Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial.

IF 9.5 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2025-08-18 DOI:10.4244/EIJ-D-24-01065

Frans B Mensink, Jonathan Los, Mohamed M Reda Morsy, Rohit M Oemrawsingh, Clemens von Birgelen, Alexander J J Ijsselmuiden, Martijn Meuwissen, Jin M Cheng, Diederik F van Wijk, Pieter C Smits, Valeria Paradies, Dirk J van Wijk, Himanshu Rai, Tim J F Ten Cate, Cyril Camaro, Peter Damman, Lokien X van Nunen, Aukelien C Dimitriu-Leen, Marleen H van Wely, Aysun Cetinyurek-Yavuz, Robert A Byrne, Niels van Royen, Robert-Jan M van Geuns

{"title":"Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial.","authors":"Frans B Mensink, Jonathan Los, Mohamed M Reda Morsy, Rohit M Oemrawsingh, Clemens von Birgelen, Alexander J J Ijsselmuiden, Martijn Meuwissen, Jin M Cheng, Diederik F van Wijk, Pieter C Smits, Valeria Paradies, Dirk J van Wijk, Himanshu Rai, Tim J F Ten Cate, Cyril Camaro, Peter Damman, Lokien X van Nunen, Aukelien C Dimitriu-Leen, Marleen H van Wely, Aysun Cetinyurek-Yavuz, Robert A Byrne, Niels van Royen, Robert-Jan M van Geuns","doi":"10.4244/EIJ-D-24-01065","DOIUrl":null,"url":null,"abstract":"Background: Prolonged lipid-lowering therapy has demonstrated its ability to induce plaque regression and improve the plaque morphology of mild atherosclerotic lesions.Aims: This trial aimed to assess the short-term effect of evolocumab in addition to high-intensity statin therapy (HIST) on relevant non-culprit coronary artery lesions using fractional flow reserve (FFR) measurements and multimodality intracoronary imaging.Methods: Patients with an acute coronary syndrome (ACS) and relevant multivessel disease were randomised to receive either evolocumab or placebo for 12 weeks in addition to HIST. Patients underwent serial FFR and intravascular ultrasound (IVUS)-near-infrared spectroscopy imaging of a non-culprit vessel. The primary endpoints were the differences in the change in FFR and in the maximum lipid core burden index within any 4 mm segment (maxLCBI4mm). The secondary endpoints were the differences in the change in IVUS-derived atheroma volume parameters.Results: Among 150 patients (mean age 64.2±8.5 years; 27 [18.0%] female) randomised to evolocumab (n=74) or placebo (n=76), 143 underwent follow-up coronary angiography. After 12 weeks of treatment, the adjusted mean change in FFR was 0.00 (95% confidence interval [CI]: -0.02 to 0.02) with evolocumab versus 0.01 (95% CI: -0.01 to 0.03) with placebo (adjusted mean difference: -0.01, 95% CI: -0.03 to 0.01; p=0.6). The adjusted mean change in the maxLCBI4mm was -27.8 (95% CI: -72.2 to 16.6) for evolocumab-treated patients versus -35.6 (95% CI: -82.5 to 11.4) for placebo-treated patients (adjusted mean difference: 7.8, 95% CI: -40.9 to 56.4; p=0.8). No between-group differences in any IVUS-derived parameter were found.Conclusions: In patients with ACS and relevant non-culprit coronary artery lesions, the addition of evolocumab to HIST for 12 weeks, compared to placebo, did not result in improvement of FFR or maxLCBI4mm. (ClinicalTrials.gov: NCT04141579).","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"910-920"},"PeriodicalIF":9.5000,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337765/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-01065","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Prolonged lipid-lowering therapy has demonstrated its ability to induce plaque regression and improve the plaque morphology of mild atherosclerotic lesions.

Aims: This trial aimed to assess the short-term effect of evolocumab in addition to high-intensity statin therapy (HIST) on relevant non-culprit coronary artery lesions using fractional flow reserve (FFR) measurements and multimodality intracoronary imaging.

Methods: Patients with an acute coronary syndrome (ACS) and relevant multivessel disease were randomised to receive either evolocumab or placebo for 12 weeks in addition to HIST. Patients underwent serial FFR and intravascular ultrasound (IVUS)-near-infrared spectroscopy imaging of a non-culprit vessel. The primary endpoints were the differences in the change in FFR and in the maximum lipid core burden index within any 4 mm segment (maxLCBI_4mm). The secondary endpoints were the differences in the change in IVUS-derived atheroma volume parameters.

Results: Among 150 patients (mean age 64.2±8.5 years; 27 [18.0%] female) randomised to evolocumab (n=74) or placebo (n=76), 143 underwent follow-up coronary angiography. After 12 weeks of treatment, the adjusted mean change in FFR was 0.00 (95% confidence interval [CI]: -0.02 to 0.02) with evolocumab versus 0.01 (95% CI: -0.01 to 0.03) with placebo (adjusted mean difference: -0.01, 95% CI: -0.03 to 0.01; p=0.6). The adjusted mean change in the maxLCBI_4mm was -27.8 (95% CI: -72.2 to 16.6) for evolocumab-treated patients versus -35.6 (95% CI: -82.5 to 11.4) for placebo-treated patients (adjusted mean difference: 7.8, 95% CI: -40.9 to 56.4; p=0.8). No between-group differences in any IVUS-derived parameter were found.

Conclusions: In patients with ACS and relevant non-culprit coronary artery lesions, the addition of evolocumab to HIST for 12 weeks, compared to placebo, did not result in improvement of FFR or maxLCBI_4mm. (ClinicalTrials.gov: NCT04141579).

查看原文本刊更多论文

PCSK9抑制剂对非罪魁祸首冠状动脉病变的影响：随机、安慰剂对照的FITTER试验

背景：长期的降脂治疗已被证明能够诱导斑块消退并改善轻度动脉粥样硬化病变的斑块形态。目的：本试验旨在评估evolocumab加高强度他汀类药物治疗（HIST）对相关非罪魁祸首冠状动脉病变的短期影响，采用分数血流储备（FFR）测量和多模式冠状动脉内成像。方法：急性冠脉综合征（ACS）和相关多血管疾病患者随机接受evolocumab或安慰剂治疗12周。患者接受了一系列FFR和血管内超声(IVUS)-非罪魁祸首血管的近红外光谱成像。主要终点是FFR变化和最大脂质核心负担指数在任何4mm段（maxLCBI4mm）的差异。次要终点是ivus衍生的动脉粥样硬化体积参数变化的差异。结果：150名患者（平均年龄64.2±8.5岁；27名[18.0%]女性）随机分到evolocumab组（n=74）或安慰剂组（n=76）， 143名患者接受了随访的冠状动脉造影。治疗12周后，evolocumab组FFR的调整平均变化为0.00(95%可信区间[CI]: -0.02至0.02)，安慰剂组为0.01 (95% CI: -0.01至0.03)（调整平均差异：-0.01,95% CI: -0.03至0.01;p=0.6）。evolocumab治疗的患者maxLCBI4mm的调整平均变化为-27.8 (95% CI: -72.2至16.6)，而安慰剂治疗的患者的调整平均变化为-35.6 (95% CI: -82.5至11.4)（调整平均差异：7.8,95% CI: -40.9至56.4;p=0.8）。各组间ivus衍生参数均无差异。结论：在ACS和相关非罪魁祸首冠状动脉病变的患者中，与安慰剂相比，在HIST中添加evolocumab 12周并没有导致FFR或maxLCBI4mm的改善。(ClinicalTrials.gov: NCT04141579)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

期刊介绍： EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.