Objective: To evaluate the efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters ≥ 2.8 mm. Methods: This prospective study included 215 consecutive patients with 238 de novo lesions, who received paclitaxel-coated balloon angioplasty in Beijing Hospital from May 2014 to June 2016. According to the reference vessel diameter, the patients were divided into large vessel disease (LVD) group (reference vessel diameter≥2.8 mm, 85 patients and 90 lesions) and small vessel disease (SVD) group (reference vessel diameter<2.8 mm, 130 patients and 148 lesions). Clinical characteristics, interventional procedures and major adverse cardiovascular events (includingall-cause mortality, non-fatal myocardial infarction and target lesion revascularization) after procedure were compared between the 2 groups. Results: (1)Patients in LVD group were younger than SVD group ((60.1±11.1) years old vs. (65.0±10.6) years old, P<0.01), and less patients had diabetes (24.7% (21/85) vs. 43.1%(56/130), P<0.01).(2)Prevalence of three-vessel disease (35.5%(30/85) vs. 53.6%(67/130), P<0.05) and complex lesions (type B2/C,34.4% (31/90) vs. 50.0%(74/148), P<0.05) were significantly lower in LVD group than in SVD group.(3) During pre-dilation, the rate with plain balloons use was significantly higher in SVD group than in LVD group(76.4%(113/148) vs. 58.9%(53/90), P<0.01), while the proportion of additional use of non-compliant balloons was significantly higher in LVD groupthan in SVD group(20.0% (18/90) vs. 3.4% (5/148) , P<0.01). The ratio of paclitaxel-coated balloon diameter/RVD was significantly lower (0.87±0.12 vs. 0.96±0.15, P<0.01) and the duration of dilationwas significantly shorter ((41.5±9.5) seconds vs. (45.1±9.1) seconds, P<0.01) in LVD group than those in SVD group. Each group had 1 failure case that was bailout stented with drug-eluting stents. The success rate of paclitaxel-coated balloon treatment was similar in LVD group and SVD group (98.9% (89/90) vs. 99.3%(147/148), P>0.05).(4) At the fourth day of procedure, there was 1 acute myocardial infarction requiring emergent target lesion revascularization in SVD group. No major adverse cardiovascular event was observed in LVD group during hospitalization. Forty-two patients with 53 lesions, including 27 LVD lesions and 26 SVD lesions,underwent coronary angiography at (9.4±4.6) months after paclitaxel-coated balloon intervention. The quantitative coronary angiography analysis showed that minimal lumen diameter significantlyincreased during follow-up than that of post-procedurein SVD group ((1.71±0.36)mm vs. (1.52±0.30)mm, P<0.05) , while in LVD group the minimal lumen diameter was similar between during follow-up and post-procedure ((2.35±0.48)mm vs. (2.19±0.34)mm, P>0.05). Major adverse cardiovascular event rate was 0 in LVD group and 2.3%(3/130) in SVD group (P>0.05) during follow up. No death was observed in this patient cohort. Conclusion: Treatment with paclitaxel-coated balloon for de novo coronary lesions with diameters≥2.8 mm is safe and effective.
目的： 探讨紫杉醇涂层球囊（PCB）治疗直径≥2.8 mm冠状动脉原发病变的临床效果。 方法： 采用前瞻性研究方法，连续入选2014年5月至2016年6月在北京医院应用PCB行冠状动脉原发病变介入治疗的冠心病患者215例（冠状动脉原发病变238处）。根据病变参考血管直径，将冠心病患者分为大血管病变组（参考血管直径≥2.8 mm，85例患者，90处病变）和小血管病变组（参考血管直径<2.8 mm，130例患者，148处病变）。比较两组患者的临床基本资料、介入治疗和术后主要不良心血管事件（包括全因死亡、非致死性心肌梗死和靶病变血运重建）发生率。 结果： （1）大血管病变组平均年龄小于小血管病变组[（60.1±11.1）岁比（65.0±10.6）岁，P<0.01]，合并糖尿病比率低于小血管病变组[24.7%（21/85）比43.1%（56/130），P<0.01]。（2）大血管病变组冠状动脉三支病变[35.5%（30/85）比53.6%（67/130），P<0.05]和复杂病变[B2或C病变，34.4%（31/90）比50.0%（74/148），P<0.05]比率均低于小血管病变组。（3）在预扩张阶段，大血管病变组单用普通球囊的比率低于小血管病变组[58.9%（53/90）比76.4%（113/148），P<0.01]，而联合使用非顺应性球囊的比率高于小血管病变组[20.0%（18/90）比3.4%（5/148），P<0.01]。大血管病变组PCB直径/参考血管直径小于小血管病变组（0.87±0.12比0.96±0.15，P<0.01），PCB释放时间短于小血管病变组[（41.5±9.5）s比（45.1±9.1）s，P<0.01]。大血管病变组和小血管病变组各有1例病变行补救性支架置入术，操作成功率分别为98.9%（89/90）和99.3%（147/148），差异无统计学意义（P>0.05）。（4）小血管病变组1例患者在术后第4天因靶病变急性血栓形成行靶病变血运重建，大血管病变组住院期间未发生主要不良心血管事件。42例患者（共53处病变，其中大血管病变组27处病变，小血管病变组26处病变）在术后（9.4±4.6）个月行冠状动脉造影。定量冠状动脉造影分析显示，小血管病变组随访期间最小管腔直径大于术后即刻[（1.71±0.36）mm比（1.52±0.30）mm，P<0.05]，大血管病变组随访期与术后即刻的最小管腔直径差异无统计学意义[(2.35±0.48)mm比（2.19±0.34）mm，P>0.05]。随访期间，大血管病变组和小血管病变组主要不良心血管事件发生率分别为0和2.3%(3/130)，差异无统计学意义（P>0.05）；两组患者均无死亡。 结论： PCB治疗直径≥2.8 mm冠状动脉原发病变安全、有效。.
Keywords: Coronary artery disease; Paclitaxel-eluting balloon; Treatment outcome.