Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real-life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF

Background: Rivaroxaban, a direct oral anticoagulant (DOAC), has become available for stroke prevention in patients with non-valular atrial fibrillation (NVAF). However, little is known about its effectiveness and safety when prescribed by general practitioners in real-life settings. Methods: GENERAL is a multicenter, prospective, non-interventional observational study of patients receiving rivaroxaban for NVAF in daily clinical practice prescribed specifically by general practitioners. The target number of participating medical institutions is 500–700 clinics with fewer than 20 beds and the target number of participants is 5000. The baseline clinical data, including antidementia medication and frailty, and follow-up data including concomitant treatment and outcomes until September 2018 (maximum three years) will be collected. The primary efficacy endpoints will be stroke and/or systemic embolism and the secondary endpoints will be major bleeding meeting the ISTH guidelines, non-major and clinically relevant bleeding, onset of symptomatic stroke (ischemic/hemorrhagic), systemic embolism, deep vein thrombosis/pulmonary thromboembolism, myocardial infarction and/or cardiovascular death, and systemic embolism. Based on the provided information, the event assessment committee will investigate the endpoint-related events. The annual incidence and predictive factors for primary/secondary endpoint will be investigated based on underlying disease, age, renal function, and CHADS2, CHA2DS2-VASC, and HAS-BLED scores using Cox regression. We will also compare the incidence of the primary/secondary endpoint between the present study, EXPAND study, and FUSHIMI AF registry study. Results: The results of this study are currently under investigation. Conclusion: This study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners

Incidence and Characteristics of Ventricular Fibrillation in Bystander-witnessed Out-of-hospital Cardiac Arrest with Cardiac Etiology in the City of Sendai, Japan

Ventricular fibrillation (VF) in out-of-hospital cardiac arrest (OHCA) is a main target for resuscitation. Methods and results: We analyzed Utstein-style data in Sendai City (population 1,020,000), Japan from January 2002 to March 2004. The incidence of OHCA overall was 62.3/100,000/year. The incidence of the bystander-witnessed VF was 2.5/100,000/year. In younger patients (20–65 years of age), the percentage of VF was 52% when cardiac origin was presumed by bystander witness, and ECG was recorded within 10 minutes from the collapse. In older patients (over 65 years of age), however, the percentage of VF was 21% when they were bystander-witnessed, and ECG was recorded within 10 minutes from the collapse. No VF was reported when the ECG was recorded more than 15 minutes after the collapse. The thirty-day survival rate was 21% in the bystander-witnessed VF cases with cardiac etiology, but 0% in the non-VF cases. The bystander CPR was significantly associated with improved 30-day survival rate. Conclusion: Younger age, male gender, and shorter collapse-to-ECG time are significantly associated with the appearance of VF in bystander-witnessed OHCA with cardiac etiology. Bystander CPR was significantly associated with the improvement in prognosis of those VF patients

Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF

BACKGROUND: Many patients with atrial fibrillation have concomitant coronary artery disease with or without acute coronary syndromes and are in need of additional antithrombotic therapy. There are few data on the long-term clinical outcome of atrial fibrillation patients with a history of acute coronary syndrome. This is a 2-year study of atrial fibrillation patients with or without a history of acute coronary syndromes