Multi-centre open-label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study

doi:10.1056/NEJMoa2605812

ASPIRED

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 2,233 emergency patients with unexplained syncope, immediate 14-day patch ECG monitoring did not reduce self-reported syncope episodes at 1 year compared with standard care.

N

2233pazienti

Disegno

UK multicentre, open-label, parallel-group randomised controlled trial; 1:1 web-based randomisation with allocation concealment, stratified by site; immediate 14-day ambulatory patch ECG monitor (BodyGuardian Mini, Preventice) fitted at emergency department/acute medical unit attendance plus standard care versus standard care alone; monthly self-report follow-up for 2 years; funded by the British Heart Foundation; sponsored by the University of Edinburgh and NHS Lothian (ACCORD); recruitment 2021–2026.

Esito

Number of self-reported episodes of syncope at 1 year

Rilevanza

1Definisce la pratica — lo studio su cui poggia la linea guida.

RisultatoSelf-reported syncope at one year did not differ (1.37 vs 1.58 episodes; P = 0.43). Monitoring more than doubled arrhythmia detection (22% vs 9%) and shortened the median time to diagnosis from 55 to 22 days; pacemakers were implanted in 6.8% vs 4.6% and antiarrhythmic therapy started in 10.8% vs 7.3%. All-cause mortality was 1.5% vs 2.9%.

Reed MJ, Goodacre S, Weir CJ, et al. N Engl J Med. 2026; published online 30 August. 10.1056/NEJMoa2605812

Discussione e critica

A patch worn out of the emergency department found the arrhythmia twice as often and a month sooner, and the patients fainted just as much — because knowing the rhythm is not the same as having a treatable one, and most unexplained syncope is not bradycardia waiting for a pacemaker. Choosing self-reported episodes as the primary endpoint was a bet that diagnosis translates into fewer faints; it did not. The mortality split of 1.5% against 2.9% is the number that will be quoted, in a trial not powered for it and with no adjustment claimed — a hypothesis, not a finding, and the reason a hard-endpoint trial should follow.