The comparison of catheter ablation on hard outcomes versus medical treatment for atrial fibrillation patients: A meta-analysis of randomized, controlled trials with trial sequential analysis

BACKGROUND: The prevailing view is that ablation does not reduce the incidence of stroke and deaths in atrial fibrillation (AF), and guidelines suggest that long-term anticoagulation is required after ablation, regardless of the success of the procedure. We performed a meta-analysis of recent randomized, controlled trials (RCTs) to verify whether ablation compared with drugs reduced the incidence of stroke and deaths. METHODS: We systematically searched the PubMed, Embase, and Cochrane Central Register of Controlled Trials databases for RCTs of AF catheter ablation (CA) compared to medical therapy (MT). The risk ratio (RR) and weighted mean difference (WMD) with 95% CIs were calculated using a random-effects model. A trial sequential analysis (TSA) was used to further validate the reliability of the primary outcomes. RESULTS: Seventeen RCTs were included, comprising 5,258 patients (CA, n = 2760; MT, n = 2498). Compared with medical therapy, CA was associated with a reduction in stroke/transient ischaemic attacks (TIAs) (p = 0.035; RR = 0.61 [95% CI, 0.386 to 0.965]; I2 = 0.0%) and deaths (p = 0.004; RR = 0.7 [95% CI, 0.55 to 0.89]; I2 = 0.0%). CA was associated with improvement in left ventricular ejection fraction (LVEF) (p = 0.000; WMD = 5.39 [95% CI, 2.45 to 8.32]; I2 = 84.4%) and the rate of maintenance of sinus rhythm (SR) (p = 0.000; RR = 3.55 [95% CI, 2.34 to 5.40]; I2 = 76.7%). CONCLUSIONS: CA for AF had more favourable outcomes in terms of stroke/TIAs, deaths, change in LVEF, and the maintenance of SR at the end of follow-up compared to MT. Besides, the TSA results supported this conclusion.