Patients’ attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation,Clinical Research in Cardiology

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Patients’ attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation
Clinical Research in Cardiology ( IF 3.8 ) Pub Date : 2021-10-28 , DOI: 10.1007/s00392-021-01959-z
Tobias Uhe ₁ , Samira Beimel _{1,

2} , Romy Langhammer ₁ , Tina Stegmann ₁ , Gerhard Hindricks ₂ , Ulrich Laufs ₁ , Nikolaos Dagres ₂ , Rolf Wachter ₁

Affiliation

Background

The interpretation of recent trials on pulmonary vein ablation (PVI) for the treatment of atrial fibrillation (AF) is hampered by the lack of blinding and sham controls. The feasibility of a sham-controlled trial has been questioned. We aimed to assess the attitude of potential participants regarding a sham-controlled trial in a common AF-patient population planned for PVI.

Methods

Patients in two tertiary care centres planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire 1 day before catheter ablation. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced, and patients were asked for their agreement in participation. Telephone follow-up of the AFEQT questionnaire was conducted 3 months after PVI.

Results

One hundred and ninety-six patients (mean age 64 ± 11 years, 63% male) were included. Seventy-nine (40%) patients expressed their agreement to participate in the hypothetical sham-controlled trial. An additional 7% agreed to participate if a cross-over option after three months was offered. Agreement rate was similar in patients with first and Redo-PVI and minimal, moderate or severe symptoms. Mean overall AFEQT at baseline was 55 ± 19 and improved by 25 ± 20 points after 3 months (p < 0.001 versus baseline).

Conclusion

With a participation rate of 40% in potential study participants, a sham-controlled trial for pulmonary vein isolation seems feasible. Patient-reported symptom relief after pulmonary vein isolation is in accordance with previous randomized open studies. The benefit of PVI should be rigorously evaluated in a sham-controlled trial.

Graphic abstract

中文翻译：

患者对房颤肺静脉隔离假对照试验的态度

背景

近期肺静脉消融 (PVI) 治疗房颤 (AF) 试验的解释因缺乏盲法和假对照而受到阻碍。假对照试验的可行性受到质疑。我们旨在评估潜在参与者对计划进行 PVI 的普通 AF 患者群体的假对照试验的态度。

方法

在导管消融前 1 天，使用心房颤动对生活质量的影响 (AFEQT) 问卷询问计划进行 PVI 的两个三级护理中心的患者当前的 AF 症状。随后，介绍了一项假设的假对照 PVI 研究的研究设计，并要求患者同意参与。AFEQT 问卷的电话随访在 PVI 后 3 个月进行。

结果

包括 196 名患者（平均年龄 64 ± 11 岁，63% 为男性）。七十九 (40%) 名患者表示同意参加假设的假对照试验。如果提供三个月后的交叉选项，另外 7% 的人同意参与。首次和重做 PVI 以及轻度、中度或重度症状的患者的协议率相似。基线时的平均总体 AFEQT 为 55 ± 19，3 个月后改善了 25 ± 20 个点（与基线相比， p < 0.001）。