Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

Conditions
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Coronary Arteriosclerosis, Angina Pectoris

Intervention / Treatment
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* Other: Percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PCI performed at a hospital with co-located (on-site) cardiac surgery | Other: Percutaneous coronary intervention (PCI)<br>* Patients undergo routine, clinically indicated PCI<br>|
| Other: 2<br>PCI performed at a hospitals without co-located (on-site) cardiac surgery | Other: Percutaneous coronary intervention (PCI)<br>* Patients undergo routine, clinically indicated PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 weeks | 
| MACE = death + MI + TVR |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergency CABG |  | hosp DC, 6 wks, 3, 6 and 9 months | 
| myocardial infarction |  | 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, angioplasty, stent, percutaneous coronary intervention, on-site cardiac surgery, randomized trial