Patients with atrial fibrillation and stable coronary artery disease were assigned to receive either rivaroxaban monotherapy or combination therapy with rivaroxaban plus a single antiplatelet agent. ...At 2 years, monotherapy was noninferior to combination therapy with respect to ischemic events and superior with respect to major bleeding.
Atrial fibrillation (AF) is the most common sustained arrhythmia and associated with increased morbidity and mortality resulting from thromboembolism and heart failure. AF often presents initially as ...paroxysmal and may progress to a sustained form over time. Sustained forms of AF may be associated with increased symptoms and cardiovascular morbidity, and AF progression may be associated with increased risk of clinically adverse events and outcomes. The present review discusses the clinical factors of arrhythmia progression and risk stratification available to assess the probability of AF progression. Furthermore, currently available treatment options for preventing AF progression are explored and evaluated.
Background:The current status and outcomes of direct oral anticoagulant (DOAC) use have not been widely evaluated in unselected patients with atrial fibrillation (AF) in the real world.Methods and ...Results:The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating medical institutions (n=80) in Fushimi, Kyoto, Japan. Follow-up data with oral anticoagulant (OAC) status were available for 3,731 patients by the end of November 2015. We evaluated OAC status and clinical outcomes according to OAC status. The number (incidence rate) of stroke/systemic embolism (SE) and major bleeding events during the median follow-up of 3.0 years was 224 (2.3%/year) and 177 (1.8%/year), respectively. After the release of DOAC, the prevalence of DOAC use increased gradually and steadily, and that of warfarin, DOAC and no OAC was 37%, 26% and 36%, respectively in 2015. On Cox proportional hazards modeling incorporating change in OAC status as a time-dependent covariate for stroke/SE and major bleeding events, use of DOAC compared with warfarin was not associated with stroke/SE events (HR, 0.95; 95% CI: 0.59–1.51, P=0.82) or major bleeding events (HR, 0.82; 95% CI: 0.50–1.36, P=0.45).Conclusions:In real-world clinical practice, there were no significant differences in stroke/SE events or major bleeding events for DOAC compared with warfarin in patients with AF.
Purpose
To investigate the distribution of plasma apixaban levels and their relationships with clinical outcomes in elderly patients with atrial fibrillation (AF).
Method
The J-ELD AF Registry is a ...multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75 years taking an on-label dose of apixaban (3015 patients from 110 institutions). Among them, plasma apixaban levels at trough were estimated by anti-Xa assay (Api-AXA) in 943 patients. Patients with standard (5 mg bid;
n
= 431) and reduced (2.5 mg bid;
n
= 512) dose were further divided into two groups with low and high Api-AXA levels (boundary: median value).
Results
The incidence rates (per 100 person-years) of events in the low- and high-Api-AXA groups were as follows: 1.48 and 1.99 (log-rank test,
P
= 0.695) for stroke or systemic embolism, 0.98 and 1.49 (
P
= 0.652) for bleeding requiring hospitalization, and 0.49 and 0.99 (
P
= 0.565) for total deaths in patients with standard dose, versus 0.84 and 1.68 (
P
= 0.414), 0.42 and 4.64 (
P
= 0.004), and 2.52 and 6.65 (
P
= 0.035) in patients with a reduced dose, respectively. In multivariate Cox regression analysis among patients with a reduced dose, a high Api-AXA level was independently associated with bleeding requiring hospitalization (HR 12.12, 95% CI: 1.56–94.22) and nonsignificantly with total deaths.
Conclusions
A high trough apixaban level in patients indicated for standard dose was not associated with adverse events, while a high apixaban level in patients indicated for a reduced dose was associated with bleeding requiring hospitalization.
Elderly patients with atrial fibrillation who were not appropriate candidates for standard doses of oral anticoagulants because of a high risk of bleeding were assigned to receive 15 mg of edoxaban ...or placebo once daily. Edoxaban was superior to placebo in preventing stroke or systemic embolism.
