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TCT 2007 Update

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TCT 2007 Update

  1. 1. ACS Critical Pathways 2007 Teleconferences This activity is supported by an educational grant from the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. This activity is co-provided by the Network for Continuing Medical Education and EduPro Resources LLC. October 31, 2007
  2. 2. Faculty <ul><li>Gregg C. Fonarow, MD </li></ul><ul><li>Eliot Corday Professor of Medicine </li></ul><ul><li>and Cardiovascular Science </li></ul><ul><li>Director, Ahmanson-UCLA Cardiomyopathy Center </li></ul><ul><li>UCLA Division of Cardiology </li></ul><ul><li>UCLA Medical Center </li></ul><ul><li>Los Angeles, California </li></ul>
  3. 3. The Network for Continuing Medical Education and EduPro Resources LLC require that CME/CNE 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. 4. Faculty Disclosure Statement <ul><li>Gregg C. Fonarow, MD , has served as a consultant to and has received research support and honoraria from Bristol-Myers Squibb Company, GlaxoSmithKline, Merck & Co., Inc., Pfizer Inc, and sanofi-aventis. </li></ul><ul><li>Deborah Murphy reports no such relationships. </li></ul><ul><li>The staff of NCME reports no such relationships. </li></ul>
  5. 5. Report From Transcatheter Cardiovascular Therapeutics (TCT) 2007 Gregg C. Fonarow, MD
  6. 6. Polling Question #1 <ul><li>Where do you currently stand on using DES? </li></ul><ul><ul><li>In light of SCAAR and other recent data, my use of DES is increasing since earlier in 2007 </li></ul></ul><ul><ul><li>In light of the GRACE Registry and other recent data, my use of DES is decreasing since earlier in 2007 </li></ul></ul><ul><ul><li>My practice has not changed since earlier in 2007 with regard to DES </li></ul></ul>
  7. 7. Highlights From TCT 2007 <ul><li>ARMYDA-4: 600 mg clopidogrel loading dose prior to PCI in patients on chronic clopidogrel therapy </li></ul><ul><li>ARMYDA-5: antiplatelet therapy for reduction of myocardial damage during angioplasty </li></ul><ul><li>HORIZONS AMI: bivalirudin vs heparin + GP IIb/IIIa inhibitors during primary angioplasty in AMI </li></ul><ul><li>SPIRIT III: 1-year follow-up stent data </li></ul><ul><li>Endeavor IV: 9- and 12-months results, Endeavor vs TAXUS stents </li></ul><ul><li>EVENT Registry: Implications of changing stent practice from 2004 to 2006 </li></ul><ul><li>SCAAR: Swedish Coronary Angiography and Angioplasty Registry </li></ul><ul><li>NY State Database and STENT Registry: Comparison of DES vs BMS </li></ul>
  8. 8. Percentage 7 8 P =.96 Patti G, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. ARMYDA-4: Composite Primary End Point of 30-day Death, MI, TVR 0 3 6 9 12 Placebo 600 mg clopidogrel reload
  9. 9. Patti G, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. 7 8 Percentage 600 mg clopidogrel reload Placebo ARMYDA-4: Individual Events at 30 Days 0 2 4 6 8 10 Death MI TVR
  10. 10. Patti G, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. ARMYDA-4: Bleeding Rates 600 mg clopidogrel reload Placebo 4 4 0 0 Percentage 0 2 4 6 Major bleeding Minor bleeding
  11. 11. ARMYDA-5: Study Design <ul><li>Patients scheduled for angiography randomized to: </li></ul><ul><ul><li>600 mg clopidogrel loading dose (n=174) 4 to 8 hours prior to angiography or </li></ul></ul><ul><ul><li>Loading with clopidogrel in the cath lab once the coronary anatomy was defined and PCI was definite (n=176) </li></ul></ul><ul><ul><li>Not included: 35 patients who underwent CABG and 53 patients treated with medical therapy </li></ul></ul><ul><li>Primary end point: death, MI, or TVR at 30 days </li></ul><ul><li>44% of patients had NSTEMI; 36% had a prior MI </li></ul>Di Sciascio G, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC.
