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. 2014 Jan 23;2014(1):CD004178. doi: 10.1002/14651858.CD004178.pub2

ACE.

Methods Study design: Multicentre RCT
Method of randomisation: Stratified by centre
Exclusions post randomisation: 7 (due to withdrawal from consent)
Losses to follow up: 8 (EVAR = 3, OSR = 5)
Intention‐to‐treat analysis: Yes
Participants Country: France
Setting: Hospital (25 centres)
Recruitment: 2003 to 2008
Number: 306 (149 OSR, 150 EVAR)
Age: 69 ± 7 years (mean)
Sex: 296 male / 3 female
Inclusion criteria: Consisted of both anatomical criteria and clinical assessment.
‐ Anatomical criteria (based on CT scan findings):
  • AAA > 5 cm in men (or) > 4.5 cm in women (or) common iliac artery aneurysm > 3.0 cm AND upper neck free of major thrombus or calcification AND ≥ 1.5 cm length AND angle between the neck and the axis of the aneurysm < 60° AND iliac arteries compatible with the introducer sheath


‐ Clinical assessment:
  • Participants graded as categories 0 to 2 of the comorbidity score of the SVS/AAVS


Exclusion criteria:
  • Previous abdominal aortic surgery

  • Ruptured aneurysm

  • Mycotic aneurysm

  • Severe Iodine allergy

  • Life expectancy deemed < 6 months, (or) category 3 of the SVS/AAVS classification

Interventions Treatment: EVAR
Control: OSR
Outcomes Primary: All‐cause mortality, major adverse events (myocardial infarction, permanent stroke, permanent haemodialysis, major amputation, paraplegia and bowel infarction)
Secondary: Vascular reinterventions and minor complications
Notes Trial was conducted in individuals considered to be at low‐to‐medium risk of surgery
Reinterventions for incisional hernia repair were not recorded
In the EVAR group, 4 participants each had surgery under local and epidural anaesthesia. Remainder all had surgery under general anaesthesia
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation done based on centre
Allocation concealment (selection bias) Low risk Allocation only notified < 24 hours
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Blinding of participants and operating surgeons not feasible in such a study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No clear data available
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Presented results based on intention‐to‐treat and presented final follow up results. All participants accounted for
Selective reporting (reporting bias) Low risk Reported on all predefined outcomes
Other bias Low risk None identified