Effects of PCSK9 inhibitors on coronary microcirculation, inflammation and cardiac function in patients with CHD after PCI: a protocol for systematic review and meta-analysis

BMJ Open. 2023 Sep 18;13(9):e074067. doi: 10.1136/bmjopen-2023-074067.

Abstract

Introduction: Coronary heart disease (CHD) is one of the common cardiovascular diseases that seriously jeopardise human health, and endothelial inflammation and dyslipidaemia are the initiating links leading to its occurrence. Percutaneous coronary intervention (PCI) is one of the most effective surgical treatments for CHD with narrowed or blocked blood vessels, which can quickly unblock the blocked vessels and restore coronary blood supply. However, most patients may experience coronary microcirculation disorders (CMDs) and decreased cardiac function after PCI treatment, which directly affects the efficacy of PCI and the prognosis of patients. Preprotein converting enzyme subtilisin/Kexin 9 (PCSK9) inhibitors are novel pleiotropy lipid-lowering drug with dual anti-inflammation and lipid-lowering effects, and represent a new clinical pathway for rapid correction of dyslipidaemia. Therefore, we designed this protocol to systematically evaluate the effects of PCSK9 inhibitors on coronary microcirculation and cardiac function in patients with CHD after PCI, and to provide high-quality evidence-based evidence for the clinical application of PCSK9 inhibitors.

Methods and analysis: This protocol is reported strictly in accordance with the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols Guidelines. We will search PubMed, EMBASE, Web of Science and three Chinese databases (CNKI, Wanfang and VIP database) according to preset search strategies, without language and publication data restrictions. We will work with manual retrieval to screen references that have been included in the literature. Google Scholar will be used to search for grey literature. The final included literature must meet the established inclusion criteria. Titles, abstracts and full text will be extracted independently by two reviewers, and disagreements will be resolved through discussion or the involvement of a third reviewer. Extracted data will be analysed using Review Manager V.5.3. The Cochrane Risk of Bias Tool will be used to evaluate the risk of bias. Publication bias will be assessed by funnel plots. Heterogeneity will be assessed by I2 test and subgroup analyses will be used to further investigate potential sources of heterogeneity. The quality of the literature will be assessed by GRADE score. This protocol will start in January 2026 and end in December 2030.

Ethics and dissemination: This study is a systematic review of published literature data and no special ethical approval was required.

Prospero registration number: CRD42022346189.

Keywords: Cardiac surgery; Coronary heart disease; Coronary intervention; Ischaemic heart disease; Myocardial infarction; Pharmacology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Coronary Disease*
  • Enzyme Inhibitors
  • Humans
  • Inflammation
  • Lipids
  • Meta-Analysis as Topic
  • Microcirculation
  • PCSK9 Inhibitors
  • Percutaneous Coronary Intervention*
  • Proprotein Convertase 9
  • Subtilisin
  • Systematic Reviews as Topic

Substances

  • Subtilisin
  • PCSK9 protein, human
  • PCSK9 Inhibitors
  • Proprotein Convertase 9
  • Enzyme Inhibitors
  • Lipids