This brings up another interesting case study.
Frank and I had a fair amount of discussion with some physicians on Twitter regarding this trial:
“The primary outcome, death, disabling stroke, serious bleeding, or cardiac arrest at 5 years for ablation vs. drug therapy, was 8% vs. 9.2% (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15, p = 0.3)”
I took issue with the way these results were frequently reported at the original meeting where they were presented, in the press, and circulated on social media among physicians. Usually something along the following lines:
“The results of this important trial indicate that ablation is not superior to drug therapy for CV outcomes at 5 years among patients with new-onset or untreated AF that required therapy.”
Something about this conclusion does not sit well with me. The CABANA trial results are not very strong evidence of superiority for ablation, but it’s also not very strong evidence of non-superiority; yet these results are often described as “negative” trials or using terminology like “Ablation is not superior…”
*Personal disclosure: I am generally a “less-is-more” person when it comes to medicine and think that the barrier for adopting an invasive or aggressive therapy should often be higher than simply beating a point null hypothesis. Even with the results of that trial, I would probably choose not to have ablation; that benefit is not enough to overcome my personal discomfort with undergoing an invasive procedure. It just does not sit well with me to see the trial reported with conclusions such as “Ablation is not superior…” which is technically right from one standpoint (after all, the data did not prove ablation to be superior), but also wrong from a different view (neither did the data prove that ablation was “not superior” - yet that is often how results of such studies are framed).
I do wonder, admittedly, what the trial statistician’s take was/is, and how the discussions went with their PI’s and clinical colleagues in the interpretation of such a result.