gold standard CT gold standard
1960 1970 1980 1990 CABG ) New device 2000 DES
Cumulative Survival rate 100 90 80 70 60 SVD DVD TVD 96.0 94.5 80.7 n=453 n=220 n=198 91.9 87.4 64.2 50 1 2 3 4 5 6 7 8 9 10 11 12 AKA-63630-5
gold standard
1977 1980 1990 Balloon Angioplasty Directional Atherectomy Laser Angioplasty Rotational Atherectomy Stents 2000 2,000,000 procedures
/
Evolution of PCI (Percutaneous Coronary Intervention) 40 30 Event Rate % 20 10 Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early 1977 1985 Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES 1985 1994 1997 2003-present Innovations over time
Coronary Stents
Evolution of PCI (Percutaneous Coronary Intervention) 40 30 Event Rate % 20 10 Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early 1977 1985 Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES 1985 1994 1997 2003-present Innovations over time
DES
N Engl J Med2003;349:1315-23
SIRIUS trial N Engl J Med2003;349:1315-23
Circulation 2004;109:1942-1947
TAXUS trial Circulation 2004;109:1942-1947
Evolution of PCI (Percutaneous Coronary Intervention) 40 30 Event Rate % 20 10 Failure Em CABG Restenosis Stent thrombosis VLST 0 POBA early 1977 1985 Dr. Don Baim BSC, FDA Panel Meeting, December 2006 POBA late Stent early Stent late DES 1985 1994 1997 2003-present Innovations over time
DES
DES or BMS DES
2000 2030 Rank Country Diabetics (millions) 1 India 31.7 79.4 2 China 20.8 42.3 3 4 5 USA Indonesia Japan 17.7 8.4 6.8 30.3 21.3 8.9 http://www.who.int/diabetes/actionnow/en/mapdiabprev.pdf
200 150 100 250 kcal 10 8 6 4 (%) 30 20 8 6 4 50 2 10 2 0 0 1940 1950 1960 1970 1980 1990 2000 0 0 2005 26 2004
1,200 1,080 1,000 800 690 740 600 400 200 0 1997 2002 2010 Source: BMI BMI
2006 12 20 192 10 1 2007 11 14 (WHO) Unite for Diabetes
Lesions Treated in Cypher PMS 100 80 60 78.9 n = 2,388 (1.2 lesions/patient) % 40 20 0 32.8 14.7 21.0 10.9 11.3 0.6 3.9 >30mm de novo ISR SVG Total Occlusion LM Ostial Bifurcation 1st Year 74.7 17.3 0.8 10.6 10.7 3.6 20.9 30.0 (n=1,184) 2nd Year 83.0 12.0 0.5 11.1 11.8 4.1 21.2 35.6 (n=1,204) P-Value <0.001 N.S. N.S. N.S. N.S. 0.003 9
Lesion Treated in TAXUS PMS 100.0 80.0 60.0 40.0 20.0 0.0 de novo ISR SVG >28mm Total Occlusion LM Ostial Bifurcatioin
DES or BMS DES
JAPANESE SUMMARY ; ARC Definite : Probable : ( 30 Possible :30
Off label
Ontario PCI Registry 2 and 3-year Clinical Results From 18,314 PCI at 12 centers in Ontario Treated December 2003 and March 2005 3,751 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 7.8 5.5 (0.7) 0.001 MI (2 yr) 5.2 5.7 (1.1) 0.95 TVR (2 yr) 10.7 7.4 (0.69) 0.001 small (< 3mm) all 3 (0.38 [17.6-7.2%])* long (>20 mm) any 2 (0.34-0.66 [12-6%])* DM any 1 (0.78-0.82 [8-6%]) Tu, et al. New England Journal of Medicine 357; 14, October 2007 *p< 0.05
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
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) 1.1 79 7173 1.2 90 7041 1.7 116 5549 0.6% per year 2.3 141 2852 2.9 152 989 Daemen J., et al., Lancet 2007; 369: 667 78. Jpn-PMS Cumulative Risk of Stent Thrombosis (Unadjusted) % 2 1 0 0 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
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
BMS compliance BMS DES AMI secondary Mal apposition
gold standard CT gold standard
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.
REACH-Registry; outpatients registry Enrolled pts number; 68,129 patients in 5,580 sites* in 44 countries 27,786 17,923 5,657 847 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
Event curves from enrollment to 1yr Event rate demonstrate linearity JAMA 2007;297:1197-1206
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;297:1197-1206
Prevalence of polyvascular disease Of the patients with symptomatic atherosclerosis, a significant proportion had symptomatic polyvascular disease JAMA 2006;295:180-189
Assessment of advanced disease Am J Cardiol 2006;98:2H-15H
Carotid artery stenosis and Stroke Stroke 2000;31:615-621 621
CAS
GW selection is important, however, back up support is more important
Final angiogram
Great progress of medical treatment Event rate has decreased 10 8 6 4 CHARISMA CAPRIE like cohort N=9,478 Placebo + ASA RRR 17.1 p 0.0 Cumulative CV event 16 12 (%) 8 4 N=19,185 CAPRIE ASA Clopidogrel RRR 8.7 p 0.043 2 Clopidogrel + ASA 0 0 6 12 18 24 30 Period Deepak L. Bhatt et al. J Am Coll Cardiol 2007;49(19 0 6 12 18 24 30 0 36 Months Period CAPRIE Steering Committee: Lancet 348: 1329-1339, 1996
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, 1706-1717, 2006 Bhatt DL, et al: N Engl J Med 354, 1706-1717, 2006
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, 1706-1717, 2006 % Bhatt DL, et al: N Engl J Med 354, 1706-1717, 2006 Eur Heart J 1998;19 supple 3
New diagram for IHD treatment Optimal PCI Optimal Medical treatment