Brignole Michele, Tomaino Marco, Aerts Arnaud, Ammirati Fabrizio, Ayala-Paredes Félix Alejandro, Deharo Jean-Claude, Del Rosso Attilio, Hamdan Mohamed H, Lunati Maurizio, Moya Angel, Gargaro Alessio
Ospedali del Tigullio, Arrhythmologic Centre, Department of Cardiology, Via Don Bobbio, 25, 16033, Lavagna, GE, Italy.
Central Hospital, Bolzano, Italy.
Trials. 2017 May 4;18(1):208. doi: 10.1186/s13063-017-1941-4.
The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research.
METHODS/DESIGN: The BIOSync study is a multicenter, patient- and outcome-assessor-blind, randomized, parallel-arm, placebo-controlled trial with the objective of assessing the clinical benefit of cardiac pacing in patients with frequently recurrent reflex syncope, suspected (but not proven) to be triggered by asystolic pauses as showing a VASIS 2B response to the TT (>3-s pause regardless of blood pressure drop). The primary and secondary endpoints are time to first post-implantation recurrence of syncope or the combination of pre-syncope or syncope, respectively. One hundred and twenty-eight consenting patients will be 1:1 randomized to dual-chamber cardiac pacing 'on' or 'off' after pacemaker implantation, and followed up until the first adjudicated primary endpoint event for a maximum of 2 years. The so-called Closed Loop Stimulation function on top of dual-chamber pacing is the pacing mode selected in the study active arm. Participating patients are asked to self-report syncopal symptoms at least every 3 months with self-administered questionnaires addressed to an independent Adjudication Committee. Patients and members of the Adjudicating Committee are blinded to randomization. The study is designed to detect a 40% relative reduction in the 2-year incidence of syncopal recurrences with 80% statistical power.
The BIOSync study is designed to definitively assess the benefit of pacing against placebo in reflex syncope patients with a cardio-inhibitory response to the TT. The study will also provide important information on the efficiency of the TT in appropriately selecting reflex syncope patients for cardiac pacing.
ClinicalTrials.gov, identifier: NCT02324920 (27 October 2016, date last accessed).
迄今为止，双腔心脏起搏治疗对倾斜试验（TT）呈心脏抑制反应的神经介导性反射性晕厥的疗效尚未得到明确评估。既往研究结果缺乏可重复性，部分原因可能是受试者选择存在差异以及设计和方法上的一些缺陷。欧洲心脏病学会（ESC）已将起搏器植入设定为该人群的IIb类适应证，建议进一步开展研究。
方法/设计：BIOSync研究是一项多中心、患者和结局评估者双盲、随机、平行组、安慰剂对照试验，旨在评估心脏起搏对频繁复发性反射性晕厥患者的临床益处，这些患者疑似（但未经证实）由心脏停搏引发，对TT呈VASIS 2B反应（无论血压下降情况，停顿超过3秒）。主要终点和次要终点分别是植入后首次晕厥复发时间以及先兆晕厥或晕厥的联合复发时间。128名同意参与的患者将在起搏器植入后按1:1随机分为双腔心脏起搏“开启”或“关闭”组，并随访至首次判定的主要终点事件发生，最长随访2年。研究的活性组所选择的起搏模式是在双腔起搏基础上的所谓闭环刺激功能。要求参与研究的患者至少每3个月通过自行填写问卷向独立的判定委员会自我报告晕厥症状。患者和判定委员会成员对随机分组情况不知情。该研究旨在以80%的统计效能检测出2年晕厥复发率相对降低40%。
BIOSync研究旨在明确评估起搏治疗相对于安慰剂对TT呈心脏抑制反应的反射性晕厥患者的益处。该研究还将提供关于TT在为心脏起搏适当选择反射性晕厥患者方面的有效性的重要信息。
ClinicalTrials.gov，标识符：NCT02324920（最后访问日期：2016年10月27日）
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