Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial methods
Aim. Evidence-backed execution summary for Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial methods from Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial.
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This experiment, in seven questions
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Shopping and prep list
What do I need before I start?
human
Subject model for the experiment.
- Use
- confirm full cohort details in the source paper
Methods:
reagent used in the protocol.
- Use
- CABANA randomized 2204 patients with AF who were ≥65 years old or <65 with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate/rhythm control drugs. Of these, 778 (35%) had NYHA class ≥ II at baseline and form the subject of this report. T...
Study Population
reagent used in the protocol.
- Use
- Patients ≥18 years old with electrocardiographic documentation of at least 2 episodes of paroxysmal AF or 1 episode of persistent AF in the 6 months prior to enrollment, and who were suitable candidates for either catheter ablation or drug therapies were eligible for enrollment. To ensure sufficient event rate...
Statistical Analysis
reagent used in the protocol.
- Use
- 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...
Pre-specified and Post Hoc Sensitivity Analyses
reagent used in the protocol.
- Use
- Given the complexities involved in interpreting an ITT analysis of a procedure-based comparison where crossover is possible, we pre-specified two sensitivity analyses for the method of treatment assignment. " As Treated " comparisons were performed using a Cox model with catheter ablation included as a t...
Treatment Data
reagent used in the protocol.
- Use
- 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...
Treatment Data
reagent used in the protocol.
- Use
- 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...
Treatment Data
reagent used in the protocol.
- Use
- The most common treatment-related adverse events in the ablation arm included hematoma (3.2%), pseudo aneurysm (1.2%), esophageal ulcer (1.2%), and severe pericardial chest pain (0.6%). The most common treatment-related adverse events in the drug therapy arm included hyper- or hypothyroidism (2.5%), gastrointestinal...
Clinical Outcome Comparisons by Intention-to-Treat
reagent used in the protocol.
- Use
- 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/...
Outcomes
To capture AF recurrence, CABANA employed a proprietary monitoring system to assess follow-up rhythm, but not all countries were able to use that system due to regulatory issues. Of the 778 patients in this sub-study, 330 (42%) used the CABANA system, and the remainder used available local recording devices. The pri...
- Use
- To capture AF recurrence, CABANA employed a proprietary monitoring system to assess follow-up rhythm, but not all countries were able to use that system due to regulatory issues. Of the 778 patients in this sub-study, 330 (42%) used the CABANA system, and the remainder used available local recording devices. The pri...
Outcomes
Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previously. The AFEQT is a 21-item instrument designed to assess AF-specific QOL in 3 domains: symptoms, daily activities, and treatment concerns....
- Use
- Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previously. The AFEQT is a 21-item instrument designed to assess AF-specific QOL in 3 domains: symptoms, daily activities, and treatment concerns....
AF Recurrence
Of the 778 HF patients, 330 (42.4%) used the CABANA recording system to detect AF recurrence following the blanking period. By 12 months, 37% of the HF ablation arm patients and 58% of the HF drug therapy arm patients recorded a recurrence of any AF ( ). At 5 years, the corresponding values were 56% (ablation arm) a...
- Use
- Of the 778 HF patients, 330 (42.4%) used the CABANA recording system to detect AF recurrence following the blanking period. By 12 months, 37% of the HF ablation arm patients and 58% of the HF drug therapy arm patients recorded a recurrence of any AF ( ). At 5 years, the corresponding values were 56% (ablation arm) a...
AF Recurrence in Heart Failure
Freedom from recurrent AF in the HF subgroup was very similar to that previously reported in the overall CABANA trial both when assessed as time to first recurrence (HR 0.56 for HF subgroup, 0.52 for overall trial) and as AF burden (at 12 months 7% in ablation patients in HF subgroup versus 6% in overall trial, 18%...
