International Journal of Cardiology Cardiovascular Risk and Prevention最新文献_第3页

Deep learning model for identifying significant tricuspid regurgitation using standard 12-lead electrocardiogram 使用标准12导联心电图识别显著三尖瓣返流的深度学习模型

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-02 DOI: 10.1016/j.ijcrp.2025.200557

Chun-Chin Chang , Ming-Tsung Hsieh , Yin-Hao Lee , Chih-Hsueh Tseng , Wei-Ming Huang , Ruey-Hsing Chou , Chin-Sheng Lin , Po-Hsun Huang

Introduction

Transthoracic echocardiography (TTE) is the current standard for detecting tricuspid regurgitation (TR); however, it incurs additional costs and is dependent on the operator's skill. In contrast, the 12-lead electrocardiogram (ECG) is widely available during initial evaluations. This study aimed to develop deep learning (DL) models using 12-lead ECG signals and clinical features to detect significant TR.

Methods

Between 2017 and 2019, a total of 5432 patients who underwent both 12-lead ECG and TTE were eligible for this study. Significant TR was identified in 570 of these patients. The DL model architecture was based on a combination of one-dimensional convolutional neural network, efficient channel attention block, and Multihead Attention modules. The model was trained on data from 3910 patients, tested on 435 patients, and validated using both internal and external cohorts.

Results

The diagnostic performance of the DL model using ECG signals, age, and sex to predict significant TR was as follows: an accuracy of 0.762, sensitivity of 0.809, specificity of 0.756, and an area under the curve (AUC) of 0.857. After incorporating additional factors such as RR interval, QRS duration, corrected QT interval, atrial fibrillation, and hypertension into the DL model, the diagnostic performance remained substantial, with an accuracy of 0.762, sensitivity of 0.836, specificity of 0.752, and an AUC of 0.866. External validation of the DL model showed satisfactory results.

Conclusions

Implementing the DL model for ECG interpretation could facilitate the diagnosis of significant TR. However, the clinical utility of this DL model requires further validation and exploration.

经胸超声心动图（TTE）是目前检测三尖瓣反流（TR）的标准；然而，它会产生额外的成本，并且取决于操作人员的技能。相比之下，12导联心电图（ECG）在初始评估中广泛使用。本研究旨在利用12导联ECG信号和临床特征开发深度学习（DL）模型，以检测显著的tr。方法2017年至2019年，共有5432例12导联ECG和TTE患者入选本研究。在这些患者中，570例发现了明显的TR。深度学习模型的结构是基于一维卷积神经网络、高效通道注意力块和多头注意力模块的组合。该模型使用来自3910名患者的数据进行训练，对435名患者进行测试，并使用内部和外部队列进行验证。结果基于心电信号、年龄和性别的DL模型预测显著TR的准确率为0.762，灵敏度为0.809，特异性为0.756，曲线下面积（AUC）为0.857。在DL模型中加入RR间期、QRS持续时间、校正QT间期、房颤、高血压等附加因素后，诊断效果仍然很好，准确率为0.762，敏感性为0.836，特异性为0.752，AUC为0.866。DL模型的外部验证结果令人满意。结论应用DL模型进行心电判读有助于诊断显著性TR，但该模型的临床应用有待进一步验证和探索。

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引用次数: 0

Efficacy and comparative performance of machine learning models for stroke risk prediction in hypertensive patients: A systematic review and meta-analysis 高血压患者卒中风险预测的机器学习模型的疗效和比较性能：系统回顾和荟萃分析

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-15 DOI: 10.1016/j.ijcrp.2025.200564

Pooya Eini , Mohammad Rezayee , Milan Kassulke , Jason Tremblay

Background

Stroke poses a significant health burden among hypertensive patients, where traditional risk models often lack precision. Machine learning (ML) has shown promise in enhancing prediction accuracy by integrating diverse data sources.

