Anti-thrombotic and Glucose loweRing THerapy in diabEtics With CAD Undergoing PCI: a Prospective Multicenter observatIonal Study on Their Use and Implications for Clinical Outcomes - The ARTHEMIS Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Reasons for prolonging DAPT over 1 year
研究概览
简要总结
Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous Coronary Intervention) risk scores. However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. This study aims to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical treatment in an unselected consecutive population of patients with DM undergoing PCI.
详细描述
Diabetes is one of the main risk factors for ischemic events in patients with coronary artery disease and diabetes is a factor in several post-PCI risk scores (including the commonly used DAPT score). However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. At large, results from randomized trials assessing the duration of DAPT have produced conflicting results and there is uncertainty about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the patterns of use and their clinical effects, including those related to prolonged DAPT is needed, in diabetic patients, especially in less selected "real world" populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •PCI with stent implantation, performed in at least one major coronary artery in the context of stable coronary artery disease or acute coronary syndrome
- •Type 2 Diabetes mellitus (previously diagnosed or diagnosed at the index admission)
- •Informed consent signed
- •Patient not simultaneously participating in any interventional study
排除标准
- •Patients with Type 1 Diabetes mellitus
- •Patients whose survival is expected to be lower than 1 year at hospital discharge
- •Patients not whiling to participate
结局指标
主要结局
Reasons for prolonging DAPT over 1 year
时间窗: 12 to 24 months follow-up
Enumeration of the anti-thrombotic agents prescribed to patients
时间窗: Baseline to 24 months follow-up
Planned duration of dual anti-platelet treatment (DAPT) after the PCI.
时间窗: From index admission to 24 months follow-up
Adherence to anti-thrombotic regimen
时间窗: 6 to 24 months follow-up
Classified qualitatively according to the assessment of the attending physician.
Actual duration of DAPT (if different from the planned duration)
时间窗: 6 to 24 months follow-up
Reasons for interrupting DAPT at a time different from the planned duration
时间窗: 6 to 24 months follow-up
次要结局
- Death rate from heart failure(6 to 24 months follow-up)
- Major Adverse Coronary Events (MACE)(6 to 24 months follow-up)
- Death rate from any cause(6 to 24 months follow-up)
- Rate of cardiovascular death(6 to 24 months follow-up)
- Rate of new spontaneous acute myocardial infarction(6 to 24 months follow-up)
- Rate of hospital admissions for acute coronary infarction(6 to 24 months follow-up)
- Rate of unplanned coronary revascularization(6 to 24 months follow-up)
- Rate of stroke/transient ischemic attack(6 to 24 months follow-up)
- Rate of hospital admission due to heart failure(6 to 24 months follow-up)
- Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale(6 to 24 months follow-up)
- Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale(6 to 24 months follow-up)
- Percentage of patients treated with different glucose-lowering drugs.(Before index admission to 24 months follow-up.)
- Diabetes control (HbA1c values)(At baseline to 24 months follow-up)