Short and Optimal Duration of Dual Antiplatelet Therapy Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,525
- 试验地点
- 1
- 主要终点
- Major cardiovascular and bleeding events
研究概览
简要总结
The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.
详细描述
"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.
With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.
Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received PCI using everolimus-eluting cobalt-chromium stents
排除标准
- •Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
研究组 & 干预措施
Thienopyridine
Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents
干预措施: Thienopyridine for 3 months (Drug)
结局指标
主要结局
Major cardiovascular and bleeding events
时间窗: 1-year
Composite of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis (definite stent thrombosis not resulting in myocardial infarction), and major bleeding (TIMI Major/Minor) Cardiovascular death, myocardial infarction and stent thrombosis are defined according to the definition in the Academic Research Consortium (ARC). Stroke is defined as ischemic or hemorrhagic stroke with symptoms lasting \> 24 hour. Major bleeding is defined according to the definition in the Thrombosis in Myocardial Infarction (TIMI).
次要结局
- Cardiovascular death/MI(1-year)
- Cardiovascular death(1-year)
- Stent Thrombosis(1-year)
- Target Lesion Failure(1-year)
- Cardiovascular death/MI/stroke/definite ST(1-year)
- CABG(1-year)
- Target Vessel Revascularization(1-year)
- Any bleeding(1-year)
- All-cause death(1-year)
- Major bleeding (TIMI Major/Minor)(1-year)
- Death/MI(1-year)
- MI(1-year)
- Stroke(1-year)
- Clinically-driven Target Lesion Revascularization(1-year)
- Target Vessel Failure(1-year)
- Major Adverse Cardiac Events(1-year)
- Target Lesion Revascularization(1-year)
- Non Target Lesion Revascularization(1-year)
研究者
Takeshi Morimoto
Professor of Medicine
Kyoto University, Graduate School of Medicine