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Published on: September 22, 2020
Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in
Jeffrey J Siracuse1, Alik Farber1, Matthew T Menard2
1Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University, Chobanian and Avedisian School of Medicine, Boston, MA.
Insights
For chronic limb-threatening ischemia (CLTI), surgical and endovascular revascularization showed similar 30-day complication rates in the BEST-CLI trial. Patient factors beyond peri-procedural risk should guide treatment decisions for CLTI.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Cardiovascular Research
Background:
- Anticipating perioperative morbidity is crucial for selecting revascularization methods in chronic limb-threatening ischemia (CLTI).
- The Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial compared surgical and endovascular approaches.
Purpose of the Study:
- To evaluate and compare systemic perioperative complications between surgical and endovascular revascularization in patients with CLTI.
- To inform clinical decision-making by assessing the safety profiles of different revascularization strategies.
Main Methods:
- Prospective randomized trial (BEST-CLI) comparing open (OPEN) and endovascular (ENDO) revascularization.
- Two cohorts: Cohort 1 (adequate great saphenous vein) and Cohort 2 (no adequate great saphenous vein).
- Data collected on major adverse cardiovascular events (MACE), serious adverse events (SAEs), and non-serious adverse events (non-SAEs) within 30 days post-procedure.
Main Results:
- No significant differences in 30-day MACE or acute renal failure between OPEN and ENDO in either cohort.
- Venous thromboembolism rates were low and similar between groups.
- Cohort 1 showed higher rates of non-SAEs in the OPEN group (23.4%) compared to ENDO (17.9%).
- SAE rates were similar between OPEN and ENDO in both cohorts (Cohort 1: 35.3% vs 31.6%; Cohort 2: 25.5% vs 23.6%).
Conclusions:
- For CLTI patients suitable for open bypass, peri-procedural complication risks are similar for both open and endovascular revascularization.
- Treatment strategy decisions for CLTI should prioritize factors like perfusion restoration effectiveness and patient preference over peri-procedure complication concerns.
Objective:
Anticipated perioperative morbidity is an important factor for choosing a revascularization method for chronic limb-threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications of patients treated with surgical and endovascular revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
Methods:
BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed.
Results:
There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events.
Conclusions:
In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant.
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