[Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2].

Deutsche medizinische Wochenschrift (1946) Pub Date : 2024-08-01 Epub Date: 2024-08-15 DOI:10.1055/a-2153-6265
Marcus Thieme, Hans Krankenberg
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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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[基于 BEST-CLI 和 BASIL-2 的慢性肢体缺血(CLTI)治疗方法]。
在全球范围内,CLTI 的血管再通率正在上升。两项前瞻性随机试验对 CLTI 患者手术治疗与血管内治疗的安全性和有效性进行了研究,结果截然不同。BEST-CLI试验随机抽取了1830名CLTI患者,BASIL-2试验则纳入了345名CLTI患者。Best-CLI将结果事件作为主要终点进行评估,结果事件除主要截肢和死亡外,还包括主要再介入治疗。只有一半的CLTI患者接受了颅骨介入治疗或手术。在大截肢和死亡方面没有差异。在中位随访(FU)2.7年后,手术组的效果明显优于血管内介入组,原因是再次介入的次数更少。BASIL-2 将无截肢存活率作为主要结果,只包括小腿病变患者。中位生存期为40个月后,发现血管内治疗效果更好。两项研究的死亡率都非常高。BEST-CLI 研究仅在一定程度上代表了 CLTI 患者,而 BASIL-2 研究则很好地展示了对膝下病变的 CLTI 患者的治疗。这两项研究都证实,CLTI 患者应在提供硬膜外手术和血管内治疗的专科中心接受治疗。在降低与 CLTI 相关的高死亡率方面,心血管风险因素管理必须发挥更重要的作用。
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