国产BuMA支架治疗冠心病近中期安全性与有效性评估

Assessment of short-medium safety and efficacy of domestic BuMA stent in the treatment of coronary artery disease

目的评估国产BuMA生物降解药物涂层冠脉支架治疗冠心病的安全性和近中期疗效。方法 2011年6月1日至2012年7月31日接受国产BuMA生物降解药物涂层冠脉支架治疗的117例冠心病患者148处病变血管的相关病变置入233枚BuMA支架。术后1、3、6、12个月进行电话随访或门诊随访,有效性评估指标包括:有无胸痛复发、心电图异常改变、重要心脏不良事件发生等。安全性评估指标包括:血液、组织、免疫等不良反应。结果有效性评估:手术即刻成功率100%,术后2例发生再狭窄(RS)(1.7%),1例发生院外猝死(0.8%)。安全性评估:无血液、组织、免疫等不良反应发生。结论国产BuMA生物降解药物涂层冠脉支架具有良好的安全性和临床近中期疗效。

Objective To To evaluate the short-medium safety and efficacy of the BuMA biodegradable drug coating coronary stent in the treatment of coronary heart disease. Method From 2011 to 2012, A total of 117 patients with coronary heart disease who received BuMA biodegradable drug coating coronary stent treatment were enrolled in the study, in which a total of 233 BuMA stents were placed in above patients with 148 coronary artery vascular lesions. Follow-ups were done by the way of telephone or interview after 1, 3, 6, and 12 months to evaluate the effective endpoints including chest pain, abnormal ECG, serious cardiac adverse events and safe endpoints including： blood, tissue, immune, and other adverse events. Results The successful rate of PCI was 100 percent, a total of 2 cases of postoperative restenosis （RS） （1.7%） occurred, a total of 1 case of sudden death occurred outside the hospital （0.8%）. Any blood, tissue, immune and other adverse events were not found. Conclusion The BuMA biodegradable drug coating coronary stent has a good short-medium safety and efficacy.