Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.

BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).

A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.

Consumption, nicotine dependence and motivation for smoke cessation during early stages of COVID-19 pandemic in Brazil: A cross-sectional study.

INTRODUCTION: The COVID-19 pandemic may have changed smoking habits. For the smoking population, information regarding smoking habits and the pandemic could potentially aid COVID-19 prevention and control measures. Our study aimed to analyze the effects of the COVID-19 pandemic on tobacco consumption, nicotine dependence levels, and motivation for smoking cessation. We also collected information from smokers regarding their awareness of the consequences of tobacco use and the increased risks smokers have for severe complications from COVID-19. METHODS: In the survey for this observational cross-sectional study, 122 smokers responded to an online form. The participants provided general data about their smoking history, their smoking habits in the months of April and May 2020, and the effect of the pandemic on their smoking habits. They also completed a Fagerström test and were measured by the Wisconsin Smoking Withdrawal Scale. RESULTS: When compared to pre-pandemic levels, the majority of smokers reported increased tobacco consumption of between 1 and 10 cigarettes per day (37.7%). Their motivation to quit smoking (59.8%) and desire to smoke (53.2%) were unchanged by the pandemic. Most participants demonstrated an awareness of the increased risks smokers have for severe COVID-19-related complications (p<0.001). We identified the following correlations: cigarettes/day before pandemic and motivation for smoking cessation (r=0.19; p=0.030), cigarettes/day and nicotine dependence level (r=0.61; p<0.001), and load consumption and nicotine dependence level (r=0.69; p<0.001). No significant correlations were observed between load consumption and motivation to quit (r=0.13; p=0.120). CONCLUSIONS: Most smokers are well aware of their increased risks for severe COVID-19-related complications. In the early stages of the COVID-19 pandemic in Brazil, most smokers reported increased cigarette consumption. In addition, motivation to quit and desire to smoke were unchanged for the majority of smokers.