OBJECTIVE: We compared long-term health-related quality-of-life outcome after randomization to immediate elective repair or imaging surveillance, and in relation to time of elective repair, in patients with small asymptomatic abdominal aortic aneurysm (AAA). METHODS: This randomized clinical trial was carried out in 16 Veterans Affairs medical centers. Study subjects were patients at good surgical risk, aged 50 to 79 years, with AAAs 4.0 to 5.4 cm in diameter. Interventions included immediate open surgical AAA repair or imaging surveillance every 6 months with repair reserved for AAAs that became symptomatic or enlarged to 5.5 cm. Main outcome measures considered were SF-36 health status questionnaire, prevalence of impotence, and maximum activity level, which were determined at randomization and at all follow-up visits. RESULTS:Eleven hundred thirty-six patients were randomized and followed up for 3.5 to 8 years (mean, 4.9 years). The two randomized groups did not differ significantly for most SF-36 scales at most times, but the immediate repair group scored higher overall in general health (P <.0001), which was particularly evident in the first 2 years after randomization, and slightly lower in vitality (P <.05). The baseline value of one SF-36 scale, physical functioning, was an independent predictor of mortality. Overall, more patients became impotent after randomization to immediate repair compared with surveillance (P <.03), but this difference did not become apparent until more than 1 year after randomization. Maximum activity level did not differ significantly between the two randomized groups, but decline over time was significantly greater in the immediate repair group (P <.02). CONCLUSIONS: For most quality-of-life measures and times there was no difference between randomized groups. Immediate repair resulted in a higher prevalence of impotence more than 1 year after randomization, but was also associated with improved perception of general health in the first 2 years.
RCT Entities:
OBJECTIVE: We compared long-term health-related quality-of-life outcome after randomization to immediate elective repair or imaging surveillance, and in relation to time of elective repair, in patients with small asymptomatic abdominal aortic aneurysm (AAA). METHODS: This randomized clinical trial was carried out in 16 Veterans Affairs medical centers. Study subjects were patients at good surgical risk, aged 50 to 79 years, with AAAs 4.0 to 5.4 cm in diameter. Interventions included immediate open surgical AAA repair or imaging surveillance every 6 months with repair reserved for AAAs that became symptomatic or enlarged to 5.5 cm. Main outcome measures considered were SF-36 health status questionnaire, prevalence of impotence, and maximum activity level, which were determined at randomization and at all follow-up visits. RESULTS: Eleven hundred thirty-six patients were randomized and followed up for 3.5 to 8 years (mean, 4.9 years). The two randomized groups did not differ significantly for most SF-36 scales at most times, but the immediate repair group scored higher overall in general health (P <.0001), which was particularly evident in the first 2 years after randomization, and slightly lower in vitality (P <.05). The baseline value of one SF-36 scale, physical functioning, was an independent predictor of mortality. Overall, more patients became impotent after randomization to immediate repair compared with surveillance (P <.03), but this difference did not become apparent until more than 1 year after randomization. Maximum activity level did not differ significantly between the two randomized groups, but decline over time was significantly greater in the immediate repair group (P <.02). CONCLUSIONS: For most quality-of-life measures and times there was no difference between randomized groups. Immediate repair resulted in a higher prevalence of impotence more than 1 year after randomization, but was also associated with improved perception of general health in the first 2 years.