Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve

Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve

Abstract

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 ma- jor 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.)

SCMR Position Paper (2020) on clinical indications for cardiovascular magnetic resonance

Abstract :
The Society for Cardiovascular Magnetic Resonance (SCMR) last published its comprehensive expert panel report of clinical indications for CMR in 2004. This new Consensus Panel report brings those indications up to date for 2020 and includes the very substantial increase in scanning techniques, clinical applicability and adoption of CMR worldwide. We have used a nearly identical grading system for indications as in 2004 to ensure comparability with the previous report but have added the presence of randomized controlled trials as evidence for level 1 indications. In addition to the text, tables of the consensus indication levels are included for rapid assimilation and illustrative figures of some key techniques are provided.

Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure

Aims
Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF.


Methods
Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF.


Conclusions
The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.

Prise en charge des patients suspects ou confirmés COVID-19 en unités d’hospitalisation (y compris les unités de soins intensifs des urgences et la réanimation) – Version Novembre 2020

Auteurs :
Lahcen Belyamani, Ahmed Rhassane El Adib, Saïd Jidane, Jamaleddine Kohen, Abderrahim Azzouzi, Taoufik Aboulhassan, Saad Zidouh, Sifeddine Nejmi, Hicham Bakkali, Chafik Kettani, Mostapha Bensghir, Abdelhamid El Bait, Mamoun Faroudy, Ali Kettani, Afak Nsiri, Saïd Younous, Nabil Kanjaa, Adnane Berdai, Mustapha Abarda, Alae El Koraichi, Hicham Belkhi, Naoufal Madani, Brahim Housni, Karim Filali, Mohamed Mouhaoui, Nabil Kenjaa, Hanane Ezzouine, Youness El Aissaoui, Mohamed Nasser Semkaoui, Ismael Labib, Hicham Sbai, Mohamed Khatouf, Yassir Sbai, Abdelhamid Hachimi, Khalid Abidi, Saloua Marzak.

Les volets traités dans ces recommandations d’experts sont les suivants :

  • Modalités de l’oxygénothérapie en fonction des moyens disponibles ;
  • Modalités de prescription de l’acide acétylsalicylique ;
  • Traitement anticoagulant ;
  • Corticothérapie ;
  • Traitements antiviraux ;
  • Traitement anti-interleukine 6 ;
  • Antibiothérapie et COVID ;
  • Place du plasma de convalescents ;
  • Sortie et suivi ambulatoire.

Registry of Arterial and Venous Thromboembolic Complications in Patients With COVID-19

Abstract

Background
Cardiovascular complications, including myocardial infarction, ischemic stroke, and pulmonary embo- lism, represent an important source of adverse outcomes in coronavirus disease-2019 (COVID-19).


Objectives
To assess the frequency of arterial and venous thromboembolic disease, risk factors, prevention and management patterns, and outcomes in patients with COVID-19, the authors designed a multicenter, observational cohort study.


Methods
We analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through our Mass General Brigham integrated health network. The total cohort was analyzed by site of care: intensive care (n 1⁄4 170); hospitalized nonintensive care (n 1⁄4 229); and outpatient (n 1⁄4 715). The primary study outcome was a composite of adjudicated major arterial or venous thromboembolism.


Results

Patients with COVID-19 were 22.3% Hispanic/Latinx and 44.2% non-White. Cardiovascular risk factors of hypertension (35.8%), hyperlipidemia (28.6%), and diabetes (18.0%) were common. Prophylactic anticoagulation was prescribed in 89.4% of patients with COVID-19 in the intensive care cohort and 84.7% of those in the hospitalized nonintensive care setting. Frequencies of major arterial or venous thromboembolism, major cardiovascular adverse events, and symptomatic venous thromboembolism were highest in the intensive care cohort (35.3%, 45.9%, and 27.0 %, respectively) followed by the hospitalized nonintensive care cohort (2.6%, 6.1%, and 2.2%, respectively) and the outpatient cohort (0% for all).


Conclusions
Major arterial or venous thromboembolism, major adverse cardiovascular events, and symptomatic venous thromboembolism occurred with high frequency in patients with COVID-19, especially in the intensive care setting,despiteahighutilizationrateofthromboprophylaxis. (JAmCollCardiol2020;76:2060–72)©2020TheAuthors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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