PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-08-06 DOI:10.1016/j.ahj.2025.07.071

Nikolaos Dagres MD , Chris P Gale PhD , Ramesh Nadarajah PhD , Serge Boveda PhD , Jose Luis Merino PhD , Jens Cosedis Nielsen PhD , Paulus Kirchhof MD , Valentina Kutyifa PhD , Miloš Táborský PhD , Holger Thiele MD , Jan G.P. Tijssen PhD , Atul Verma MD , Tom De Potter MD , Frieder Braunschweig PhD , Béla Merkely PhD , Philipp Sommer MD , Kevin Vernooy PhD , Mahmoud Suleiman MD , Helmut Pürerfellner MD , Gerhard Hindricks PhD

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引用次数: 0

Abstract

Background

Randomized clinical trials from over 20 years ago demonstrated that an implantable cardioverter defibrillator (ICD) improved survival for patients with severely reduced left ventricular ejection fraction (LVEF) after myocardial infarction (MI) compared with optimal medical therapy (OMT) alone. Since then advances in therapy have led to the reduction in the incidence of sudden cardiac death (SCD) in this population, whilst complication rates from ICD implantation are still substantial.

Objectives

To determine whether OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality.

Design

The PROFID EHRA trial is an investigator-driven, prospective, parallel-group, randomized, open-label, blinded outcome assessment (PROBE), multi-center, noninferiority trial without dedicated investigational medical device (Proof of Strategy Trial) with 2 groups with 1:1 randomization. PROFID-EHRA will recruit approximately 3,595 patients with documented history of MI at least 3 months prior, LVEF ≤35%, on OMT for at least 3 months, and with New York Heart Association class II or III, who will be randomized to OMT or OMT plus ICD, to collect 374 first primary outcome events within a median observation period of around 28 months from about 180 clinical sites in an estimated 13 countries. The primary outcome is time from randomization to the occurrence of all-cause death. Secondary outcomes include time from randomization to death from cardiovascular causes, to SCD, to first hospital readmission for cardiovascular causes after date of randomization, the average length of hospital stay during follow-up, and quality of life trajectories.

Clinical Trial

Trials.gov NCT05665608

查看原文本刊更多论文

植入式除颤器预防心肌梗死后心源性猝死：PROFID EHRA随机临床试验的设计和基本原理

背景：20多年前的随机临床试验表明，与单纯最佳药物治疗（OMT）相比，植入式心律转复除颤器（ICD）可提高心肌梗死（MI）后左室射血分数（LVEF）严重降低患者的生存率。自那时以来，治疗的进步导致该人群中心源性猝死（SCD）的发生率降低，但ICD植入的并发症发生率仍然很高。目的：确定不植入ICD的OMT在全因死亡率方面是否不低于植入ICD的OMT。设计：PROFID EHRA试验是一项研究者驱动、前瞻性、平行组、随机、开放标签、盲法结果评估（PROBE）、多中心、无专用研究性医疗设备的非效性试验（策略证明试验），两组1:1随机化。PROFID-EHRA将招募约3,595名至少3个月前有心肌梗死病史的患者，LVEF≤35%，接受OMT治疗至少3个月，纽约心脏协会II或III级，将随机分为OMT或OMT + ICD，在约28个月的中位观察期内收集374个第一主要结局事件，来自约13个国家的180个临床站点。主要结局是从随机化到全因死亡发生的时间。次要结局包括从随机化到心血管原因死亡的时间，到SCD，到随机化日期后心血管原因第一次住院，随访期间的平均住院时间，以及生活轨迹的质量。概要：PROFID-EHRA试验将为心肌梗死和LVEF严重降低的患者使用ICD植入提供当代证据。临床：Trials.gov NCT05665608。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.