Vitamin K Antagonist Versus Direct Oral Anticoagulant Treatments in Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Comparison of the number of severe bleeding events occurring in patients with hemophilia receiving a vitamin K antagonist treatment versus patients with hemophilia receiving a direct oral anticoagulant treatment.
研究概览
简要总结
Hemophilia is a rare X-linked bleeding disorder responsible for deficiency of coagulation factor VIII (FVIII) or IX (FIX). The main clinical manifestation is increased bleeding throughout the life which is directly correlated to the severity of the hemophilia, either mild (FVIII/FIX: 6-40), moderate (FVIII/FIX: 1-5%), or severe (FVIII/FIX<1%). Thanks to new therapies and long-term specialized follow-up by hemophilia treatment centers (HTCs), the life expectancy of patients with hemophilia (PWH) has improved considerably, even reaching that of the general population (1).
Healthcare professionals are so more confronted to PWH with age-related pathologies, in particular cardiovascular pathologies such as atrial fibrillation, acute coronary syndromes or thromboembolic events (arterial or venous). It is now recommended in PWH that an anticoagulant treatment (AC) be prescribed as in the general population (2,3,4). The recently published COCHE study demonstrated a significantly increased risk of bleeding in PWH receiving antithrombotic treatment. This bleeding risk depended significantly on the type of antithrombotic treatment, which was higher for anticoagulant vs antiplatelet drugs, on basal levels of FVIII or FIX, and on the HAS-BLED score (5).
Nowadays in the general population, among anticoagulant drugs, direct oral anticoagulants (DOACs) are preferred to vitamin K antagonist (KVA), thanks to their reduced risk of bleeding particularly intracerebral bleeding and better anticoagulant stability over time (6). However, we do not yet know precisely whether DOACs could occupy the same place in the PWH population because of the lack of evidence-based data due to the very small number of these patients, although some authors already recommend them over KVA. The KADOAH study was therefore set up to try to provide initial elements for future recommendations. Its main objective was to compare the level of bleeding risk of PWH treated with VKA vs DOACs.
详细描述
The KADOAH study is an observational, retrospective and multicenter case-control study conducted in Hemophilia Treatment Centers (HTC) of the French Grand-Ouest interregion including HTCs of Brest, Caen, Le Mans, Nantes, Rennes and Rouen.
Objectives of the KADOAH study are:
- To compare the risk of bleeding events of 2 types of long-term anticoagulant treatment, vitamin K antagonists (VKA) versus Direct Oral Anticoagulants (DOAC), in patients with hemophilia,
- To describe the different types of bleeding events that occur during anticoagulant treatments in patients with hemophilia,
- To investigate for the influence of the HAS-BLED score on the risk of bleeding events in patients with hemophilia receiving a long-term anticoagulant treatment.
Inclusion criteria:
- Cases :
- Males at any ages with hemophilia of any severity and of any type,
- Patients having received or receiving a long-term anticoagulant treatment (during at least 6 consecutive months) during the period from 2012 to 2021,
- Regular follow-up in a hemophilia treatment center.
- Controls cross-matched with cases on :
- Age (+/- 5 years),
- Hemophilia type (either A or B)
- Hemophilia severity (for mild hemophilia: same basal factor level +/- 5%),
- HAS-BLED score (same score +/- 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males at any ages with hemophilia of any severity and of any type,
- •Patients having received or receiving a long-term anticoagulant treatment (during at least 6 consecutive months) during the period from 2012 to 2021,
- •Regular follow-up in a hemophilia treatment center.
- •Controls : patients with hemophilia cross-matched with cases on:
- •Age (+/- 5 years),
- •Hemophilia type (either A or B)
- •Hemophilia severity (for mild hemophilia: same basal factor level +/- 5%),
- •HAS-BLED score (same score +/- 1).
排除标准
- •Lost to medical follow-up,
- •Refusal to participate in the study,
- •Unable to understand the study's French letter of non-opposition and information.
研究组 & 干预措施
Cases
Patients with hemophilia receiving an anticoagulant treatment in the period 2012-2021
干预措施: Vitamin K Antagonist - Drug (Drug)
结局指标
主要结局
Comparison of the number of severe bleeding events occurring in patients with hemophilia receiving a vitamin K antagonist treatment versus patients with hemophilia receiving a direct oral anticoagulant treatment.
时间窗: All over the duration of the anticoagulant treatment in the period 2012-2021
Number of severe bleeding events
次要结局
- The influence of the HAS-BLED score on the risk of severe bleeding events in patients with hemophilia receiving an anticoagulant treatment.(All over the duration of the anticoagulant treatment in the period 2012-2021)
- Comparison of the number of severe bleeding events occurring in patients with hemophilia receiving an anticoagulant treatment versus their cross-matched controls not receiving an anticoagulant treatment.(All over the duration of the anticoagulant treatment in the period 2012-2021)
- Description of the types of severe bleeding events occurring in patients with hemophilia receiving an anticoagulant treatment (either vitamin K antagonist or direct oral anticoagulant treatment).(All over the duration of the anticoagulant treatment in the period 2012-2021)
- The influence of a treatment with proton pomp inhibitor on the risk of gastrointerstinal bleeding events in patients with hemophilia receiving an anticoagulant treatment.(All over the duration of the anticoagulant treatment in the period 2012-2021)