对离子包裹型共价碳—硅多聚体生物涂层支架的临床研究(1)
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(河北省涿州市医院 河北 涿州 072750)
【摘要】目的：了解离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)与雷帕霉素药物涂层支架(火鸟支架)的远期再狭窄率。方法：共入选92人，其中男性66人，女性26人，年龄59.98±11.68岁，分为离子包裹型共价碳—硅多聚体生物涂层支架组及雷帕霉素药物涂层支架(火鸟支架)组，使用离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)组32人，男27人，女5人，使用雷帕霉素药物涂层支架(火鸟支架)组60 人，男39人，女21人，试验主要终点为：6个月的支架段再狭窄率、支架段的晚期管腔丢失和主要不良事件(MACE，包括死亡、QMI或NQMI和/或TLR)。次要终点为： 6月和12月靶病变的血运重建(TLR)。结论：离子包裹型共价碳—硅多聚体生物涂层支架组与火鸟支架组相比较6个月的再狭窄率、心肌梗塞发生率及心源性死亡率无显著性差异，且其较其他药物涂层支架价格便宜更能为患者所接受，故离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)在临床中有广泛的应用空间。
【关键词】 离子包裹型共价碳—硅多聚体生物涂层支架；雷帕霉素药物涂层支架(火鸟支架)；6个月的再狭窄率及死亡率，12个月的再狭窄率及死亡率
The clinical study of ion-coated covalent carbon - Silicon polymer biological -eluting stent
Meng Xiangru Wang Hongwei
【Abstract】 Objective: To study the long-term restenosis rate of ion-coated covalent carbon - Silicon polymer biological -eluting stent and the rapamycin drug-eluting stent(XTRM-FIT). Methods: A total of 92 , males 66andfemales 26，age 59.98 ± 11.68 years old, which was divided into a group with ion-coated covalent carbon - Silicon polymer biological -eluting stent group and a group with rapamycin drug-eluting stent, there was 32 in ion-coated carbon covalent - silicon polymer biological -eluting stent(XTRM—FIT) group , males 27 and females 5, there was 60 in rapamycin drug-eluting stent group , males 39 and females 21. The primary endpoint for the study: the rate of restenosis in-lesion, late lumen loss (LLL)and major adverse events (MACE, including death, QMI or NQMI and / or TLR) at 6 months. And the secondary endpoints are: the target lesion revascularization (TLR)at 6 months and 12 months .Conclusion: There was no significant difference between the ion-coated covalent carbon - Silicon polymer biological -eluting stent group and Firebird stent group in restenosis rate the incidence of myocardial infarction and cardiac mortality at 6 months, and the price was more acceptable than other drug-eluting stents for patients, so the ion-coated covalent carbon - Silicon polymer biological -eluting stent (XTRM-FIT) can be in a extensive clinical applied space. ......
(河北省涿州市医院 河北 涿州 072750)
【摘要】目的：了解离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)与雷帕霉素药物涂层支架(火鸟支架)的远期再狭窄率。方法：共入选92人，其中男性66人，女性26人，年龄59.98±11.68岁，分为离子包裹型共价碳—硅多聚体生物涂层支架组及雷帕霉素药物涂层支架(火鸟支架)组，使用离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)组32人，男27人，女5人，使用雷帕霉素药物涂层支架(火鸟支架)组60 人，男39人，女21人，试验主要终点为：6个月的支架段再狭窄率、支架段的晚期管腔丢失和主要不良事件(MACE，包括死亡、QMI或NQMI和/或TLR)。次要终点为： 6月和12月靶病变的血运重建(TLR)。结论：离子包裹型共价碳—硅多聚体生物涂层支架组与火鸟支架组相比较6个月的再狭窄率、心肌梗塞发生率及心源性死亡率无显著性差异，且其较其他药物涂层支架价格便宜更能为患者所接受，故离子包裹型共价碳—硅多聚体生物涂层支架(XTRM—FIT)在临床中有广泛的应用空间。
【关键词】 离子包裹型共价碳—硅多聚体生物涂层支架；雷帕霉素药物涂层支架(火鸟支架)；6个月的再狭窄率及死亡率，12个月的再狭窄率及死亡率
The clinical study of ion-coated covalent carbon - Silicon polymer biological -eluting stent
Meng Xiangru Wang Hongwei
【Abstract】 Objective: To study the long-term restenosis rate of ion-coated covalent carbon - Silicon polymer biological -eluting stent and the rapamycin drug-eluting stent(XTRM-FIT). Methods: A total of 92 , males 66andfemales 26，age 59.98 ± 11.68 years old, which was divided into a group with ion-coated covalent carbon - Silicon polymer biological -eluting stent group and a group with rapamycin drug-eluting stent, there was 32 in ion-coated carbon covalent - silicon polymer biological -eluting stent(XTRM—FIT) group , males 27 and females 5, there was 60 in rapamycin drug-eluting stent group , males 39 and females 21. The primary endpoint for the study: the rate of restenosis in-lesion, late lumen loss (LLL)and major adverse events (MACE, including death, QMI or NQMI and / or TLR) at 6 months. And the secondary endpoints are: the target lesion revascularization (TLR)at 6 months and 12 months .Conclusion: There was no significant difference between the ion-coated covalent carbon - Silicon polymer biological -eluting stent group and Firebird stent group in restenosis rate the incidence of myocardial infarction and cardiac mortality at 6 months, and the price was more acceptable than other drug-eluting stents for patients, so the ion-coated covalent carbon - Silicon polymer biological -eluting stent (XTRM-FIT) can be in a extensive clinical applied space. ......
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