Background: To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all-cause mortality, and stroke, non-central nervous system (non-CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real-world clinical setting.
Methods: The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single-arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors.
Background: To determine the rate of undiagnosed atrial fibrillation (AF) we screened for AF using an oscillometric blood pressure (BP) monitor device followed by a single-lead handheld electrocardiogram (ECG), with confirmation by 12-lead ECG as the reference standard.
Methods and results: From October 2017 to August 2019, 1,148 patients were enrolled without known AF, who were aged ≥65 years with moderate-to-high stroke risk, at 71 centers in Japan. After exclusion of 7 patients with confirmed AF at the index visit, 1,141 patients were asked to use an oscillometric BP monitor twice daily for 2 weeks (max: 4 weeks) to detect an irregular pulse.
Background: The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global regions, in Japanese patients with non-valvular atrial fibrillation in real-world clinical practice.
Methods: In this prospective, open-label, single-arm, observational study, 11,308 patients with non-valvular atrial fibrillation newly prescribed rivaroxaban (15/10 mg once daily) at 1416 sites across Japan were enrolled and followed for a mean of 2.5 years.
This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m) as underweight (< 18.5), normal weight (18.
View Article and Find Full Text PDFAim: Detection of coagulase-negative Staphylococcus in blood culture may be a result of either bacteremia or contamination. This often leads to diagnostic uncertainly. Our objective was to develop a method for differentiating whether a coagulase-negative Staphylococcus sp.
View Article and Find Full Text PDFBackground: It is important to understand the risk of thromboembolism and bleeding in patients with nonvalvular atrial fibrillation (NVAF) receiving direct oral anticoagulants; however, data on risk factors in Japanese patients are limited.
Methods: XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation) is a prospective observational study examining the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. We investigated risk factors for stroke/noncentral nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI) and major bleeding using 1-year follow-up data.
The correlation of fractional flow reserve, which is presently the gold standard for evaluating myocardial ischemia, with three-dimensional quantitative coronary analysis-based quantitative flow ratio (QFR) is well-known. This study aims to evaluate the relationship of QFR after second-generation drug-eluting stent (2nd gen-DES) implantation to clinical outcomes. A total of 61 consecutive lesions, on which 2nd gen-DES implantation was performed from October 2014 to December 2015, were analyzed.
View Article and Find Full Text PDFIntroduction: Prior stroke is a risk factor for stroke and bleeding during anticoagulation in patients with atrial fibrillation (AF). Although rivaroxaban is widely prescribed to reduce their risk of stroke in patients with nonvalvular AF (NVAF), the real-world evidence on rivaroxaban treatment is limited. We aimed to examine the outcomes of rivaroxaban treatment in NVAF patients with prior ischemic stroke/transient ischemic attack (TIA) by using the data of the Xarelto Post-Authorization Safety and Effectiveness Study in Japanese -Patients with AF, a prospective, single-arm, observational study.
View Article and Find Full Text PDFDirect oral anticoagulants (DOACs), such as rivaroxaban, reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, it is still unclear whether the stroke reduction benefit outweighs the bleeding risk in elderly Japanese patients with NVAF. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of rivaroxaban in Japanese clinical practice.
View Article and Find Full Text PDFThe approved dose of oral anticoagulant rivaroxaban for patients with non-valvular atrial fibrillation (NVAF) in Japan is 15 mg once daily (od) in patients whose creatinine clearance is ≥ 50 mL/min, but recent real-world studies have demonstrated that these patients often received less than the recommended dose due to bleeding concerns. The effect of under-dosing on safety and effectiveness outcomes remains unclear. We used 1-year follow-up data from the XAPASS, a real-world Japanese prospective, single-arm, observational study.
View Article and Find Full Text PDFBackground: Rivaroxaban is a direct oral anticoagulant administered to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a prospective, observational, post-marketing surveillance study that examined the safety and effectiveness of rivaroxaban in routine clinical practice. This sub-analysis of the XAPASS investigated the outcomes of patients with worsening renal function (WRF).
View Article and Find Full Text PDFBackground: Catheter ablation has become a popular interventional treatment for cardiac tachyarrhythmias and the number has been on the rise year by year. However, little is known about its efficacy and safety in the real-world settings.
Method: Japanese Catheter Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center.
Background: Although the efficacy and safety of the factor Xa inhibitor rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) were shown in global and Japanese phase III clinical trials, safety and effectiveness data from unselected patients in everyday clinical practice are limited. The objective of the XAPASS (Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation) is to investigate the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice.
Methods: The XAPASS is a prospective, single-arm, real-world observational study mandated by the Japanese authority as post-marketing surveillance.
Background And Purpose: In expectation of better outcome of catheter ablation of atrial fibrillation (AF), several strategies of extra-PV (pulmonary vein) substrate modification have been utilized. We assessed whether substrate modification or ablation of extra-PV source is a predictor of complications.
Methods: Japanese Heart Rhythm Society requested electrophysiology centers to register the data of patients who underwent AF ablation.
Background: The phase III Japanese Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (J-ROCKET AF) showed that the rivaroxaban group had a lower event rate of intracranial bleeding than the warfarin group and that rivaroxaban was noninferior to warfarin for the principal safety outcome. However, safety and effectiveness data from unselected patients with AF in everyday clinical practice in Japan are lacking.
Methods: The Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a real-world, prospective, single-arm, observational study mandated by the Japanese authority as postmarketing surveillance.
Background: Pericardial effusion (PE) is one of the most frequent complications from catheter ablation of atrial fibrillation (AF). We assessed the prevalence and predictive factors of PE that require invasive treatment as an early complication of AF ablation.
Methods: The Japanese Heart Rhythm Society requested electrophysiology centers to register the relevant data of patients who underwent AF ablation during 6 months from 2011 to 2015.
Background: To obtain a perspective of the current status of catheter ablation for the cure of atrial fibrillation, the Japanese Heart Rhythm Society conducted a nationwide survey: the Japanese Catheter Ablation Registry of Atrial Fibrillation. In this report, we aimed to evaluate the periprocedural use of direct oral anticoagulants with respect to thromboembolic or bleeding complications.
Methods: Using an online questionnaire, the Japanese Heart Rhythm Society requested electrophysiology centers in Japan to register the relevant data of patients who underwent atrial fibrillation ablation over selected five-months from 2011 to 2014.
Chronic inflammation is known to occur in diabetes mellitus (DM) and contributes to atrial fibrosis, possible substrates for atrial fibrillation. We tested the hypothesis that dipeptidyl peptidase (DPP)-4 inhibitors prevent the formation of atrial fibrosis through their anti-inflammatory activity, beyond the effects of controlling blood glucose.DM models obtained by administration of streptozotocin (STZ) were divided into 3 groups: with PKF275-055, a DPP-4 inhibitor in group D, glibenclamide in group SU, and no additional drug in group P.
View Article and Find Full Text PDFBackground And Methods: The Japanese Heart Rhythm Society performs an annual survey, J-CARAF, to collect data on the atrial fibrillation (AF) ablation procedure, and requests its members to register data for AF ablation performed in specified months. We compared data from the latest survey (September 2013, n=1049) with that of the previous survey (September 2012, n=1246) to investigate trends related to the AF ablation procedure.
Results: Patients in the latest survey were older (September 2012 vs.