Klinik für Diagnostische Radiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
J Vasc Interv Radiol. 2010 Feb;21(2):186-94. doi: 10.1016/j.jvir.2009.10.021.
To evaluate safety and efficacy of cryoplasty versus conventional angioplasty for focal popliteal arterial occlusive disease.
Patients with focal atherosclerotic stenoses and occlusions of the popliteal artery were randomized to cryoplasty or conventional angioplasty as the initial treatment strategy. The primary objective was target lesion patency. The secondary endpoint was treatment success without the need for stents. Duplex ultrasonography was performed at 3, 6, 9, and 15 months.
Eighty-six patients (mean age, 72 years; age range, 50-94 years) were enrolled in this study. Forty patients were randomized to cryoplasty and 46 to conventional angioplasty. Demographics, risk factors, clinical stage of disease, and lesion details were comparable. On intention-to-treat basis, initial success was 35% for cryoplasty versus 54% for conventional angioplasty (P = .02). The rate of grade C dissection was 35% after cryoplasty and 26% after conventional angioplasty (P = .4). Optional long-term percutaneous transluminal angioplasty (PTA) was performed in 58% of cryoplasty patients. The rate of stent placement for dissection and/or residual stenosis was 30% after cryoplasty (including long-term dilation) and 39% after conventional angioplasty (P = .34). The mean (+/-standard deviation) target lesion patency at 9 months was 79.3% +/- 7.5 for cryoplasty and 66.7% +/-8.1 for conventional angioplasty; however, the results are not significant (P = .14).
Cryoplasty of the popliteal artery alone showed a lower anatomic success when compared with conventional angioplasty. Combined with optional long-term PTA, however, stent placement was not needed more often. There was a trend toward higher patency after cryoplasty, but differences were not statistically significant and results of long-term follow-up have to be awaited.
评估冷冻血管成形术与传统血管成形术治疗局灶性腘动脉闭塞性疾病的安全性和疗效。
将患有局灶性动脉粥样硬化性狭窄和腘动脉闭塞的患者随机分为冷冻血管成形术组或传统血管成形术组，作为初始治疗策略。主要目标是靶病变通畅率。次要终点是无需支架治疗的治疗成功。在 3、6、9 和 15 个月时进行双功能超声检查。
本研究共纳入 86 例患者（平均年龄 72 岁；年龄范围 50-94 岁）。40 例患者随机分为冷冻血管成形术组，46 例患者随机分为传统血管成形术组。两组患者的人口统计学、危险因素、疾病临床分期和病变细节均相似。意向治疗基础上，冷冻血管成形术组的初始成功率为 35%，传统血管成形术组为 54%（P =.02）。冷冻血管成形术后夹层发生率为 35%，传统血管成形术后夹层发生率为 26%（P =.4）。58%的冷冻血管成形术患者选择进行选择性长期经皮腔内血管成形术（PTA）。冷冻血管成形术后因夹层和/或残余狭窄而放置支架的比例为 30%（包括长期扩张），传统血管成形术后为 39%（P =.34）。9 个月时，冷冻血管成形术组的平均（+/-标准差）靶病变通畅率为 79.3% +/- 7.5%，传统血管成形术组为 66.7% +/-8.1%；然而，结果没有统计学意义（P =.14）。
与传统血管成形术相比，单纯行冷冻血管成形术治疗腘动脉时，解剖学成功率较低。然而，结合选择性长期 PTA，支架放置的需求并不更高。冷冻血管成形术后有更高的通畅率趋势，但差异无统计学意义，需要等待长期随访结果。
