Evidence map›Paper›PMID 38307365›Full record

ArticleAmerican heart journal2024

Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial.

Riccardo Cappato, Daniel B Mark, Adam P Silverstein, Peter A Noseworthy, Gianluca Bonitta, Jeanne E Poole, Jonathan P Piccini, Tristram D Bahnson, Melanie R Daniels, Hussein R Al-Khalidi and 3 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in American heart journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00911508 (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00911508 nacompletednot on this map

Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

TypeinterventionalSponsorMayo ClinicRan2009 to 2017Enrolled2,204ConditionsAtrial Fibrillation, ArrhythmiaArmsLeft atrial ablation, Rate or Rhythm Control Therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Riccardo CappatoIRCCS MultiMedica, Milan, Italy.
Daniel B MarkDuke Clinical Research Institute, Duke University, Durham, NC. Electronic address: daniel.mark@duke.edu.
Adam P SilversteinDuke Clinical Research Institute, Duke University, Durham, NC.
Peter A NoseworthyMayo Clinic, Rochester, MN.
Gianluca BonittaL'altra Statistica Consultancy and Training, Biostatistics Office, Roma, Italy.
Jeanne E PooleUniversity of Washington Medical Center, Seattle, WA.
Jonathan P PicciniDuke Clinical Research Institute, Duke University, Durham, NC.
Tristram D BahnsonDuke Clinical Research Institute, Duke University, Durham, NC.
Melanie R DanielsDuke Clinical Research Institute, Duke University, Durham, NC.
Hussein R Al-KhalidiDuke Clinical Research Institute, Duke University, Durham, NC.
Kerry L LeeDuke Clinical Research Institute, Duke University, Durham, NC.
Douglas L PackerIntermountain Medical Center, Murray, UT.
CABANA Investigators
Duke University · USIntermountain Medical Center · USMayo Clinic in Arizona · USMultiMedica · ITUniversity of Washington Medical Center · US

Funding

NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)U01FD006292 · FDA · MEDICAL DEVICE INNOVATION CONSORTIUM · PI SMITH, RICHARD · 2018 to 2025
$76.1M
CABANA-AF TrialU01HL089786 · NHLBI · DUKE UNIVERSITY · PI AL-KHALIDI, HUSSEIN · 2009 to 2014
$10.7M
Catheter Ablation versus Antiarrythmic Drug Therapy for Atrial Fibrilllation TriaU01HL089709 · NHLBI · MAYO CLINIC ROCHESTER · PI PACKER, DOUGLAS L · 2009 to 2014
$4.4M
Neurocognition and Greater Maintenance of Sinus Rhythm in AF (NOGGIN AF)R01AG074185 · NIA · DUKE UNIVERSITY · PI MATHEW, JOSEPH P, PICCINI, JONATHAN PAUL · 2021 to 2025
$3.7M
Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)R01HL131535 · NHLBI · MAYO CLINIC ROCHESTER · PI MONTORI, VICTOR MANUEL · 2016 to 2020
$3.2M
Influence of genetic variation on QT prolongation over the lifecourse and as a cardiotoxic drug responseR01HL143070 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI NEWTON-CHEH, CHRISTOPHER HOLMES · 2018 to 2021
$3.0M
Optimizing stroke prevention for older adults with atrial fibrillation: Towards rigorous evaluation and judicious application of a new deviceR01AG062436 · NIA · MAYO CLINIC ROCHESTER · PI NOSEWORTHY, PETER A, YAO, XIAOXI · 2020 to 2024
$2.5M
Gastrointestinal Safety of Antithrombotic Drug RegimensR01HS025402 · AHRQ · MAYO CLINIC ARIZONA · PI ABRAHAM, NEENA S · 2017 to 2020
$1.6M
Cabana Image Analysis LabU01HL089645 · NHLBI · MAYO CLINIC ROCHESTER · PI ROBB, RICHARD A · 2009 to 2014
$1.6M
CABANA EQOL TrialU01HL089907 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2009 to 2014
$1.3M
Multimorbidity, Rurality, and Outcomes in Atrial Fibrillation in the CommunityR21AG062580 · NIA · MAYO CLINIC ROCHESTER · PI CHAMBERLAIN, ALANNA M · 2019 to 2020
$451k
AHRQ HHS R01 HS025402FDA HHS U01 FD006292NHLBI NIH HHS R01 HL131535NHLBI NIH HHS R01 HL143070NHLBI NIH HHS U01 HL089645NHLBI NIH HHS U01 HL089709NHLBI NIH HHS U01 HL089786NHLBI NIH HHS U01 HL089907NIA NIH HHS R01 AG062436NIA NIH HHS R01 AG074185NIA NIH HHS R21 AG062580
6 · The paper itself

Abstract

backgroundThe finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations in outcome and in the effectiveness of atrial fibrillation (AF) ablation versus drug therapy in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. This paper describes these differences and investigates potential causes.

methodsThe examination of treatment effects by geographic region was a prespecified analysis. CABANA enrolled patients from 10 countries, with 1,285 patients at 85 North American (NA) sites and 919 at 41 non-NA sites. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Death and first atrial fibrillation recurrence were secondary endpoints.

resultsAt least 1 primary endpoint event occurred in 157 patients (12.2%) from NA and 33 (3.6%) from non-NA sites over a median 54.9 and 40.5 months of follow-up, respectively (NA/non-NA adjusted hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.48-3.21, P < .001). In NA patients, 78 events occurred in the ablation and 79 in the drug arm, (HR 0.91, 95% CI 0.66, 1.24) while 11 and 22 events occurred in non-NA patients (HR 0.51, 95% CI 0.25,1.05, interaction P = .154). Death occurred in 53 ablation and 51 drug therapy patients in the NA group (HR 0.96, 95% CI 0.65,1.42) and in 5 ablation and 16 drug therapy patients in the non-NA group (HR 0.32, 95% CI 0.12,0.86, interaction P = .044). Adjusting for baseline regional differences or prognostic risk variables did not account for the regional differences in treatment effects. Atrial fibrillation recurrence was reduced by ablation in both regions (NA: HR 0.54, 95% CI 0.46, 0.63; non-NA: HR 0.44, 95% CI 0.30, 0.64, interaction P = .322).

conclusionsIn CABANA, primary outcome events occurred significantly more often in the NA group but assignment to ablation significantly reduced all-cause mortality in the non-NA group only. These differences were not explained by regional variations in procedure effectiveness, safety, or patient characteristics. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT0091150; https://clinicaltrials.gov/study/NCT00911508.

Indexed as

Atrial FibrillationCatheter AblationHeart ArrestStrokeAnti-Arrhythmia AgentsHemorrhageHumansRecurrenceTreatment OutcomeAnti-Arrhythmia Agents

Identifiers

PMID38307365
PMCPMC11070931
OpenAlexW4391452132

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.