Journal of the American College of Cardiology · 2025
Using Compression Stockings to Prevent Recurrence of Vasovagal Syncope: A Randomized Sham-Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tavolinejad Hamed, Bozorgi Ali, Emkanjoo Zahra, Oraii Alireza, Shahabi Javad, Mollazadeh Reza, Kiarsi Mohamadreza, Yadangi Somayeh, Babaei Mohammadreza, Oraii Saeed, Hosseini Kaveh, Sadeghian Saeed, Zadkamali Mostafa, Mohsenzadeh Amin, Alaeddini Farshid, Raj Satish R, Fedorowski Artur, Tajdini Masih
Аннотация
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.
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.