  12. 12. ARMYDA-5: Results PRUs = platelet reactivity units. Di Sciascio G, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. NS 5% 4% Minor bleeding .04 .005 272 PRUs 245 PRUs 241 PRUs 186 PRUs Platelet reactivity at PCI At 2 hours: .56 11% 8% Death, MI, or TVR at 30 days P Value Cath-lab treatment Pretreatment
  13. 13. HORIZONS AMI: 2 Primary End Points at 30 Days 1) Net Adverse Clinical Events 2) Major Bleeding (non-CABG) <ul><ul><li>Intracranial bleeding </li></ul></ul><ul><ul><li>Intraocular bleeding </li></ul></ul><ul><ul><li>Retroperitoneal bleeding </li></ul></ul><ul><ul><li>Access site bleed requiring intervention/surgery </li></ul></ul><ul><ul><li>Hematoma ≥5 cm </li></ul></ul><ul><ul><li>Hgb  ≥3 g/dL with an overt source </li></ul></ul><ul><ul><li>Hgb  ≥4 g/dL w/o overt source </li></ul></ul><ul><ul><li>Reoperation for bleeding </li></ul></ul><ul><ul><li>Blood product transfusion </li></ul></ul>and Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC.
  14. 14. HORIZONS AMI: 2 Primary End Points at 30 Days (cont) = or <ul><ul><li>All-cause death </li></ul></ul><ul><ul><li>Reinfarction </li></ul></ul><ul><ul><li>Ischemic TVR </li></ul></ul><ul><ul><li>Stroke </li></ul></ul>Major adverse cardiovascular events (major secondary end point) Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. 1) Net Adverse Clinical Events 2) Major Bleeding (non-CABG)
  15. 15. HORIZONS AMI: Study Drugs a 97.7% and 7.5% during PCI; b For giant thrombus or refractory no reflow after PCI. CCL = cardiac catheterization laboratory. Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. UFH + GP IIb/IIIa (N=1802) Bivalirudin (N=1800) UFH prerandomization 65.6% 65.6% Antithrombin in CCL - UFH 98.9% 4.1% - Bivalirudin 0.4% 96.9% - Peak ACT 264 [228, 320] 357 [300, 402] GP IIb/IIIa in CCL 94.5% a 7.2% a - Bail-out per protocol b - 4.4% - Abciximab 49.9% 4.0% - Eptifibatide 44.4% 3.1% - Tirofiban 0.2% 0.1%
  16. 16. Primary Outcome Measures (ITT) <ul><ul><li>a Not related to CABG; b MACE = All-cause death, reinfarction, ischemic TVR or stroke. </li></ul></ul>Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. Diff = 0.0% [-1.6, 1.5] RR = 0.99 [0.76, 1.30] P sup = 1.00 Diff = -3.3% [-5.0, -1.6] RR = 0.60 [0.46, 0.77] P NI ≤ .0001 P sup ≤ .0001 Diff = -2.9% [-4.9, -0.8] RR = 0.76 [0.63, 0.92] P NI ≤ .0001 P sup = .006 1  end point 1  end point 0 5 10 20 15 12.1 9.2 8.3 4.9 5.5 5.4 Net adverse clinical events Major bleeding a MACE b 30-day event rates (%) Bivalirudin monotherapy (N=1800) Heparin + GP IIb/IIIa inhibitor (N=1802)
  17. 17. 30-day Net Adverse Clinical Events Number at risk Bivalirudin 1800 1660 1633 1626 1620 1607 1544 Heparin + GP IIb/IIIa 1802 1635 1591 1578 1569 1552 1482 Primary End Point Net adverse clinical events (%) Time in Days 12.2% 9.3% HR [95%CI] = 0.75 [0.62, 0.92] P =.006 Heparin + GP IIb/IIIa inhibitor (n=1802) Bivalirudin monotherapy (n=1800) Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC.
