Evidence mapPaperPMID 39790185Full record

ArticleCardiovascular diagnosis and therapy2024

Assessing the impact of evolocumab on thin-cap fibroatheroma and endothelial function in patients with very high-risk atherosclerotic cardiovascular disease: a study protocol for a randomized controlled trial.

Bingyu Gao, Nan Nan, Mingduo Zhang, Jinfan Tian, Yanlong Ren, Yuguo Xue, Min Zhang, Xiantao Song, Changjiang Ge

Abstract read
In one paragraph

Article in Cardiovascular diagnosis and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Bingyu GaoDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.ORCID https://orcid.org/0000-0003-0372-6387
Nan NanDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Mingduo ZhangDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Jinfan TianDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Yanlong RenDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Yuguo XueDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Min ZhangDepartment of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Xiantao Song *Department of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.
Changjiang Ge *Department of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Engineering Research Center of Cardiovascular Wisdom Diagnosis and Treatment, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The prevalence of very high-risk atherosclerotic cardiovascular disease (ASCVD) is significant in China, with suboptimal rates of low-density lipoprotein cholesterol (LDL-C) compliance exacerbating plaque instability and causing a higher incidence of major adverse cardiac events (MACEs). Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are effective in reducing LDL-C levels, increase the stability of vulnerable plaque, and influence the progression of atherosclerosis through multiple mechanisms as demonstrated in animal studies. However, there is currently a lack of Methods: This randomized, open-label, prospective clinical study involves 240 patients with very high-risk ASCVD who meet the criteria outlined in the 2023 Chinese lipid management guidelines. Patients recruitment will be processed in Beijing Anzhen Hospital from January 2021 to December 2024. Patients with thin-cap fibroatheroma (TCFA) detected by optical coherence tomography (OCT) are randomly assigned in a 1:1 ratio to the evolocumab group (evolocumab 140 mg every 2 weeks plus atorvastatin 40 mg nightly) or the standard treatment group (atorvastatin 40 mg nightly). The primary endpoint is the absolute change of the minimum fibrous cap thickness (FCT) at a median follow-up of 1 year. The secondary endpoints are other OCT metrics, assessment of MACE rates, alterations in serum lipid profiles and markers of inflammation, endothelial function, and adverse drug reactions. Logistic regression, analysis of covariance (ANCOVA), Kaplan-Meier curve survival analysis, and Cox regression will be used to investigate the relationship between variables and endpoints. Discussion: The purpose of this study is to evaluate the efficacy of high-intensity statin therapy combined to PCSK9i for the secondary prevention of coronary artery disease in Chinese patients with very high-risk ASCVD. The results will provide evidence to optimize the management of this high-risk population. Trial Registration: This study was registered on chictr.org.cn (ChiCTR2000032570).

Indexed as

Atherosclerotic cardiovascular disease (ASCVD)endothelial functionoptical coherence tomographyPCSK9 inhibitorsthin-cap fibroatheroma

Identifiers

PMID39790185
PMCPMC11707485

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.