摘要
目的评价新型螺旋刻痕球囊扩张导管在经皮冠状动脉介入治疗中的短期安全性和有效性。方法采用多中心、前瞻性、随机对照非劣效性试验设计。由解放军北部战区总医院牵头, 纳入2021年10月至2022年3月在3家中心收治的207例拟行经皮冠状动脉介入治疗的患者。按1∶1随机分为螺旋刻痕球囊组(n=104)和ScoreFlex球囊组(n=103), 随访30 d。主要终点为器械使用成功率, 定义为成功输送至靶病变、正常扩张回缩、成功撤出且预扩张后残余狭窄≤50.0%, 非劣效界值设定为-9.0%。次要终点包括手术成功率、30 d靶病变失败复合终点及患者相关的心血管临床复合终点。同时统计两组非器械相关不良事件及器械相关并发症发生率。结果螺旋刻痕球囊组年龄(60.1±9.3)岁, 男性69例(66.3%), ScoreFlex球囊组(61.2±9.0)岁, 男性74例(71.8%)。主要终点:螺旋刻痕球囊组器械使用成功率98.1%(102/104), ScoreFlex球囊组100.0%(103/103), 率差95%CI下限为-4.6%, 大于非劣效界值-9.0%, 证实非劣效性成立(P<0.001)。次要终点:两组手术成功率均为100.0%;均未发生30 d 靶病变失败复合终点和患者相关的心血管临床复合终点。安全性分析:螺旋刻痕球囊组和ScoreFlex球囊组非器械相关不良事件发生率分别为1.9%(2/104)和2.9%(3/103), 差异无统计学意义(P=0.683);两组均未发生器械相关并发症。结论新型螺旋刻痕球囊扩张导管在器械使用成功率方面非劣效于ScoreFlex球囊, 30 d安全性和有效性良好, 可作为经皮冠状动脉介入治疗的有效选择。
Objective:Evaluate the short-term safety and effectiveness of a novel helical scoring balloon catheter in the treatment of coronary lesions during percutaneous coronary intervention(PCI).Methods:This study employed a multicenter,prospective,randomized controlled non-inferiority trial design.Led by the General Hospital of Northern Theater Command,it enrolled 207 patients scheduled for PCI across three centers between October 2021 and March 2022.Patients were randomized 1∶1 to the spiral-scored balloon group(n=104)or the ScoreFlex balloon group(n=103)with 30-day follow-up.The primary endpoint was device success rate,defined as successful delivery to the target lesion,normal inflation and deflation,successful withdrawal,and residual stenosis≤50.0%after pre-ballooning.The non-inferiority margin was set at-9.0%.Secondary endpoints included procedure success rate,30-day target lesion failure,and patient-oriented cardiovascular clinical composite endpoint.The incidence of non-device-related adverse events and device-related complications was also assessed in both groups.Results:The spiral-scored balloon group had an average age of(60.1±9.3)years,with 69 males(66.3%).The ScoreFlex balloon group had an age of(61.2±9.0)years,with 74 males(71.8%).For the primary endpoint,the device success rate was 98.1%(102/104)in the spiral-scored balloon group and 100.0%(103/103)in the ScoreFlex balloon group.The lower limit of the 95%CI for the rate difference was-4.6%,exceeding the non-inferiority margin of-9.0%,confirming non-inferiority(P<0.001).For secondary endpoints,the procedure success rates were 100.0%in both groups.Neither group experienced the 30-day target lesion failure or patient-reported cardiovascular clinical composite endpoint.Safety analysis showed the incidence of non-device-related adverse events was 1.9%(2/104)in the spiral-scored balloon group and 2.9%(3/103)in the ScoreFlex balloon group,with no statistically significant difference(P=0.683).No device-related complications occurred in either group.Conclusions:The novel spiral scoring balloon catheter was noninferior to the ScoreFlex scoring balloon for device success and demonstrated favorable 30-day safety and effectiveness,supporting its use as an option for coronary lesion preparation during PCI.
作者
齐斌
徐凯
荆全民
韩雅玲
Qi Bin;Xu Kai;Jing Quanmin;Han Yaling(Department of Cardiology,General Hospital of Northern Theater Command,National Key Laboratory of Cold Zone Cardiovascular Disease,Shenyang 110016,China)
出处
《中华心血管病杂志》
北大核心
2026年第1期63-68,共6页
Chinese Journal of Cardiology
关键词
冠状动脉狭窄
经皮冠状动脉介入治疗
刻痕球囊
随机对照试验
非劣效性
Coronary artery stenosis
Percutaneous coronary intervention
Scoring balloon
Randomized controlled trial
Noninferiority