Methods

Following PRISMA guidelines, we searched 5 databases from inception to September 2025. Eligible studies reported the performance of ML models in hypertensive cohorts. Data were pooled using random-effects models, with heterogeneity assessed via I², subgroup analyses, meta-regression, and leave-one-out sensitivity. The risk of bias was evaluated using PROBAST + AI, and the evidence quality was assessed using the GRADE approach.

Results

Ten studies (n = 13,299 stroke cases) were included. Pooled sensitivity was 0.88 (95 % CI: 0.80–0.93), specificity 0.88 (95 % CI: 0.77–0.94), positive likelihood ratio 7.1 (95 % CI: 3.4–15.1), negative likelihood ratio 0.14 (95 % CI: 0.08–0.26), and AUC-ROC 0.94 (95 % CI: 0.91–0.96), indicating good discriminative ability. Heterogeneity was high for both sensitivity (I² = 79.5 %) and specificity (I² = 76.8 %), potentially due to variations in study design and populations. Subgroup analyses showed consistent performance in Chinese studies (sensitivity 0.85, specificity 0.84) and those using multimodal features (sensitivity 0.84, specificity 0.83), with higher sensitivity for ischemic/hemorrhagic-specific models (0.90). Meta-regression explained 73.9 % of variance and No publication bias was detected (Deeks' p = 0.654).

Conclusion

ML models demonstrate good performance for stroke prediction in hypertensive patients. However, heterogeneity underscores the need for standardized approaches. This evidence, rated moderate by GRADE, supports ML integration in clinical practice for improved prevention.

背景中风是高血压患者的重要健康负担，传统的风险模型往往缺乏准确性。机器学习（ML）已经显示出通过整合不同的数据源来提高预测准确性的希望。方法按照PRISMA指南检索5个数据库，检索时间为成立至2025年9月。符合条件的研究报告了ML模型在高血压队列中的表现。使用随机效应模型汇总数据，通过I2、亚组分析、meta回归和遗漏敏感性评估异质性。使用PROBAST + AI评估偏倚风险，使用GRADE方法评估证据质量。结果纳入10项研究（n = 13299例）。合并敏感性为0.88 (95% CI: 0.80 ~ 0.93)，特异性为0.88 (95% CI: 0.77 ~ 0.94)，阳性似然比为7.1 (95% CI: 3.4 ~ 15.1)，阴性似然比为0.14 (95% CI: 0.08 ~ 0.26)， AUC-ROC为0.94 (95% CI: 0.91 ~ 0.96)，表明鉴别能力较好。敏感性（I2 = 79.5%）和特异性（I2 = 76.8%）的异质性都很高，可能是由于研究设计和人群的差异。亚组分析显示，中国研究（敏感性0.85，特异性0.84）和使用多模态特征的研究（敏感性0.84，特异性0.83）表现一致，对缺血/出血特异性模型的敏感性更高（0.90）。meta回归解释了73.9%的方差，未发现发表偏倚（Deeks’p = 0.654）。结论ml模型对高血压患者脑卒中有较好的预测效果。然而，异质性强调了标准化方法的必要性。该证据被GRADE评为中等，支持ML整合到临床实践中以改善预防。

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引用次数: 0

Corrigendum to ‘Clinical efficacy comparison between extracorporeal shock wave therapy and enhanced external counterpulsation for coronary heart disease’ [Int. J. Cardio. Cardiovas. Risk Prev. 28 (2026) 200574] 体外冲击波治疗与强化体外反搏治疗冠心病的临床疗效比较[j]。j .有氧运动。Cardiovas。风险预警28(2026)200574]。

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI: 10.1016/j.ijcrp.2026.200582

Ting Zhao , Suping Lan , Yun Zhang , Yupin Dong , Lunyan Lu , Xu Chen , Song Li , Yuncheng Li , Shen Wang , Yue Wang , Xiaofan Wu , Xinjian Li

