Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,876
- 试验地点
- 71
- 主要终点
- MACE = death + MI + TVR
研究概览
简要总结
Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty can cause injury to the heart artery that might require open heart surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart surgery will be needed is very small. Nevertheless, without more research, many state Departments of Health and all national heart organizations do not want to change the requirement for having on-site open heart surgery wherever angioplasty is performed. Some States already allow this; and European heart organizations already allow it, as well.
This study is designed to determine whether the safety and benefits of angioplasty are the same at hospitals that perform angioplasty either with or without open heart surgery backup.
Patient who enter the study have a heart catheterization at a hospital without a heart surgery program. If they need angioplasty, then they are randomized to either stay at the hospital without heart surgery for their angioplasty or to be transferred for the procedure to a hospital with heart surgery. For every four patients, three stay at the hospital without heart surgery and one is transferred.
The study is designed to show that there is no detectable difference between the safety and benefits of the procedure at the two types of hospital (with and without heart surgery). The cost of the procedure at the two hospital types is also compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Pre-catheterization:
- •Must be undergoing diagnostic cardiac catheterization for suspected CAD
- •Be at least 18 years of age
- •Must not be pregnant (negative pregnancy test) or must not be of childbearing potential must be able to give informed consent.
- •Post-catheterization:
- •Coronary artery disease judged to be clinically and angiographically significant
- •Ability to perform PCI with equipment available at the local site
- •Procedure risk judged to be not high (see below)
排除标准
- •Pre-catheterization:
- •Inability to give informed consent
- •ST-segment elevation myocardial infarction
- •Pregnancy
- •Post-catheterization:
- •High likelihood of requiring a device not available at the hospitals without SOS
- •No need for PCI
- •Need for coronary artery bypass surgery
- •High procedural risk (see below)
- •High procedural risk criteria are:
- •PCI of unprotected left main coronary artery
- •PCI of left circulation lesion in the presence of critical (>70%) unprotected left main coronary artery lesion
- •Poor left ventricular function (EF< 20%) and need to perform PCI in a vessel supplying significant myocardium
研究组 & 干预措施
1
PCI performed at a hospital with co-located (on-site) cardiac surgery
干预措施: Percutaneous coronary intervention (PCI) (Other)
2
PCI performed at a hospitals without co-located (on-site) cardiac surgery
干预措施: Percutaneous coronary intervention (PCI) (Other)
结局指标
主要结局
MACE = death + MI + TVR
时间窗: 9 Months
Mortality
时间窗: 6 weeks
次要结局
- emergency CABG(hosp DC, 6 wks, 3, 6 and 9 months)
- target vessel revascularization (TVR)(hosp DC, 6 wks, 3, 6 and 9 months)
- any subsequent revascularization (ASR)(hosp DC, 6 wks, 3, 6 and 9 months)
- major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)(hosp DC, 6 wks, 3, 6 and 9 months)
- heart failure and class(hosp DC, 6 wks, 3, 6 and 9 months)
- composite adverse endpoint (MACE)(hosp DC, 6 wks, 3, 6 and 9 months)
- myocardial infarction(hosp DC, 6 wks, 3, 6 and 9 months)
- stroke(hosp DC, 6 wks, 3, 6 and 9 months)
- total direct medical cost(hosp DC, 6 wks, 3, 6 and 9 months)
- angina and class(hosp DC, 6 wks, 3, 6 and 9 months)
- angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)(hosp DC, 6 wks, 3, 6 and 9 months)
- angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)(hosp DC, 6 wks, 3, 6 and 9 months)
- MACE = death + MI + TVR(hosp DC, 6 wks, 3, 6 and 9 months)
- MACE = death + MI + ASR(hosp DC, 6 wks, 3, 6 and 9 months)
- completeness of revascularization(hosp DC, 6 wks, 3, 6 and 9 months)
- percent of patients with complete or partial revascularization(hosp DC, 6 wks, 3, 6 and 9 months)
- bleeding (non-CABG transfusion, vascular repair)(hosp DC, 6 wks, 3, 6 and 9 months)
- length of stay(hosp DC, 6 wks, 3, 6 and 9 months)
研究者
Thomas Aversano
Associate Professor of Medicine
Johns Hopkins University