Comerota A J, Weaver F A, Hosking J D, Froehlich J, Folander H, Sussman B, Rosenfield K
Temple University Hospital, Philadelphia, Pennsylvania 19140, USA.
Am J Surg. 1996 Aug;172(2):105-12. doi: 10.1016/S0002-9610(96)00129-8.
The purpose of this study was to prospectively evaluate the treatment of patients with occluded lower extremity bypass grafts, comparing surgical revascularization with catheter-directed thrombolysis.
One hundred twenty-four patients (68% male and 32% female) with lower limb bypass graft occlusion (46 autogenous and 78 prosthetic) were prospectively randomized to surgery (n = 46) or intra-arterial catheter-directed thrombolysis (n = 78) with recombinant tissue plasminogen activator (rt-PA) 0.1 mg/kg/h modified to 0.05 mg/kg/h for up to 12 hours, or urokinase (UK) 250,000 U bolus followed by 4,000 U/min for 4 hours, then 2,000 U/min for up to 36 hours. A composite clinical outcome including death, amputation, ongoing/recurrent ischemia, and major morbidity was analyzed on an intent-to-treat basis at 30 days and 1 year.
The average duration of graft occlusion was 34.0 days, with 58 (48%) presenting with acute ischemia (0 to 14 days) and 64 (52%) with chronic ischemia (> 14 days). Thirty-nine percent randomized to lysis failed catheter placement and required surgical revascularization. Overall, there was a better composite clinical outcome at 30 days (P = 0.023) and 1 year (P = 0.04) in the surgical group compared with lysis, due predominately to a reduction in ongoing/recurrent ischemia, most notable in autogenous grafts. However, following successful catheter placement, patency was restored by lysis in 84%, and 42% had a major reduction in their planned operation. One-year results of successful lysis compared favorably with the best surgical procedure, which was new graft placement. Acutely ischemic patients (0 to 14 days) randomized to lysis demonstrated a trend toward a lower major amputation rate at 30 days (P = 0.074) and significantly at 1 year (P = 0.026) compared with surgical patients, while those with > 14 days ischemia showed no difference in limb salvage but higher ongoing/recurrent ischemia in lytic patients (P < 0.001). Patients with occluded prosthetic grafts had greater major morbidity than did those with occluded autogenous grafts (P < 0.02).
Proper catheter positioning currently limits the potential of catheter-directed thrombolysis for lower extremity bypass graft occlusion. Patients with graft occlusion > 14 days have a significantly better outcome when treated surgically, with a new bypass being the best surgical option. However, in patients with acute limb ischemia (< 14 days) successful thrombolysis of occluded lower extremity bypass grafts improves limb salvage and reduces the magnitude of the planned surgical procedure. Patients with occluded prosthetic grafts suffer more major morbid events compared with occluded autogenous grafts.
本研究的目的是前瞻性评估下肢搭桥血管闭塞患者的治疗，比较外科血管重建术与导管定向溶栓治疗。
124例下肢搭桥血管闭塞患者（男性68%，女性32%），其中自体血管搭桥46例，人工血管搭桥78例，前瞻性随机分为手术组（n = 46）或动脉内导管定向溶栓组（n = 78）。重组组织型纤溶酶原激活剂（rt-PA）初始剂量为0.1 mg/kg/h，调整为0.05 mg/kg/h，持续12小时，或尿激酶（UK）250,000 U静脉推注，随后4,000 U/min持续4小时，然后2,000 U/min持续36小时。在30天和1年时，基于意向性分析评估包括死亡、截肢、持续性/复发性缺血和严重并发症在内的综合临床结局。
血管闭塞的平均持续时间为34.0天，58例（48%）表现为急性缺血（0至14天），64例（52%）表现为慢性缺血（> 14天）。随机接受溶栓治疗的患者中有39%置管失败，需要进行外科血管重建术。总体而言，与溶栓组相比，手术组在30天（P = 0.023）和1年（P = 0.04）时的综合临床结局更好，主要是由于持续性/复发性缺血减少，在自体血管搭桥中最为明显。然而，成功置管后，84%的患者通过溶栓恢复了血管通畅，42%的患者计划手术大幅减少。成功溶栓的1年结果与最佳外科手术（即新血管搭桥）相比具有优势。与手术患者相比，随机接受溶栓治疗的急性缺血患者（0至14天）在30天时主要截肢率有降低趋势（P = 0.074），在1年时显著降低（P = 0.026），而缺血> 14天的患者在保肢方面无差异，但溶栓患者的持续性/复发性缺血更高（P < 0.001）。人工血管搭桥闭塞患者的严重并发症比自体血管搭桥闭塞患者更多（P < 0.02）。
目前合适的导管定位限制了导管定向溶栓治疗下肢搭桥血管闭塞的潜力。血管闭塞> 14天的患者手术治疗效果明显更好，新的搭桥手术是最佳手术选择。然而，对于急性肢体缺血（< 14天）的患者，成功溶栓闭塞的下肢搭桥血管可改善保肢情况并减少计划手术的规模。与自体血管搭桥闭塞患者相比，人工血管搭桥闭塞患者发生更多严重不良事件。
