Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial methods
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Verification of HF Classification Using Baseline QOL Data
Heart failure remains an inexact phenotypic clinical diagnosis based primarily on expert clinician integration of multiple different types of data. CABANA did not collect specific biomarker or other clinical or test data relevant to the diagnosis of HF. Left ventricular function imaging was assumed to be part of routine care and was collected as available.
Statistical Analysis
Descriptive summary statistics included counts (percentages) for categorical variables, and medians (25 th and 75 th percentiles) for continuous variables. The primary statistical comparisons were performed with treatment assigned as randomized (intention to treat [ITT]). Kaplan-Meier (KM) cumulative event rates were estimated for each treatment group with time-to-event measured (in months) from the time of randomization. Treatment effect sizes for most clinical outcomes were expressed as hazard ratios (HRs) with associated 95% confidence intervals (CIs) and were estimated using a covariate adjusted Cox proportional hazards model. The Cox model was constructed as a stratified model (NYHA class II or greater versus all others) using the entire CABANA cohort and was adjusted for the following list of pre-specified baseline patient characteristics: age, sex, race/ethnicity, AF type, year...
Statistical Analysis
The QOL endpoints were analyzed with a repeated-measure mixed-effects model with baseline score and month 3, 12, 24, 36, 48, and 60 responses included as outcomes and time, treatment group, and time x treatment group included as fixed effects. For each follow-up point, we generated point estimates for each treatment group as well as treatment group mean differences (ablation score - drug score). Precision of estimates was assessed with 95% CIs. Since the model does not require either complete data on all patients or a uniform length of follow-up, we did not impute missing values.
Treatment Data
In the ablation group, 344 (91.0%) HF patients underwent ablation at a median of 24 days following randomization, while 34 (9.0%) patients did not receive ablation. Among the catheter ablation patients with HF and post-blanking follow-up, 155/330 (47%) were on a rhythm control drug at the end of the blanking period ( ) and 76/325 (23%) were on a rhythm control drug at the latest of one or more follow-up contacts.
Treatment Data
In the drug therapy alone group, 89 (22.3%) received an ablation procedure at a median of 351 days following randomization (25 th percentile 162, 75 th percentile 725). At the end of the blanking period, 307/383 (80%) were on a rhythm control drug ( ) and 188/376 (50%) were receiving one of these drugs at the latest of one or more follow-up contacts.
Clinical Outcome Comparisons by Intention-to-Treat
The CABANA primary outcome event (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 34/378 (9.0%) HF patients in the catheter ablation group and in 49/400 (12.3%) HF patients in drug therapy (HR for ablation vs drug therapy 0.64; 95% CI, 0.41 to 0.99) ( ). Death from any cause occurred in 23/378 (6.1%) HF patients in the ablation arm and 37/400 (9.3%) HF patients in the drug therapy arm (HR 0.57; 95% CI, 0.33 to 0.96) ( ). Death from cardiovascular causes occurred in 12/378 (3.2%) patients in the ablation arm and 14/400 (3.5%) patients in the drug therapy arm (HR 0.70; 95% CI, 0.31 to 1.57). Deaths due to HF occurred in 6 patients in the ablation arm and 4 patients in the drug therapy arm. Death or CV hospitalization occurred in 212/378 (56.1%) patients in the ablation arm and 245/400 (61.3%) patients in the drug therapy arm (HR 0.84; 95% CI, 0.70 to 1.02). HF...
Treatment Assignment Sensitivity Analyses
In a pre-specified "as treated" analysis, the ablation arm showed a 42% reduction in the primary composite endpoint (HR 0.58; 95% CI, 0.37 to 0.90) in HF patients. Reductions were also seen in all-cause mortality (HR 0.50; 95% CI, 0.30 to 0.85); the composite of death or CV hospitalization (HR 0.84; 95% CI, 0.70 to 1.01); and the composite of death or HF hospitalization (HR 0.59; 95% CI, 0.41 to 0.87). No deaths occurred within the first 30 days after initiation of either therapy. One disabling stroke occurred within the first 30 days of treatment after initiation of drug therapy.
