Department of Cardiovascular Medicine, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
Cardiology Department, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
BMJ Open. 2023 Jul 11;13(7):e072541. doi: 10.1136/bmjopen-2023-072541.
Percutaneous coronary intervention (PCI)-related myocardial infarction (type 4a MI) and major periprocedural myocardial injury have been demonstrated leading to poor prognosis of patients with coronary heart disease (CHD) undergoing elective PCI and still remain high occurrence even after the therapy of dual antiplatelet agents and statins. Proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has been shown to be effectively in reducing the risk of acute MI (AMI). However, the effect of alirocumab on preventing PCI-related MI or major periprocedural myocardial injury in patients with CHD undergoing elective PCI remains uncertain.
Alirocumab effect on Preventing Periprocedural ischaemic Events in coronary heart diseAse patients undergoing coronary StEnting trial is a multicentre, open-label, randomised controlled trial aiming to determine whether alirocumab could reduce the incidence of type 4a MI or major periprocedural myocardial injury in patients with CHD undergoing elective PCI. In total, 422 non-AMI CHD patients planned to undergo elective PCI will be randomly assigned to receive standard pharmacotherapy of CHD (control group) or additional use of subcutaneous alirocumab 75 mg 1 day before procedure (alirocumab group). The primary outcome is type 4a MI or major periprocedural myocardial injury defined as high-sensitivity cardiac troponin elevating above 5×99 th percentile upper reference limit in 48 hours after PCI. Patients will continue receiving standard pharmacotherapy or additional biweekly subcutaneous alirocumab 75 mg for 3 months according to the initial randomisation group. We will follow up for 3 months and record all the major adverse cardiovascular events (MACEs). Incidence of PCI-related MI or major periprocedural myocardial injury, and MACE in 3 months after PCI will be compared between control group and alirocumab group.
Ethics approval has been obtained from the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University with approval number: (2022)02-140-01. The results of this study will be reported through peer-reviewed journals and conference presentations.
ChiCTR2200063191.
经皮冠状动脉介入治疗（PCI）相关的心肌梗死（4a 型 MI）和主要围手术期心肌损伤已被证明会导致接受择期 PCI 的冠心病（CHD）患者预后不良，即使在双联抗血小板和他汀类药物治疗后，其发生率仍然很高。前蛋白转化酶枯草溶菌素/糜蛋白酶 9 抑制剂阿利西尤单抗已被证明能有效降低急性心肌梗死（AMI）的风险。然而，阿利西尤单抗在预防 CHD 患者择期 PCI 相关的 MI 或主要围手术期心肌损伤方面的效果尚不确定。
阿利西尤单抗对接受冠状动脉支架置入术的冠心病患者预防围手术期缺血事件的影响（Alirocumab effect on Preventing Periprocedural ischaemic Events in coronary heart diseAse patients undergoing coronary StEnting trial）是一项多中心、开放标签、随机对照试验，旨在确定阿利西尤单抗是否能降低接受择期 PCI 的 CHD 患者发生 4a 型 MI 或主要围手术期心肌损伤的发生率。总共将有 422 名非 AMI CHD 患者计划接受择期 PCI，他们将被随机分配接受冠心病标准药物治疗（对照组）或在术前 1 天皮下注射阿利西尤单抗 75mg（阿利西尤单抗组）。主要结局是在 PCI 后 48 小时内高敏肌钙蛋白升高超过 99 百分位上限 5 倍定义的 4a 型 MI 或主要围手术期心肌损伤。根据初始随机分组，患者将继续接受标准药物治疗或每两周皮下注射阿利西尤单抗 75mg 3 个月。我们将进行 3 个月的随访，并记录所有主要不良心血管事件（MACE）。将比较对照组和阿利西尤单抗组在 PCI 后 3 个月时的 PCI 相关 MI 或主要围手术期心肌损伤发生率和 MACE。
中山大学附属第三医院医学伦理委员会已批准本研究（批准号：（2022）02-140-01）。本研究结果将通过同行评议期刊和会议报告进行报告。
ChiCTR2200063191。
