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Stop vasodepressor drugs in reflex syncope: a randomised controlled trial
  1. Diana Solari1,
  2. Francesca Tesi2,
  3. Matthias Unterhuber3,
  4. Germano Gaggioli4,
  5. Andrea Ungar2,
  6. Marco Tomaino3,
  7. Michele Brignole1
  1. 1Department of Cardiology, Arrhythmologic Center, Ospedali del Tigullio, Lavagna, Italy
  2. 2Department of Cardiology and Geriatric Medicine, University of Florence, AOU Careggi, Florence, Italy
  3. 3Division of Cardiology, Ospedale Generale regionale, Bolzano, Italy
  4. 4Division of Cardiology, Ospedale Villa Scassi, Genova, Italy
  1. Correspondence to Professor Michele Brignole, Department of Cardiology, Ospedali del Tigullio, Via don Bobbio, Lavagna 16033, Italy; mbrignole{at}ASL4.liguria.it

Abstract

Objectives 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.

Methods 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).

Results 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).

Conclusions Recurrence of syncope and presyncope can be reduced by discontinuing/reducing vasoactive therapy in most elderly patients affected by reflex vasodepressor syncope.

Trial registration number NCT01509534; EudraCT2013-004364-63; Results.

  • CARDIAC PROCEDURES AND THERAPY

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