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. 2023 Jul 11;13(7):e072541.
doi: 10.1136/bmjopen-2023-072541.

Alirocumab effect on preventing periprocedural ischaemic events in coronary heart disease patients undergoing coronary stenting (APPEASE trial): study protocol of a multicentre, open-label, randomised controlled trial

Zhuoshan Huang #  1   2   3 , Xiaodong Zhuang #  2   3 , Shaozhao Zhang  2   3 , Yiquan Huang  2   3 , Lianxiong Yuan  4 , Aiwen Lin  5 , Leile Tang  1 , Zhenyu Xiong  2   3 , Odong Christopher  2   3 , Yang Chen  1 , Bingyuan Wu  1 , Yesheng Ling  1 , Suhua Li  1 , Qiang Jie  5 , Longgen Xiong  6 , Xiaoxian Qian  1 , Xinxue Liao  7   3 , Jinlai Liu  8
Affiliations

Alirocumab effect on preventing periprocedural ischaemic events in coronary heart disease patients undergoing coronary stenting (APPEASE trial): study protocol of a multicentre, open-label, randomised controlled trial

Zhuoshan Huang et al. BMJ Open. .

Abstract

Introduction: 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.

Methods and analysis: 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 and dissemination: 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.

Trial registration number: ChiCTR2200063191.

Keywords: coronary heart disease; coronary intervention; myocardial infarction.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Physiopathological mechanisms of PCI-related myocardial infarction/injury and PCSK9. (A) Aetiology of type 4a myocardial infarction and PCI-related myocardial injury. (B) Atherogenic mechanisms of PCSK9 and effect of PCSK9 inhibitors. LCI-C, low-density lipoprotein cholesterol; PCI, percutaneous coronary intervention; PCSK9, proprotein convertase subtilisin/kexin type 9.
Figure 2
Figure 2
Study design and flow chart of APPEASE. APPEASE, Alirocumab effect on Preventing Periprocedural ischaemic Events in coronary heart diseAse patients undergoing coronary StEnting; CHD, coronary heart disease; hs-cTn, high-sensitivity cardiac troponin; MACE, major adverse cardiovascular events; PCI, percutaneous coronary intervention; R, randomise.
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