  18. 18. 30-day Major Bleeding (non-CABG) Number at risk Bivalirudin 1800 1697 1675 1668 1664 1653 1590 Heparin + GP IIb/IIIa 1802 1651 1617 1606 1598 1581 1511 Primary End Point Major bleeding (%) Time in Days 8.4% 5.0% HR [95%CI] = 0.59 [0.45, 0.76] P <.0001 Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. Heparin + GP IIb/IIIa inhibitor (n=1802) Bivalirudin monotherapy (n=1800)
  19. 19. 30-day Bleeding End Points a Primary end point; b life threatening. Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. UFH + GP IIb/IIIa (N=1802) Bivalirudin (N=1800) P Value Protocol Major, non-CABG a 8.3% 4.9% <.0001 Protocol Major, All 10.8% 6.8% <.0001 Protocol Minor 15.4% 8.6% <.0001 Blood transfusion 3.5% 2.1% .01 TIMI Major 5.0% 3.1% .003 TIMI Minor 4.6% 2.8% .008 TIMI Major or Minor 9.6% 5.9% <.0001 GUSTO LT b or Severe 0.6% 0.4% .65 GUSTO Moderate 5.0% 3.1% .003 GUSTO LT or Sev or Mod 5.6% 3.5% .003
  20. 20. 30-day MACE Components a a CEC adjudicated. Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. UFH + GP IIb/IIIa (N=1802) Bivalirudin (N=1800) P Value Death 3.1% 2.1% .058 - Cardiac 2.9% 1.8% .035 - Noncardiac 0.2% 0.3% .75 Reinfarction 1.8% 1.8% .90 - Q wave 1.2% 1.4% .66 - Non – Q wave 0.7% 0.4% .50 Ischemic TVR 1.9% 2.6% .18 - Ischemic TLR 1.8% 2.5% .14 - Ischemic remote TVR 0.3% 0.3% 1.0 Stroke 0.6% 0.7% .69
  21. 21. SPIRIT III: MACE Through 365 Days MACE = cardiac death, MI, or ischemia-driven TLR. Stone GW, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. 0 3 6 12 9 MACE (%) 0 90 180 270 365 Days 9.9% 5.8% TAXUS XIENCE HR = 0.57 [0.36 – 0.90 ] P logrank = .01 Number at risk XIENCE 669 651 642 626 614 TAXUS 332 312 309 292 287
  22. 22. Endeavor IV: Primary End Point Result at 9 Months Leon MB, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. P for Noninferiority <.001 ∆ = 3.8% 6.6% 7.2% Endeavor (n=50/758) Taxus (n=54/759) TVF Rate Target Vessel Failure
  23. 23. a Day 83, 145, 171. Leon MB, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. Endeavor IV: Clinical Events at 12 Months .267 9.4 (70 7.7 (58) TVF – % (#) 1.000 6.6 (49) 6.5 (49) MACE – % (#) .753 6.7 (50) 6.3 (47) TVR – % (#) .085 4.2 (31) 2.5 (19) TVR (non-TL) – % (#) .228 3.2 (24) 4.5 (34) TLR – % (#) .250 0 0.4 a (3) 31-360 days .625 0.1 (1) 0.4 (3) 0-30 days .124 0.1 (1) 0.8 (6) Stent Thrombosis (all) – % (#) .260 3.1 (23) 2.1 (16) Death (cardiac) + MI (all) – % (#) .131 2.4 (18) 1.3 (10) Non – Q wave 1.000 0.1 (1) 0.3 (2) Q Wave .208 2.6 (19) 1.6 (12) MI (all) – % (#) 1.000 0.5 (4) 0.5 (4) Cardiac 1.000 1.1 (8) 1.1 (8) Death (all) – % (#) P Value Taxus n=741 Endeavor n=749
  24. 24. EVENT Registry: Bleeding Complications Kleiman N, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. 0.6 0.0% 2.0% 4.0% 6.0% TIMI Major 0.2 0.2 1.0 0.8 0.5 3.5 2.0 1.8 5.2 4.1 3.4 TIMI Minor Transfusion Any bleed or transfusion Not mutually exclusive WAVE 2 WAVE 1 WAVE 3
  25. 25. EVENT Registry: Adjudicated Stent Thrombosis From Procedure to 1 Year Follow-up Kleiman N, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. 2.2% 0% WAVE 2 WAVE 1 WAVE 3 P = .046 P = .027 (Logistic regression) In Hospital 6 Months 12 Months Wave 2 is ARC Probable ; Wave 3 is ARC Definite or Probable Wave 1 to Wave 3 1.1 0.8 0.9 1.9 1.0 1.2 (Log rank) 0.4 0.2 0.1
