Sedation, vascular access, and two climbing scores
PVI-SHAM-AF randomised 262 patients with symptomatic atrial fibrillation 2:1. One arm received pulmonary vein isolation; the other received a sham procedure in which patients received sedation and vascular access but no catheter. Patients and assessors were both blinded.[1]
At six months the AFEQT quality-of-life score had risen from 61.3 to 81.1 after ablation and from 59.2 to 74.9 after the sham. The gap between those two climbs did not reach significance (p=0.36).[1]
Freedom from atrial fibrillation split the arms
Freedom from atrial fibrillation did separate the arms, at 73 per cent against 52 per cent. Patients and assessors were both blinded.[1]
After the sham, AFEQT rose from 59.2 to 74.9 among patients who received sedation and vascular access but no catheter. That climb is consistent with the setting of the procedure — sedation, vascular access, being followed — shifting the quality-of-life score. Another reading sits in the same figures: the score after ablation still moved farther, from 61.3 to 81.1, and with 262 patients the gap may have been too small for p=0.36 to call it significant.[1]
On safety, five vascular complications were seen, three in the ablation arm and two in the sham arm. Serious adverse events numbered six in the ablation arm and four in the sham arm. The trial was presented at the ESC Congress in Munich and published the same day in The Lancet.[1]
Six months for a person with symptomatic atrial fibrillation
For someone with symptomatic atrial fibrillation, the six-month blinded comparison shows freedom from atrial fibrillation at 73 per cent after pulmonary vein isolation against 52 per cent after the sham, an AFEQT gap that did not reach significance, and more vascular complications and serious adverse events in the ablation arm than in the sham arm. The figures describe that trade-off for the people who entered this trial.[1]