Aortic & peripheral vascular disease
Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia
Primary result · MALE or all-cause death (primary trial outcome)Result — go to the resultHazard ratio 0.65 95% CI 0.56–0.76Authors' conclusion
Analysis of as-treated outcomes from the BEST-CLI trial demonstrates the safety and clinical superiority of bypass with SSGSV among patients with CLTI who were deemed suitable for either open surgical bypass or ENDO revascularization. Assessment of great saphenous vein quality should be incorporated into the evaluation of patients with CLTI who are surgical candidates.
Study context
- Population
- Patients with chronic limb-threatening ischemia (CLTI) due to infrainguinal peripheral artery disease deemed acceptable for either open surgical bypass or ENDO treatmentpatients with CLTI
- Participants
- 1,780 patients
- Comparison
- SSGSV bypass, alternative conduits (AC) bypass, and ENDO, by initial revascularization received
- SSGSVn = 621
- ACn = 236
- ENDOn = 923reference
Methodological detailsmultivariable Cox regression models, analyses for all treated patients and excluding early technical failure
- Multivariable Cox regression models
- Analyses for all treated patients and excluding early technical failure
Primary result
MALE or all-cause death (primary trial outcome)
Hazard ratio
0.65
95% CI 0.56–0.76
P < 0.001
As reported in the abstract
Further findings
| Outcome | Hazard ratio | P value | |
|---|---|---|---|
| Major amputationSSGSV vs ENDO · risk-adjusted | 0.70 (95% CI 0.52–0.94) | P = 0.017 | |
| MALE or perioperative deathSSGSV vs ENDO · risk-adjusted | 0.51 (CI 0.41–0.62) | P < 0.001 | |
| Reintervention-amputation-deathSSGSV vs ENDO · risk-adjusted | 0.69 (95% CI 0.61–0.79) | P < 0.001 | |
| 0.512Hazard ratio (log scale) |
AC bypass vs ENDO: MALE or perioperative death and reintervention-amputation-death
- AC bypass was associated with reduced MALE or perioperative death and reintervention-amputation-death compared with ENDO
Long-term mortality
- No significant differences by initial treatment received
SSGSV vs ENDO excluding early technical failure
- Significant benefits of SSGSV over ENDO remained
By level of disease treated (subgroup)
- Improved outcomes of SSGSV greatest among patients who underwent femoropopliteal revascularization
Safety
MALE within 30 days
- MALE within 30 days: P <0.001
- MALE within 30 days: No significant differences in 30-day mortality, major adverse cardiovascular events, or serious adverse events
Original publication
Summarised from the published abstract; every number is checked against it