Incidence of Hemocompatibility Events With or Without Aspirin in Patients With CH-VAD: a Multi-centre, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The primary endpoint was survival free from non-surgical HRAEs at 12 months, estimated using Kaplan-Meier methods.
研究概览
简要总结
The goal of this observational study is to investigate the impact of oral warfarin anticoagulation combined with or without aspirin on the incidence of non-surgical hemocompatibility-related adverse events (HRAEs) and survival in advanced heart failure patients after implantation of the fully magnetic levitation left ventricular assist device (CH-VAD).
The main question it aims to answer is : The incidence of non-surgical HRAEs and survival treated with oral warfarin anticoagulation combined with or without aspirin in Chinese CH-VAD implanted advanced heart failure patients.
CH-VAD has been approved in China for the treatment of patients with advanced heart failure.
详细描述
This was a multi-center, retrospective observational study including patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025. Patients who died during the index hospitalization were excluded. Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) were also excluded to avoid exposure misclassification. Patients were divided into two groups: those receiving aspirin in addition to warfarin (ASA+VKA) versus those receiving warfarin alone (VKA only). Warfarin was started once the patient was clinically stable and able to tolerate oral medication, with a target international normalized ratio (INR) of 2.0-2.5. For patients receiving aspirin, the dose was 100 mg daily.
The primary endpoint was a composite of survival free of major nonsurgical HRAEs at 12 months. Nonsurgical events were defined as any event occurring > 14-days post implant to avoid perioperative confounding. The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025.
排除标准
- •Patients who died during the index hospitalization.
- •Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) .
研究组 & 干预措施
Non-Aspirin group
Non-Aspirin group receiving the VKA without aspirin regimen after CH-VAD implantation.
干预措施: CH-VAD (Device)
Aspirin group
Aspirin group receiving the VKA and aspirin regimen after CH-VAD implantation.
干预措施: CH-VAD (Device)
结局指标
主要结局
The primary endpoint was survival free from non-surgical HRAEs at 12 months, estimated using Kaplan-Meier methods.
时间窗: Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days.
The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism. Nonsurgical events were defined as any event occurring \> 14-days post implant to avoid perioperative confounding.
次要结局
- Secondary endpoints were the individual components of the composite.(Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days.)