Early IMPROVE Trial Results for Ruptured Aortic Aneurysm
Published date : 16 February 2014
Article date : 16 February 2014
Early results have been published for the IMPROVE trial which is for patients with ruptured abdominal aortic aneurysm. It is designed to test the hypothesis that a policy of endovascular repair, whenever possible, saves lives in comparison to the standard treatment of open surgical repair. The trial is supported by the NIHR Health Technology Assessment programme.
The trial recruited 600 patients over a 27 month period, to provide 90% power to detect (as significant at 5%) a difference in 30-day mortality of 14%, with mortality estimated at 44.6% in the open repair group and 30.4% in the EVAR first strategy group.
The proportion of patients leaving hospital alive was almost the same in the endovascular repair (EVAR) group (64%) and in the open repair group (62%).
EVAR appeared to be more beneficial in women than men.
Patients in the EVAR group were discharged from hospital sooner and nearly always directly to home, compared with the open repair group where about a quarter of patients needed a period of convalescent care.
Patients operated on outside routine working hours had worse outcomes compared to those treated during routine working hours.
Patients who received EVAR under local anaesthesia did much better than those who received EVAR under general anaesthesia.
The average costs were similar between the EVAR and open repair groups but the NHS will need to know more about longer-term costs for both treatments.
