背景:药物涂层球囊(DCB)比药物洗脱支架(DES)潜在的血栓形成更少。
目的:探讨单抗血小板治疗在经皮冠状动脉介入治疗中的安全性和可行性。
方法:所有参与者西罗莫司涂层球囊欧洲注册中心(EASTBOURNE)是一个前瞻性研究人员驱动的注册中心,评估一种新型西罗莫司涂层球囊(SCB)在现实世界人群中的性能。这项预先指定的事后分析旨在比较单一抗血小板治疗(SAPT)或双重抗血小板治疗(DAPT)患者的结果;两组患者抗血小板药物的选择和方案的持续时间由操作者自行决定。主要终点是12个月时的靶病变血运重建(TLR)。次要终点是根据出血学术研究联盟(BARC)标准的3-5级出血和12个月随访时的主要不良心血管事件(MACE)。
结果:在2016年9月至2020年11月参加研究的2123例患者中,113例患者(5.8%)接受了SAPT,而1826例患者(94.1%)在SCB后接受了DAPT。大多数患者接受DCBPCI治疗的是新病变(n=1091,56.3%),而848例患者(47.7%)接受DCB血运重建治疗的支架内再狭窄。术后1个月内SAPT组无TLR病例发生,在服用单一抗血小板药物的患者随访期间,未发现急性闭塞事件.此外,在SAPT和DAPT方案之间,TLR没有观察到差异,在从头治疗的情况下,12个月时SAPT和DAPT的TLR总发生率分别为7.7%和5.6%(p=0.6).SAPT和DAPT方案在12个月时的MACE累积率没有差异(n=12[11.2%]vs.n=162[8.9%],p=0.4),从头和支架内再狭窄组的结果一致。
结论:我们对EASTBOURNE注册的事后分析表明,在西罗莫司-DCBPCI术后使用单一抗血小板药物治疗新发或支架内再狭窄病变是安全有效的,并有助于控制特定人群的出血风险。
结论:该手稿旨在探索使用西罗莫司药物涂层球囊血管成形术后单一抗血小板方案的可行性。在使用西罗莫司涂层球囊(SCB)治疗的2123例患者中,113例患者(5.8%)接受单一抗血小板治疗(SAPT),1826例患者(94.1%)接受双重抗血小板治疗DAPT。SAPT组术后1个月内无1例靶病变血运重建,在服用单一抗血小板药物的患者随访期间,未发现急性闭塞事件.SAPT和DAPT方案在12个月时的主要不良心血管事件的累积率没有差异,并且从头和支架内再狭窄组的结果一致。
BACKGROUND: Drug coated balloons (DCB) are potentially less thrombogenic than drug eluting stents (DES).
OBJECTIVE: To explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons.
METHODS: The All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator\'s discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3-5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up.
RESULTS: Among 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups.
CONCLUSIONS: Our post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population.
CONCLUSIONS: The manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.