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Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope : A Randomized Sham-Controlled Trial

Tavolinejad, Hamed ; Bozorgi, Ali ; Emkanjoo, Zahra ; Oraii, Alireza ; Shahabi, Javad ; Mollazadeh, Reza ; Kiarsi, Mohamadreza ; Yadangi, Somayeh ; Babaei, Mohammadreza and Oraii, Saeed , et al. (2025) In Journal of the American College of Cardiology 86(6). p.412-422
Abstract

Background: Vasovagal syncope (VVS) is a common yet challenging condition with limited effective treatments. Elastic compression stockings (ECS) have been proposed as a potential therapy, but their real-world effectiveness remains unclear. Objectives: This study sought to compare the effectiveness of lower extremity compression with thigh-high ECS vs sham stockings for the prevention of VVS recurrence. Methods: This multicenter, parallel, blinded, randomized sham-controlled trial enrolled adults 18 to 65 years of age with ≥2 VVS episodes in the past year. Participants were randomized 1:1 to receive either thigh-length, open-toe active ECS (25-30 mm Hg pressure to the leg), or identical-looking sham ECS (≤10 mm Hg pressure). All... (More)

Background: Vasovagal syncope (VVS) is a common yet challenging condition with limited effective treatments. Elastic compression stockings (ECS) have been proposed as a potential therapy, but their real-world effectiveness remains unclear. Objectives: This study sought to compare the effectiveness of lower extremity compression with thigh-high ECS vs sham stockings for the prevention of VVS recurrence. Methods: This multicenter, parallel, blinded, randomized sham-controlled trial enrolled adults 18 to 65 years of age with ≥2 VVS episodes in the past year. Participants were randomized 1:1 to receive either thigh-length, open-toe active ECS (25-30 mm Hg pressure to the leg), or identical-looking sham ECS (≤10 mm Hg pressure). All participants received standard care (education and lifestyle modifications) but no medications for preventing VVS recurrence. ECS adherence was tracked using diary booklets. The coprimary outcomes were: 1) the proportion of participants with ≥1 VVS recurrence; and 2) the time to first VVS recurrence (ie, VVS-free survival). Results: Among 266 participants (mean age 39 years, 58% female), during 12 months of follow-up, VVS recurred in 29.1% (n = 39 of 134) of participants in the treatment group and 34.8% (n = 46 of 132) in the control group (absolute risk reduction: 5.7%; P = 0.315). VVS-free survival was not significantly different (HR: 0.81; 95% CI: 0.53-1.24; P = 0.333). ECS adherence was suboptimal, with discontinuation rates of 37.3% in the treatment arm vs 34.8% in the sham arm. Discontinuation rates, duration of using ECS, and adherence rates were similar between treatment groups. The median number of recurrent episodes was similar (treatment: 2.5 vs sham: 2; P = 0.839). However, significantly fewer VVS episodes occurred while actively wearing ECS (32.7% vs 45.1%; P = 0.024). Conclusions: Treating syncope with thigh-high lower limb compression using ECS did not reduce the cumulative incidence of VVS recurrence, and did not change VVS-free survival. Additionally, ECS did not reduce the frequency of multiple VVS episodes. The results do not support routine use of thigh-length ECS, although it may be helpful for selected patients when added to standard care. Because our study specifically tested thigh-high ECS, future studies should aim to assess the effectiveness of more extensive compression targeting pelvic and abdominal venous pooling.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
compression stockings, neurally mediated syncope, randomized controlled trial, reflex syncope, vasovagal syncope
in
Journal of the American College of Cardiology
volume
86
issue
6
pages
412 - 422
publisher
Elsevier
external identifiers
  • scopus:105011606478
ISSN
0735-1097
DOI
10.1016/j.jacc.2025.05.049
language
English
LU publication?
no
additional info
Publisher Copyright: © 2025 American College of Cardiology Foundation
id
586f471b-aae7-4b62-8b09-f56e146b571d
date added to LUP
2025-08-04 19:21:56
date last changed
2025-08-05 08:45:01
@article{586f471b-aae7-4b62-8b09-f56e146b571d,
  abstract     = {{<p>Background: Vasovagal syncope (VVS) is a common yet challenging condition with limited effective treatments. Elastic compression stockings (ECS) have been proposed as a potential therapy, but their real-world effectiveness remains unclear. Objectives: This study sought to compare the effectiveness of lower extremity compression with thigh-high ECS vs sham stockings for the prevention of VVS recurrence. Methods: This multicenter, parallel, blinded, randomized sham-controlled trial enrolled adults 18 to 65 years of age with ≥2 VVS episodes in the past year. Participants were randomized 1:1 to receive either thigh-length, open-toe active ECS (25-30 mm Hg pressure to the leg), or identical-looking sham ECS (≤10 mm Hg pressure). All participants received standard care (education and lifestyle modifications) but no medications for preventing VVS recurrence. ECS adherence was tracked using diary booklets. The coprimary outcomes were: 1) the proportion of participants with ≥1 VVS recurrence; and 2) the time to first VVS recurrence (ie, VVS-free survival). Results: Among 266 participants (mean age 39 years, 58% female), during 12 months of follow-up, VVS recurred in 29.1% (n = 39 of 134) of participants in the treatment group and 34.8% (n = 46 of 132) in the control group (absolute risk reduction: 5.7%; P = 0.315). VVS-free survival was not significantly different (HR: 0.81; 95% CI: 0.53-1.24; P = 0.333). ECS adherence was suboptimal, with discontinuation rates of 37.3% in the treatment arm vs 34.8% in the sham arm. Discontinuation rates, duration of using ECS, and adherence rates were similar between treatment groups. The median number of recurrent episodes was similar (treatment: 2.5 vs sham: 2; P = 0.839). However, significantly fewer VVS episodes occurred while actively wearing ECS (32.7% vs 45.1%; P = 0.024). Conclusions: Treating syncope with thigh-high lower limb compression using ECS did not reduce the cumulative incidence of VVS recurrence, and did not change VVS-free survival. Additionally, ECS did not reduce the frequency of multiple VVS episodes. The results do not support routine use of thigh-length ECS, although it may be helpful for selected patients when added to standard care. Because our study specifically tested thigh-high ECS, future studies should aim to assess the effectiveness of more extensive compression targeting pelvic and abdominal venous pooling.</p>}},
  author       = {{Tavolinejad, Hamed and Bozorgi, Ali and Emkanjoo, Zahra and Oraii, Alireza and Shahabi, Javad and Mollazadeh, Reza and Kiarsi, Mohamadreza and Yadangi, Somayeh and Babaei, Mohammadreza and Oraii, Saeed and Hosseini, Kaveh and Sadeghian, Saeed and Zadkamali, Mostafa and Mohsenzadeh, Amin and Alaeddini, Farshid and Raj, Satish R. and Fedorowski, Artur and Tajdini, Masih}},
  issn         = {{0735-1097}},
  keywords     = {{compression stockings; neurally mediated syncope; randomized controlled trial; reflex syncope; vasovagal syncope}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{6}},
  pages        = {{412--422}},
  publisher    = {{Elsevier}},
  series       = {{Journal of the American College of Cardiology}},
  title        = {{Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope : A Randomized Sham-Controlled Trial}},
  url          = {{http://dx.doi.org/10.1016/j.jacc.2025.05.049}},
  doi          = {{10.1016/j.jacc.2025.05.049}},
  volume       = {{86}},
  year         = {{2025}},
}