药物球囊治疗冠状动脉支架内再狭窄的临床疗效

Clinical efficacy of drug balloon therapy for patients with coronary artery in-stent restenosis with unstable angina pectoris

目的探讨药物球囊治疗冠状动脉支架内再狭窄后病变血管内膜腔的变化。方法选取2016年5月至2017年12月确诊的不稳定型心绞痛患者,其在东南大学医学院附属江阴医院曾接受经皮冠状动脉药物洗脱支架植入术,因心绞痛再次接受冠状动脉造影检查,确定为支架内再狭窄的患者96例作为研究对象,将患者分为药物球囊治疗组(47例)及支架植入组(49例),比较术后即刻最小内膜腔面积、支架最小截面积、支架膨胀率等,术后12个月复查冠状动脉造影及血管内超声检查,比较两组心血管事件、最小内膜腔面积、支架最小截面积、内膜增生面积等。结果经冠状动脉造影及血管内超声检查:药物球囊治组疗术后即刻靶病变最小内膜腔面积和支架最小截面积均小于支架植入组[(10.8±2.8)mm^2 vs (11.8±3.2)mm^2;(11.2±2.9)mm^2 vs (12.0±3.2)mm^2],差异具有统计学意义(t=2.112、1.987,P=0.025、0.042);支架相对膨胀率药物球囊治疗组低于支架组(86.7%vs 90.3%),差异具有统计学意义(χ^2=2.012,P=0.045)。术后随访12个月,药物球囊治疗组发生心血管事件7例,支架植入组心血管事件9例,2组差异无统计学意义(P=0.699);药物球囊治疗组与支架植入组支架植入处最小内膜腔面积[(10.6±2.6)mm^2 vs (10.8±2.7)mm^2]比较,差异无统计学意义(P=0.896);2组患者支架植入处内膜均有增生,但药物球囊治疗组与支架植入组内膜增生面积[(0.30±0.12)mm^2 vs (0.39±0.15)mm^2]比较,差异无统计学意义(P=0.845);药物球囊治疗组与支架植入组支架最小截面积[(10.9±2.7)mm^2 vs (11.2±3.0)mm^2]比较,差异无统计学意义(P=0.723)。结论药物球囊治疗支架内再狭窄后12个月其靶病变血管最小内膜腔面积、支架最小截面积、内膜增生面积与支架植入组相当,临床应用安全可靠。

Objective To explore the changes of endovascular lumen after drug balloon therapy for coronary artery in-stent restenosis in patients with unstable angina pectoris. Methods Ninety-six patients with unstable angina pectoris who had previously undergone coronary artery drug-eluting stent implantation and developed in-stent restenosis were tested by coronary arteriography at the Affiliated Jiangyin Hospital of College of Medicine of Southeast University. The patients were divided into either a drug balloon therapy group(47 cases) or a Nano stent implantation group(49 cases). The minimal intima cavity area, minimum bracket section area, and neointimal area were compared at postoperative 12 months by intravascular unltrasound(IVUS). Cardiovascular events and bleeding events were compared during postoperative 12 months. Results The minimal intima cavity area and minimum bracket section area were significantly smaller in the drug balloon therapy group than in the Nano stent implantation group immediately after operation [(10.8±2.8) mm^2 vs(11.8±3.2) mm^2;(11.2±2.9) mm^2 vs(12.0±3.2) mm^2, P=0.025 and 0.042, respectively]. There were seven cases of cardiovascular events in the drug balloon therapy group and nine cases in the Nano stent implantation group during postoperative 12 months(P=0.699). There was no significant difference in the minimum intimal cavity area between the drug balloon group and the Nano stent group [(10.6±2.6) mm^2 vs(10.6±2.6) mm^2;P=0.896]. Intimal hyperplasia was found in both groups, but the neointimal area was(0.30±0.12) mm^2 in the drug balloon therapy group and(0.39±0.15) mm^2 in the Nano stent implantation group at postoperative 12 months(P=0.845). There was also no significant difference in minimum bracket section area at postoperative 12 months between the two groups [(10.9±2.7) mm vs(11.2±3.0) mm^2, P=0.723]. Conclusion Drug-eluting balloon therapy for in-stent restenosis is clinically safe and reliable compared with Nano stent implantation.