Dataset Information

Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST).

ABSTRACT:

Aims

Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines.

Methods

This prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries. Patients were randomized 1 : 1 to RF ablation or AAD treatment. The primary endpoint was the rate of persistent AF/atrial tachycardia (AT) at 3 years.

Results

After early study termination following slow enrolment, 255 (79%) of the planned 322 patients were enrolled (RF ablation, n = 128, AAD, n = 127); 36% of patients in the RF ablation group and 41% in the AAD group completed 3 years of follow-up. For the primary endpoint, the Kaplan-Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF ablation [2.4% (95% confidence interval (CI), 0.6-9.4%)] than with AAD therapy [17.5% (95% CI, 10.7-27.9%); one-sided P = 0.0009]. Patients ≥65 years were ∼4 times more likely to progress to persistent AF/AT than patients <65 years, suggesting RF ablation can delay disease progression [hazard ratio: 3.87 (95% CI, 0.88-17.00); P = 0.0727]. Primary adverse events were reported for eight patients in the RF ablation group.

Conclusions

Radiofrequency ablation is superior to guideline-directed AAD therapy in delaying the progression from paroxysmal to persistent AF.

SUBMITTER: Kuck KH

PROVIDER: S-EPMC7947582 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDelaying atrial fibrillation (AF) progression is a key goal in cardiovascular treatment. However, numbers of previously published studies on delayed AF progression are relatively limited. The purpose of this study was to determine whether a cryoballoon catheter ablation (CA) strategy could delay AF progression compared to anti-arrhythmic drug (AAD) treatment in patients with paroxysmal AF.MethodsA total of 204 subjects were enrolled in the trial, including 102 in the cryoballoon CA group and 102 in the AAD group. Participants were followed up with for 36 months. The primary study endpoint was the first occurrence of persistent atrial tachyarrhythmia, while secondary endpoints included the event rates of persistent atrial tachyarrhythmia at 1 and 2 years. The primary safety endpoint was serious adverse events.ResultsOverall, the 36-month follow-up was completed by 154 subjects (75.5%). At 3 years, documented progression from paroxysmal AF to persistent atrial tachyarrhythmia had occurred in 2 of the 102 patients assigned to undergo cryoballoon CA [2.203% (95% confidence interval (CI), 0.554-8.537)] and in 17 of the 102 patients assigned to receive AADs [20.223% (95% CI, 13.040-30.604)] [hazard ratio (HR), 0.107; 95% CI, 0.043-0.262; P < 0.001]. Lower rates of progression in the cryoballoon CA group compared to the AAD group were already obvious at 1 year [1.053% (95% CI, 0.149-7.238) vs. 5.284% (95% CI, 2.233-12.237)] [HR, 0.193; (95% CI, 0.039-0.956; P = 0.09)] and 2 years [2.203% (95% CI, 0.554-8.537) vs. 12.430% (95% CI, 7.066-21.371)] (HR, 0.169; 95% CI, 0.057-0.501, P < 0.001). Serious adverse events occurred in 7 of the 102 patients (6.9%) in the cryoballoon CA group and 9 of the 102 patients (8.8%) in the AAD group.ConclusionCryoballoon CA was superior to AAD therapy in preventing the occurrence of persistent atrial tachyarrhythmia in patients with paroxysmal AF who had not received prior rhythm control therapy. Serious adverse events were rare.

Project description:ImportanceCatheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain.ObjectiveTo determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.Design, setting, and participantsAn open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017.InterventionsPulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096).Main outcomes and measuresPrespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points).ResultsAmong 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001).Conclusions and relevanceAmong patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation.Trial registrationClinicalTrials.gov Identifier: NCT00911508.