Dataset Information

Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities.

ABSTRACT:

Background

Rhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America.

Objectives

This study sought to describe outcomes in the CABANA trial as a function of race/ethnicity.

Methods

CABANA randomized 2,204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in the present analysis, and participants were subgrouped as racial/ethnic minority or nonminority with the use of National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest.

Results

Of 1,280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with nonminorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, respectively, and had more symptomatic heart failure (37.0% vs 22.0%), hypertension (92.1% vs 76.8%, respectively), and ejection fraction <40% (20.8% vs 7.1%). Racial/ethnic minorities treated with ablation had a 68% relative reduction in the primary endpoint (adjusted hazard ratio [aHR]: 0.32; 95% confidence interval [CI]: 0.13-0.78) and a 72% relative reduction in all-cause mortality (aHR: 0.28; 95% CI: 0.10-0.79). Primary event rates in racial/ethnic minority and nonminority participants were similar in the ablation arm (4-year Kaplan-Meier event rates 12.3% vs 9.9%); however, racial and ethnic minorities randomized to drug therapy had a much higher event rate than nonminority participants (27.4% vs. 9.4%).

Conclusion

Among racial or ethnic minorities enrolled in the North American CABANA cohort, catheter ablation significantly improved major clinical outcomes compared with drug therapy. These benefits, which were not seen in nonminority participants, appear to be due to worse outcomes with drug therapy. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).

SUBMITTER: Thomas KL

PROVIDER: S-EPMC8354144 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).MethodsThe CABANA trial randomized 2204 patients with AF who were ≥65 years old or <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >II at baseline and form the subject of this article. The CABANA trial's primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest.ResultsOf the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2).ConclusionsIn patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508; Unique identifier: NCT0091150.

Project description:BackgroundAmong patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).MethodsCABANA randomized patients with AF age ≥65 years or <65 years with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence.ResultsCABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) (P<0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men, P=0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62-1.65) in women and 0.73 (95% CI, 0.51-1.05) in men (interaction P value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51-0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40-0.58] for men; interaction P value=0.060).ConclusionsClinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.

Project description:ImportanceIn patients with paroxysmal atrial fibrillation (AF), rhythm control with either antiarrhythmic drugs (AADs) or catheter ablation has been associated with decreased symptoms, prevention of adverse remodeling, and improved cardiovascular outcomes. Adoption of advanced cardiovascular therapeutics, however, is often slower among patients from racial/ethnic minority groups and those with lower income.ObjectiveTo ascertain the cumulative rates of AAD and catheter ablation use for the management of paroxysmal AF and to investigate for the presence of inequities in AF management by evaluating the association of race/ethnicity and socioeconomic status with their use in the United States.Design, setting, and participantsThis cohort study obtained inpatient, outpatient, and pharmacy claims data from the Optum Clinformatics Data Mart between October 1, 2015, and June 30, 2019. Adult patients (aged ≥18 years) in the database with a diagnosis of incident paroxysmal AF were identified. Patients were excluded if they did not have continuous insurance enrollment for at least 1 year before and at least 6 months after study entry.ExposuresRace/ethnicity and zip code-linked median household income.Main outcomes and measuresTreatment with a rhythm control strategy, and catheter ablation specifically, among those who received rhythm control. Multivariable logistic regression models were used to assess the association of race/ethnicity and zip code-linked median household income with a rhythm control strategy (AADs or catheter ablation) vs a rate control strategy as well as with catheter ablation vs AADs among those receiving rhythm control.ResultsOf the 109 221 patients who met the inclusion criteria, 55 185 were men (50.5%) and 73 523 were White (67.3%), with a median (interquartile range) age of 75 (68-82) years. A total of 86 359 patients (79.1%) were treated with rate control, 19 362 patients (17.7%) with AADs, and 3500 (3.2%) with catheter ablation. Between 2016 and 2019, the cumulative percentage of patients treated with catheter ablation increased from 1.6% to 3.8%. In multivariable analyses, Black race (adjusted odds ratio [aOR], 0.89; 95% CI, 0.83-0.94; P < .001) and lower zip code-linked median household income (aOR for <$50 000: 0.83 [95% CI, 0.79-0.87; P < .001]; aOR for $50 000-$99 999: 0.92 [95% CI, 0.88-0.96; P = <.001] compared with ≥$100 000) were independently associated with lower use of rhythm control. Latinx ethnicity (aOR, 0.73; 95% CI, 0.60-0.89; P = .002) and lower zip code-linked median household income (aOR for <$50 000: 0.61 [95% CI, 0.54-0.69; P < .001]; aOR for $50 000-$99 999: 0.81 [95% CI, 0.72-0.90; P < .001] compared with ≥$100 000) were independently associated with lower catheter ablation use among those receiving rhythm control.Conclusions and relevanceThis study found that despite increased use of rhythm control strategies for treatment of paroxysmal AF, catheter ablation use remained low and patients from racial/ethnic minority groups and those with lower income were less likely to receive rhythm control treatment, especially catheter ablation. These findings highlight inequities in paroxysmal AF management based on race/ethnicity and socioeconomic status.