引用次数: 0

Comment on “phenotype-specific associations of circulating adipokine levels with carotid atherosclerosis: a systematic review and meta-analysis” 对“循环脂肪因子水平与颈动脉粥样硬化的表型特异性关联：系统回顾和荟萃分析”的评论

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-11 DOI: 10.1016/j.ijcrp.2025.200563

Zhenxing Deng , Bin Cao

引用次数: 0

A study of extended lipid profile in patients with acute coronary syndrome: Focus on Lipoprotein(a) and PCSK9 急性冠状动脉综合征患者扩展脂质谱的研究：关注脂蛋白(A)和PCSK9

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-04 DOI: 10.1016/j.ijcrp.2025.200558

Pradeep Kumar , Sudesh Prajapathi , Abhishek Singh , Akshyaya Pradhan , Ayush Shukla , Monika Bhandari , Akhil Sharma , Pravesh Vishwakarma , Gaurav Chaudhary , Sharad Chandra , Rishi Sethi , Sudhanshu Dwivedi , Raman Puri

Background

Lipoprotein(a) [Lp(a)] and PCSK9 are emerging lipid biomarkers implicated in atherogenesis and residual cardiovascular risk, but their relationship with coronary disease complexity in acute coronary syndrome (ACS) is unclear. This study evaluates their serum levels in first-episode ACS patients versus controls and explores their relationship with SYNTAX score–defined coronary severity.

Methods

This single-centre observational study enrolled 160 patients presenting with their first episode of ACS (aged 18–75) and 40 age-matched healthy controls. All participants were free from lipid-lowering therapy and major comorbidities. Fasting serum samples were collected to measure the standard lipid profile, Lp(a), and PCSK9 levels. The severity of coronary artery disease was quantified using the SYNTAX score after coronary angiography.

Results

The ACS cohort (mean age 55.7 years; 73.1 % male) most frequently presented with STEMI (53.7 %). Traditional risk factors included smoking/tobacco use (48.8 %), diabetes (40.0 %), and hypertension (38.1 %). Median SYNTAX score was 19.4. Compared with controls, ACS patients had significantly lower HDL-C and higher LDL/HDL and cholesterol/HDL ratios. Lp(a) (38.9 vs. 15.9 mg/dL, p < 0.001) and PCSK9 (272.3 vs. 169.6 ng/mL, p < 0.001) were markedly elevated in ACS patients. Neither Lp(a) nor PCSK9 correlated with SYNTAX score. LDL-C showed a modest positive correlation with Lp(a) (r = 0.163, p = 0.040). Higher SYNTAX scores were associated with more extensive multivessel disease.

Conclusion

Patients with ACS exhibited significantly higher Lp(a) and PCSK9 levels compared with healthy controls, but these biomarkers did not reflect angiographic disease complexity. Their role may lie more in underlying cardiovascular risk assessment than in predicting anatomical severity.

脂蛋白(a) [Lp(a)]和PCSK9是新兴的脂质生物标志物，与动脉粥样硬化和残留心血管风险有关，但它们与急性冠状动脉综合征（ACS）中冠状动脉疾病复杂性的关系尚不清楚。本研究评估了首发ACS患者与对照组的血清水平，并探讨了它们与SYNTAX评分定义的冠状动脉严重程度的关系。方法本单中心观察性研究纳入了160例首次出现ACS发作的患者（18-75岁）和40例年龄匹配的健康对照。所有参与者均无降脂治疗和主要合并症。采集空腹血清样本，测量标准血脂、Lp(a)和PCSK9水平。冠状动脉造影后使用SYNTAX评分量化冠状动脉疾病的严重程度。结果ACS队列（平均年龄55.7岁，73.1%为男性）最常表现为STEMI（53.7%）。传统的危险因素包括吸烟/烟草使用（48.8%）、糖尿病（40.0%）和高血压（38.1%）。SYNTAX得分中位数为19.4。与对照组相比，ACS患者的HDL- c显著降低，LDL/HDL和胆固醇/HDL比值显著升高。Lp(a) （38.9 vs. 15.9 mg/dL, p < 0.001）和PCSK9 （272.3 vs. 169.6 ng/mL, p < 0.001）在ACS患者中显著升高。Lp(a)和PCSK9与SYNTAX评分均无相关性。LDL-C与Lp(a)呈正相关（r = 0.163, p = 0.040）。较高的SYNTAX评分与更广泛的多血管疾病相关。结论ACS患者Lp(a)和PCSK9水平明显高于健康对照组，但这些生物标志物不能反映血管造影疾病的复杂性。它们的作用可能更多地在于潜在的心血管风险评估，而不是预测解剖严重程度。

