Immediate 14-day ECG monitoring after unexplained syncope did not reduce recurrences

Design

Multicentre, open-label, randomised controlled trial

Population

2,234 adults with syncope unexplained after ED evaluation

Primary outcome

Patient-reported syncope episodes at 1 year

Effect

Mean 1.37 vs 1.58; incidence rate ratio 0.89 (95% CI 0.68 to 1.18)

ASPIRED was an open-label randomised trial at 45 UK hospitals. It enrolled 2,234 adults (mean age 58) whose syncope remained unexplained after emergency department assessment, and assigned them to immediate 14-day ambulatory ECG monitoring or to local standard care.

At one year, patient-reported syncope episodes averaged 1.37 with monitoring and 1.58 with usual care (rate ratio 0.89, 0.68 to 1.18). Adverse events were more frequent with monitoring, 49 against 8, with one serious event in each group.

Immediate monitoring for every unexplained faint is often requested to reassure the patient and the clinician. This trial shows it does not reduce further episodes. It does not show monitoring is useless for diagnosis: patients with high-risk features, such as exertional syncope, palpitations or an abnormal ECG, still need arrhythmia investigation. The change is to stop ordering it as routine for low-risk patients.

• Risk-stratify every syncope patient: history, examination, 12-lead ECG
• Investigate for arrhythmia when there are high-risk features
• Do not order a 14-day monitor routinely for low-risk unexplained syncope
• Give clear advice on prodromal symptoms and driving
• Arrange outpatient review if episodes recur

Why it matters

A widely used 'just to be safe' investigation did not change what matters to patients, further faints.

Don't overread it

The primary outcome was recurrence, not diagnostic yield; the trial does not argue against monitoring in high-risk syncope.

The statistics, in plain English

An incidence rate ratio of 0.89 means about 11% fewer episodes, but the interval from 0.68 to 1.18 includes an 18% increase, so no difference was shown. The very large standard deviations (5.1 and 8.6 around means under 2) mean most patients had no further episodes and a few had many, which makes averages unstable.

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