MPH, Department of Cardiology, The Children's Hospital, 300 Longwood Ave, Boston, MA 02115, USA.
Circulation. 2011 Nov 29;124(22):2388-96. doi: 10.1161/CIRCULATIONAHA.111.018200. Epub 2011 Oct 31.
We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon therapy (HPB) for the treatment of pulmonary artery stenosis.
This prospective, randomized, multicenter, investigational device exemption trial compared CB with HPB. Patient eligibility was determined at the precatheterization assessment; vessel eligibility was determined at catheterization. In all vessels, low-pressure balloon dilation to 8 atm was performed, and if it was not successful, the vessel was randomized to CB or HPB. The primary efficacy outcome was percent change in minimum lumen diameter. A core laboratory performed all vessel measurements and angiographic assessment of vessel damage. The primary safety outcome was any serious adverse event attributable to vessel dilation as assessed by the Data and Safety Monitoring Board. Seventy-three patients from 8 institutions were enrolled between 2004 and 2008. In these patients, 72 vessels responded to low-pressure balloon dilation. Of the 173 vessels that met eligibility criteria, 107 were randomized to CB and 66 to HPB. In randomized vessels, CB therapy was associated with greater percent increase in lumen diameter (85% versus 52%; P=0.004). After crossover was introduced, 26 of 47 vessels treated with HPB underwent CB therapy and experienced an additional 48% increase in lumen diameter; the final diameter after CB was 99% greater than the initial diameter. There were no serious adverse events related to treatment in a study vessel.
CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.
我们旨在确定切割球囊治疗（CB）与传统高压球囊治疗（HPB）治疗肺动脉狭窄的安全性和疗效。
这项前瞻性、随机、多中心、研究性器械豁免试验比较了 CB 与 HPB。在经皮血管成形术前评估中确定患者的入选条件；在导管插入术中确定血管的入选条件。在所有血管中，先以 8 个大气压进行低压球囊扩张，如果不成功，则将血管随机分为 CB 或 HPB 组。主要疗效终点是最小管腔直径的百分比变化。一个核心实验室对所有血管进行测量和血管造影评估血管损伤。主要安全性终点是由数据和安全监测委员会评估的与血管扩张相关的任何严重不良事件。2004 年至 2008 年期间，8 家机构共纳入 73 例患者。在这些患者中，72 条血管对低压球囊扩张有反应。在符合入选标准的 173 条血管中，107 条血管随机分为 CB 组，66 条血管随机分为 HPB 组。在随机分组的血管中，CB 治疗组管腔直径的百分比增加更大（85%比 52%；P=0.004）。引入交叉治疗后，66 条接受 HPB 治疗的血管中有 26 条接受了 CB 治疗，管腔直径进一步增加了 48%；最终 CB 后的直径比初始直径大 99%。在研究血管中，没有与治疗相关的严重不良事件。
对于对低压球囊无反应的肺动脉狭窄，CB 治疗比 HPB 治疗更有效，且具有相当的安全性。
