Angina Pectoris, Coronary Arteriosclerosis
Conditions
Keywords
coronary artery disease, angioplasty, stent, percutaneous coronary intervention, on-site cardiac surgery, randomized trial
Brief summary
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.
Interventions
OTHERPercutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
Sponsors
Duke University
Maryland Medical Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 6 weeks |
| MACE = death + MI + TVR | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| heart failure and class | hosp DC, 6 wks, 3, 6 and 9 months |
| angina and class | hosp DC, 6 wks, 3, 6 and 9 months |
| stroke | hosp DC, 6 wks, 3, 6 and 9 months |
| composite adverse endpoint (MACE) | 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 |
| emergency CABG | 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 |
| 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 |
| total direct medical cost | 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 |
| angiographic (end-procedure) complications (embolization, dissection, no reflow, etc) | hosp DC, 6 wks, 3, 6 and 9 months |
| myocardial infarction | hosp DC, 6 wks, 3, 6 and 9 months |
Countries
United States
Outcome results
None listed