Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
J Vasc Surg. 2011 Feb;53(2):340-6. doi: 10.1016/j.jvs.2010.08.064. Epub 2010 Nov 3.
Acute limb ischemia (ALI) of the lower extremities remains a challenging clinical dilemma. Treatment of ALI has shifted toward endovascular therapies. The purpose of this study was to assess outcomes in patients treated for ALI with intra-arterial thrombolysis and/or adjuvant endovascular techniques.
Consecutive patients with ALI of the lower extremities treated via endovascular intra-arterial methods between January 1, 2005 and September 30, 2007 were identified and reviewed. Comparisons of success, thrombolysis days, and all 30-day outcomes except mortality were performed using generalized estimating equations with logistic and proportional odds regression. Thirty-day mortality was assessed using logistic regression. Long-term patency, limb salvage, and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models.
The analyzed dataset included 129 limbs treated in 119 patients presenting with ALI (class I 68%, class IIa 23%, class IIb 9%). The mean follow-up was 16.8 months (range: 0-43 months). Technical success was achieved in 82% cases. The 30-day mortality rate was 6.0% with all 30-day deaths occurring in females (P = .002). One (0.76%) central nervous system hemorrhage (CNS) was noted in this cohort. Primary patency for the entire cohort at 12 and 24 months was 50.1% (95% confidence interval [CI], 39.5-60.7) and 37.7% (95% CI, 26.2-49.1), respectively, while secondary patency was 74.0% (95% CI, 64.9-83.1) and 65.3% (95% CI, 54.5-76.2). Multivariable analyses identified patients presenting with femoropopliteal (hazard ratio [HR] 2.63) or tibial thrombosis (HR 2.80); graft thrombosis (vs native artery thrombosis, HR 2.57) and long-term dialysis (HR 3.66, 95% CI, 2.35-5.71, P < .001) were associated with poorer primary patency rates. Cumulative limb salvage at 24 months was 68.8% (95% CI: 59.5-78.1) with female gender (HR 3.34, P = .002) and thrombolysis ≥ 3 days (HR 2.35, P = .019) associated with an increased risk of limb loss. Overall 36-month survival was 84.5% (95% CI: 77.5-91.6). Women had decreased survival rates both in the short- and midterm (HR 6.29; 95% CI, 1.78-22.28; P = .004).
Endovascular therapy with thrombolysis remains an effective treatment option for patients presenting with lower extremity ALI. Thrombolysis should be limited to <3 days. Female gender negatively affects the rates of limb salvage and survival.
下肢急性肢体缺血（ALI）仍然是一个具有挑战性的临床难题。ALI 的治疗已经转向血管内治疗。本研究的目的是评估接受动脉内溶栓和/或辅助血管内技术治疗的 ALI 患者的结局。
连续纳入 2005 年 1 月 1 日至 2007 年 9 月 30 日期间接受血管内动脉内方法治疗的下肢 ALI 患者，并对其进行回顾性分析。使用广义估计方程，采用逻辑和比例优势回归比较成功率、溶栓天数和除死亡率以外的所有 30 天结局。使用逻辑回归评估 30 天死亡率。使用时间事件方法（包括 Kaplan-Meier 估计和 Cox 比例风险模型）评估长期通畅率、肢体挽救率和生存率。
分析数据集包括 119 例患者的 129 条肢体出现 ALI（I 级 68%，IIa 级 23%，IIb 级 9%）。平均随访时间为 16.8 个月（范围：0-43 个月）。82%的病例达到技术成功。30 天死亡率为 6.0%，所有 30 天死亡均发生在女性（P=0.002）。本队列中仅发生 1 例（0.76%）中枢神经系统出血（CNS）。全队列 12 个月和 24 个月的主要通畅率分别为 50.1%（95%置信区间 [CI]：39.5-60.7）和 37.7%（95%CI：26.2-49.1），而次要通畅率分别为 74.0%（95%CI：64.9-83.1）和 65.3%（95%CI：54.5-76.2）。多变量分析确定了出现股腘或胫血栓形成的患者（风险比 [HR] 2.63）或出现移植物血栓形成（与原生动脉血栓形成相比，HR 2.57）和长期透析（HR 3.66，95%CI：2.35-5.71，P<.001）与较低的主要通畅率相关。24 个月时累积肢体挽救率为 68.8%（95%CI：59.5-78.1），女性（HR 3.34，P=0.002）和溶栓≥3 天（HR 2.35，P=0.019）与肢体丧失风险增加相关。总体 36 个月生存率为 84.5%（95%CI：77.5-91.6）。女性在短期和中期的生存率均下降（HR 6.29；95%CI：1.78-22.28；P=0.004）。
溶栓联合血管内治疗仍然是治疗下肢 ALI 的有效治疗选择。溶栓治疗应限制在 3 天以内。女性会降低肢体挽救率和生存率。
