Ouriel K, Shortell C K, DeWeese J A, Green R M, Francis C W, Azodo M V, Gutierrez O H, Manzione J V, Cox C, Marder V J
Department of Surgery, University of Rochester, NY 14642.
J Vasc Surg. 1994 Jun;19(6):1021-30. doi: 10.1016/s0741-5214(94)70214-4.
Despite the widespread use of intraarterial thrombolytic therapy for peripheral arterial occlusive disease, a randomized study comparing its efficacy with that of operative intervention has never been performed. This study evaluates the potential of intraarterial urokinase infusion to provide clinical benefits in patients with acute peripheral arterial occlusion.
Patients with limb-threatening ischemia of less than 7 days' duration were randomly assigned to intraarterial catheter-directed urokinase therapy or operative intervention. Anatomic lesions unmasked by thrombolysis were treated with balloon dilation or operation. The primary end points of the study were limb salvage and survival.
A total of 57 patients were randomized to the thrombolytic therapy group, and 57 patients were randomized to the operative therapy group. Thrombolytic therapy resulted in dissolution of the occluding thrombus in 40 (70%) patients. Although the cumulative limb salvage rate was similar in the two treatment groups (82% at 12 months), the cumulative survival rate was significantly improved in patients randomized to the thrombolysis group (84% vs 58% at 12 months, p = 0.01). The mortality differences seemed to be primarily attributable to an increased frequency of in-hospital cardiopulmonary complications in the operative treatment group (49% vs 16%, p = 0.001). The benefits of thrombolysis were achieved without significant differences in the duration of hospitalization (median 11 days) and with only modest increases in hospital cost in the thrombolytic treatment arm (median $15,672 vs $12,253, p = 0.02).
Intraarterial thrombolytic therapy was associated with a reduction in the incidence of in-hospital cardiopulmonary complications and a corresponding increase in patient survival rates. These benefits were achieved without an appreciable increase in the duration of hospitalization and with only modest increases in hospital cost, suggesting that thrombolytic therapy may offer a safe and effective alternative to operation in the initial treatment of patients diagnosed with acute limb-threatening peripheral arterial occlusion.
尽管动脉内溶栓疗法广泛应用于外周动脉闭塞性疾病，但尚未进行过将其疗效与手术干预疗效进行比较的随机研究。本研究评估动脉内输注尿激酶为急性外周动脉闭塞患者带来临床益处的可能性。
将肢体缺血时间小于7天且有肢体威胁的患者随机分为动脉内导管定向尿激酶治疗组或手术干预组。溶栓后暴露的解剖学病变采用球囊扩张或手术治疗。该研究的主要终点是肢体挽救和生存。
共有57例患者被随机分配至溶栓治疗组，57例患者被随机分配至手术治疗组。溶栓治疗使40例（70%）患者的闭塞血栓溶解。尽管两个治疗组的累积肢体挽救率相似（12个月时为82%），但随机分配至溶栓组的患者累积生存率显著提高（12个月时为84%对58%，p = 0.01）。死亡率差异似乎主要归因于手术治疗组住院期间心肺并发症发生率增加（49%对16%，p = 0.001）。溶栓治疗的益处体现在住院时间无显著差异（中位数11天），且溶栓治疗组的住院费用仅适度增加（中位数15,672美元对12,253美元，p = 0.02）。
动脉内溶栓治疗与住院期间心肺并发症发生率降低及患者生存率相应提高相关。这些益处的实现并未使住院时间明显延长，且住院费用仅适度增加，这表明在诊断为急性肢体威胁性外周动脉闭塞的患者初始治疗中，溶栓治疗可能是一种安全有效的手术替代方法。
