Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
Department of Diabetes Care Medicine, and Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
JACC Cardiovasc Interv. 2017 Jun 12;10(11):1147-1157. doi: 10.1016/j.jcin.2017.03.012.
The authors sought to investigate the prognostic impact of revascularization for poor-risk CLI patients in real-world settings.
Critical limb ischemia (CLI) is often accompanied with various comorbidities, and frailty is not rare in the population. Although previous studies suggested favorable outcomes of revascularization for CLI patients, those studies commonly included the healthier, that is, less frail patients.
This was a multicenter prospective observational study, registering patients who presented with CLI and who required assistance for their daily lives because of their disability in activities of daily living (ADL) and/or impairment of cognitive function. Revascularization was either planned (revascularization group) or not planned (non-revascularization group). The primary endpoint was 1-year survival, and was compared between the revascularization and non-revascularization groups, using the propensity score-matching method.
Between January 2014 and April 2015, a total of 662 patients were registered, of those 100 non-revascularization patients were included. A total of 625 patients (94.4%) completed the 1-year follow-up. Death was observed in 223 patients (33.7%). After propensity score matching, the 1-year survival rate was 55.9% in the revascularization group versus 51.0% in the non-revascularization group, with no significant difference (p = 0.120). In the subgroups alive at 1 year after revascularization, health-related quality of life was significantly improved compared with baseline, whereas ADL scores were unchanged from baseline and still remained significantly worse than before CLI onset.
The 1-year overall survival rate was not significantly different between the revascularization and non-revascularization groups in poor-risk CLI patients. (Poor-Risk Patients With and Without Revascularization Therapy for Critical Limb Ischemia; [PRIORITY Registry]; UMIN000012871).
作者旨在探讨真实世界环境中，对高危 CLI 患者进行血运重建的预后影响。
严重肢体缺血（CLI）常伴有多种合并症，人群中衰弱并不少见。尽管先前的研究表明 CLI 患者血运重建有良好的结果，但这些研究通常包括更健康的、即衰弱程度较低的患者。
这是一项多中心前瞻性观察研究，登记了患有 CLI 且因日常生活活动（ADL）能力丧失和/或认知功能受损而需要帮助的患者。血运重建要么计划进行（血运重建组），要么不计划进行（非血运重建组）。主要终点是 1 年生存率，并使用倾向评分匹配法比较血运重建组和非血运重建组之间的差异。
2014 年 1 月至 2015 年 4 月期间，共登记了 662 例患者，其中 100 例非血运重建患者纳入研究。共有 625 例患者（94.4%）完成了 1 年随访。共有 223 例患者（33.7%）死亡。经过倾向评分匹配后，血运重建组的 1 年生存率为 55.9%，非血运重建组为 51.0%，差异无统计学意义（p=0.120）。在血运重建后存活 1 年的亚组中，健康相关生活质量较基线显著改善，而 ADL 评分与基线相比无变化，仍明显差于 CLI 发病前。
在高危 CLI 患者中，血运重建组和非血运重建组的 1 年总体生存率无显著差异。（严重肢体缺血伴或不伴血运重建治疗的高危患者；[PRIORITY 注册研究]；UMIN000012871）。
