Byrne Raphael M, Taha Ashraf G, Avgerinos Efthymios, Marone Luke K, Makaroun Michel S, Chaer Rabih A
Department of Surgery, Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.
Department of Surgery, Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa; Department of Vascular Surgery, Assiut University, Assiut, Egypt.
J Vasc Surg. 2014 Apr;59(4):988-95. doi: 10.1016/j.jvs.2013.10.054. Epub 2013 Dec 17.
Thrombolysis as a treatment for acute limb ischemia (ALI) has become a first-line therapy based on studies published over 2 decades ago. The purpose of this study was to assess outcomes of patients treated for ALI using contemporary thrombolytic agents and endovascular techniques.
Consecutive patients with ALI of the lower extremities treated between 2005 and 2011 were identified, and their records were retrospectively reviewed. All patients were treated with tissue plasminogen activator delivered via catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombolysis (PMT), with other adjunctive endovascular or surgical interventions. Procedural success, thrombolysis duration, and 30-day and long-term outcomes were obtained for the whole series and were also compared between the CDT and PMT groups. Limb salvage and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models.
A total of 154 limbs were treated in 147 patients presenting with ALI (Rutherford class I, 9.7%; class IIa, 70.1%; class IIb, 20.1%). The mean follow-up was 15.20 months (range, 0.56-56.84 months). Indications for intervention included embolization (14.3%), thrombosed bypass (36.4%), thrombosed stent (26.6%), native artery thrombosis (24.0%), and thrombosed popliteal aneurysm (3.2%). Technical success was achieved in 83.8% of cases, with a 30-day mortality rate of 5.2%. Procedural complications included systemic bleeding (5.2%), access site hematoma (4.5%), acute renal failure (1.9%), and distal embolization (9.7%). The mean runoff score decreased from 13.42 preintervention to 7.43 postintervention. Adjuvant revascularization procedures were required in 89.0% of patients and were endovascular (68.8%), hybrid (9.1%), or open (11.0%). Only 3.2% of patients required a fasciotomy. The overall rate of major amputation was 15.0% (18.1% for CDT only, 11.3% for PMT; P = NS). Predictors of limb loss by Cox proportional hazards models included end-stage renal disease (hazard ratio [HR], 8.563; P < .001) and poor pedal outflow, with an incremental protective effect for improved pedal outflow (HR, 0.205; P < .001 for one pedal outflow vessel; HR, 0.074; P < .001 for ≥ two pedal outflow vessels). Gender, smoking, diabetes, Rutherford score, runoff score, thrombosed popliteal aneurysm, and PMT were not significant predictors of limb loss. The use of PMT was a significant predictor of technical success (odds ratio, 2.67; P = .046).
Endovascular therapy with thrombolysis using tissue plasminogen activator remains an effective treatment option for patients presenting with mild or moderate lower extremity ALI, with equal benefit derived with CDT or PMT. Patients with end-stage renal disease or poor pedal outflow have an increased risk of limb loss and may benefit from alternative revascularization strategies.
基于20多年前发表的研究,溶栓作为急性肢体缺血(ALI)的一种治疗方法已成为一线治疗手段。本研究的目的是评估使用当代溶栓药物和血管内技术治疗ALI患者的疗效。
确定2005年至2011年间接受治疗的连续性下肢ALI患者,并对其记录进行回顾性分析。所有患者均接受通过导管定向溶栓(CDT)和/或药物机械溶栓(PMT)给予的组织型纤溶酶原激活剂治疗,以及其他辅助性血管内或外科干预。获得整个系列的手术成功率、溶栓持续时间以及30天和长期疗效,并在CDT组和PMT组之间进行比较。使用事件发生时间方法评估肢体挽救和生存率,包括Kaplan-Meier估计和Cox比例风险模型。
147例ALI患者共治疗了154条肢体(卢瑟福分级I级,9.7%;IIa级,70.1%;IIb级,20.1%)。平均随访时间为15.20个月(范围0.56 - 56.84个月)。干预指征包括栓塞(14.3%)、搭桥血管血栓形成(36.4%)、支架内血栓形成(26.6%)、原位动脉血栓形成(24.0%)和腘动脉瘤血栓形成(3.2%)。83.8%的病例获得技术成功,30天死亡率为5.2%。手术并发症包括全身出血(5.2%)、穿刺部位血肿(4.5%)、急性肾衰竭(1.9%)和远端栓塞(9.7%)。平均流出道评分从干预前的13.42降至干预后的7.43。89.0%的患者需要辅助性血运重建手术,其中血管内手术(68.8%)、杂交手术(9.1%)或开放手术(11.0%)。仅3.2%的患者需要进行筋膜切开术。主要截肢的总体发生率为15.0%(仅CDT组为18.1%,PMT组为11.3%;P = 无显著性差异)。Cox比例风险模型中肢体丢失的预测因素包括终末期肾病(风险比[HR],8.563;P < 0.001)和足部流出道不佳,足部流出道改善有递增的保护作用(HR,0.205;一条足部流出道血管时P < 0.001;两条及以上足部流出道血管时HR,0.074;P < 0.001)。性别、吸烟、糖尿病、卢瑟福评分、流出道评分、腘动脉瘤血栓形成和PMT不是肢体丢失的显著预测因素。使用PMT是技术成功的显著预测因素(优势比,2.6;P = 0.046)。
使用组织型纤溶酶原激活剂进行溶栓的血管内治疗仍然是轻度或中度下肢ALI患者的一种有效治疗选择,CDT或PMT带来的益处相同。终末期肾病或足部流出道不佳的患者肢体丢失风险增加,可能从替代的血运重建策略中获益。