Objectives: As the main implant material, coronary stent is one of the main factors that affect clinical treatment outcome and patient cost. The choice for coronary stent in clinic depends on multiply factors including patient preference, medical personnel expertise and current technology, and no recognized method has been established for the evaluation and choice of coronary stent. In this study, we aim to evaluate the safety, effectiveness, and economy of a few drug-eluting coronary stents in clinic.
Methods: A retrospective analysis was employed to study the cases treated by drug-eluting stent intervention in a third grade hospital from January 2018 to December 2019. Based on the specific products, these cases were assigned into a domestic stent A group, a domestic stent B group, a domestic stent C group, and an imported stent group. According to the severity of the disease, they were divided into an angina pectoris, an acute myocardial infarction, and an ischemic heart disease subgroups. Layer analysis was carried out for inter-subgroup comparisons in terms of safety (indicated by mortality rate, complication rate, and infection rate), efficacy (indicated by 31-day return rate, 365-day myocardial infarction rate, restenosis rate, secondary intervention rate, and thrombosis rate), and economy (indicated by averaged total cost and coronary stent cost).
Results: Among the 4 products, there was no difference in safety (P>0.05). Except for patients with acute myocardial infarction, there was no significant difference in the effectiveness of the 4 products for the other 2 diseases. The economical aspect of the domestic stent B and the domestic stent C was better than that of the domestic stent A and the imported stent (all P<0.05).
Conclusions: With all the indicators of these 4 stents taken into consideration, we conclude that hospitals may appropriately increase the share of domestic coronary stent in product selection and in-hospital management. This measure helps increase product localization rate and ease the financial burden for patients by reducing coronary stent cost.
目的: 冠状动脉支架作为主要的人体植入材料，是影响临床治疗效果与患者费用负担的主要因素之一，其临床使用选择与患者偏好、医护人员的经验和技术等多方面因素相关。如何对其进行评价和选择尚未有公认的方法。本研究评估不同冠状动脉药物涂层支架临床应用的安全性、有效性和经济性。方法: 回顾性分析2018年1月至2019年12月于某三甲医院进行冠状动脉支架置入术患者的相关资料。根据置入支架的不同将患者分为国产A支架组、国产B支架组、国产C支架组和进口支架组，又根据疾病的严重程度分为心绞痛、急性心肌梗死、缺血性心脏病亚组进行分层分析，对比各亚组在临床应用中的安全性指标(病死率、手术并发症发生率、感染发生率)，有效性指标(31 d内非计划重返率、365 d内心肌梗死发生率、支架内再狭窄率、支架内血栓率、二次介入手术率)、经济性指标(人均总费用、冠状动脉支架费用)。结果: 4种产品的安全性差异无统计学意义(P>0.05)；除急性心肌梗死外，4种产品对其他2种疾病的有效性差异均无统计学意义(均P>0.05)，国产B支架、国产C支架在经济性方面优于国产A支架和进口支架(均P<0.05)。结论: 建议医院在冠状动脉支架品种的遴选与院内管理中，适当提高国产冠状动脉支架的份额，以提高国产化率和降低冠状动脉支架费用的支出，从而减轻患者的费用负担。.
Keywords: drug-eluting coronary stent; economy; efficacy; real-world data; safety.