Association between ventricular arrhythmia (premature ventricular contractions burden and nonsustained ventricular tachycardia) and cardiovascular events in patients without structural heart disease.

Background: Premature ventricular contractions (PVCs) and nonsustained ventricular tachycardia (NSVT) are common arrhythmias in cardiovascular clinical settings. However, the clinical significance of PVCs and NSVT in the absence of structural heart disease has not yet been fully elucidated. This study aimed to evaluate the association between PVCs, NSVT, and clinical outcomes.

Efficacy and Safety of Low-Dose Edoxaban by Body Weight in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the Randomized ELDERCARE-AF Trial.

Background: The ELDERCARE-AF trial showed that low-dose edoxaban benefits elderly patients with nonvalvular atrial fibrillation considered ineligible for standard oral anticoagulants due to high bleeding risk, but whether this applied to patients with extremely low body weight was unclear.

Methods And Results: This was a prespecified subanalysis by body weight (≤45, >45 kg) of the phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven ELDERCARE-AF trial, which compared low-dose edoxaban (15 mg once daily) with placebo in Japanese patients considered ineligible for oral anticoagulants at the recommended therapeutic strength or the approved doses. The primary efficacy and safety end points were stroke or systemic embolism and major bleeding (International Society on Thrombosis and Hemostasis definition), respectively.

Duration of Initial Intensive Rivaroxaban Therapy for Patients With Venous Thromboembolism - Subanalysis of the J'xactly Study.

Rivaroxaban, a direct oral anticoagulant, is used as a first-line treatment to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, whether 21 days is optimal for the initial treatment duration has not been investigated. In this subanalysis of the prospective multicenter observational J'xactly study, which included 1,039 Japanese patients with acute symptomatic/asymptomatic DVT/PE who were prescribed rivaroxaban, the VTE recurrence rate and incidence of bleeding complications were assessed in 667 patients who underwent intensive rivaroxaban treatment (15 mg, twice daily) for a short (1-8 days), intermediate (9-16), or standard (17-24) duration.

Rivaroxaban Treatment for Patients With Unprovoked or Provoked Venous Thromboembolism - Subanalysis of the J'xactly Study.

The efficacy and safety of direct oral anticoagulants (DOACs) in patients with unprovoked venous thromboembolism (VTE) remain unclear. In this subanalysis of the J'xactly study, a multicenter prospective observational study, we evaluated the safety and effectiveness of rivaroxaban in patients with acute VTE according to unprovoked (n=388) or provoked (n=557) VTE status. Median follow-up was 21.

Laboratory Test Predictors for Major Bleeding in Elderly (≥80 Years) Patients With Nonvalvular Atrial Fibrillation Treated With Edoxaban 15 mg: Sub-Analysis of the ELDERCARE-AF Trial.

Background We investigated the predictors related to major bleeding events during treatment with edoxaban 15 mg in patients aged ≥80 years with nonvalvular atrial fibrillation and high bleeding risk, for whom standard oral anticoagulants are inappropriate, focusing on standard laboratory tests related to bleeding. Methods and Results This was a prespecified subanalysis of the on-treatment analysis set of the ELDERCARE-AF (Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients) trial. Major bleeding was the primary safety end point.

Clinical Outcome After Discontinuation of Anticoagulation Therapy in Japanese Patients With Venous Thromboembolism - Insights From the J'xactly Study.

Rivaroxaban, a direct oral anticoagulant, is used as first-line treatment to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, the frequency of rivaroxaban discontinuation and the subsequent clinical outcomes remain unclear. The study was a subanalysis of the prospective, multicenter, observational J'xactly study, conducted in Japan, and included patients who underwent anticoagulant discontinuation without major bleeding and recurrent VTE.

Clinical Outcomes of Very Elderly Patients With Atrial Fibrillation Receiving On-label Doses of Apixaban: J-ELD AF Registry Subanalysis.

Background Increasing age predisposes patients with atrial fibrillation to both thromboembolic and bleeding events; however, data on outcomes of very elderly patients (aged ≥85 years) receiving appropriate antithrombotic therapy are still limited. Methods and Results The J-ELD AF (Multicenter Prospective Cohort Study to Investigate the Effectiveness and Safety of Apixaban in Japanese Elderly Atrial Fibrillation Patients) Registry is a multicenter prospective observational study of Japanese patients with nonvalvular atrial fibrillation aged ≥75 years taking on-label doses (standard dose of 5 mg BID or reduced dose of 2.5 mg BID) of apixaban.

Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two-year postmarketing surveillance study (ETNA-AF-Japan).

Background: Direct oral anticoagulants (DOACs) are the recommended first-line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, the safety and effectiveness of edoxaban for this indication requires monitoring over the long term in real-world settings.

Methods: ETNA-AF-Japan (trial no.

