Trial Outcomes & Findings for Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair (NCT NCT00746122)

NCT ID: NCT00746122

Last Updated: 2019-12-19

Results Overview

Mortality, at 3 pre-specified time points

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 613 participants
• Primary outcome timeframe: 30 days, 1-year and 3-years from randomisation
• Results posted on: 2019-12-19

Participant Flow

Recruitment from 1st September 2009 to 31st July 2013. After 600 recruitment target 13 more patients were randomised before sites could be closed down.

Exclusions: persons younger than 50 years, prior AAA repair

Participant milestones

Measure	Open Repair Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Overall Study STARTED	297	316
Overall Study COMPLETED	297	316
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Open Repair n=297 Participants Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=316 Participants Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair	Total n=613 Participants Total of all reporting groups
Age, Continuous	76.7 years STANDARD_DEVIATION 7.8 • n=297 Participants	76.7 years STANDARD_DEVIATION 7.4 • n=316 Participants	76.7 years STANDARD_DEVIATION 7.6 • n=613 Participants
Sex: Female, Male Female	63 Participants n=297 Participants	70 Participants n=316 Participants	133 Participants n=613 Participants
Sex: Female, Male Male	234 Participants n=297 Participants	246 Participants n=316 Participants	480 Participants n=613 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	6 participants n=297 Participants	7 participants n=316 Participants	13 participants n=613 Participants
Region of Enrollment United Kingdom	291 participants n=297 Participants	309 participants n=316 Participants	600 participants n=613 Participants

PRIMARY outcome

Timeframe: 30 days, 1-year and 3-years from randomisation

Mortality, at 3 pre-specified time points

Outcome measures

Measure	Open Repair n=297 Participants Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=316 Participants Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Mortality 30-day mortality	111 Participants	112 Participants
Mortality 1-year mortality	133 Participants	130 Participants
Mortality 3-year mortality	165 Participants	151 Participants

SECONDARY outcome

Timeframe: 3-years from randomisation

QALYs are a product of length of life and quality of life, since both of these are important to patients. Therefore, it is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.

QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life, and freedom from pain and mental disturbance.

Outcome measures

Measure	Open Repair n=297 Participants Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=316 Participants Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation	0.97 life-years Standard Deviation 1.02	1.14 life-years Standard Deviation 1.03

SECONDARY outcome

Timeframe: 3 years

Hospital costs to enable cost-effectiveness evaluation in Pounds (£)

Outcome measures

Measure	Open Repair n=297 Participants Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=316 Participants Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Hospital Costs to Enable Cost-effectiveness Evaluation	19483 GBP (£) Standard Deviation 22412	16878 GBP (£) Standard Deviation 19624

Adverse Events

Open Repair

Serious events: 125 serious events

Other events: 3 other events

Deaths: 297 deaths

Endovascular Strategy

Serious events: 117 serious events

Other events: 5 other events

Deaths: 316 deaths

Serious adverse events

Measure	Open Repair n=243 participants at risk；n=297 participants at risk Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=259 participants at risk；n=316 participants at risk Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Vascular disorders Not discharged from hospital alive	42.1% 125/297 • Number of events 125 • During pre-operative Computed Tomography (CT) scan, on days 0 or 1 Death during pre-op CT scan This is an emergency trial where patients die without surgery. This trial compared two types of surgery, endovascular repair and open surgery. The strategy of endovascular repair requires the patient to have a pre-operative CT scan, which may cause a slight delay in reaching the operating theatre. Therefore, the only major adverse event considered during this trial was death during CT scan.	37.0% 117/316 • Number of events 117 • During pre-operative Computed Tomography (CT) scan, on days 0 or 1 Death during pre-op CT scan This is an emergency trial where patients die without surgery. This trial compared two types of surgery, endovascular repair and open surgery. The strategy of endovascular repair requires the patient to have a pre-operative CT scan, which may cause a slight delay in reaching the operating theatre. Therefore, the only major adverse event considered during this trial was death during CT scan.

Other adverse events

Measure	Open Repair n=243 participants at risk；n=297 participants at risk Immediate Open Surgery Open repair: Standard treatment of emergency open surgery	Endovascular Strategy n=259 participants at risk；n=316 participants at risk Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR EVAR: Emergency endovascular aneurysm repair
Vascular disorders Major lower limb amputation after aneurysm repair	1.2% 3/243 • Number of events 3 • During pre-operative Computed Tomography (CT) scan, on days 0 or 1 Death during pre-op CT scan This is an emergency trial where patients die without surgery. This trial compared two types of surgery, endovascular repair and open surgery. The strategy of endovascular repair requires the patient to have a pre-operative CT scan, which may cause a slight delay in reaching the operating theatre. Therefore, the only major adverse event considered during this trial was death during CT scan.	1.9% 5/259 • Number of events 5 • During pre-operative Computed Tomography (CT) scan, on days 0 or 1 Death during pre-op CT scan This is an emergency trial where patients die without surgery. This trial compared two types of surgery, endovascular repair and open surgery. The strategy of endovascular repair requires the patient to have a pre-operative CT scan, which may cause a slight delay in reaching the operating theatre. Therefore, the only major adverse event considered during this trial was death during CT scan.

Additional Information

Professor Janet Powell

Imperial College London

Phone: 44-2033117312

Email: j.powell@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place