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1
2 gold standard CT gold standard
3
4 CABG ) New device 2000 DES
5 Cumulative Survival rate SVD DVD TVD n=453 n=220 n= AKA
6 gold standard
7
8 Balloon Angioplasty Directional Atherectomy Laser Angioplasty Rotational Atherectomy Stents ,000,000 procedures
9 /
10 Evolution of PCI (Percutaneous Coronary Intervention) Event Rate % Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES present Innovations over time
11
12 Coronary Stents
13 Evolution of PCI (Percutaneous Coronary Intervention) Event Rate % Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES present Innovations over time
14
15 DES
16 N Engl J Med2003;349:
17 SIRIUS trial N Engl J Med2003;349:
18 Circulation 2004;109:
19 TAXUS trial Circulation 2004;109:
20 Evolution of PCI (Percutaneous Coronary Intervention) Event Rate % Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES present Innovations over time
21 DES
22 DES or BMS DES
23 Rank Country Diabetics (millions) 1 India China USA Indonesia Japan
24 kcal (%)
25 1,200 1,080 1, Source: BMI BMI
26 (WHO) Unite for Diabetes
27 Lesions Treated in Cypher PMS n = 2,388 (1.2 lesions/patient) % >30mm de novo ISR SVG Total Occlusion LM Ostial Bifurcation 1st Year (n=1,184) 2nd Year (n=1,204) P-Value <0.001 N.S. N.S. N.S. N.S
28 Lesion Treated in TAXUS PMS de novo ISR SVG >28mm Total Occlusion LM Ostial Bifurcatioin
29 DES or BMS DES
30
31 JAPANESE SUMMARY ; ARC Definite : Probable : ( 30 Possible :30
32 Off label
33 Ontario PCI Registry 2 and 3-year Clinical Results From 18,314 PCI at 12 centers in Ontario Treated December 2003 and March ,751 DES cases (38% of PCI, 82.9% TAXUS Stent) 3,751 propensity-matched BMS patients Received 1 year of ASA + Plavix Follow-up out to 3 years BMS DES (OR) p-value Death (0.7) MI (2 yr) (1.1) 0.95 TVR (2 yr) (0.69) small (< 3mm) all 3 (0.38 [ %])* long (>20 mm) any 2 ( [12-6%])* DM any 1 ( [8-6%]) Tu, et al. New England Journal of Medicine 357; 14, October 2007 *p< 0.05
34 K-M plots of cumulative event up to 2 Years for on- and off -label BMS and DES J Am Coll Cardiol 2008;51:607-14
35 Stent Thrombosis: Trend in foreign countries Bern/Rotterdam Cumulative Incidence of Stent Thrombosis in Patients with SES or PES SCAAR SCAAR: Stent Thrombosis (Unadjusted) in Total Cohort (n = 41,775) Days after PCI Cumulativ e Incidence (% ) Cumulativ e Events (n) Patients at Risk (n) % per year Daemen J., et al., Lancet 2007; 369: Jpn-PMS Cumulative Risk of Stent Thrombosis (Unadjusted) % BMS (n = 20,058) DES (n = 21,717) ST rate in Japan: Lower? or Reasonable? 0.3% per year 1 0.5% per year 0.5% per year Time (years) James S., et al. ESC 2007; Oral presentation. 2 Japan PMS
36 Q1 '07 Q3 100% 80% 60% 40% 20% 0% MRG and Internal BSC Estimates The trend of DES use Q1 '04 Q3 Q1 '05 Q3 Q1 '06 Q3 Japan Q3 Q1 '03
37 BMS compliance BMS DES AMI secondary Mal apposition
38
39 gold standard CT gold standard
40 Atherothrombosis is polyvascular disease Clinical entity caused by the same pathological mechanism Stroke TIA Myocardial infarction Angina pectoris PAD 1. Drouet L. Cerebrovasc Dis 2002; 13(suppl 1): 1 6.
41 REACH-Registry; outpatients registry Enrolled pts number; 68,129 patients in 5,580 sites* in 44 countries 27,786 17,923 5, Japan 5,197 5,916 North America Latin America Western Europe Eastern Europe Middle East Asia Australia 1,931 2,872 * up to 15 patients/site (up to 20 in the US) 2007
42 Event curves from enrollment to 1yr Event rate demonstrate linearity JAMA 2007;297:
43 CV event as a function of number of symptomatic disease Event rates increased in stepwise fashion with the number of symptomatic vascular beds. JAMA 2007;297:
44 Prevalence of polyvascular disease Of the patients with symptomatic atherosclerosis, a significant proportion had symptomatic polyvascular disease JAMA 2006;295:
45
46 Assessment of advanced disease Am J Cardiol 2006;98:2H-15H
47 Carotid artery stenosis and Stroke Stroke 2000;31:
48 CAS
49 GW selection is important, however, back up support is more important
50 Final angiogram
51
52 Great progress of medical treatment Event rate has decreased CHARISMA CAPRIE like cohort N=9,478 Placebo + ASA RRR 17.1 p 0.0 Cumulative CV event (%) 8 4 N=19,185 CAPRIE ASA Clopidogrel RRR 8.7 p Clopidogrel + ASA Period Deepak L. Bhatt et al. J Am Coll Cardiol 2007;49( Months Period CAPRIE Steering Committee: Lancet 348: , 1996
53 CHARISMA Medication use Plavis+ASA n 7,802 Placebo+ASA n 7,801 ASA Plavix and Placebo Plavix non blinded -bloker ARB Ramipril ACEI Statins Lipid lowering agent Antidiabetic agent 7,775 (99.7) 7,750 (99.3) 773 ( 9.9) 4,292 (55.0) 1,990 (25.5) 1,387 (17.8) 3,607 (46.2) 5,991 (76.8) 1,114 (14.3) 3,259 (41.8) 7,777 (99.7) 7,760 (99.5) 814 (10.4) 4,344 (55.7) 2,020 (25.9) 1,424 (18.3) 3,612 (46.3) 6,001 (76.9) 1,094 (14.0) 3,237 (41.5) % Bhatt DL, et al: N Engl J Med 354, , 2006 Bhatt DL, et al: N Engl J Med 354, , 2006
54 CHARISMA CAPRIE Medication use Plavis+ASA n 7,802 Placebo+ASA n 7,801 CAPRIE (n=19,185) ASA 7,775 (99.7) 7,777 (99.7) Plavix or placebo 7,750 (99.3) 7,760 (99.5) Plavix non non-blinded 773 ( 9.9) 814 (10.4) -blocker 4,292 (55.0) 4,344 (55.7) 39.6 ARB 1,990 (25.5) 2,020 (25.9) 1,387 (17.8) 1,424 (18.3) ACEI 3,607 (46.2) 3,612 (46.3) 29.8 Statins Lipid lowering agent 5,991 (76.8) 1,114 (14.3) 6,001 (76.9) 1,094 (14.0) 25.5 Anti diabetic agent 3,259 (41.8) 3,237 (41.5) 17.6 Bhatt DL, et al: N Engl J Med 354, , 2006 % Bhatt DL, et al: N Engl J Med 354, , 2006 Eur Heart J 1998;19 supple 3
55 New diagram for IHD treatment Optimal PCI Optimal Medical treatment
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