JOURNAL CLUB

Presenter : Dagim (R)

Moderator : Dr. Abdulhakim(Ass’t Prof. of Int. medicine)

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OUT LINE
• Introduction
• Methodology
• Statistical analysis
• Result and discussion
• Critical appraisal
• Local applicability

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Introduction

• AF is a common cardiac arrhythmia that is prevalent throughout the world

• In developing countries, it is more often related to rheumatic valvular heart

disease (RVHD), especially mitral valve disease

• The management of AF may require multiple strategies to control heart rate and
restore sinus rhythm

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Cont.….

• AF increases the risk of stroke by a factor of 5 and is responsible for up to 20% of

strokes

• Rivaroxaban is a novel oral anticoagulant documented effective for stroke

prevention in atrial fibrillation without need for regular monitoring of coagulation
status

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Cont.….

• Atrial fibrillation may occur because of different pathophysiological conditions

that lead to remodeling of the left atrium

• Patients with atrial fibrillation are at increased risk for embolic stroke owing to
formation of thrombus in the left atrium, which can embolize and occlude
branches of the intracerebral circulation

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Primary Hypotheses

• In patients with rheumatic valvular heart disease (RVHD) and who are in atrial
fibrillation or flutter (AF/flutter) and have other stroke risk factors

• 1. Rivaroxaban is non-inferior to vitamin K antagonists (VKAs) for prevention of

stroke or systemic embolism

• 2. In patients with RVHD, either with AF/flutter but unsuitable for VKA therapy,
or with sinus rhythm but with high risk, rivaroxaban is superior to aspirin for
prevention of stroke or systemic embolism

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Study design
• This program is a comprehensive evaluation of RVHD, AF/flutter and stroke
includes three major components

1. A multi-centre registry of RVHD

2. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban

versus standard VKA therapy to evaluate non-inferiority of rivaroxaban to VKA,
with testing for superiority if non-inferiority is satisfied

3. A prospective, randomized, open-label superiority trial comparing rivaroxaban to

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Non-Inferiority Trial of rivaroxaban
versus VKA

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Superiority Trial of rivaroxaban versus
aspirin

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Study Population

• From August 2016 through September 2019, a total of 4565 patients were enrolled
from 138 trial sites across 24 countries

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Cont.….

• Published: This article was published on August 28, 2022, at NEJM.org.Study

• type: intention-to-treat analysis

• Sponsor: Hamilton Health Sciences, Hamilton, ON, Canada

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Inclusion and Exclusion Criteria

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Superiority Trial

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Outcome Measures

A: Primary outcome

the primary efficacy outcome was a composite of total stroke or systemic embolism

B: Secondary outcomes secondary outcomes were myocardial infarction and death

from vascular (cardiac or noncardiac) causes

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Statistical Analysis

• The efficacy analyses were performed on the basis of the intention-to-treat

principle

• Only events that occurred up to 5 days after permanent discontinuation of trial

medication

• Results are reported as point estimates with 95% confidence intervals

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Results and Safety Outcomes

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Cont.….

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Cont.….

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Conclusions

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Strengths and limitations
• Strengths
• Randomized,multi-stage (MAMS), parallel group strategy trial

• Clearly stated primary and secondary outcomes

• high rate of retention of participants

• The completeness of data

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Limitations

• This study was limited to people > 18 years of age

• Open-label

• Small sample size

• Grant from Bayer

• Multiple exclusion criteria

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Ethical consideration

• The trial was planned and led by the Population Health Research Institute, which
designed, conducted, analyzed, and reported the trial results

• Bayer grant an unrestricted to cover the costs of the trial, without any agreements
regarding confidentiality

• Written informed consent was obtained from all the patients before
randomization

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Critical appraisal

• Journal quality

• Title

• Validity

• Coherency with other study

• Local applicability

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Others Trial and study

• Rocket AF trial

• International REMEDY study

• Framingham Heart Study

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Cont.….

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Cont.….

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Media coverage and Page view

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 THANK YOU!

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