Cook Endovascular Graft for AAA

1
Cook Endovascular Graftfor AAA

• Clinical Data
• From Two Prospective Studies
• Two Independent Registries
• Paul Chandeysson
• DCD/PVDB

2
Australia-New Zealand Study

• August 1994 - December 1998
• 291 patients at 16 centers
• Follow-up to June 1999
• Implantation success 98.6
• 6 Early deaths
• 3 AAA ruptures
• 3 Late conversions

3
U.S. Study

• January 2000 - July 2001
• 432 patients at 15 centers
• 52 roll-in endovascular patients
• 200 standard-risk endovascular patients
• 100 high-risk endovascular patients
• 80 surgical patients
• Study patients followed at 1 and 6 months and
  annually

4
Hypotheses

• Primary
• Superior morbidity index at 30 days
• Secondary
• Equivalent survival at 30 days
• Equivalent survival at 1 year
• Equivalent treatment success at 1 year
• Superior clinical utility

5
Patient Population

• Roll-in
  Standard-risk Surgical High-risk
• Age (yr) 74 71
  69 77
• Weight (kg) 83.6 89.4
  82.1 81.4
• Hypertension () 67 64 83
  68
• Alcohol abuse () 4 3.6 10
  3.1
• Still smokes () 18 21
  35 18
• Women () 9.6 6.5
  11.2 8

6
Patient Mortality

• Roll-in Standard-risk
  Surgical High-risk
• Patients 52 199
  80 100
• Within 30 days 1 ( 1.9) 1 (0.5) 2
  (2.5) 2 (2)
• gt30 days,lt1 yr. 5 ( 9.6) 6 (3.0) 1
  (1.25) 7 (7)
• Within 1 year 6 (11.5) 7 (3.5)
  3 (3.75) 9 (9)

7
Patient Morbidity (30 days)

• Roll-in Standard-risk Surgical
  High-risk
• Patients 52 199
  80 100
• Morbidity index 0.35 0.26
  0.92 0.52
• Cardiovascular 1 (1.9) 6 (3.0)
  9 (11.2) 14 (14)
• Pulmonary 0 2 (1.0)
  12 (15.0) 2 ( 2)
• Renal 3 (5.8) 5 (2.5)
  8 (10.0) 6 ( 6)
• Bowel 1 (1.9) 2 (1.0)
  3 ( 3.8) 1 ( 1)
• Wound 2 (3.8) 9 (4.5)
  6 ( 7.5) 2 ( 2)
• Neurological 0 0
  2 ( 2.5) 0
• Vascular 10 (19.2) 21 (10.6)
  25 (31.2) 20 (20)

8
Effectiveness Data (1 year)

• Roll-in Standard-risk High-risk
• Patients 52 200
  100
• Implant success 52 199
  100
• Endoleak , 12 mo. 1 14
  4
• Rupture of AAA 0 0
  1
• Conversions 0 2
  1
• Other procedures 3 21
  12
• Loss of patency 0 2
  1
• Growth of AAA 0 2
  1

9
Western Australia Registry

• Through July 2001
• 170 of 291 patients in A-NZ study
• Follow-up up as long as 6 years
• 3 late AAA ruptures
• 3 late conversions
• Survival analysis to 5 years

10
Eurostar Registry

• January 1998 - March 2001
• 828 patients at 45 centers
• Follow-up to 3 years
• Implantation success 97.7
• 13 Early deaths 1.6
• 1 late AAA rupture 0.1
• 0 late conversions

11
Additional Clinical Data Being Collected

• 2 year follow-up of U.S. endovascular patients
• Results of Continued Access IDE Study
• Registry of 50 women patients (15
  currently enrolled)
• Additional Eurostar registry patients
• Registry of 438 patients in France
• Registry of 515 patients in Australia

12
Conclusions

• A large amount of clinical data
• High rate of implantation success
• Low rate of operative mortality
• All hypotheses met
• Does not eliminate aneurysm rupture
• Continued follow-up necessary
• Additional treatments may be needed
• No excess renal failure