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引用次数: 0

Letter to the Editor: Trends in coronary artery disease mortality among hyperlipidemic patients: Geographic, gender, and racial insights from CDC WONDER data (1999–2020) 致编辑的信：高脂血症患者冠状动脉疾病死亡率趋势：来自CDC WONDER数据的地理、性别和种族见解（1999-2020）

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI: 10.1016/j.ijcrp.2026.200581

Mohamed Fawzi Hemida MD

引用次数: 0

Association between body roundness index trajectories and the risk of cardiometabolic multimorbidity in Chinese middle-aged and older adults: Evidence from the China health and retirement longitudinal study 中国中老年人身体圆度指数轨迹与心血管代谢多病风险之间的关系：来自中国健康与退休纵向研究的证据

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-03 DOI: 10.1016/j.ijcrp.2025.200556

Laixi Zhang , Mi Yan , Chunyu Hu, Yuanling Tao, Zhen Cheng, Yalan Zhang, Jiayang Shi, Bing Zou, Li Sun, Zongtao Chen

Background

Cardiometabolic multimorbidity (CMM) is a growing global public health concern, particularly among aging populations. Body Roundness Index (BRI), a novel anthropometric measure reflecting visceral adiposity, may outperform BMI in predicting cardiometabolic risk. This study aimed to investigate the association between longitudinal BRI trajectories and the risk of CMM in a longitudinal cohort.

Methods

8412 participants were ultimately selected from in the China Health and Retirement Longitudinal Study database. BRI measurements were repeatedly obtained from these participants between 2011 and 2016. Group-based trajectory modeling (GBTM) was applied to identify BRI trajectories from 2011 to 2016, with CMM between 2017 and 2020 designated as the primary outcome. We executed a Cox proportional hazards regression model to assess the association between BRI trajectories and the incidence of CMM. In the sensitivity analysis, we stratified cumulative BRI into quartiles to assess whether the association with CMM remained consistent.

Results

Based on the GBTM, participants were categorized into three distinct BRI trajectory groups. These groups, labeled Low-stable, Moderate-stable, and High-stable, comprised 48.23 %, 42.21 %, and 9.56 % of the study population, respectively. Compared to the Low-stable group, Moderate-stable (HR = 1.99, 95 % CI: 1.69–2.35) and High-stable (HR = 2.88, 95 % CI: 2.28–3.63) groups had significantly increased risks of CMM. Subgroup analyses revealed a significant interaction between BMI level and BRI trajectory on CMM outcomes. Sensitivity results supported these findings.

Conclusion

Persistently high BRI trajectories significantly increase CMM risk. BRI is a simple, noninvasive marker with public health utility for early identification and prevention of cardiometabolic diseases, especially in resource-limited settings.

