Objective: To evaluate the safety and feasibility of treating de novo coronary lesions with paclitaxel-eluting balloon. Methods: This is a retrospective study, which enrolled 76 patients with 80 de novo coronary lesions treated with paclitaxel-eluting balloons(<30% residual stenosis and there was no blood flow limited dissection after pretreatment) from April 2015 to November 2016 in Guangdong general hospital. The data of basic characteristics,procedures,devices and follow-up information were retrieved and analyzed. The primary endpoint was the composite of cardiac death, recurrent myocardial infarction and target lesion revascularization. Results: (1)The age was (63.3±10.3) years. There were 68.4%(52/76) acute coronary syndrome patients, prevalence of type 2 diabetes was 36.8%(28/76), and 64.5%(49/76)patients with at least one high bleeding risk. (2)The lesion length was (17.4±7.6)mm, and the stenosis was (88.1±8.2)%.The reference vessel diameter≥2.75 mm accounted for 51.2% (41/80), and bifurcation stenosis accounted for 67.5%(54/80). (3)53.7%(43/80) lesions were pretreated with scoring balloon to optimize plaque modification. The paclitaxel-eluting balloon length and diameter were (22.3±5.5)mm and (2.74±0.52)mm.The residual stenosis was (12.3±10.3)%. Procedural success was 88.8%(71/80).Bail-out stenting rate was 5.0%(4/80). (4)The median follow-up duration was 12(6, 25) months. Primary endpoint occurred in 3 cases (3.9%), including 2 cardiac deaths(1 patient died of recurrent myocardial infarction, and 1 patient died of acute heart failure induced by severe mitral insufficiency), and one patient receivedtarget lesion revascularization. Conclusion: In case of no more than 30% residual stenosis and no blood flow limited dissection after lesion pretreatment,it is safe and feasible to treat de novo coronary lesionsusing paclitaxel-eluting balloon.
目的： 探讨紫杉醇洗脱球囊治疗冠状动脉原发病变的安全性和可行性。 方法： 纳入2015年4月至2016年11月在广东省人民医院使用紫杉醇洗脱球囊治疗的冠状动脉原发病变患者76例（共80处原发病变，接受预处理后残余狭窄<30%，且未发生限制冠状动脉血流的夹层）。回顾性分析患者的基线资料、介入治疗情况和即刻效果,并进行临床随访，主要终点是心原性死亡、再发心肌梗死和靶病变血运重建。 结果： （1）患者年龄（63.3±10.3）岁，急性冠状动脉综合征患者占68.4%（52/76），合并糖尿病者占36.8%（28/76），合并至少1项出血高危因素者占64.5%（49/76）。（2）以紫杉醇洗脱球囊处理的冠状动脉原发病变长度为（17.4±7.6）mm，狭窄程度为（88.1±8.2）%，51.2%（41/80）的病变参考血管直径≥2.75 mm，分叉病变占67.5%（54/80）。（3）53.7%（43/80）的冠状动脉病变使用嵌入式球囊进行预处理。紫杉醇洗脱球囊长度为（22.3±5.5）mm，直径为（2.74±0.52）mm，术后残余狭窄为（12.3±10.3）%。技术成功率为88.8%（71/80），补救性支架置入率为5.0%（4/80）。（4）术后随访时间中位数为12（6，25）个月，主要终点事件发生率为3.9%（3/76），其中心原性死亡2例（再发心肌梗死导致死亡1例，合并重度二尖瓣关闭不全患者发生急性心力衰竭导致死亡1例），靶病变血运重建1例。 结论： 使用紫杉醇涂层球囊治疗预处理后残余狭窄<30%且无限制血流夹层的冠状动脉原发病变安全、可行。.
Keywords: Coronary artery disease; Paclitaxel-eluting balloon; Treatment outcome.