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Evidence quotes (7)
Heart failure remains an inexact phenotypic clinical diagnosis based primarily on expert clinician integration of multiple different types of data. CABANA did not collect specific biomarker or other clinical or test data relevant to the diagnosis of HF. Left ventricular function imaging was assumed to be part of routine care and was collected as available.
Descriptive summary statistics included counts (percentages) for categorical variables, and medians (25 th and 75 th percentiles) for continuous variables. The primary statistical comparisons were performed with treatment assigned as randomized (intention to treat [ITT]). Kaplan-Meier (KM) cumulative event rates were estimated for each treatment group with time-to-event measured (in months) from the time of randomization. Treatment effect sizes for most clinical outcomes were expressed as hazard ratios (HRs) with associated 95% confidence intervals (CIs) and were estimated using a covariate adjusted Cox proportional hazards model. The Cox model was constructed as a stratified model (NYHA class II or greater versus all others) using the entire CABANA cohort and was adjusted for the following list of pre-specified baseline patient characteristics: age, sex, race/ethnicity, AF type, years since onset of AF, history of heart failure, structural heart disease, CHA 2 DS 2 -VASc score, history of coronary artery disease, and hypertension. An interaction term treatment group x HF (defined by NYHA ≥ Class II) was included in the model. Statistical testing of treatment differences w...
The QOL endpoints were analyzed with a repeated-measure mixed-effects model with baseline score and month 3, 12, 24, 36, 48, and 60 responses included as outcomes and time, treatment group, and time x treatment group included as fixed effects. For each follow-up point, we generated point estimates for each treatment group as well as treatment group mean differences (ablation score - drug score). Precision of estimates was assessed with 95% CIs. Since the model does not require either complete data on all patients or a uniform length of follow-up, we did not impute missing values.
In the ablation group, 344 (91.0%) HF patients underwent ablation at a median of 24 days following randomization, while 34 (9.0%) patients did not receive ablation. Among the catheter ablation patients with HF and post-blanking follow-up, 155/330 (47%) were on a rhythm control drug at the end of the blanking period ( ) and 76/325 (23%) were on a rhythm control drug at the latest of one or more follow-up contacts.
In the drug therapy alone group, 89 (22.3%) received an ablation procedure at a median of 351 days following randomization (25 th percentile 162, 75 th percentile 725). At the end of the blanking period, 307/383 (80%) were on a rhythm control drug ( ) and 188/376 (50%) were receiving one of these drugs at the latest of one or more follow-up contacts.
The CABANA primary outcome event (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 34/378 (9.0%) HF patients in the catheter ablation group and in 49/400 (12.3%) HF patients in drug therapy (HR for ablation vs drug therapy 0.64; 95% CI, 0.41 to 0.99) ( ). Death from any cause occurred in 23/378 (6.1%) HF patients in the ablation arm and 37/400 (9.3%) HF patients in the drug therapy arm (HR 0.57; 95% CI, 0.33 to 0.96) ( ). Death from cardiovascular causes occurred in 12/378 (3.2%) patients in the ablation arm and 14/400 (3.5%) patients in the drug therapy arm (HR 0.70; 95% CI, 0.31 to 1.57). Deaths due to HF occurred in 6 patients in the ablation arm and 4 patients in the drug therapy arm. Death or CV hospitalization occurred in 212/378 (56.1%) patients in the ablation arm and 245/400 (61.3%) patients in the drug therapy arm (HR 0.84; 95% CI, 0.70 to 1.02). HF hospitalization occurred in 34/378 (9.0%) patients in the ablation arm and 37/400 (9.3%) patients in the drug therapy arm (HR 0.89; 95% CI, 0.56 to 1.44).
In a pre-specified "as treated" analysis, the ablation arm showed a 42% reduction in the primary composite endpoint (HR 0.58; 95% CI, 0.37 to 0.90) in HF patients. Reductions were also seen in all-cause mortality (HR 0.50; 95% CI, 0.30 to 0.85); the composite of death or CV hospitalization (HR 0.84; 95% CI, 0.70 to 1.01); and the composite of death or HF hospitalization (HR 0.59; 95% CI, 0.41 to 0.87). No deaths occurred within the first 30 days after initiation of either therapy. One disabling stroke occurred within the first 30 days of treatment after initiation of drug therapy.
Machine-readable layer
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