Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack

Study Overview
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Brief Summary
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The purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

Detailed Description
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BACKGROUND: The Occluded Artery Trial (OAT) is an international study with 3200 participants. Its goal is to determine if delayed mechanical reperfusion by means of percutaneous transluminal coronary angioplasty (PTCA) and stenting reduces death, heart attacks, and hospitalization in individuals with New York Heart Association (NYHA) Class IV heart failure and a persistently occluded infarct-related artery (IRA) 3 to 28 days following a heart attack. While left ventricular (LV) function improvement has been suggested as a benefit of late reperfusion, solid evidence to support this claim is lacking. Furthermore, while stenting has reduced reocclusion rates after total occlusion PTCA, the reocclusion rate after a recent heart attack is unknown. DESIGN NARRATIVE: This study is a substudy of OAT and will enroll 380 participants. The primary aims of the study include the following: 1) to compare long-term patency rates between the two treatment groups (conventional medical therapy or PTCA and stenting) by means of follow-up coronary angiography one year after enrollment; and 2) to compare the change in global LV ejection fraction between the two treatment groups utilizing baseline and follow-up contrast LV angiograms. Secondary aims include the following: 1) comparison of regional wall motion and LV volumes; 2) study of the effect of reocclusion and spontaneous recanalization on LV function; and 3) study of the effect of duration of occlusion on changes in LV function after Percutaneous Coronary Intervention (PCI). The substudy will be conducted at 21 OAT study sites. The Substudy Coordinating Center (SCC) is at the University of Alberta in Edmonton, Canada. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute, which is the DCC for the OAT study. The Angiographic Core Laboratory is at the University of British Columbia.

Official Title
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TOSCA-2: An Angiographic Substudy (Ancillary) of the Occluded Artery Trial (OAT)

Conditions
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Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction

Intervention / Treatment
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* Device: PCI with stenting
* Behavioral: Optimal Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has experienced a heart attack 3 to 28 days prior to study entry Has a persistently occluded IRA

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy | Device: PCI with stenting<br>* PCI with stenting of the occluded culprit infarct-related artery<br>Behavioral: Optimal Medical Therapy<br>* Participants will receive optimal medical therapy.<br>|
| Active Comparator: 2<br>Optimal medical therapy alone without PCI of the occluded culprit artery | Behavioral: Optimal Medical Therapy<br>* Participants will receive optimal medical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV ejection fraction |  | 1 year | 
| Infarct-related artery patency (measured by contrast LV and coronary angiography) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of regional wall motion and LV volumes |  | 1 year | 
| Effect of reocclusion and spontaneous recanalization on LV function |  | 1 year | 
| Effect of duration of occlusion on changes in LV function after PCI |  | 1 year |