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TCT 2007 Update
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
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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
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. 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. 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
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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
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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%
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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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
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. 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. 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
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