The edition · Top Clinical Updates
Catheter ablation for atrial fibrillation beat a sham procedure by 2.6 points, and missed
A double-blind sham-controlled trial finds most of the symptom benefit of ablation was not the ablation. Plus what happened after a caesarean antibiotic trial was published, and a negative immunotherapy trial in early lung cancer.
The edition in brief
Today's cross-specialty desk is about how much of what we do survives a fair test. PVI-SHAM-AF randomised 262 patients with symptomatic atrial fibrillation 2:1 to catheter ablation or a sham procedure, double-blind. Quality of life improved substantially in both arms - from 61.3 to 81.1 with ablation and from 59.2 to 74.9 with sham - and the between-group difference was 2.6 points (95% CI -2.7 to 8.0, p=0.36). Ablation did not show superiority over sham for symptom relief at six months. A cooperative group phase 3 trial of adding atezolizumab to stereotactic body radiation therapy in inoperable early-stage non-small-cell lung cancer closed at the first interim analysis for futility. Overall survival hazard ratio was 1.04 (95% CI 0.69-1.58), two-year survival 82% in both groups, and grade 3 or higher adverse events rose from 3% to 12%. Against those, an analysis of 1,663,441 US deliveries shows evidence does sometimes land: adjunctive azithromycin at unscheduled caesarean rose from 2.2% to 39.6% after the 2016 trial, and postpartum infection fell by an adjusted 2.0 percentage points relative to vaginal birth. A first-in-human phase 1 trial of a long-acting small interfering RNA targeting lipoprotein(a) reduced concentrations by up to 97% at 48 weeks after a single dose, in 70 otherwise healthy adults, with no drug-related adverse events. No clinical outcomes have been tested.
Evidence to practice, measured: azithromycin at caesarean went from 2% to 40%
Confirm adjunctive azithromycin is in your unscheduled caesarean protocol, and audit actual administration rather than trusting the protocol.
Immunotherapy added to stereotactic radiotherapy in early lung cancer: stopped for futility
Adding atezolizumab to stereotactic radiotherapy in inoperable early-stage lung cancer does not improve survival and increases serious toxicity: do not offer it outside a trial.
One injection, lipoprotein(a) down 97% at 48 weeks - in 70 healthy volunteers
Note it and wait: a single dose suppresses lipoprotein(a) for a year, but nobody has shown that lowering it prevents anything.
When a procedure trial has no sham arm, the improvement you quote includes the procedure's theatre
Quote the between-group difference, not the improvement from baseline, whenever you are describing what a procedure will do for symptoms.
PVI-SHAM-AF: ablation did not beat a sham procedure for symptom relief
If you are offering ablation purely for symptom relief, tell the patient a blinded trial found only a 2.6-point advantage over a sham procedure, well short of significance.
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