In Reply Dr Lucijanic and colleagues express concern about the proportion of patients randomized to the drug group of the trial who crossed over to receive an ablation, and the biases those crossovers may have introduced in the analysis. As noted in the publication,1 there were also crossovers among patients randomized to the ablation group, namely patients who did not undergo the ablation after being randomized. This could also have introduced bias. Our concern about crossovers in either direction and biases introduced by the crossovers was precisely why prespecified sensitivity analyses (as-treated and per-protocol analyses) were performed and reported1 and discussed in the online Supplement 3. The crossover of patients in the drug group to receive an ablation was primarily symptom-driven and due to the fact that drug options for treating the symptoms had been exhausted. The reasons some patients in the ablation group never underwent ablation were primarily because of patient or family refusal.
Packer DL, Mark DB, Lee KL. Catheter Ablation Compared With Drug Therapy for Atrial Fibrillation—Reply. JAMA. 2019;322(11):1106. doi:https://doi.org/10.1001/jama.2019.10688
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