背景心脏代谢多病（CMM）是一个日益增长的全球公共卫生问题，特别是在老龄化人群中。身体圆度指数（BRI）是一种反映内脏脂肪的新型人体测量指标，在预测心脏代谢风险方面可能优于BMI。本研究旨在调查纵向队列中纵向BRI轨迹与CMM风险之间的关系。方法从中国健康与退休纵向研究数据库中最终选择8412名参与者。在2011年至2016年期间，从这些参与者那里反复获得BRI测量值。采用基于群体的轨迹模型（GBTM）识别2011 - 2016年的“一带一路”发展轨迹，并将2017 - 2020年的CMM模型指定为主要结果。我们使用Cox比例风险回归模型来评估BRI轨迹与CMM发病率之间的关系。在敏感性分析中，我们将累积BRI分层为四分位数，以评估与CMM的关联是否保持一致。基于GBTM，参与者被分为三个不同的“一带一路”轨迹组。这些被标记为低稳定、中稳定和高稳定的组分别占研究人群的48.23%、42.21%和9.56%。与低稳定组相比，中稳定组（HR = 1.99, 95% CI: 1.69-2.35）和高稳定组（HR = 2.88, 95% CI: 2.28-3.63） CMM的风险显著增加。亚组分析显示BMI水平和BRI轨迹对CMM结果有显著的相互作用。敏感性结果支持这些发现。结论持续高的BRI轨迹显著增加CMM风险。BRI是一种简单、无创的标志物，具有早期识别和预防心脏代谢疾病的公共卫生效用，特别是在资源有限的环境中。

{"title":"Association between body roundness index trajectories and the risk of cardiometabolic multimorbidity in Chinese middle-aged and older adults: Evidence from the China health and retirement longitudinal study","authors":"Laixi Zhang , Mi Yan , Chunyu Hu, Yuanling Tao, Zhen Cheng, Yalan Zhang, Jiayang Shi, Bing Zou, Li Sun, Zongtao Chen","doi":"10.1016/j.ijcrp.2025.200556","DOIUrl":"10.1016/j.ijcrp.2025.200556","url":null,"abstract":"<div><h3>Background</h3><div>Cardiometabolic multimorbidity (CMM) is a growing global public health concern, particularly among aging populations. Body Roundness Index (BRI), a novel anthropometric measure reflecting visceral adiposity, may outperform BMI in predicting cardiometabolic risk. This study aimed to investigate the association between longitudinal BRI trajectories and the risk of CMM in a longitudinal cohort.</div></div><div><h3>Methods</h3><div>8412 participants were ultimately selected from in the China Health and Retirement Longitudinal Study database. BRI measurements were repeatedly obtained from these participants between 2011 and 2016. Group-based trajectory modeling (GBTM) was applied to identify BRI trajectories from 2011 to 2016, with CMM between 2017 and 2020 designated as the primary outcome. We executed a Cox proportional hazards regression model to assess the association between BRI trajectories and the incidence of CMM. In the sensitivity analysis, we stratified cumulative BRI into quartiles to assess whether the association with CMM remained consistent.</div></div><div><h3>Results</h3><div>Based on the GBTM, participants were categorized into three distinct BRI trajectory groups. These groups, labeled Low-stable, Moderate-stable, and High-stable, comprised 48.23 %, 42.21 %, and 9.56 % of the study population, respectively. Compared to the Low-stable group, Moderate-stable (HR = 1.99, 95 % CI: 1.69–2.35) and High-stable (HR = 2.88, 95 % CI: 2.28–3.63) groups had significantly increased risks of CMM. Subgroup analyses revealed a significant interaction between BMI level and BRI trajectory on CMM outcomes. Sensitivity results supported these findings.</div></div><div><h3>Conclusion</h3><div>Persistently high BRI trajectories significantly increase CMM risk. BRI is a simple, noninvasive marker with public health utility for early identification and prevention of cardiometabolic diseases, especially in resource-limited settings.</div></div>","PeriodicalId":29726,"journal":{"name":"International Journal of Cardiology Cardiovascular Risk and Prevention","volume":"28 ","pages":"Article 200556"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145683592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Clinical efficacy comparison between extracorporeal shock wave therapy and enhanced external counterpulsation for coronary heart disease 体外冲击波治疗与强化体外反搏治疗冠心病的临床疗效比较

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2026-01-07 DOI: 10.1016/j.ijcrp.2026.200574

Ting Zhao , Suping Lan , Yun Zhang , Yupin Dong , Lunyan Lu , Xu Chen , Song Li , Yuncheng Li , Shen Wang , Yue Wang , Xiaofan Wu , Xinjian Li

Objective

This study aims to evaluate the clinical efficacy of extracorporeal cardiac shock wave therapy(CSWT) and enhanced external counterpulsation(EECP),both individually and in combination,in patients with coronary artery disease(CAD),and to explore effective non-invasive treatment strategies.

