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Updated: Jun 16, 2025
Assessing Therapeutic Angiogenesis in a Murine Model of Hindlimb Ischemia
Published on: June 8, 2019
[Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2]
Marcus Thieme1,2, Hans Krankenberg1
1REGIOMED-Gefäßzentrum, Klinikum Sonneberg, Sonneberg, Deutschland.
Insights
Surgical treatment showed better long-term results in the BEST-CLI trial for critical limb ischemia (CLI), while endovascular therapy was superior in the BASIL-2 trial for lower leg CLI. Both trials highlight the need for specialized centers and risk factor management.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- Critical Limb Ischemia (CLI) treatment rates are rising globally.
- Two major trials, BEST-CLI and BASIL-2, investigated surgical versus endovascular approaches for CLI.
- These trials yielded contrasting outcomes, necessitating a comparative analysis.
Purpose of the Study:
- To compare the safety and efficacy of surgical versus endovascular treatment for CLTI.
- To analyze the primary endpoints and patient populations of the BEST-CLI and BASIL-2 trials.
- To provide insights into optimal treatment strategies for CLI patients.
Main Methods:
- BEST-CLI: Randomized 1830 CLTI patients, primary endpoint: outcome events (death, amputation, reintervention).
- BASIL-2: Randomized 345 CLTI patients with lower leg lesions, primary outcome: amputation-free survival.
- Both trials involved prospective, randomized designs with median follow-up periods of 2.7 and 40 months, respectively.
Main Results:
- BEST-CLI found surgery superior due to fewer reinterventions after 2.7 years; no difference in death or amputation.
- BASIL-2 found endovascular therapy superior after 40 months for lower leg lesions.
- Both studies noted remarkably high mortality rates in CLI patients.
Conclusions:
- Patients with CLTI should be treated in specialized centers offering both surgical and endovascular options.
- BEST-CLI may not fully represent all CLTI patients, while BASIL-2 is more specific to below-the-knee lesions.
- Aggressive cardiovascular risk factor management is crucial to reduce high mortality in CLTI.
Abstract:
The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. Best-CLI evaluated outcome events as the primary endpoint, which includes major reinterventions in addition to major amputations and death. Only half of the CLTI patients received a crural intervention or surgery. There were no differences in major amputations or death. After a median follow-up (FU) of 2,7 years, the surgery group showed significantly better results compared to the endovascular group, due to fewer re-interventions. BASIL-2 used amputation-free survival as the primary outcome and only included patients with lower leg lesions. After a median FU of 40 months, endovascular therapy was found to be superior. The extremely high mortality rate was remarkable in both studies. The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.
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