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TCT 2006 highlight
1. CVD Critical Pathways Group 2006 Teleconferences November 8, 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 LP, and Merck/Schering Plough Partnership. He has served as a consultant on scientific/advisory boards of AstraZeneca Pharmaceuticals LP, 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. John S. Wilson, MD , representing the Allegheny General Hospital in Pittsburgh, Pennsylvania, reports no such relationships. Faculty Disclosure Statement
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6. Highlights From the 2006 Transcatheter Cardiovascular Therapeutics (TCT) Conference Christopher P. Cannon, MD
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11. CYPHER RCT Stent Thrombosis 4-Year Follow-up: Expanded Definition Data from 4 pooled RCT: SIRIUS, E and C SIRIUS and RAVEL. *Log Rank Test P -value. Cutlip D. Presented at TCT; October 2006; Washington, DC. Definite + Probable + Possible .9951 3.2% (27) 3.2% (27) All Thrombosis .7623 2.9% (25) 2.8% (23) Late + Very Late Summary: .1666 1.6% (13) 2.5% (21) Very Late (361-1440) .0066 1.4% (12) 0.2% (2) Late (31-360 days) .4702 0.2% (2) 0.5% (4) Early (0-30 days) P Value* BMS N=870 Patients CYPHER N=878 Patients Thrombosis
12. CYPHER RCT Stent Thrombosis 4-Year Follow-up: Expanded Definition Definite + Probable Data from 4 pooled RCT: SIRIUS, E and C SIRIUS and RAVEL. *Log Rank (exact) Test P -value. Cutlip D. Presented at TCT; October 2006; Washington, DC. .6985 1.7% (15) 1.5% (13) All Thrombosis .3863 1.5% (13) 1.1% (9) Late + Very Late Summary: .2557 0.5% (4) 1.0% (8) Very Late (361-1440) .0098 1.0% (9) 0.1% (1) Late (31-360 days) .4702 0.2% (2) 0.5% (4) Early (0-30 days) P Value* BMS N=870 Patients CYPHER N=878 Patients Thrombosis
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17. PREMIER Registry: Mortality Among Patients Continuing vs Discontinuing Thienopyridine Therapy Spertus JA, et al. Circulation. 2006;113:2803-2809. The Kaplan-Meier mortality plots show the rate of death for those who continued thienopyridine therapy (solid line) and those who did not (dashed line). The origin is at the time of the patient’s MI, but the lines begin at the 1-month assessment point. 15 10 5 0 Mortality (%) Continued Discontinued P <.001 Months 0 1 2 3 4 5 6 7 8 9 10 11 12 62 65 65 66 67 68 68 Discontinued 420 429 430 431 431 431 431 Continued N at Risk
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19. Angioscopy Follow-up 6 Months After SES or BMS Implanatation Takano M, et al. Eur Heart J. 2006;27:2189-2195. Grade 0 No neointima Grade 1 Thin neointima Grade 2 Full neointima Visible Thrombus P =.031 Frequency of Persistence of Thrombus (%) * P <.001 compared with the corresponding segment in the BMS. n=7 SES n=7 BMS 0 20 40 60 80 100 (N=46, 66 lesions: 33 SES, 33 BMS) Edge Body Overlapping Segment n=21 n=33 n=12 SES n=28 n=33 n=5 BMS * * * P <.0005 P <.05 P <.001 P =.63 P =.80 P =.70 Stent Coverage Grade 0 0.5 1 1.5 2 2.5
20. Milan/Siegburg Experience 2.6% 3.2% 3.5% 5.5% 29.0% 2.0% 8.7% Unstable angina Prior Brachy Rx Thrombus Diabetes Unprot. left main Bifurcation Renal failure Premature antiplatelet d/c Several patient and lesion subgroups have a higher stent thrombosis rate than identified in RCTs Stent thrombosis after DES (SES or PES) occurred in 29/2229 pts (1.3%) at 9.3 ± 5.6 mos Iakovou I, et al. JAMA. 2005;293:2126-2130. 1.3%
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27. STENT Thrombosis Registry: 9-Month Clinical Outcomes Simonton C. Presented at TCT; October 2006; Washington, DC. 25.0 20.0 15.0 10.0 5.0 0.0 Percent of Patients Death MI TVR MACE SAT DES-Rx NON DES-Rx P >.05 for all DES Restenosis Patients Unadjusted Outcomes 8.1 5.1 3.5 5.1 11.6 10.3 19.8 15.4 3.5 0.0
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29. ACUITY-PCI: Composite Ischemia 0 5 10 15 0 5 10 15 20 25 30 35 Event Rate (%) Days from Randomization Estimate P (log rank) 8.4% Heparin* + IIb/IIIa (N=2561) Bivalirudin + IIb/IIIa (N=2609) .15 9.4% Bivalirudin alone (N=2619) .45 8.9% Heparin* + IIb/IIIa vs Bivalirudin + IIb/IIIa vs Bivalirudin Alone P =.36 *Heparin = unfractionated or enoxaparin. Stone GW. Presented at TCT; October 2006; Washington, DC.
30. ACUITY-PCI: Major Bleeding (Non-CABG) 0 5 10 15 0 5 10 15 20 25 30 35 Estimate P (log rank) 6.8% Heparin* + IIb/IIIa (N=2561) Bivalirudin + IIb/IIIa (N=2609) .31 7.6% Bivalirudin alone (N=2619) <.001 3.5% Days from Randomization Heparin* + IIb/IIIa vs Bivalirudin + IIb/IIIa vs Bivalirudin Alone P <.0001 Event Rate (%) *Heparin = unfractionated or enoxaparin. Stone GW. Presented at TCT; October 2006; Washington, DC.
31. ACUITY-PCI: Net Clinical Outcomes 0 5 10 15 0 5 10 15 20 25 30 35 Days from Randomization Estimate P (log rank) 13.5% Heparin* + IIb/IIIa (N=2561) Bivalirudin + IIb/IIIa (N=2609) .10 15.1% Bivalirudin alone (N=2619) .049 11.7% Heparin* + IIb/IIIa vs Bivalirudin + IIb/IIIa vs Bivalirudin Alone P =.001 Event Rate (%) *Heparin = unfractionated or enoxaparin. Stone GW. Presented at TCT; October 2006; Washington, DC.
34. 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
35. 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
36. 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?
38. Concluding Remarks Christopher P. Cannon, MD Next program: Wednesday, December 6, 2006 – 3:00 PM ET (12:00 Noon PT) Topic: Highlights From the 2006 American Heart Association Scientific Sessions Faculty: Gregg C. Fonarow, MD