Fisher C M, Fletcher J P, May J, White G H, Lord R S, Crozier J, Conner G
University of Sydney and Westmead Hospital, Australia.
Eur J Vasc Endovasc Surg. 1996 Apr;11(3):349-52. doi: 10.1016/s1078-5884(96)80084-0.
To evaluate the efficacy of the addition of plaque ablation by hot-tip laser to balloon angioplasty.
Prospective randomised clinical trial.
Patients with either occlusion orf > 50% diameter stenosis less than 3 cm in length in the superficial femoral artery, and with two or three calf vessel run-off were eligible and randomised to receive either balloon angioplasty alone or with laser assistance. Treatment failure in follow-up was defined as reocclusion or recurrence of greater that 50% stenosis at the site of angioplasty.
Ninety limbs (82 patients) were entered into the study. Forty-four patients had mild claudication, 32 more severe symptoms and 6 rest pain or ulceration. More patients with diabetes (5 of 5, p = 0.04, Fisher's exact test) and occlusions (16 of 22, p < 0.05, chi(2)) were randomised to the laser group. Initial technical success was obtained in all lesions. The median duration of follow-up was 1 year. Failure occurred in 40 limbs during follow-up. Three segments, all with initial occlusions and undergoing laser angioplasty re-occluded within 2 days, one requiring immediate thrombectomy. Another 20 limbs underwent further intervention. Overall success (+/- S.D.) (Kaplan-Meier) at 1 year was 67% (+/- 5%) and at 2 years 43% (+/- 7%). Only increased age, initial occlusion, female sex, and not smoking were significantly (p < 0.05, Cox's proportional hazards) associated with failure; on multivariate analysis, age and occlusion were the best independent predictors. There was no significant difference (p > 0.05) in outcome between limbs undergoing laser assisted balloon angioplasty and balloon alone either overall of within the stenosis or occlusion subgroups.
This study found no significant benefit was gained by the addition of laser to balloon angioplasty and that the long term success was modest for lesions considered to be suitable for angioplasty.
评估在球囊血管成形术基础上增加热尖端激光斑块消融术的疗效。
前瞻性随机临床试验。
入选标准为股浅动脉闭塞或直径狭窄超过50%且长度小于3 cm，同时伴有两至三支小腿血管分支的患者，将其随机分为两组，分别接受单纯球囊血管成形术或球囊血管成形术联合激光辅助治疗。随访期内治疗失败定义为血管成形术部位再次闭塞或狭窄程度复发超过50%。
90条肢体（82例患者）纳入本研究。44例患者有轻度间歇性跛行，32例症状较重，6例有静息痛或溃疡。更多糖尿病患者（5例中的5例，p = 0.04，Fisher精确检验）和闭塞患者（22例中的16例，p < 0.05，卡方检验）被随机分配至激光治疗组。所有病变均取得了初始技术成功。随访的中位时间为1年。随访期间40条肢体出现失败。三个节段，均为初始闭塞且接受激光血管成形术治疗，在2天内再次闭塞，其中1例需要立即进行血栓切除术。另外20条肢体接受了进一步干预。1年时总体成功率（±标准差）（Kaplan-Meier法）为67%（±5%），2年时为43%（±7%）。仅年龄增加、初始闭塞、女性以及不吸烟与失败显著相关（p < 0.05，Cox比例风险模型）；多因素分析显示，年龄和闭塞是最佳的独立预测因素。在总体上以及狭窄或闭塞亚组内，接受激光辅助球囊血管成形术的肢体与单纯接受球囊血管成形术的肢体在结局方面无显著差异（p > 0.05）。
本研究发现，在球囊血管成形术基础上增加激光治疗未带来显著益处，对于被认为适合血管成形术的病变，其长期成功率一般。
