XIENCE支架是拥有最多短程DAPT治疗证据的药物洗脱支架，10年超长期安全性极佳！

2025-04-25 00:00:00

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PCI术后12个月的DAPT治疗曾经被各国指南视为铁律，近年来，随着以XIENCE 系列支架为试验器械的研究（STOPDAPT-2，STOPDAPT-3，XIENCE 28/90）结果的公布，为短程DAPT增添新证，成为改写国内外指南的循证依据。STOPDAPT-2验证了缩短DAPT至1个月后继续氯吡格雷单药治疗方案在不增加缺血风险的基础上，明显降低出血风险，且未增加心血管事件发生风险^[1]。最新发表的STOPTDAPT 3 研究在1个月短DAPT基础上进一步探索阿司匹林对PCI术后大出血事件的影响，结果表明以阿司匹林为基础的DAPT仍应是PCI术后的标准抗栓策略^[2]。XIENCE 28/90研究则指出，植入XIENCE支架的高出血风险患者接受更短时间DAPT治疗后，缺血事件发生风险未增加、BARC 3-5型出血事件发生率降低，可见XIENCE支架为缩短DAPT疗程、优化患者长期临床预后做出瞩目贡献！此外，整合现有XIENCE支架真实世界数据还可发现，与Resolute支架、Synergy支架和Orsiro支架相比，XIENCE支架的短期、长期安全性和有效性更佳，更具有10年超长期安全性^[3]！为帮助广大医务人员系统了解由全球领先的医疗健康公司雅培自主研发的XIENCE支架的卓越性能，《门诊》杂志罗列总结XIENCE支架主要研究成果，奉上学术饕餮盛宴！

支架的选择对PCI术后即刻和长期临床获益至关重要

XIENCE支架

心血管疾病（CVD）是全球首要致死原因，每年约夺走1,800万人生命。据统计，全球累积开展经皮冠状动脉介入治疗（PCI）超600万次，在所有接受PCI治疗的患者中，54%患者存在复杂病变、40%患者符合高出血风险标准、25%患者患有糖尿病^[4-6]。

备1个月和3个月DAPT

图1: XIENCE支架具备充分的双抗治疗（DAPT）证据

图2: XIENCE支架是一款可运用于更多类型的病变的药物洗脱支架（FDA/CE推荐）

*XIENCE Skypoint尚未在中国大陆上市

XIENCE支架拥有独特设计和卓越性能

XIENCE支架

XIENCE支架家族始终传承独特Multi-link三灵弯长连接支架平台以及氟化共聚物涂层设计，采用疗效被广泛证实的依维莫司药物涂层，可确保支架的完整性和良好通过性，纵向强度显著大于其他药物洗脱支架，且血栓发生率极低。血小板粘附是支架内血栓形成的重要因素，而XIENCE支架独特的氟化共聚物涂层具有良好的生物相容性、药物控制能力、以及机械延展性和稳定性，相比不锈钢金属有着更高的白蛋白吸附率和更低的单核细胞粘附水平，从而抑制血小板聚集和炎症反应并且可以防止急性血栓的发生、促进内皮化，以保证支架植入后的疗效和安全性^[9、11-12]。在阿司匹林单药治疗和P2Y₁₂抑制剂单药治疗的体外实验中，XIENCE支架的血小板粘附显著少于Synergy支架和Resolute Onyx支架^[9、11-12]；在阿司匹林单药治疗的体外实验中，XIENCE支架的血小板粘附显著少于Orsiro支架^[13]，且发现Orsiro支架的薄支架梁对临床结果无影响，甚至不利于患者临床预后（图3）。由此可见XIENCE支架出色的低血栓发生率得益于独特的支架设计和氟化共聚物涂层。

图3: XIENCE氟化共聚物支架的血小板粘附性最小

有充分证据支持证明，XIENCE系列药物洗脱支架拥有极佳的短期和长期临床结果。

XIENCE支架早期临床研究结果

XIENCE支架

XIENCE系列支架手术成功率和急性期疗效极佳，各类病变患者的器械成功率均为99%，急性支架内血栓发生率仅为0.3%^[5-6]。

PPPSTEMI患者植入XIENCE支架后30天内的明确支架内血栓发生率显著降低，下降幅度达4倍PPP卫生经济学效益更优P

图4: CARDIOBASE研究结果

图5:与Resolute支架相比，XIENCE支架的支架内血栓发生率明显更低

XIENCE支架不但可保证短期的疗效，并且长期安全性也值得信赖。

XIENCE支架长期临床研究结果

XIENCE支架

XIENCE 28研究通过倾向评分分层分析，选取XIENCE V USA研究作为历史对照组，随访1-6个月结果显示（图6），高出血风险患者植入XIENCE支架后接受1个月DAPT治疗，全因死亡或心肌梗死发生风险未增加（3.5% vs. 4.3%，P=0.0005），BARC 3-5型出血事件发生风险显著降低（2.2% vs. 4.5%，P<0.016）。XIENCE 90研究也通过倾向评分分层分析，选取XIENCE V USA研究作为历史对照组（图7），随访3-12个月结果显示，植入XIENCE支架的高出血风险患者接受3个月DAPT治疗后，全因死亡或心肌梗死发生风险未增加（5.4% vs. 5.4%，P=0.0063），BARC 3-5型出血事件发生风险显著降低（2.2% vs. 6.3%，P<0.016）。^[3]

图6: XIENCE 28研究结果

图7: XIENCE 90研究结果

3年生活质量得到切实改善未发生支架内血栓表现良好

图8: 植入XIENCE支架的严重钙化病变患者1年随访结果

图9: 植入XIENCE支架的终末期慢性肾病患者（包括血液透析患者）的1年随访结果

PPPPP

图10: XIENCE支架的安全性优于Resolute支架和Synergy支架

图11: PRISON IV研究结果

总结

XIENCE支架

XIENCE支架凭借Multi-link结构、氟化共聚物涂层以及依维莫司药物的独特三要素设计，拥有最多的1个月和3个月短程DAPT治疗（阿司匹林和P2Y₁₂抑制剂）研究数据，相比其他药物支架，XIENCE支架可运用于更多类型的病变，且具有极佳的10年超长期安全性：81%患者术后没有发生心绞痛，93%患者7年内没有发生临床驱动的靶病变血运重建，术后3年内患者生活质量持续改善，晚期和极晚期支架内血栓发生率始终极低，术后10年支架内血栓发生率仅为0.8%，XIENCE系列支架的有效性和安全性历经20余年临床验证^[10、24-25]。自2023年起XIENCE家族中XIENCE Alpine与XIENCE Xpedition 48两款支架积极响应国家集采政策，进入集采名单，惠及术者与患者。XIENCE药物洗脱支架使术者安心，患者放心。

参考文献

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