国产新型生物可吸收支架治疗复杂冠状动脉病变3年的安全性及有效性

Safety and efficacy of domestically produced novel bioabsorbable vascular scaff old in the treatment of complex coronary artery lesions for 3 years

目的探讨置入国产新型生物可吸收支架(BVS)治疗复杂冠状动脉病变患者的安全性及有效性。方法本研究为回顾性、匹配对照的单中心观察性研究,连续入选2020年6月至2021年6月于广东医科大学附属医院冠心病专科进行BVS治疗冠心病患者45例(BVS组),同期按匹配研究要求选取置入药物洗脱支架(DES)冠心病患者45例(DES组)。比较两组患者的基线资料、手术资料和随访资料以评估安全性和有效性。安全性的主要指标为:手术耗时、术中不良事件等,有效性终点为靶病变失败(TLF),包括心原性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建。结果本研究共入选90例患者,均接受了至少3年的临床随访。两组分叉病变和弥漫性长病变分别为20例和25例,90例患者中复查冠状动脉造影或冠状动脉CT血管造影50例;BVS组中稳定性冠心病、糖尿病史、高血压病史、吸烟史的占比,预扩张球囊压力、术后舒张压均高于DES组,家族史占比低于DES组,差异均有统计学意义(均P<0.05);两组间心原性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建率比较,差异均无统计学意义(均P>0.05)。二元Logistic回归模型分析结果显示靶病变直径狭窄比是支架内再狭窄的独立危险因素(OR2.786,95%CI 1.096~7.081,P=0.031)。结论与传统DES相比,置入BVS治疗复杂冠状动脉病变在3年内具有一致的安全性和有效性。靶病变直径狭窄比是支架内再狭窄的独立危险因素。

Objective To investigate the safety and efficacy of novel bioabsorbable vascular scaffold(BVS)in the treatment of patients with complex coronary artery disease.Methods This was a retrospective,matched,single-center observational study.45 patients with coronary atherosclerotic cardiopathy received BVS treatment in the cardiovascular medicine department Department of the Affiliated Hospital of Guangdong Medical University from June 2020 to June 2021(BVS),and 45 patients treated with drug-eluting stents(DES)group were selected according to matching study requirements during the same period.Baseline,surgical,and follow-up data were compared between the two groups to evaluate safety and effi cacy.The main measures of safety were:surgical time,intraoperative adverse events,etc.,and the end point of efficacy was target lesion failure(TLF),including cardiac death,target vessel myocardial infarction,and ischa-driven target lesion revascularization.Results A total of 90 patients were enrolled in this study,all of whom were followed up for at least 3 years.There were 20 cases of bifurcation lesions and 25 cases of diffuse long lesions in the two groups,and 50 cases of imaging were reviewed among the 90 patients.The proportion of stable coronary heart disease,history of diabetes,history of hypertension,history of smoking,pre-dilated balloon pressure and postoperative diastolic blood pressure in BVS group was higher than that in DES group,and the proportion of family history was lower than that in DES group(all P<0.05).There were no statistically signifi cant diff erences in the rates of cardiac death,target vessel myocardial infarction,and ischemia-driven revascularization of target lesions between the two groups(all P>0.05).Binary Logistic regression model analysis showed that the diameter stenosis ratio of target lesions was an independent risk factor for intrastent restenosis(OR 2.786,95%CI 1.096–7.081,P=0.031).Conclusions Compared with traditional DES,BVS implantation has consistent safety and effi cacy in the treatment of complex coronary artery disease within 3 years.The diameter stenosis ratio of target lesions was an independent risk factor for intrastent restenosis.