Secondary analysis
Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization
- Secondary analysis of the BEST-CLI randomised trial
- prespecified secondary objective
- 2 parallel trials
Authors' conclusion
Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.
Study context
- Population
- Patients with chronic limb-threatening ischemia; cohort 1 with single-segment great saphenous vein, cohort 2 lacking suitable single-segment great saphenous vein1,193 cohort 1, 335 cohort 2 analysed
- Comparison
- Surgical bypass vs endovascular intervention
- Primary endpoint
- HRQoL (Vascular Quality-of-Life (VascuQoL), EQ-5D, SF-12 PCS, SF-12 MCS, SF-6D R2, numeric rating scales of pain)
- Follow-up
- Over the trial duration
Primary result
As reported in the abstract
HRQoL, cohort 1 (single-segment great saphenous vein) · over follow-up (mean 2.9 years)
Bypass (Bypass)
4.7
mean · SD 1.4
Endo
4.8
mean · SD 1.5
Bypass vs EndoDifference (95% CI)P value
VascuQoL; favoring Endo
−0.14(−0.25 to −0.02)
P = 0.02SF-12 MCS; favoring Endo
−1.03(−1.89 to −0.18)
P = 0.02SF-6D R2; favoring Endo
−0.01(−0.02 to −0.001)
P = 0.03pain at present (numeric rating scale); favoring Endo
0.26(0.03–0.49)
P = 0.03pain, usual level previous week; favoring Endo
0.26(0.04–0.48)
P = 0.02pain, worst level previous week; favoring Endo
0.29(0.02–0.56)
P = 0.04- No difference between treatment arms on EQ-5D
- difference, −0.01 [95% CI, −0.03 to 0.004]; P=0.12
- No difference between treatment arms on SF-12 PCS
- difference, −0.41 [95% CI, −1.2 to 0.37]; P=0.31
Secondary outcomes
Health-related quality of life (HRQoL), cohort 2 · mean follow-up 2.0 years
- HRQoL significantly improved from baseline for both groups on all measures; no differences between Bypass and Endo on any measure
Original publication
Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization. Circulation. Published 10 April 2024. doi:10.1161/circulationaha.123.065277
Summarised from the published abstract; every number is checked against it