Methods

A total of 259 patients with CAD admitted between January 2023 and June 2024 were enrolled and randomly assigned to four groups:the Control group(n = 65) received conventional medication only; the EECP group(n = 65) received conventional medication plus EECP treatment(EECP; total duration 36 h); the CSWT group(n = 64) received conventional medication plus CSWT therapy(CSWT; total duration 4.5 h); and the Combination group(EECP + CSWT group,n = 65) received conventional medication combined with both CSWT(4.5 h) and EECP(36 h).Coronary stenosis severity, cardiac function indices, blood biochemistry and other indicators were evaluated at baseline and 12 months after treatment.

Results

Baseline characteristics showed no significant differences among the groups(P > 0.05). After 12 months of treatment, the Gensini score of the EECP + CSWT group decreased by 20 points, which was significantly lower than that of the EECP group (−5 points, P < 0.05), the CSWT group (−15 points, P < 0.05) and the control group (−0.5 points, P < 0.05). Secondly, compared with the control group, the CSWT group, EECP group and EECP + CSWT group showed more significant improvements in cardiac function and blood biochemical parameters (P < 0.05). The EECP + CSWT group exhibited the most pronounced therapeutic efficacy, followed by the EECP group and the CSWT group; all three intervention groups were significantly superior to the Control group (P < 0.05).

Conclusion

Both CSWT and EECP effectively improve the severity of coronary artery disease, cardiac function,and blood biochemical parameters in CAD patients.The combination of these two therapies demonstrates synergistic effects, yielding significantly superior outcomes compared to either monotherapy.

目的评价体外心脏冲击波治疗（CSWT）和体外强化反搏（EECP）单独或联合治疗冠心病（CAD）的临床疗效，探讨有效的无创治疗策略。方法纳入2023年1月至2024年6月期间收治的CAD患者259例，随机分为4组：对照组（n = 65）仅接受常规药物治疗；EECP组（65例）给予常规药物治疗加EECP治疗（EECP，总持续时间36 h）；CSWT组（n = 64）采用常规药物加CSWT治疗（CSWT，总持续时间4.5 h）；联合组（EECP + CSWT组，n = 65）采用常规药物联合CSWT（4.5 h）和EECP（36 h）治疗。在治疗前及治疗后12个月评估冠状动脉狭窄严重程度、心功能指标、血液生化等指标。结果两组患者基线特征差异无统计学意义（P > 0.05）。治疗12个月后，EECP + CSWT组Gensini评分下降20分，显著低于EECP组（- 5分，P < 0.05）、CSWT组（- 15分，P < 0.05）和对照组（- 0.5分，P < 0.05）。其次，与对照组相比，CSWT组、EECP组和EECP + CSWT组心功能和血液生化指标改善更为显著（P < 0.05）。EECP + CSWT组治疗效果最显著，其次为EECP组和CSWT组；三个干预组均显著优于对照组（P < 0.05）。结论CSWT和EECP均能有效改善冠心病患者冠状动脉病变严重程度、心功能及血液生化指标。这两种疗法的结合显示出协同效应，与任何单一疗法相比，产生明显更好的结果。

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引用次数: 0

Comments on: “Association between body roundness index trajectories and the risk of cardiometabolic multimorbidity in Chinese middle-aged and older adults: Evidence from the China health and retirement longitudinal study” 评论：“中国中老年人身体圆度指数轨迹与心血管代谢多病风险的关系：来自中国健康与退休纵向研究的证据”

