scholarly journals Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0251325
Author(s):  
Takanori Ikeda ◽  
Satoshi Ogawa ◽  
Takanari Kitazono ◽  
Jyoji Nakagawara ◽  
Kazuo Minematsu ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Central Nervous System ◽  
Real World ◽  
Japanese Patients ◽  
Systemic Embolism ◽  
Long Term Follow Up

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. Results In total, 10,664 and 10,628 patients were included in the safety and effectiveness analyses, respectively. In the safety population, mean (standard deviation) age was 73.1 (9.8) years and Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, previous Stroke/TIA (2 points) (CHADS2) score was 2.2 (1.3). Incidences (95% confidence intervals) of any and major bleeding were 3.77 (3.53–4.01) and 1.16 (1.03–1.29) events per 100 patient-years, respectively. Age ≥75 years, creatinine clearance <50 mL/min, diabetes mellitus, and vascular disease were independently associated with incidence of major bleeding. The primary composite effectiveness outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction occurred at an incidence (95% confidence interval) of 1.32 (1.18–1.46) events per 100 patient-years. Age ≥75 years, hypertension, prior ischemic stroke/transient ischemic attack, and concomitant use of antiplatelets were independently associated with incidence of the composite outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction. Conclusion In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up.

scholarly journals Long-term follow-up of rivaroxaban use in Japanese patients with non-valvular atrial fibrillation

2017 ◽  
Vol 16 ◽  
pp. 12-14
Author(s):  
Makoto Suzuki ◽  
Akira Mizukami ◽  
Shunsuke Kuroda ◽  
Maki Ohno ◽  
Ryota Iwatsuka ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Japanese Patients ◽  
Long Term Follow Up

scholarly journals Implications of new-onset atrial fibrillation for in-hospital and long-term prognosis in patients with acute myocardial infarction: the CBD Bank study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W Yang ◽  
G Lip ◽  
H Li
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Acute Myocardial Infarction ◽  
Independent Predictor ◽  
Cardiovascular Death ◽  
Long Term Follow Up ◽  
Long Term Prognosis ◽  
New Onset

Abstract Background Atrial fibrillation (AF) often coexists with coronary artery disease. Data on the incidence and prognostic impact of new-onset AF following acute myocardial infarction (AMI) with current optimal therapy are insufficient, especially in Asian populations. Purpose To investigate the incidence of new-onset AF following AMI and to assess its impact on in-hospital and long-term prognosis. Methods We included consecutive AMI patients between December 2012 and July 2019, and excluded those with prior known AF on presentation. New-onset AF was defined as newly detected AF during the index hospitalization following AMI. The primary outcomes comprised of all-cause death and cardiovascular death occurred during hospitalization; and all-cause death and cardiovascular death during long-term follow-up among those AMI survivors. Follow-up visits were routinely scheduled after discharge, at 1 month, 3 months, 6 months, 12 months and every 12 months thereafter. Results Of 3686 patients enrolled, new-onset AF was documented in 138 (3.7%) patients during a mean duration of hospitalization of 8.8±5.8 days. Independent risk factors of new-onset AF were age ≥75 years, left atrial diameter ≥40mm, high levels of cardiac troponin-I or high sensitive C reactive protein. During hospitalization, all-cause death occurred in 22 (15.9%) new-onset AF patients and 67 (1.9%) non-AF patients (p&lt;0.001); cardiovascular death occurred in 19 (13.8%) new-onset AF patients and 58 (1.6%) non-AF patients (p&lt;0.001). On multivariable logistic analysis, new-onset AF was an independent predictor of in-hospital all-cause death (OR 5.85, 95% CI: 3.24–10.55) and cardiovascular death (OR 5.44, 95% CI: 2.90–10.20). Apart from the in-hospital deaths, another 265 (7.7%) were lost to follow-up; thus, 3332 patients were included in the long-term follow-up analysis: 106 new-onset AF and 3226 non-AF patients. After a mean follow-up period of 1096.7±682.0 days, all-cause death occurred in 19 new-onset AF patients and 249 non-AF patients; corresponding rates were 8.08 (95% CI: 5.15–12.67) vs. 2.55 (95% CI: 2.25, 2.88) per 100 person-years, respectively (p&lt;0.001). Cardiovascular death occurred in 11 new-onset AF patients and 150 non-AF patients; corresponding rates were 4.68 (95% CI: 2.59–8.45) vs. 1.53 (95% CI: 1.31–1.80) per 100 person-years, respectively (p=0.002). After multivariable Cox adjustment, there was no significant association between new-onset AF and long-term all-cause death (HR 1.45, 95% CI: 0.90–2.35) or cardiovascular death (HR 1.21, 95% CI: 0.65–2.26). Conclusion New-onset AF following AMI was an independent predictor of increased risk of in-hospital mortality, but had no independent association with long-term death. Funding Acknowledgement Type of funding source: None

High rate of recurrence at long-term follow-up after new-onset atrial fibrillation during acute myocardial infarction

EP Europace ◽  
2018 ◽  
Vol 20 (12) ◽  
pp. e179-e188 ◽  
Author(s):  
Charles Guenancia ◽  
Clémence Toucas ◽  
Laurent Fauchier ◽  
Karim Stamboul ◽  
Fabien Garnier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Acute Myocardial Infarction ◽  
High Rate ◽  
Long Term Follow Up ◽  
Onset Atrial Fibrillation ◽  
New Onset

scholarly journals Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation in relation to the Patients’ Age: Results from a Large Real-World Multicenter Observational Project

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Luigi Sciarra ◽  
Saverio Iacopino ◽  
Giuseppe Arena ◽  
Claudio Tondo ◽  
Paolo Pieragnoli ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Age Groups ◽  
Cryoballoon Ablation ◽  
Efficacy And Safety ◽  
Long Term Follow Up ◽  
High Degree ◽  
Af Recurrence

Background. The real-world efficacy and safety of atrial fibrillation (AF) ablation in particularly young and elderly patients are still under debate. The aim of the analysis was to investigate the effect of age on the efficacy and safety of cryoballoon ablation (CBA). Methods. 2,534 patients underwent pulmonary vein isolation (PVI) by way of CBA for paroxysmal or persistent drug-resistant and symptomatic AF. The population was divided into age quartiles for evaluation, including (1) <53 years, (2) ≥53 and <61 years, (3) ≥61 and <67 years, and (4) ≥67 years. Furthermore, outcomes were analyzed in patients <41 years, ≥41 and ≤74, and >74 years old. Procedural data and complications were collected, and atrial fibrillation recurrences were evaluated during follow-up. Results. Procedural-related complications (4.1%) were similar in the four subgroups according to age. At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% ( p = 0.21 ), respectively (with increasing age). At 24-month follow-up, similar incidences of AF recurrence were observed in the four subgroups. When the sample was arbitrarily divided into the three age groups, a higher rate of recurrence was observed in older patients with regard to long-term follow-up (freedom from AF recurrence was 71.8% and 40.9%, respectively, at 12 and 24-month follow-up). In the univariate and multivariate analysis, age did not result in a significant predictor of AF recurrence during follow-up; however, a trend toward higher AF recurrences rates in patients ≥67 years was observed. Conclusion. The data demonstrated a high degree of safety during CBA across all patient ages. Procedural performance and complications were similar between different ages; AF recurrences seem to be more frequent in patients over 74 years.

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