药物涂层球囊和药物洗脱支架介入治疗对冠心病预后影响的回顾性对比研究
The difference effect on the prognosis between drug-coated balloon and drug eluting stent interventional therapy in patients with coronary heart disease: a retrospective comparative study
摘要目的:比较药物涂层球囊(DCB)和药物洗脱支架(DES)介入治疗对冠心病患者预后的影响。方法:回顾性分析首都医科大学宣武医院2018年12月至2021年7月因小血管病变、支架内再狭窄和分支病变行冠状动脉介入治疗的346例冠心病患者的临床资料。应用DES 179例(DES组),其中小血管病变81例,支架内再狭窄35例,分支病变63例;应用DCB 167例(DCB组),其中小血管病变69例,支架内再狭窄62例,分支病变36例。比较两组出院后1年内主要不良心脑血管事件(MACCE)发生情况,以非劣效性界值为4%进行非劣效性分析。结果:DCB组和DES组MACCE发生率及小血管病变、支架内再狭窄、分支病变患者MACCE发生率比较差异均无统计学意义[3.59%(6/167)比7.26%(13/179)、1.45%(1/69)比4.94%(4/81)、8.06%(5/62)比14.29%(5/35)和0比6.35%(4/63), P>0.05]。非劣效性分析结果显示,DCB对改善冠心病患者预后的作用不劣于DES(95% CI - 8.41%~1.07%)。 结论:对于靶血管为小血管病变、支架内再狭窄和分支病变的冠心病患者而言,DCB对改善冠心病预后的作用不劣于DES。
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abstractsObjective:To compare the effect of prognosis between drug-coated balloon (DCB) and drug eluting stent (DES) interventional therapy in patients with coronary heart disease.Methods:The clinical data of 346 coronary heart disease patients underwent interventional therapy because of small vessel lesion, in-stent restenosis and bifurcation lesion in Xuanwu Hospital, Capital Medical University from December 2018 to July 2021 were retrospectively analyzed. Among them, 179 patients were treated with DES (DES group), including small vessel lesion 81 cases, in-stent restenosis 35 cases, and bifurcation lesion 63 cases; 167 patients were treated with DCB (DCB group), including small vessel lesion 69 cases, in-stent restenosis 62 cases, and bifurcation lesion 36 cases. The major adverse cardiac and cerebrovascular event (MACCE) within 1 year after discharge was compared between two groups. Non-inferiority was analyzed, and non-inferiority margin was set to be 4%.Results:There was no statistical difference in the incidence of MACCE between DCB group and DES group: 3.59% (6/167) vs. 7.26% (13/179), P>0.05. There were no statistical differences in the incidences of MACCE in patients with small vessel lesion, in-stent restenosis and bifurcation lesion between DCB group and DES group: 1.45% (1/69) vs. 4.94% (4/81), 8.06% (5/62) vs. 14.29% (5/35) and 0 vs. 6.35% (4/63); P>0.05. Non-inferiority analysis result showed that DCB was non-inferior to DES on the prognosis in patients with coronary heart disease (95% CI - 8.41% to 1.07%). Conclusions:Non-inferiority of DCB versus DES is shown in coronary heart disease patients with small vessel lesion, in-stent restenosis and bifurcation lesion.
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