  26. 26. Carlsson J, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. SCAAR: Adjusted Death/MI Total Cohort BMS 10049 9529 9343 8112 6742 5265 3486 1892 5 DES 6523 6222 6069 4428 2947 1868 908 322 0 BMS 9434 8424 8223 6896 5431 4012 2433 1285 2 DES 6165 5673 5512 3792 2508 1525 780 287 0 0.25 0.20 0.15 0.10 0.05 0.00 0 1 2 3 4 Cumulative risk of death or MI RR: 1.03 (0.93, 1.15) BMS DES On label use N=17,664 Time (years) 0.25 0.20 0.15 0.10 0.05 0.00 0 1 2 3 4 Cumulative risk of death or MI RR: 0.96 (0.88, 1.06) BMS DES Off label use N=16,866 Time (years)
  27. 27. Carlsson J, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. SCAAR: Restenosis at Clinically Driven Re-angiography BMS 3987 3794 3698 3079 2188 1140 50 0 0 DES 3235 3142 3080 2354 1389 630 21 0 0 BMS 3586 3291 3202 2649 1812 909 24 0 0 DES 2158 2034 1966 1407 846 339 11 0 0 0.10 0.08 0.06 0.04 0.02 0.00 0 1 2 3 4 Cumulative risk of death or MI RR: 0.39 (0.3, 0.51) BMS DES On label use N=12,186 Time (years) 0.10 0.08 0.06 0.04 0.02 0.00 0 1 2 3 4 Cumulative risk of death or MI RR: 0.66 (0.5, 0.88) BMS DES Off label use N=9,155 Time (years) RRR 60% ARR 4% RRR 40% ARR 2.5%
  28. 28. NY State Database and STENT Registry Brodie BR, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. Clinical Outcomes of DES vs BMS in the New York Database 2.98 ( P <.001) 2.23 ( P <.001) 1.17 1.17 Adjusted HR Second analysis of significant predictors of mortality (n=4,983) 2.30 1.85 1.19 1.19 Adjusted HR for BMS/DES 2.17 1.77 1.25 1.26 Unadjusted HR for BMS/DES 9.4% 6.1% 7.8% 4.8% DES (n=6,384) 16.6% 13.5% 9.2% 5.6% BMS (n=7,834) Rate of subsequent TVR Rate of subsequent TLR MI or death Mortality 2-year data
  29. 29. NY State Database and STENT Registry Brodie BR, et al. Presented at: Transcatheter Cardiovascular Therapeutics 2007; October 20-25, 2007; Washington, DC. Clinical Outcomes of DES vs BMS in the STENT Registry 35.4% 2% Year 1-2 19% 9% 30 days to 1 year 45.6% 57.7% Timing of stent thrombosis <30 days 16.1% 24.7% MACE 9.1% 16% Death or MI 8.8% 11.9% TVR 4.1% 6.7% MI 5.7% 11% Death DES (n=5,996) BMS (n=1,359) 2-year data
  30. 30. Featured Institution Paoli Hospital Paoli, Pennsylvania
  31. 31. Polling Question <ul><li>1) We are currently on the same item </li></ul><ul><li>2) We have since moved to the next checkbox on the checklist </li></ul><ul><li>3) We have progressed by more than one item on the checklist </li></ul><ul><li>4) ACS pathways are up-to-date and regularly followed </li></ul>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.)
  32. 32. Progress Checklist: Immediate Goals  Assemble team and set up meeting of working group  Develop draft pathways  Circulate pathways to all cardiology, ED, and CV nursing staff for comments  Circulate discharge plan and other tools to all cardiology, ED, and CV nursing staff for comments
  33. 33. Progress Checklist: Short-term Goals/Activities  Finalize critical pathways  Launch critical pathways  Circulate memo  Grand rounds/conference: Cardiology/IM  Grand rounds/conference: Emergency Department  Grand rounds/conference: Nursing
  34. 34. Progress Checklist: Long-term Goals/Activities  Monitor data: which registry?  NRMI  AHA Get With The Guidelines  ACC National Cardiovascular Data Registry  CRUSADE  GRACE  REACH  Other
  35. 35. Question-and-Answer Session
  36. 36. Concluding Remarks Gregg C. Fonarow, MD Next Program Christopher P. Cannon, MD Wednesday, November 14, 2007 12:00 Noon Eastern Time (9:00 AM Pacific Time) Report From the American Heart Association (AHA) Scientific Sessions 2007

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