Women are underrepresented in cardiac resynchronization therapy trials.
Introduction: Current guidelines for cardiac resynchronization therapy (CRT) device implant are the same across both sexes however women have been traditionally underrepresented in randomized controlled trials (RCTs). We aimed to identify if the number of women included in CRT trials is representati...
| Publicado en: | Journal of Cardiovascular Electrophysiology Vol. 33; no. 12; pp. 2653 - 2658 |
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| Autores principales: | , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Dec2022
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=160784768&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 160784768 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10453873 GSB jtl: Journal of Cardiovascular Electrophysiology issn: 10453873 maglogo: Y pubinfo: dt: Dec2022 vid: 33 iid: 12 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 160784768 159968578 160784768 160784768 10.1111/jce.15715 160784768 ppf: 2653 ppct: 5 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Women are underrepresented in cardiac resynchronization therapy trials. aug: au: Ahmad, Javaria Ahmad, Hassaan A. Surapaneni, Phani Penagaluri, Ashritha Desai, Sapna Dominic, Paari affil: Department of Medicine, Louisiana State University Health Sciences Center, Shreveport Louisiana,, USA sug: subj: Cardiac Resynchronization Therapy Evaluation Research, Medical Research Subject Recruitment Heart Failure Therapy Women Sex Factors Outcome Assessment Human Female Male Heart Failure Risk Factors Bundle-Branch Block Myocardial Diseases Heart Failure Mortality Comparative Studies Funding Source Female Male ab: Introduction: Current guidelines for cardiac resynchronization therapy (CRT) device implant are the same across both sexes however women have been traditionally underrepresented in randomized controlled trials (RCTs). We aimed to identify if the number of women included in CRT trials is representative of the real‐world burden of heart failure (HF) in women. Methods: RCTs evaluating the benefit of CRT in HF patients referenced in the 2012 EHRA/HRS expert consensus statement on CRT in HF were included. Studies were evaluated for gender representation, baseline variables, and gender‐based analysis of outcomes. Results: A total of 10 CRT trials including 8107 patients were studied. Of the total patient population in these RCTs, only 23% were women. Analysis of outcomes based on sex was reported only in 5 out of 10 trials. Of these five trials reporting sex‐based outcomes, multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT‐CRT) and resynchronization–defibrillation for ambulatory heart failure trial (RAFT) showed a greater benefit in women compared to men. Both MADIT and RAFT trials had a lower ejection fraction (EF) cut‐off in the inclusion criteria (EF ≤ 30%) compared to the studies that did not find gender‐based differences in the outcome (inclusion criteria: EF ≤ 35% or 40%). Additionally, women had less ischemic cardiomyopathy and more left bundle branch block (LBBB) compared to men in these two trials. Conclusion: Women are underrepresented in CRT trials; however, they have been shown to derive a greater benefit from CRT compared to men. Appropriate measures should be taken in future studies to enhance the participation of women in clinical trials for more generalizable evidence. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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