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The bleeding with antithrombotic therapy study 2: Rationale, design, and baseline characteristics of the participants
Masahito Takagi1, Kanta Tanaka1, Kaori Miwa1
1Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Insights
This study clarifies bleeding risks associated with modern antithrombotic therapies in patients with vascular diseases. Findings will help develop new models to predict and manage bleeding complications.
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Antithrombotic therapies are crucial for managing cardiovascular and cerebrovascular diseases.
- Current antithrombotic strategies, including newer agents, require updated risk assessment for bleeding complications.
- Understanding bleeding risk is essential for optimizing patient safety and treatment efficacy.
Purpose of the Study:
- To clarify the bleeding risk associated with current antithrombotic strategies in clinical practice.
- To investigate the association between bleeding complications and cerebral small vessel disease.
- To identify novel biomarkers and develop risk stratification models for bleeding.
Main Methods:
- Prospective, multicentre, observational study involving 5306 patients with cerebrovascular or cardiovascular diseases.
- Baseline multimodal magnetic resonance imaging to assess cerebral small vessel disease.
- Two-year follow-up with a primary outcome of major bleeding events as defined by the International Society on Thrombosis and Hemostasis.
Main Results:
- Over 5000 patients were enrolled, with a high prevalence of cerebrovascular disease (94.3%) and atrial fibrillation (20.0%).
- A significant proportion of patients used antiplatelet agents (70.2%), including dual antiplatelet therapy (10.4%), and anticoagulants (24.8%), with a notable use of direct oral anticoagulants (19.4%).
- Over 200 major bleeding events were recorded by April 2020.
Conclusions:
- The study provides crucial data on the incidence of bleeding complications with contemporary oral antithrombotics in real-world settings.
- Results are expected to enhance understanding of the link between bleeding risk, small vessel disease, and other biomarkers.
- The findings will facilitate the creation of improved risk stratification models for antithrombotic-related bleeding.
Aims:
The bleeding risk of current antithrombotic strategies in clinical settings, including recently developed agents, needs to be clarified.
Methods And Design:
In an investigator-initiated, prospective, multicentre, observational study, patients with cerebrovascular or cardiovascular diseases who were taking oral antiplatelet or anticoagulant agents were enrolled. Compulsory multimodal magnetic resonance images were acquired at baseline to assess cerebral small vessel disease. Six-month follow-up will be performed for two years. The primary outcome is major bleeding as defined by the International Society on Thrombosis and Hemostasis.
Results:
Between October 2016 and March 2019, 5306 patients (71.7 ± 11.2 years old, 1762 women) were enrolled. Previous intracranial haemorrhage was documented in 181 patients (3.4%), cerebrovascular disease (including asymptomatic) requiring antithrombotic therapy in 5006 patients (94.3%), and atrial fibrillation in 1061 patients (20.0%). At entry, 3726 patients (70.2%) were taking antiplatelet agents alone, including 551 (10.4%) using dual antiplatelet agents, 1317 (24.8%) taking anticoagulants alone, and the remaining 263 (5.0%) taking both. The leading antiplatelet agent was clopidogrel (2014 patients), and the leading combination of dual antiplatelet medication was clopidogrel plus aspirin (362). Use of direct oral anticoagulants (1029 patients, 19.4%) exceeded warfarin use (554, 10.4%). The number of pivotal bleeding events exceeded 200 in April 2020.
Conclusions:
This study is expected to provide the incidence of bleeding complications of recent oral antithrombotics in clinical practice and identify their associations with underlying small vessel disease and other biomarkers. Novel risk stratification models for bleeding risk will be able to be created based on the study results.
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