# Presentation: 688657

## Cook Endovascular Graftfor AAA

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

## 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

## 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

## 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

## 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

## 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)
- >30 days,<1 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)

## 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)

## 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

## 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

## 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

## 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

## 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