Mid-Term Prognosis After Landiolol Treatment in Atrial Fibrillation/Atrial Flutter Patients With Chronic Heart Failure - A Prospective Observational Survey (AF-CHF Landiolol Survey).

The aim of the prospective post-marketing AF-CHF Landiolol Survey was to evaluate the safety and effectiveness of landiolol for the treatment of atrial fibrillation or atrial flutter in patients with cardiac dysfunction in clinical practice in Japan. This analysis reports mid-term prognoses with a focus on switching from landiolol to oral β-blockers. The AF-CHF Landiolol Survey took place between June 2014 and May 2016 and involved 1,121 patients with cardiac dysfunction and atrial fibrillation/atrial flutter.

Final 5-Year Results in Randomized Japanese Patients Implanted With a Thin-Strut, Bioabsorbable, Polymer-Coated, Everolimus-Eluting SYNERGY Stent (From the EVOLVE II Study).

SYNERGY is a thin-strut, platinum-chromium metal alloy stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer. EVOLVE II was a global randomized controlled trial that enrolled 1,684 patients treated with either a SYNERGY or durable polymer PROMUS Element Plus (PE+) everolimus-eluting stent, including 155 patients from Japanese sites. This substudy analyzed 5-year clinical outcomes in the Japanese and non-Japanese cohorts.

Efficacy and Safety of Landiolol in Patients With Ventricular Tachyarrhythmias With or Without Renal Impairment - Subanalysis of the J-Land II Study.

Post hoc analysis was used to investigate the effects of renal function on the efficacy and safety of landiolol using data from the J-Land II study, which evaluated landiolol in patients with hemodynamically unstable ventricular tachycardia (VT) or ventricular fibrillation (VF) who were refractory to Class III antiarrhythmic drugs. Patient data from the J-Land II study (n=29) were stratified by renal function (estimated glomerular filtration rate [eGFR] <45 and ≥45 mL/min/1.73 m) and analyzed.

Oral Anticoagulant Use in Elderly Japanese Patients With Non-Valvular Atrial Fibrillation - Subanalysis of the ANAFIE Registry.

Oral anticoagulants (OACs) are effective in preventing stroke in patients with atrial fibrillation (AF), but are challenging for elderly patients because of the higher risk of bleeding complications. The ANAFIE Registry is a prospective multicenter observational study of elderly (≥75 years) Japanese AF patients. This subanalysis evaluated the current use of OACs.

Impact of Blood Pressure Visit-to-Visit Variability on Adverse Events in Patients With Nonvalvular Atrial Fibrillation: Subanalysis of the J-RHYTHM Registry.

Background Blood pressure (BP) variability has reportedly been a risk factor for various clinical events. To clarify the influence of BP visit-to-visit variability on adverse events in patients with nonvalvular atrial fibrillation, a post hoc analysis of the J-RHYTHM Registry was performed. Methods and Results Of 7406 outpatients with nonvalvular atrial fibrillation from 158 institutions, 7226 (age, 69.

A novel and simple scoring system for assessing the indication for catheter ablation in patients with atrial fibrillation: The HEAL-AF Score.

Introduction: A scoring system to determine indications for catheter ablation (CA) in atrial fibrillation (AF) is desired.

Methods And Results: Among 2898 consecutive patients with AF, CA was performed in 938 (32.4%).

Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA-AF-Japan): One-year safety and effectiveness analyses.

Background: The safety and effectiveness of edoxaban in real-world clinical settings have not yet been elucidated thoroughly among Japanese patients with nonvalvular atrial fibrillation (NVAF). We report the one-year interim results of ETNA-AF-Japan (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation: UMIN000017011), an ongoing two-year study.

Methods: ETNA-AF-Japan is a prospective, real-world multicenter observational study that analyzes the long-term safety and effectiveness of edoxaban.

Postmarketing surveillance on clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA-AF-Japan): Three-month interim analysis results.

Background: Direct oral anticoagulants are the first-line drugs for anticoagulation therapy in nonvalvular atrial fibrillation (NVAF). However, a real-world, large-scale, clinical study on edoxaban has not been performed. Our ongoing postmarketing surveillance, ETNA-AF-Japan (doxaban reatment in routie clinical prctice in patients with non-valvular trial ibrillation; UMIN000017011), was designed to collect such data.

Impact of electrophysiological and pharmacological noninducibility following pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation.

Background: Two methods for testing inducibility of atrial fibrillation (AF)-atrial pacing and isoproterenol infusion-have been proposed to determine the endpoint of catheter ablation. However, the utility of the combination for testing electrophysiological inducibility (EPI) and pharmacological inducibility (PHI) is unclear.

Methods: After pulmonary vein isolation (PVI), inducibility of atrial tachyarrhythmia was assessed with the dual methods in 291 consecutive patients with AF (65% paroxysmal) undergoing initial catheter ablation.