- Use
- Freedom from recurrent AF in the HF subgroup was very similar to that previously reported in the overall CABANA trial both when assessed as time to first recurrence (HR 0.56 for HF subgroup, 0.52 for overall trial) and as AF burden (at 12 months 7% in ablation patients in HF subgroup versus 6% in overall trial, 18%...
Adverse Effects of Treatment
Catheter ablation, as well as surgical MAZE procedures, work by creating scars that block pulmonary vein triggers of AF and in some cases interrupt the reentrant circuits that allow AF to perpetuate. While the elimination of AF usually improves cardiac performance and clinical outcomes, in theory aggressive or repea...
- Use
- Catheter ablation, as well as surgical MAZE procedures, work by creating scars that block pulmonary vein triggers of AF and in some cases interrupt the reentrant circuits that allow AF to perpetuate. While the elimination of AF usually improves cardiac performance and clinical outcomes, in theory aggressive or repea...
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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.
Measurement outputs
What raw and processed outputs should exist?
The CABANA trial design and methods have been previously reported in detail., Trial registration is at ClinicalTrials.gov: NCT0091150. Each site's Institutional Review...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
To capture AF recurrence, CABANA employed a proprietary monitoring system to assess follow-up rhythm, but not all countries were able to use that system due to regulatory issues...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previo...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
The MAFSI is a modification of the Bubien-Kay Symptom Checklist and in the version used for CABANA includes a 10-item symptom checklist that assesses both frequency and severity...
- Raw artifact
- Per-sample or per-animal endpoint measurements collected during the experiment
- Processed artifact
- Structured table with cleaned measurements ready for comparison
- Reported as
- Summary statistics and between-group or across-timepoint comparisons
Analysis plan
How should the outputs become interpretable results?
Acquisition
Collect raw experimental outputs with enough metadata to preserve sample identity, condition, and timing.
inferred from protocolPreprocessing / cleaning
Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previously.
from paperScoring or quantification
Quantify the primary readouts for this experiment: The CABANA trial design and methods have been previously reported in detail., Trial registration is at ClinicalTrials.gov: NCT0091150. Each site's Institutional Review...; To capture AF recurrence, CABANA employed a proprietary monitoring system to assess follow-up rhythm, but not all countries were able to use that system due to regulatory issues...; Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previo...; The MAFSI is a modification of the Bubien-Kay Symptom Checklist and in the version used for CABANA includes a 10-item symptom checklist that assesses both frequency and severity....
from paperStatistical comparison
Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previo...; Descriptive summary statistics included counts (percentages) for categorical variables, and medians (25 th and 75 th percentiles) for continuous variables. The primary statistic...; Recurrent atrial fibrillation incidence rates were estimated using a Fine-Gray model adjusted for baseline covariates listed above, with death treated as a competing risk.; 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, trea...
from paperReporting output
Report representative outputs alongside summary comparisons for The CABANA trial design and methods have been previously reported in detail., Trial registration is at ClinicalTrials.gov: NCT0091150. Each site's Institutional Review..., To capture AF recurrence, CABANA employed a proprietary monitoring system to assess follow-up rhythm, but not all countries were able to use that system due to regulatory issues..., Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previo..., The MAFSI is a modification of the Bubien-Kay Symptom Checklist and in the version used for CABANA includes a 10-item symptom checklist that assesses both frequency and severity....
inferred from protocolStructured statistical methods
Two QOL instruments were used as co-primary endpoints in CABANA: the AF Effect on Quality of Life (AFEQT), and the Mayo AF-Specific Symptom Inventory (MAFSI), as reported previo...; Descriptive summary statistics included counts (percentages) for categorical variables, and medians (25 th and 75 th percentiles) for continuous variables. The primary statistic...; Recurrent atrial fibrillation incidence rates were estimated using a Fine-Gray model adjusted for baseline covariates listed above, with death treated as a competing risk.; 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, trea...
source structuredSource and audit
What supports the facts on this page?
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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"text": "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..."
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"text": "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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