药物涂层球囊在NSTE-ACS患者中的安全性和有效性比较:9个月随访结果分析

Safety and efficacy of drug-coated balloon in patients with non-ST elevation acute coronary syndrome:9-month follow-up analysis

目的:探讨在非ST抬高型急性冠状动脉综合征(NSTE-ACS)患者中应用药物涂层球囊处理靶病变,并与药物涂层支架相比,观察其9个月有效性及安全性。方法:连续入选97例NSTE-ACS患者,入院给予冠状动脉(冠脉)造影,55例给予药物涂层支架治疗,42例给予药物球囊治疗,随访9个月并复查冠脉造影,观察两组主要不良心脏事件(MACE)。结果:两组患者术后即刻药物涂层支架组残余狭窄优于药物球囊组[(23.36±12.54)%∶(29.69±12.37)%;P=0.02],且药物球囊组A、B型夹层发生率明显高于药物涂层支架组(11.9%∶0%;P=0.00),9个月随访复测冠脉造影显示两组患者靶病变再狭窄率[(31.67±12.35)%∶(33.41±13.45)%;P=0.46]和晚期管腔丢失[(0.24±0.02)∶(0.21±0.02);P=0.56]无明显差异。两组总体MACE(9.1%∶9.5%,HR:1.07,95%CI:0.26~4.4;P=0.92)无显著差异,两组靶病变再次血运重建(5.5%∶9.5%,HR:1.91,95%CI:0.39~9.32;P=0.42)也无显著差异。结论:药物球囊在NSTE-ACS患者中是安全有效的。

Objective:To compare the effect and safety of DCB in NSTE-ACS patients with DES.Method:The 97 consecutive patients with NSTE-ACS were enrolled in this study.Coronary angiography was performed on admission.DES were implanted in 55 patients and DCB in 42 patients.All patients were followed up for 9 months with coronary reangiography.Result:Residual stenosis after procedure in DES group was better than that in DCB group[(23.36±12.54)%vs.(29.69±12.37);P=0.02],and the incidence of type A and B dissection in DCB group was significantly higher than that in DES group(11.9%vs.0%;P=0.00).Coronary angiography at 9 months follow-up showed that target lesions restenosis[(31.67±12.35)%vs.(33.41±13.45)%;P=0.46]and late lumen loss[(0.24+0.02)vs.(0.21+0.02);P=0.56]in both groups have no significant difference.There was no significant difference in MACE(9.1%vs.9.5%,HR:1.07,95%CI:0.26-4.4;P=0.92)and TLR(5.5%vs.9.5%,HR:1.91,95%CI:0.39-9.32;P=0.42)between the two groups.Conclusion:DCB is safe and effective in patients with NSTE-ACS.