Arrhythmias & electrophysiologyCohort study
Incorporating a Shortened Long-Term Effectiveness END Point Into Catheter Ablation Trials: Statistical Properties and Implications
- Patient-level data from 4 prospective studies were aggregated
Authors' conclusion
The proposed end point of a 6-month follow-up duration, inclusive of a 2-month blanking period, demonstrated reasonable levels of agreement with the current 12-month effectiveness end point. Enabling historical comparison, a 12-month survival rate can be reliably extrapolated from a 6-month survival rate using linear approximation.
Study context
- Population
- Patients in trials of paroxysmal atrial fibrillation ablation4 prospective studies
- Exposure
- current vs proposed
Main finding
As reported in the abstract
concordances ranging from
83% to 92%
sensitivities ranging from
57% to 76%
Observational data: associations, not effects.
Further findings
Estimated 12-month survival rate by linear approximation, 4 pooled studies
- estimated 12-month survival rate
- 72.5%
- true 12-month survival rate
- 71.0%
- error
- −1.5%
Error of estimated vs true 12-month survival rate, each study individually
- errors ranging from
- −3.6% to 0.3%
New performance goal for trials using a 6-month end point
- new performance goal
- 56.2%
Original publication
Summarised from the published abstract; every number is checked against it