Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial
Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial
复制标题
糖尿病患者股腘动脉冷冻成形术与传统球囊血管成形术：前瞻性随机单中心对照试验的长期结果
DOI：
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发表时间：
2010
影响因子：
2.9
通讯作者：
D. Siablis
中科院分区：
文献类型：
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作者：
S. Spiliopoulos;K. Katsanos;D. Karnabatidis;A. Diamantopoulos;G. Kagadis;N. Christeas;D. Siablis
本研究的目的是研究冷冻成形术与传统球囊血管成形术在糖尿病患者股腘动脉中的即时和长期结果。将50例糖尿病患者（41例男性，平均年龄68岁）随机分配至股腘动脉冷冻成形术（组100; 24例患者，31处病变）或传统球囊血管成形术（组COBA; 26例患者，34处病变）。技术成功定义为残余狭窄<30%，无任何支架植入。主要终点包括技术成功、一期通畅、二次病变内再狭窄（>50%）和无靶病变再通。进行考克斯比例风险回归分析以校正异质性的混杂因素。总体而言，61.3%（19/31）的COBA组和61.3%（19/31）的COBA组为原发病变。两组中均超过70%的病变为跨大西洋协会共识（TASC）B和C级，其中41.4%的患者发生严重肢体缺血，COBA组为38.7%。即刻技术成功率分别为58.0%和64.0%（p = 0.29）。根据3年Kaplan-Meier估计值，患者生存率（CHTO组86.8% vs. COBA组87.0%，p = 0.54）和保肢率（CHTO组和COBA组分别为95.8% vs. 92.1%，p = 0.60）无显著差异。在CHTO组中，二元再狭窄增加的趋势不显著（风险比[HR] 1.3; 95% CI 0.6-2.6，p = 0.45）。与COBA组相比，COMO组的一期通畅率显著较低（HR 2.2; 95% CI 1.1-4.3，p = 0.02）。由于复发症状，在CHTO组中需要显著更多的重复干预事件（HR 2.5; 95% CI 1.2-5.3，p = 0.01）。与传统球囊血管成形术相比，冷冻成形术与较低的一期通畅率和长期随访后更多的临床驱动重复手术相关。
The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as <30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (>50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan–Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6–2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1–4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2–5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.
影响因子：
4.3
作者：
Faries, PL;Rohan, DI;LoGerfo, FW
通讯作者：
LoGerfo, FW
经皮治疗周围血管疾病：糖尿病和炎症的作用。
影响因子：
4.3
作者：
Nguyen,LouisL
通讯作者：
Nguyen,LouisL