11.7 Days Days % % RR = 0.83 p = 0.000003 RR = 0.81 p = 0.000001 Adapted with permission from www.clinicaltrialresults.org.
  • 10. Anticoagulation for PCI < 8h since SC dose > 8 h since SC dose Additional Enox/Plac NO 0.3 mg/kg IV Additional UFH/Plac GP IIb/IIIa ACT 200 s* ACT 200 s* No GP IIb/IIIa ACT 250 s* ACT 250 s* * ACT TESTING ONLY BY UNBLINDED MEDICAL PROFESSIONAL Sheath Removal Closure Device End of PCI No Closure Device Wait 6 hours after last sc/IV dose After PCI STUDY MEDICATION SHOULD NOT BE + Groin Hemostasis STARTED UNLESS CLINICALLY INDICATED ONLY blinded study drug to be used All Pts receive BOTH blinded Enox/Plac AND UFH/Plac Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 11. Baseline Characteristics PCI Cohort N = 4,676 41 11 16 51 23 37 82 57 Prior MI (%) Hypertension (%) Hyperlipidemia (%) Current smoker (%) Diabetes (%) Anterior MI (%) Male (%) Age (yrs)-median ALL P = NS for ENOX vs UFH 27 92 0.7 20 87 > 3 (%) LMWH within 7 d (%) Killip Class I (%) TIMI Risk Score (STEMI) UFH within 3 h (%) CrCl (ml/min)-median Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 12. PCI Cohort: Primary Endpoint Death or Nonfatal MI by 30 days ENOX Days 13.8% 0 5 10 15 0 5 10 15 20 25 30 Death or MI (%) UFH 10.7% RR 0.77 p=0.001 Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 13. PCI Cohort: Safety Event ENOX UFH RR P-Value n=2,238 n=2,377 TIMI Major Bleed 1.4% 1.6% 0.87 (0.55-1.39) 0.56 TIMI Minor Bleed 3.3% 2.4% 1.34 (0.95-1.88) 0.09 TIMI Major or 4.6% 4.0% 1.15 (0.88-1.51) 0.31 Minor Bleed ICH 0.2% 0.4% 0.42 (0.13-1.35) 0.18 Stroke 0.3% 0.9% 0.30 (0.12-0.75) 0.006 Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 14. PCI Performed on Blinded Study Drug
    • Two scenarios in which a patient underwent PCI on study drug:
    • 1) Blinded study drug never discontinued and PCI performed on blinded study drug
    • 2) Blinded study drug discontinued prior to PCI and then resumed at time of PCI
    Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 15. Death or Nonfatal MI by 30 days Among PCI Patients in Whom Study Drug Was Not Discontinued (n=1501) 0 5 10 15 20 0 5 10 15 20 25 30 Days UFH ENOX 14.2% 18.9% Death or MI (%) RR 0.75 p=0.018 Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 16. Death or Nonfatal MI by 30 days Among PCI Patients in Whom Study Drug Was Discontinued and Resumed For PCI (n=677) 0 5 10 15 20 0 5 10 15 20 25 30 Days UFH ENOX 5.9% 14.4% Death or MI (%) RR 0.41 p=0.004 Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 17. Conclusion
    • When compared to UFH as adjunctive therapy among patients undergoing PCI, ENOX:
      • Reduced death or MI
      • Reduced stroke
      • No difference in bleeding
    Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 18.
    • ENOX was associated with ↓ risk of death or reMI both among patients in whom antithrombin was continued as well as discontinued prior to PCI.
    • ENOX associated with both delayed onset and ↓ occurrence of reMI, both of which may expand window of opportunity to perform PCI following fibrinolytic administration.
    Conclusion (cont.) Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 19. Clinical Implications
    • Among STEMI pts treated with lytic, ENOX can be administered as the sole antithrombin therapy before and during PCI without the need for additional antithrombin inhibition.
    • Periprocedural ENOX is preferable to UFH in the management of these patients.
    Gibson M. Presented at World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Adapted with permission from www.clinicaltrialresults.org.
  • 20.  
  • 21. Nordman AJ, et al. Hot Line Session. Presented at World Congress of Cardiology, September 3, 2006, Barcelona.
  • 22. Nordman AJ, et al. Hot Line Session. Presented at World Congress of Cardiology, September 3, 2006, Barcelona.
  • 23. Nordman AJ, et al. Hot Line Session. Presented at World Congress of Cardiology, September 3, 2006, Barcelona.
