Objective

The aim of this study was to provide long term survival and limb salvage rates for patients with non-revascularisable (NR) chronic limb threatening ischaemia (CLTI).

Methods

This was a retrospective review of prospectively collected data, derived from a randomised controlled trial (JUVENTAS) investigating the use of a regenerative cell therapy. Survival and limb salvage of the index limb in CLTI patients without viable options for revascularisation at inclusion were analysed retrospectively. The primary outcome was amputation free survival, a composite of survival and limb salvage, at five years after inclusion in the original trial.

Results

In 150 patients with NR-CLTI, amputation free survival was 43% five years after inclusion. This outcome was driven by an equal rate of all cause mortality (35%) and amputation (33%). Amputation occurred predominantly in the first year. Furthermore, 33% of those with amputation subsequently died within the investigated period, with a median interval of 291 days.

Conclusion

Five years after the initial need for revascularisation, about half of the CLTI patients who were deemed non-revascularisable survived with salvage of the index limb. Although the prospects for these high risk patients are still poor, under optimal medical care, amputation free survival seems comparable with that of revascularisable CLTI patients, while the major amputation rate within one year, especially among NR-CLTI patients with ischaemic tissue loss, is very high.

中文翻译：

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不可血运重建的慢性肢体威胁性缺血患者的长期生存和肢体挽救

客观的

本研究的目的是为不可血运重建 (NR) 的慢性肢体威胁缺血 (CLTI) 患者提供长期生存率和肢体挽救率。

方法

这是对前瞻性收集的数据的回顾性审查，这些数据来自一项调查再生细胞疗法使用的随机对照试验 (JUVENTAS)。回顾性分析了入组时没有可行的血运重建选择的 CLTI 患者索引肢体的存活率和肢体挽救情况。主要结果是无截肢生存率，包括生存率和保肢率，在纳入原始试验后五年。

结果

在 150 名 NR-CLTI 患者中，纳入后五年的无截肢生存率为 43%。这一结果是由相等的全因死亡率 (35%) 和截肢 (33%) 驱动的。截肢主要发生在第一年。此外，33% 的截肢者随后在调查期间内死亡，中位间隔为 291 天。

结论

在最初需要血运重建五年后，大约一半被认为不可血运重建的 CLTI 患者在索引肢体的抢救中幸存下来。虽然这些高危患者的前景仍然不佳，但在最佳医疗护理下，无截肢生存率似乎与可血运重建的 CLTI 患者相当，而一年内的主要截肢率，尤其是在缺血性组织丢失的 NR-CLTI 患者中，很高。