DREAM.
| Methods |
Study design: Multicentre RCT Method of randomisation: Computer‐generated permuted block sequence; in blocks of four Exclusions post randomisation: 6 participants did not undergo aneurysm repair following randomisation. 4 declined procedure (3 OSR vs 1 EVAR), 1 died from ruptured AAA before repair (OSR) and 1 died from pneumonia (EVAR) Losses to follow up: None Intention‐to‐treat analysis: Yes |
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| Participants |
Country: The Netherlands (26 centres) and Belgium (4 centres) Setting: Hospital Recruitment: November 2000 to December 2003 Number: 351 (EVAR = 173; OSR = 178) Age: Mean 70.1 years Sex: Male:female 10:1 Inclusion criteria: AAA of at least 5 cm in diameter Exclusion criteria: Participants requiring emergency repair, or participants with inflammatory aneurysms, presence of anatomical variations, connective tissue disease, history of organ transplant, or life expectancy < 2 years |
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| Interventions |
Treatment: EVAR Control: OSR |
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| Outcomes | All‐cause mortality; aneurysm‐related mortality; complications; reintervention rate | |
| Notes | Participants in both groups were followed up regularly for two years and were subsequently sent questionnaires about health. During year 3 and 4, only EVAR participants had a follow‐up visit organised, whereas OSR group participants were advised to see their respective physicians. Five years post randomisation, all participants were contacted by telephone | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization carried out centrally with the use of a computer‐generated permuted‐block sequence and stratified according to study centre in blocks of four patients." |
| Allocation concealment (selection bias) | Low risk | Adequate randomisation technique |
| 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 | Low risk | Outcome assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis was intention‐to‐treat basis |
| Selective reporting (reporting bias) | Low risk | Reported on all predefined outcomes |
| Other bias | Low risk | None identified |