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Effect of catheter ablation versus antiarrhythmic drugs on atrial fibrillation: A meta-analysis of randomized controlled trials.

ABSTRACT: The aim of the present study was to compare the health outcomes of catheter ablation therapy against those of antiarrhythmic drugs (AADs) in the management of atrial fibrillation (AF). The effects of catheter ablation and AADs on a number of parameters were compared, including AF recurrence, all-cause mortality, stroke/transient ischemic attack (TIA) and quality of life (QoL). A systematic literature search of PubMed, Embase and the Cochrane Central Register of Controlled Trials was conducted to obtain relevant randomized controlled trials. The relative risks (RRs) and 95% confidence intervals (CIs) of AF recurrence, all-cause mortality and stroke/TIA between catheter ablation and AADs were subsequently calculated. Weighted mean differences (WMDs) and 95% CIs were used to evaluate the QoL between the two therapy groups. In total, 11 randomized trials, which included 1,763 AF patients, were eligible for the meta-analysis. Overall, the results indicated that catheter ablation produces superior outcomes compared with AADs in reducing AF recurrence (RR, 0.47; 95% CI, 0.38-0.58; P<0.001) and improving the QoL (physical component summary: WMD, 2.23; 95% CI, 0.24-4.21; P=0.03; mental component summary: WMD, 2.69; 95% CI, 0.04-5.35; P=0.05). However, no statistically significant difference was identified between the two groups with regard to the incidence of all-cause mortality (RR, 0.87; 95% CI, 0.37-2.06; P=0.76) and stroke/TIA (RR, 1.83; 95% CI, 0.73-4.55; P=0.20). In summary, catheter ablation was demonstrated to markedly reduce AF recurrence and improve QoL when compared with AAD therapy. However, the incidence rates of all-cause mortality and stroke/TIA were comparable between catheter ablation and AAD therapy.

SUBMITTER: Shi LZ

PROVIDER: S-EPMC4508979 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Effect of catheter ablation versus antiarrhythmic drugs on atrial fibrillation: A meta-analysis of randomized controlled trials.

Shi Lei-Zhi LZ Heng Rui R Liu Shi-Min SM Leng Fei-Yan FY

Experimental and therapeutic medicine 20150603 2

The aim of the present study was to compare the health outcomes of catheter ablation therapy against those of antiarrhythmic drugs (AADs) in the management of atrial fibrillation (AF). The effects of catheter ablation and AADs on a number of parameters were compared, including AF recurrence, all-cause mortality, stroke/transient ischemic attack (TIA) and quality of life (QoL). A systematic literature search of PubMed, Embase and the Cochrane Central Register of Controlled Trials was conducted to ...[more]

PMID: 26622399

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Project description:ImportanceEarly rhythm control of atrial fibrillation (AF) with either antiarrhythmic drugs (AADs) or catheter ablation has been reported to improve cardiovascular outcomes compared with usual care; however, the optimal therapeutic modality to achieve early rhythm control is unclear.ObjectiveTo assess the safety and efficacy of AF ablation as first-line therapy when compared with AADs in patients with paroxysmal AF.Data sourcesPubMed/MEDLINE, Scopus, Google Scholar, and various major scientific conference sessions from January 1, 2000, through November 23, 2020.Study selectionRandomized clinical trials (RCTs) published in English that had at least 12 months of follow-up and compared clinical outcomes of ablation vs AADs as first-line therapy in adults with AF. The quality of individual studies was assessed using the Cochrane risk of bias tool. Six RCTs met inclusion criteria, including 1212 patients.Data extraction and synthesisTwo investigators independently extracted data. Reporting was performed in compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines. Analysis was performed using a random-effects model with the Mantel-Haenszel method, and results are presented as 95% CIs.Main outcomes and measuresMain outcomes were safety and efficacy of AF ablation as first-line therapy when compared with AADs. Trials were evaluated as having low risk of selection and attrition biases, high risk of performance bias, and with unclear risk for detection biases due to unblinding and open-label designs.ResultsA total of 6 RCTs involving 1212 patients with AF were included (609 were randomized to AF ablation and 603 to drug therapy; mean [SD] age, 56 [11] years). Compared with AADs, catheter ablation use was associated with reductions in recurrent atrial arrhythmia (32.3% vs 53%; risk ratio [RR], 0.62; 95% CI, 0.51-0.74; P < .001; I2 = 40%), with a number needed to treat with ablation to prevent 1 arrhythmia of 5. Use of ablation was also associated with reduced symptomatic atrial arrhythmia (11.8% vs 26.4%; RR, 0.44; 95% CI, 0.27-0.72; P = .001; I2 = 54%) and hospitalization (5.6% vs 18.7%; RR, 0.32; 95% CI, 0.19-0.53; P < .001) with no significant difference in serious adverse events between the groups (4.2% vs 2.8%; RR, 1.52; 95% CI, 0.81-2.85; P = .19).Conclusions and relevanceIn this meta-analysis of randomized clinical trials including first-line therapy of patients with paroxysmal AF, catheter ablation compared with antiarrhythmic drugs was associated with reductions in recurrence of atrial arrhythmias and hospitalizations, with no difference in major adverse events.

Project description:IntroductionAtrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF.Methods and analysisThe trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30 s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%.Ethics and disseminationThe PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator.Trial registration numberClinicalTrials.gov Registry (NCT04011800).

Project description:BackgroundIn the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with drug therapy by intention-to-treat, but did improve the quality of life and freedom from atrial fibrillation recurrence. In the heart failure subgroup, ablation improved both survival and quality of life. Cost-effectiveness was a prespecified CABANA secondary end point.MethodsMedical resource use data were collected for all CABANA patients (N=2204). Costs for hospital-based care were assigned using prospectively collected bills from US patients (n=1171); physician and medication costs were assigned using the Medicare Fee Schedule and National Average Drug Acquisition Costs, respectively. Extrapolated life expectancies were estimated using age-based survival models. Quality-of-life adjustments were based on EQ-5D-based utilities measured during the trial. The primary outcome was the incremental cost-effectiveness ratio, comparing ablation with drug therapy on the basis of intention-to-treat, and assessed from the US health care sector perspective.ResultsCosts in the first 3 months averaged $20 794±SD 1069 higher with ablation compared with drug therapy. The cumulative within-trial 5-year cost difference was $19 245 (95% CI, $11 360-$27 170) and the lifetime mean cost difference was $15 516 (95% CI, -$2963 to $35,512) higher with ablation than with drug therapy. The drug therapy arm accrued an average of 12.5 life-years (LYs) and 10.7 quality-adjusted life-years (QALYs). For the ablation arm, the corresponding estimates were 12.6 LYs and 11.0 QALYs. The incremental cost-effectiveness ratio was $57 893 per QALY gained, with 75% of bootstrap replications yielding an incremental cost-effectiveness ratio <$100 000 per QALY gained. With no quality-of-life/utility adjustments, the incremental cost-effectiveness ratio was $183 318 per LY gained.ConclusionsCatheter ablation of atrial fibrillation was economically attractive compared with drug therapy in the CABANA Trial overall at present benchmarks for health care value in the United States on the basis of projected incremental QALYs but not LYs alone.

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Effect of catheter ablation versus antiarrhythmic drugs on atrial fibrillation: A meta-analysis of randomized controlled trials.

Publications

Effect of catheter ablation versus antiarrhythmic drugs on atrial fibrillation: A meta-analysis of randomized controlled trials.

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