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Safety and Efficacy of Perioperative Use of Evolocumab in Myocardial Infarction Patients: Study Protocol for a Multicentre Randomized Controlled Trial

Advances in Therapy volume 38, pages 1801–1810 (2021)Cite this article

Abstract

Introduction

The SECURE-PCI study supports a perioperative loading dose of statins, although whether an intensive lipid-lowering strategy prior to percutaneous coronary intervention further benefits acute coronary syndrome patients remains controversial. Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients. Nonetheless, whether it can be safely used in perioperative MI patients and whether perioperative application can benefit patients are still unknown. This study aims to evaluate the safety and efficacy of this treatment regimen.

Methods

A multicentre, prospective, randomized, controlled superiority trial will be conducted in 530 statin-naïve MI patients. All eligible patients will be randomized to the evolocumab group (140 mg subcutaneously injected once before revascularization + 14 days after the first dose) or the control group (no evolocumab injection). Evolocumab will then be administered depending on the patient's lipid profile. Both groups will be treated simultaneously with standardized secondary preventive medications. The primary end points are major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes) within 12 months. The secondary end point is post-infarction angina after pain relief. The safety end points include myopathy, impaired liver or renal function, and other adverse events during the follow-up period.

Outcomes

This is the first trial to evaluate the safety and efficacy of evolocumab pre-treatment on prognosis in MI patients. Perioperative evolocumab injection may be a new, safe way to improve prognosis.

Trial registration

Chinese Clinical Trial Registry (http://www.chictr.org.cn; ChiCTR1900024526). Registered on 13 July 2019 and updated on 31 May 2020. The study is currently recruiting patients.

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Acknowledgements

Funding

This is an investigator-initiated trial supported by Sir Run Run Shaw Hospital, which had no role in the design of the study; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The journal’s Rapid Service Fee was funded by Sir Run Run Shaw Hospital, China. No other external funding was received for this study.

Medical Writing and Editorial Assistance

The manuscript has been edited for proper English language, grammar, punctuation, spelling, and overall style by highly qualified native English-speaking editors at American Journal Experts (AJE).

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given final approval for this version to be published.

Authorship Contributions

Concept and design: Yi Luan, Wenbin Zhang and Guosheng Fu. Drafting of the manuscript: Yi Luan, Min Wang, Liding Zhao and Tian Xu. Critical revision of the manuscript for important intellectual content: All authors. Administrative, technical, or material support: Wenbin Zhang, Guosheng Fu. Supervision: Wenbin Zhang, Guosheng Fu.

List of Investigators

The Perioperative Evolocumab Use Investigator Groups include the following: Qingchun campus of Sir Run Run Shaw Hospital affiliated with Zhejiang University, Hangzhou, China; Xiasha campus of Sir Run Run Shaw Hospital affiliated with Zhejiang University, Hangzhou, China; Shuangling campus of Sir Run Run Shaw Hospital affiliated with Zhejiang University, Hangzhou, China; Longyou People's Hospital, Longyou, China; Deqing People’s Hospital, Deqing, China; and First People’s Hospital of Fuyang, Hangzhou, China.

Disclosures

Yi Luan, Min Wang, Liding Zhao, Tian Xu, Guosheng Fu and Wenbin Zhang have nothing to disclose.

Compliance with Ethics Guidelines

The study has been approved by the ethics committee of Sir Run Run Shaw Hospital (ethics approval numbers: keyan20200414-13 and keyan20200522-31) and will be performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Informed consent will be obtained from all participants.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

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Affiliations

  1. Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People’s Republic of China

    Yi Luan, Min Wang, Liding Zhao, Tian Xu, Guosheng Fu & Wenbin Zhang

Authors
  1. Yi Luan
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  2. Min Wang
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  3. Liding Zhao
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  4. Tian Xu
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  5. Guosheng Fu
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  6. Wenbin Zhang
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Corresponding authors

Correspondence to Yi Luan, Guosheng Fu or Wenbin Zhang.

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Luan, Y., Wang, M., Zhao, L. et al. Safety and Efficacy of Perioperative Use of Evolocumab in Myocardial Infarction Patients: Study Protocol for a Multicentre Randomized Controlled Trial. Adv Ther 38, 1801–1810 (2021). https://doi.org/10.1007/s12325-021-01662-5

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  • DOI: https://doi.org/10.1007/s12325-021-01662-5

Keywords

  • Evolocumab
  • Myocardial infarction
  • Perioperative