A LANDMARK study presented at the European Society of Cardiology (ESC) 2024 Congress in London, UK, has provided conclusive evidence that a widely used catheter ablation procedure significantly reduces the burden of atrial fibrillation (AF), offering substantial improvements in symptoms and quality of life compared to a sham treatment.
This is the first double-blind randomised trial to directly compare pulmonary vein isolation (PVI) ablation with a placebo procedure, addressing long-standing concerns about the potential placebo effect of this common treatment.
The study, known as the SHAM-PVI trial, involved 126 patients from two National Health Service (NHS) trusts in the UK, all of whom had symptomatic paroxysmal or persistent AF, and had previously been treated with at least one antiarrhythmic drug. Participants were randomly assigned to undergo either the PVI ablation, which uses cryoablation to freeze and destroy tissue causing irregular heartbeats, or a sham procedure designed to mimic the experience of ablation without delivering actual treatment.
Principal investigator Rick Veasey highlighted the significance of the trial, stating: “Our results provide conclusive evidence for the benefit of PVI ablation in individuals with symptomatic AF, putting concerns about a substantial placebo effect to rest.”
At the 6-month follow-up, the ablation group saw an average 60% reduction in AF burden, compared to a 35% reduction in the sham group. The difference was even more pronounced in patients with persistent AF, where the ablation group experienced a 71% reduction in AF burden, compared to 45% in the sham group. Patients with intermittent AF also benefited more from ablation, with a 16% reduction in AF burden, versus a 3% increase in the sham group.
The study also revealed significant improvements in quality of life and symptom relief in the ablation group, reinforcing the procedure’s effectiveness. Lead author Rajdip Dulai emphasised: “We expected that PVI would be more effective than a placebo, and the results proved our hypothesis correct. Patients with symptomatic AF should be referred for ablation treatment without hesitation.”
This groundbreaking trial is expected to solidify PVI ablation as the standard treatment for symptomatic AF, offering new hope to patients with AF worldwide.
Ada Enesco, EMJ
Reference
Dulai R et al. SHAM-PVI – A randomised sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation. ESC, 30 August–2 September, 2024.
