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Published on: January 18, 2018
The impact of revascularization strategy on clinical failure, hemodynamic failure, and chronic limb-threatening
Matthew T Menard1, Alik Farber2, Gheorghe Doros3
1Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Insights
Open surgical bypass (OPEN) offers superior clinical and hemodynamic benefits for chronic limb-threatening ischemia (CLTI) compared to endovascular (ENDO) treatment. OPEN surgery effectively resolves symptoms and prevents recurrence, reducing the need for reintervention and limb loss.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Ischemia Management
Background:
- Chronic limb-threatening ischemia (CLTI) requires revascularization for symptom resolution and limb salvage.
- Sustained clinical and hemodynamic benefits are crucial for long-term CLTI management.
- Comparing endovascular (ENDO) versus open surgical bypass (OPEN) revascularization is essential for optimal patient outcomes.
Purpose of the Study:
- To compare clinical and hemodynamic failure rates between ENDO and OPEN revascularization in CLTI patients.
- To evaluate the resolution of initial CLTI symptoms and prevention of recurrent CLTI after both procedures.
- To analyze outcomes based on the availability of suitable single segment great saphenous vein (SSGSV).
Main Methods:
- Secondary analysis of the BEST-CLI trial, including two cohorts: suitable SSGSV (cohort 1) and lacking suitable SSGSV (cohort 2).
- Assessment of clinical failure (death, amputation, reintervention, WIfI stage degradation) and hemodynamic failure (amputation, reintervention, ABI/TBI changes, stenosis).
- Time-to-event analyses using intention-to-treat assignment and multivariate stratified Cox regression models.
Main Results:
- In cohort 1 (suitable SSGSV), OPEN significantly favored reduced time to clinical failure, hemodynamic failure, and improved symptom resolution.
- In cohort 2 (lacking suitable SSGSV), OPEN showed significantly lower hemodynamic failure rates; no significant difference in clinical failure or symptom resolution.
- Multivariate analysis confirmed OPEN associated with lower clinical/hemodynamic failure risk and higher symptom resolution/prevention rates in cohort 1, adjusted for covariates like ESRD, diabetes, and WIfI stage.
Conclusions:
- Initial OPEN surgical bypass, especially with available saphenous vein, provides durable clinical and hemodynamic benefits for CLTI.
- OPEN revascularization is associated with improved outcomes, including enhanced symptom resolution and reduced reintervention rates compared to ENDO.
- Durable revascularization is key to preventing persistent CLTI, reinterventions, and limb loss.
Objective:
Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial.
Methods:
As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); (3) time to resolution of presenting CLTI symptoms; and (4) incidence of recurrent CLTI. Time-to-event analyses were performed by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N = 1434; cohort 2: lacking suitable SSGSV, N = 396), and multivariate stratified Cox regression models were created.
Results:
In cohort 1, there was a significant difference in time to clinical failure (log-rank P < .001), hemodynamic failure (log-rank P < .001), and resolution of presenting symptoms (log-rank P = .009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank P = .006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with a significantly lower risk of clinical and hemodynamic failure in both cohorts and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1, including after adjustment for key baseline patient covariates (end-stage renal disease [ESRD], prior revascularization, smoking, diabetes, age >80 years, WIfI stage, tissue loss, and infrapopliteal disease). Factors independently associated with clinical failure included age >80 years in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2.
Conclusions:
Durable clinical and hemodynamic benefit after revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions, and limb loss. When compared with ENDO, initial treatment with OPEN surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms.
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