OBJECTIVE: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1-5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. METHODS: Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. RESULTS:Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (-3.9 in EVAR, -6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. CONCLUSIONS: Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.
RCT Entities:
OBJECTIVE: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1-5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. METHODS:Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. RESULTS: Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (-3.9 in EVAR, -6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. CONCLUSIONS:Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.
Authors: Anne R Cotter; Kim Vuong; Linda Mustelin; Yi Yang; Malika Rakhmankulova; Colleen J Barclay; Russell P Harris Journal: BMJ Open Date: 2017-12-12 Impact factor: 2.692