Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Duke Evidence-based Practice Center, Duke Clinical Research Institute, Duke University, Durham, NC.
Am Heart J. 2014 Apr;167(4):489-498.e7. doi: 10.1016/j.ahj.2013.12.012. Epub 2014 Jan 4.
For patients with critical limb ischemia (CLI), the optimal treatment to enhance limb preservation, prevent death, and improve functional status is unknown. We performed a systematic review and meta-analysis to assess the comparative effectiveness of endovascular revascularization and surgical revascularization in patients with CLI.
We systematically searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1995 to August 2012. Two investigators screened each abstract and full-text article for inclusion, abstracted the data, and performed quality ratings and evidence grading. Random-effects models were used to compute summary estimates of effects, with endovascular treatment as the control group.
We identified a total of 23 studies, including 1 randomized controlled trial, which reported no difference in amputation-free survival at 3 years (odds ratio [OR] 1.22, 95% CI 0.84-1.77) and all-cause mortality (OR 1.07, 0.73-1.56) between the 2 treatments. Meta-analysis of the observational studies showed a statistically nonsignificant reduction in all-cause mortality at 6 months (11 studies, OR 0.85, 0.57-1.27) and amputation-free survival at 1 year (2 studies, OR 0.76, 0.48-1.21) in patients treated with endovascular revascularization. There was no difference in overall death, amputation, or amputation-free survival at ≥2 years.
The currently available literature suggests that there is no difference in clinical outcomes for patients with CLI treated with endovascular or surgical revascularization. There is a paucity of high-quality data available to guide clinical decision making, especially as it pertains to patient subgroups or anatomical considerations.
对于患有严重肢体缺血(CLI)的患者,增强肢体保存、预防死亡和改善功能状态的最佳治疗方法尚不清楚。我们进行了一项系统评价和荟萃分析,以评估 CLI 患者血管内血运重建和手术血运重建的比较效果。
我们系统地检索了 PubMed、Embase 和 Cochrane 系统评价数据库中 1995 年 1 月至 2012 年 8 月发表的相关英文文献。两名研究者筛选了每个摘要和全文文章的纳入情况,提取数据,并进行了质量评价和证据分级。使用随机效应模型计算效应的汇总估计值,以血管内治疗为对照组。
我们共确定了 23 项研究,包括 1 项随机对照试验,该试验报告 3 年内免于截肢的存活率(比值比[OR]1.22,95%置信区间[CI]0.84-1.77)和全因死亡率(OR 1.07,95%CI0.73-1.56)在两种治疗方法之间无差异。对观察性研究的荟萃分析显示,血管内血运重建治疗的患者在 6 个月时全因死亡率(11 项研究,OR0.85,95%CI0.57-1.27)和 1 年时免于截肢的存活率(2 项研究,OR0.76,95%CI0.48-1.21)有统计学上无显著降低。在 2 年以上,总体死亡率、截肢率或免于截肢的存活率无差异。
目前的文献表明,血管内或手术血运重建治疗 CLI 患者的临床结局无差异。目前可用于指导临床决策的高质量数据很少,特别是在涉及患者亚组或解剖学考虑的情况下。