  • 24. Cause-Specific Non-Cardiac Deaths in Patients Treated with SES Nordman AJ, et al. Hot Line Session. Presented at World Congress of Cardiology, September 3, 2006, Barcelona. Trial F/U (y) N Cause of Death 1x septic shock; 1x stroke; 1x pulmonary embolism (PE) 3 1 DIABETES 1x pancreatic cancer 1 1 SES-SMART 3 2 1 15 10 3x cancer (2x colon cancer, 1x rectum cancer) 1 BASKET 1x cancer (lung) ; 1x sepsis 3 E-SIRIUS 1x cancer (lung) 3 C-SIRIUS 4x cancer (2x renal, 1x colon, 1x unspecified) ; 4x respiratory failure; 2x stroke (1x hemorrhagic, 1x ischemic); 2x sepsis; 1x lymphoma ; 1x car accident; 1x seizure disorder (Alzheimer’s disease) 4 SIRIUS 4x cancer (lung, prostate, pancreas, GI) ; 3x stroke (2x hemorrhagic, 1x ischemic); 2x pneumonia; 1x PE 4 RAVEL
  • 25. Nordman AJ, et al. Hot Line Session. Presented at World Congress of Cardiology, September 3, 2006, Barcelona, Spain.
  • 26. Late Stent Thrombosis in Drug-eluting Stents (DES) vs Bare Metal Stents (BMS) Slides Courtesy of Deepak Bhatt, MD
  • 27. Incidence of Late Stent Thrombosis: > 6 Months RR = 7.1 p = 0.025 RR = 3.7 p = 0.014 p = 0.33 Per 1,000 pts Bavry, Kumbhani, Helton, Borek, Mood, Bhatt. AJM 2006. In press 0 1 2 3 4 5 6 7 DES/BMS SES/BMS PES/BMS
  • 28. Incidence of Late Stent Thrombosis: > 1 Year RR = 5.7 p = 0.049 RR = 5.0 p = 0.02 p = 0.22 Per 1,000 pts Bavry, Kumbhani, Helton, Borek, Mood, Bhatt. AJM 2006. In press 0 1 2 3 4 5 6 7 DES/BMS SES/BMS PES/BMS
  • 29. Median Time of Late Stent Thrombosis p = 0.04 p = 0.0003 p = 0.0052 Months Bavry, Kumbhani, Helton, Borek, Mood, Bhatt. AJM 2006. In press 0 4 8 12 16 20 DES/BMS SES/BMS PES/BMS
  • 30. Lagerqvist B, et al. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 31. Lagerqvist B, et al. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 32. Lagerqvist B, et al. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 33. Lagerqvist B, et al. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 34. Lagerqvist B, et al. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 35. de Winter RJ. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 36. de Winter RJ. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 37. de Winter RJ. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 38. de Winter RJ. Hot Line Session. Presented at World Congress of Cardiology, September 4, 2006, Barcelona, Spain.
  • 39. Featured Institution University of Texas Health Science Center San Antonio, Texas University of Texas College of Pharmacy Austin, Texas
  • 40. Polling Question #2
    • 1) We are currently on the same item
    • 2) We have since moved to the next checkbox on the checklist
    • 3) We have progressed by more than one item on the checklist
    • 4) ACS pathways are up-to-date and regularly followed
    If you participated in a previous teleconference, how much progress have you made since then? (Please refer to the checklists on the next 3 slides.)
  • 41. Progress Checklist: Immediate Goals Circulate discharge plan and other tools to all cardiology, ED, and CV nursing staff for comments  Circulate pathways to all cardiology, ED, and CV nursing staff for comments  Develop draft pathways  Assemble team and set up meeting of working group 
  • 42. Progress Checklist: Short-term Goals/Activities Grand rounds/conference: Cardiology/IM  Grand rounds/conference: Emergency Dept.  Grand rounds/conference: Nursing  Circulate memo  Launch critical pathways  Finalize critical pathways 
  • 43. Progress Checklist: Long-term Goals/Activities  NRMI  AHA Get With The Guidelines  ACC National Cardiovascular Data Registry  CRUSADE  GRACE  REACH  Other Monitor data: which registry? 
  • 44. Question-and-Answer Session
  • 45. Concluding Remarks Christopher P. Cannon, MD Next program: Wednesday, October 11, 2006 – 3PM ET (12 Noon PT) Topic: Diabetes and Metabolic Syndrome in Patients Hospitalized With CVD Faculty: Gregg C. Fonarow, MD