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2026-01-08 DOI: 10.1016/j.ijcrp.2026.200578

Bin Cao , Bingning Ma

引用次数: 0

Observational, Multicenter study on long-term Effectiveness and tolerability of aliROcumab (OMERO): an Italian real-life experience aliROcumab （OMERO）的长期有效性和耐受性的观察性多中心研究：意大利的现实生活经验

IF 2.1 Q3 PERIPHERAL VASCULAR DISEASE

International Journal of Cardiology Cardiovascular Risk and Prevention

Pub Date : 2026-03-01 Epub Date: 2025-12-04 DOI: 10.1016/j.ijcrp.2025.200549

Alberico L. Catapano , Aldo Pietro Maggioni , Francesco Rossi , Eleonora Consolo , Lucia Notarianni , Giancarlo Agnelli , the OMERO study group

Background

The OMERO study (Observational Multicenter study on Effectiveness and tolerability of aliROcumab in real-world) aimed to evaluate the long-term effectiveness, safety and adherence of alirocumab in a cohort of Italian patients with elevated cholesterol at high- or very-high cardiovascular risk.

Methods

Italian patients with elevated cholesterol received alirocumab for at least six months before the inclusion visit and were monitored for up to five years. The achievement of the recommended LDL-Cholesterol (LDL-C) goal (70 mg/dL in high-risk patients; 100 mg/dL in very-high-risk patients) after one year, regardless of modifications of concurrent lipid-lowering therapy or treatment adherence, was the primary endpoint of the study. The evaluation of the lipid profile, the concomitant use of lipid-lowering therapies, the treatment adherence and the occurrence of adverse events were also investigated.

Results

517 (68.6 %) of the 754 FAS patients met the primary endpoint 12 months after beginning their treatment with alirocumab. Median (mean ± SD) LDL-C reductions at the final visit (median or mean follow-up period) were −60.7 % (−57.4 % ± 19.3 %) compared to baseline. The primary endpoint was achieved by 341(70.7%) of the 482 patients with an LDL-C measurement 3 years after initiating alirocumab. Adherence to the alirocumab regimen was approximately 100 % during the observation period. Eighteen (2.3 %) of the 797 patients included in the safety population experienced at least one adverse drug reaction.

Conclusion

The effectiveness of alirocumab in reducing LDL-C and its favorable safety and tolerability profile have been consistently confirmed in a real-world setting among Italian patients treated for up to 3 years.

背景：OMERO研究（aliROcumab在现实世界中的有效性和耐受性的多中心观察性研究）旨在评估aliROcumab在一组具有高或极高心血管风险的胆固醇升高患者中的长期有效性、安全性和依从性。方法意大利胆固醇升高患者在纳入前接受alirocumab治疗至少6个月，并监测长达5年。一年后达到推荐的ldl -胆固醇（LDL-C）目标（高危患者为70 mg/dL；高危患者为100 mg/dL），无论是否修改同时进行的降脂治疗或坚持治疗，都是该研究的主要终点。血脂评估，同时使用降脂疗法，治疗依从性和不良事件的发生也进行了调查。结果754例FAS患者中有517例（68.6%）在开始使用alirocumab治疗12个月后达到了主要终点。与基线相比，最终访视时（中位或平均随访期）LDL-C中位数（平均±SD）降低为- 60.7%（- 57.4%±19.3%）。482例患者中有341例（70.7%）在开始alirocumab治疗3年后进行了LDL-C检测，达到了主要终点。在观察期间，阿里单抗方案的依从性约为100%。纳入安全人群的797例患者中有18例（2.3%）经历了至少一次药物不良反应。alirocumab在降低LDL-C方面的有效性及其良好的安全性和耐受性已经在现实世界的意大利患者中治疗了长达3年的时间。

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引用次数: 0