Background:Despite the well-established benefits in patients with nonvalvular atrial fibrillation (NVAF), anticoagulants have been underused in elderly patients. The All Nippon AF In the Elderly ...(ANAFIE) Registry is a multicenter, prospective, observational study with 2-year follow-up of Japanese patients aged ≥75 years with a definitive diagnosis of NVAF, aiming to collect detailed information on clinical status and therapeutic challenges in this patient population.Methods and Results:Patients were enrolled from October 2016 to January 2018. A total of 32,726 patients (57.2% male) were included. The average age, CHADS2score, and creatinine clearance were 81.5±4.8 years (26.2% of patients were aged ≥85 years), 2.9±1.2, and 48.4±21.8 mL/min, respectively. Paroxysmal AF was the most common clinical AF type (42.0%), and most patients (97.2%) had comorbidities. Most patients (91.9%) were receiving anticoagulant therapy; of these, 27.8% and 72.2% were treated with warfarin and direct oral anticoagulants, respectively. The average number of concomitant drugs used was 6.6±3.2, including anticoagulants.Conclusions:The ANAFIE Registry is the largest prospective registry study of elderly Japanese patients with NVAF to date. Baseline data indicate that patients in this age group are treated in a manner similar to their younger counterparts.
Randomized clinical trials demonstrated the efficacy and safety of apixaban in preventing stroke in patients with atrial fibrillation (AF). However, data on patients with low creatinine clearance ...(CCr), especially CCr 15-29 mL/min, are limited.
The J-ELD AF Registry is a large-scale, multicenter prospective observational study of Japanese nonvalvular AF patients aged ≥75 years taking on-label dose (standard dose of 5 mg bid or reduced dose of 2.5 mg bid) of apixaban. The entire cohort (3,015 patients from 110 institutions) was divided into 3 CCr subgroups: CCr ≥50 mL/min (n = 1,165, 38.6%), CCr 30-49 mL/min (n = 1,395, 46.3%), and CCr 15-29 mL/min (n = 455, 15.1%).
The event incidence rates (/100 person-years) were 1.76, 1.39, and 1.67 for stroke or systemic embolism (log rank P = .762); 1.39, 1.93, and 3.13 for bleeding requiring hospitalization (log rank P = .159); 1.75, 2.76, and 7.87 for total deaths (log rank P < .001); and 0.46, 0.84, and 2.62 for cardiovascular deaths (log rank P < .001), respectively. After adjusting for confounders by Cox regression analysis, CCr 15-29 was an independent risk for total death and cardiovascular death but not for stroke or systemic embolism, or bleeding requiring hospitalization.
The incidence of events in each CCr value group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and significantly higher for total deaths and cardiovascular deaths only in the CCr 15- to 29-mL/min group, in Japanese nonvalvular AF patients aged ≥75 years.
Background:Venous thromboembolism (VTE) has a long-term risk of recurrence, which can be prevented by anticoagulation therapy.Methods and Results:The COMMAND VTE Registry is a multicenter registry ...enrolling 3,027 consecutive patients with acute symptomatic VTE between January 2010 and August 2014. The entire cohort was divided into the transient risk (n=855, 28%), unprovoked (n=1,477, 49%), and cancer groups (n=695, 23%). The rate of anticoagulation discontinuation was highest in the cancer group (transient risk: 37.3% vs. unprovoked: 21.4% vs. cancer: 43.5% at 1 year, P<0.001). The cumulative 5-year incidences of recurrent VTE, major bleeding and all-cause death were highest in the cancer group (recurrent VTE: 7.9% vs. 9.3% vs. 17.7%, P<0.001; major bleeding: 9.0% vs. 9.4% vs. 26.6%, P<0.001; and all-cause death: 17.4% vs. 15.3% vs. 73.1%, P<0.001). After discontinuation of anticoagulation therapy, the cumulative 3-year incidence of recurrent VTE was lowest in the transient risk group (transient risk: 6.1% vs. unprovoked: 15.3% vs. cancer: 13.2%, P=0.001). The cumulative 3-year incidence of recurrent VTE beyond 1 year was lower in patients on anticoagulation than in patients off anticoagulation at 1 year in the unprovoked group (on: 3.7% vs. off: 12.2%, P<0.001), but not in the transient risk and cancer groups (respectively, 1.6% vs. 2.5%, P=0.30; 5.6% vs. 8.6%, P=0.44).Conclusions:The duration of anticoagulation therapy varied widely in discordance with current guideline recommendations. Optimal duration of anticoagulation therapy should be defined according to the risk of recurrent VTE and bleeding as well as death.