Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack (TOSCA-2)

University Health Network, Toronto

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction; Cardiovascular Diseases; Heart Diseases; Coronary Disease

Treatments: Device: PCI with stenting; Behavioral: Optimal Medical Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00025766

989

R01HL067683 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Has experienced a heart attack 3 to 28 days prior to study entry
• Has a persistently occluded IRA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

1

Experimental group

Description:

PCI with stenting of the occluded culprit infarct-related artery plus optimal medical therapy

Treatment:

Behavioral: Optimal Medical Therapy

Device: PCI with stenting

2

Active Comparator group

Description:

Optimal medical therapy alone without PCI of the occluded culprit artery

Treatment:

Behavioral: Optimal Medical Therapy