Solari Diana, Tesi Francesca, Unterhuber Matthias, Gaggioli Germano, Ungar Andrea, Tomaino Marco, Brignole Michele
Department of Cardiology, Arrhythmologic Center, Ospedali del Tigullio, Lavagna, Italy.
Department of Cardiology and Geriatric Medicine, University of Florence, AOU Careggi, Florence, Italy.
Heart. 2017 Mar;103(6):449-455. doi: 10.1136/heartjnl-2016-309865. Epub 2016 Sep 23.
Most elderly patients affected by reflex vasodepressor syncope take one or more hypotensive drugs. The role of these drugs in causing syncope has not yet been established. We hypothesised that recurrence of syncope and presyncope can be reduced by discontinuing/reducing vasoactive therapy without increasing the risk of cardiovascular and neurological events.
This randomised, parallel, prospective, trial was conducted from January 2014 to March 2016 in four general hospitals. Of 328 initially screened participants, 58 patients (mean (SD) age 74±11 years) affected by vasodepressor reflex syncope, which was reproduced by tilt testing (n=54) or carotid sinus massage (n=4), were randomised to stop/reduce vasoactive therapy or to continue it. Primary end point was recurrence of syncope, presyncope or adverse events (defined as stroke, cerebral transient ischaemic attacks, worsening heart failure, myocardial infarction).
Of 58 patients who were randomised, 55 completed the trial. After 1 month, systolic blood pressure was significantly higher in the 'stop/reduce' group than in the 'continue' group, in both supine (141±13 mm Hg vs 128±14 mm Hg; p=0.004) and standing (133±13 mm Hg vs 122±15 mm Hg; p=0.02) positions. During a mean follow-up of 13±7 months, the primary combined end point occurred in seven 'stop/reduce' patients (23%): three had syncope, three had presyncope and one had heart failure. Conversely, it occurred in 13 'continue' patients (54%): 10 had syncope, 2 had presyncope and 1 had cerebral transient ischaemic attack. The log-rank p value was 0.02 and the HR was 0.37 (95% CI 0.15 to 0.91).
Recurrence of syncope and presyncope can be reduced by discontinuing/reducing vasoactive therapy in most elderly patients affected by reflex vasodepressor syncope.
NCT01509534; EudraCT2013-004364-63; Results.
大多数患有反射性血管减压性晕厥的老年患者服用一种或多种降压药物。这些药物在引发晕厥中的作用尚未明确。我们推测，停用/减少血管活性治疗可降低晕厥和晕厥前症状的复发率，且不会增加心血管和神经系统事件的风险。
本随机、平行、前瞻性试验于2014年1月至2016年3月在四家综合医院进行。在最初筛查的328名参与者中，58例（平均（标准差）年龄74±11岁）受血管减压性反射性晕厥影响的患者，通过倾斜试验（n = 54）或颈动脉窦按摩（n = 4）诱发晕厥，被随机分为停用/减少血管活性治疗组或继续治疗组。主要终点是晕厥、晕厥前症状或不良事件（定义为中风、脑短暂性缺血发作、心力衰竭恶化、心肌梗死）的复发。
随机分组的58例患者中，55例完成了试验。1个月后，“停用/减少”组仰卧位（141±13 mmHg对128±14 mmHg；p = 0.004）和站立位（133±13 mmHg对122±15 mmHg；p = 0.02）的收缩压均显著高于“继续”组。在平均13±7个月的随访期间，主要联合终点在7例“停用/减少”组患者中出现（23%）：3例发生晕厥，3例出现晕厥前症状，1例出现心力衰竭。相反，13例“继续”组患者中出现该终点（54%）：10例发生晕厥，2例出现晕厥前症状，1例出现脑短暂性缺血发作。对数秩检验p值为0.02，风险比为0.37（95%置信区间0.15至0.91）。
在大多数受反射性血管减压性晕厥影响的老年患者中，停用/减少血管活性治疗可降低晕厥和晕厥前症状的复发率。
NCT01509534；EudraCT2013 - 004364 - 63；结果
