Pulmonary Vein Isolation versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients with Atrial Fibrillation

doi:10.1016/s0140-6736(26)01558-8

PVI-SHAM-AF

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 262 patients with symptomatic atrial fibrillation, pulmonary vein isolation did not improve AF-specific quality of life at 6 months compared with a sham procedure.

N

262pazienti

Disegno

multicentre (8 sites in Germany, 1 in Poland), prospective, double-blind, sham-controlled RCT; 2:1 PVI vs sham procedure; participants, care providers, investigators and outcome assessors masked; follow-up at 3, 6 and 12 months

Esito

change in AFEQT score from baseline to 6 months after randomisation

Rilevanza

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

RisultatoAFEQT summary score rose from 61.3 (SD 20.1) to 81.1 (16.6) with ablation and from 59.2 (19.0) to 74.9 (19.5) with sham; Hodges-Lehmann between-group difference in change 2.6 (95% CI −2.7 to 8.0; p = 0.36) — no superiority. Freedom from atrial fibrillation at 6 months 73% vs 52%. Procedure-related serious adverse events in 10 patients (6 ablation, 4 sham), including one ischaemic stroke in the sham group; one death in each group, neither procedure-related.

Wachter R, Haag P, Uhe T, et al. Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial. Lancet. 2026 Aug 30 (online first). doi:10.1016/S0140-6736(26)01558-8. Presented at ESC Congress 2026, Hot Line 8, 30 August 2026. 10.1016/s0140-6736(26)01558-8

Discussione e critica

The second sham-controlled test of pulmonary vein isolation, and it contradicts the first: SHAM-PVI (n = 126, JAMA 2024) found ablation better than a sham on symptoms as well as burden, while here the AFEQT gain of about 20 points was matched by 16 points after a sham procedure. The rhythm result is not in doubt — 73% free of atrial fibrillation against 52% — so what is in doubt is how much of the symptom relief patients report belongs to the ablation rather than to having undergone a procedure. This trial is twice the size and its sham was deeper (a venous sheath and an hour of sedation against phrenic pacing in SHAM-PVI); six months is short for either, and a pooled reading of the two is now the honest position rather than a verdict from one.