Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.
详细描述
Drug Eluting Stents (DES) are the devices of choice for coronary angioplasty, including in patients with high-bleeding risk.
Different studies have been done to determine which strategy improves bleeding outcomes without risking the benefit of stenting. Different Double Anti-Platelet Therapy (DAPT) durations in different devices have shown that it is safe to reduce DAPT, with an increase in ischemic events but a better net clinical outcome.
Safety and efficacy of Drug Eluting Balloons (DEB) were proved when it was compared with Bare Metal Stents (BMS) in de-novo coronary lesions by presenting no events of target vessel closure after treatment.
Our hypothesis is that treating this group of high-bleeding risk patients with DEB will be no-inferior in terms of target vessel failure at 12 months when compared with DES for treatment of de-novo coronary lesions in high bleeding risk population, reducing incidence of significant bleeding events with DAPT reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomized treatment will not be revealed to patient at any time during procedure or afterwards until follow-up is done.
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 18 years old or older with an ischemic de-novo lesion(s) in a 2.5 - 4.0 mm reference diameter coronary artery suitable for elective percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DEB or DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria:
- •Major criteria:
- •Anticipated use of long-term oral anticoagulation
- •Severe or end-stage CKD (eGFR <30 mL/min)
- •Hemoglobin < 11 g/dL
- •Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
- •Moderate or severe baseline thrombocytopenia (<100,000/uL)
- •Chronic bleeding diathesis
- •Liver cirrhosis with portal hypertension
- •Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
- •Previous spontaneous intracranial hemorrhage
- •Previous traumatic intracranial hemorrhage within the past 12 months
- •Presence of Brain arteriovenous malformation (AVM)
- •Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
- •Non deferrable major surgery while on DAPT
- •Recent major surgery or major trauma within 30 days before PCI
- •Minor Criteria:
- •Age 75 years old and older
- •Moderate Chronic Kidney Disease (CKD) (eGFR 30-59 mL/min)
- •Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
- •Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
- •Long term use of NSAIDs or steroids
- •Any ischemic stroke at any time not meeting major criterion
排除标准
- •STEMI undergoing primary PCI
- •Any ACS undergoing urgent PCI
- •Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
- •Unprotected left main lesion
- •Life expectancy < 12 months
- •Reference vessel diameter < 2.5 mm or > 4.0 mm
- •Bifurcation lesion requiring 2-stent technique
- •Chronic total occlusion
- •In-stent restenosis
- •Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation
- •Inability to give written consent
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
Composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization
次要结局
- Target Lesion Revascularization(12 months)
- Cardiovascular death(12 months)
- Target Vessel Revascularization(12 months)
- Non-cardiovascular death(12 months)
- Subgroup analysis of target lesion failure(12 months)
- Myocardial Infarction related to the treated vessel(12 months)
- Target Vessel Failure (TVF)(12 months)
- Major Bleeding(12 months)
- Technical success(Periprocedural)
- Subgroup analysis of major bleeding events(12 months)
研究者
Daniel Fernando Zazueta Salido
Principal Investigator
Instituto Nacional de Cardiologia Ignacio Chavez