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INTRODUCTION AND OBJECTIVES: This article reports the results of the 2020 Spanish Catheter Ablation Registry, a year marked by the SARS-CoV-2 pandemic. METHODS: Data were collected retrospectively through completion and return of a specific form by the participating centers. RESULTS: Data from 97 centers (67 public, 30 private) were analyzed. A total of 15 169 ablation procedures were reported with a mean of 155 ± 117 and a median [interquartile range] of 115 [62-227]. Because of the SARS-CoV-2 pandemic, both procedures and participating centers markedly decreased (-3380 procedures, -18%) and there were 5 centers less than in 2019. The most common procedure continued to be atrial fibrillation ablation (4513; 30%), well ahead of the remaining substrates, followed by ablation of the cavotricuspid isthmus (3188; 21%), and intranodal re-entry tachycardia (2808; 18%). Ablation of these 3 substrates continued to form the bulk of the procedures. The total success rate was slightly lower than in previous years (88%) with a similar complication rate (n = 309; 2%) and mortality (n = 7; 0.04%). A total of 243 procedures were performed in pediatric patients (1.6%). CONCLUSIONS: The Spanish Catheter Ablation Registry systematically and continuously reflects the national trajectory, which, in 2020, was markedly affected by the SARS-CoV-2 pandemic. Although slightly lower than in previous years, the success rate remained high, with a low complication rate.

Introduction and objectives: This article reports the results of the 2020 Spanish Catheter Ablation Registry, a year marked by the SARS-CoV-2 pandemic. Methods: Data were collected retrospectively through completion and return of a specific form by the participating centers. Results: Data from 97 centers (67 public, 30 private) were analyzed. A total of 15 169 ablation procedures were reported with a mean of 155 117 and a median [interquartile range] of 115 [62-227]. Because of the SARS-CoV-2 pandemic, both procedures and participating centers markedly decreased ( 3380 procedures, 18%) and there were 5 centers less than in 2019. The most common procedure continued to be atrial fibrillation ablation (4513; 30%), well ahead of the remaining substrates, followed by ablation of the cavotricuspid isthmus (3188; 21%), and intranodal re-entry tachycardia (2808; 18%). Ablation of these 3 substrates continued to form the bulk of the procedures. The total success rate was slightly lower than in previous years (88%) with a similar complication rate (n = 309; 2%) and mortality (n = 7; 0.04%). A total of 243 procedures were performed in pediatric patients (1.6%).Conclusions: The Spanish Catheter Ablation Registry systematically and continuously reflects the national trajectory, which, in 2020, was markedly affected by the SARS-CoV-2 pandemic. Although slightly lower than in previous years, the success rate remained high, with a low complication rate. C 2021 Sociedad Espan ̃ola de Cardiologı ́a. Published by Elsevier Espan ̃a, S.L.U. All rights reserved. Introducción y objetivos Se describen los resultados del Registro Español de Ablación con Catéter de 2020, año marcado por la pandemia por SARS-CoV-2. Métodos La recogida de datos fue restrospectiva mediante la cumplimentación y envío de un formulario específico por los centros participantes. Resultados Se analizaron los datos de 97 centros (67 públicos, 30 privados). Se comunicaron 15.169 procedimientos de ablación (media, 155 ± 117; mediana, 115 [62-227]). La pandemia de SARS-CoV-2 ha condicionado una disminución notable tanto de los procedimientos (–3.380 casos, –18%) como de los centros participantes (5 menos que en 2019). La ablación de FA sigue siendo el procedimiento más frecuente (4.513; 30%), a distancia de los demás sustratos; junto con la ablación del ICT (3.188; 21%) y la taquicardia por reentrada intranodular (2.808; 18%), son los 3 sustratos más abordados. La tasa total de éxito reportada es discretamente inferior a las de años previos (88%), con similares tasas de complicaciones (309; 2%) y mortalidad (7; 0,04%). Se realizaron 243 procedimientos en pacientes pediátricos (1,6%). Conclusiones El Registro Español de Ablación con Catéter recoge de manera sistemática e ininterrumpida la trayectoria nacional, que este año se ha visto notablemente marcada por la pandemia por SARS-CoV-2. Aunque discretamente inferior a las años previos, la tasa de éxito sigue siendo alta, con una baja tasa de complicaciones.

BACKGROUND Direct-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation. METHODS In this randomised, double-blind, phase 2 dose-finding study, we compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients aged 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and increased bleeding risk. The study was conducted at 93 sites in 14 countries, including 12 European countries, Canada, and Japan. Participants were randomly assigned (1:1:1) to a treatment group using an interactive web response system, with randomisation stratified by whether patients were receiving a direct-acting oral anticoagulant before the study start. Masking was achieved using a double-dummy design, with participants receiving both the assigned treatment and a placebo that resembled the non-assigned treatment. The primary endpoint was the composite of major or clinically relevant non-major bleeding according to International Society on Thrombosis and Haemostasis criteria, assessed in all patients who took at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT04218266, and EudraCT, 2019-002365-35. FINDINGS Between Jan 30, 2020, and June 21, 2021, 862 patients were enrolled. 755 patients were randomly assigned to treatment. Two patients (assigned to asundexian 20 mg) never took any study medication, resulting in 753 patients being included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The mean age of participants was 73·7 years (SD 8·3), 309 (41%) were women, 216 (29%) had chronic kidney disease, and mean CHA2DS2-VASc score was 3·9 (1·3). Asundexian 20 mg resulted in 81% inhibition of FXIa activity at trough concentrations and 90% inhibition at peak concentrations; asundexian 50 mg resulted in 92% inhibition at trough concentrations and 94% inhibition at peak concentrations. Ratios of incidence proportions for the primary endpoint were 0·50 (90% CI 0·14-1·68) for asundexian 20 mg (three events), 0·16 (0·01-0·99) for asundexian 50 mg (one event), and 0·33 (0·09-0·97) for pooled asundexian (four events) versus apixaban (six events). The rate of any adverse event occurring was similar in the three treatment groups: 118 (47%) with asundexian 20 mg, 120 (47%) with asundexian 50 mg, and 122 (49%) with apixaban. INTERPRETATION The FXIa inhibitor asundexian at doses of 20 mg and 50 mg once daily resulted in lower rates of bleeding compared with standard dosing of apixaban, with near-complete in-vivo FXIa inhibition, in patients with atrial fibrillation. FUNDING Bayer.