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Research

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COMPLETE

Official Title

A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction

Status

Ongoing

Overview

To determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

Study Design

Randomized, prospective, multicenter, open label trial with blinded assessment of outcomes

Primary Endpoint

Primary Objective
To determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

Key Secondary Objectives
1. To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization
2. To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at 6 months and 5 year/final follow up compared to baseline.

Other Secondary Objectives
To determine whether an initial strategy of complete revascularization is superior to an initial strategy of culprit lesion only revascularization in reducing the composite of CV death, new MI, ischemia-driven revascularization or re-hospitalization for unstable angina or hospitalization for heart failure and each component of the key secondary objectives taken separately as well as all-cause mortality, stroke, stent thrombosis, major bleeding, economic evaluation, including health resource utilization, costs and cost-effectiveness.

Number of Patients

3900

Number of Sites

120

Number of Countries

30

Study Period

2013–2018

Principal Investigator

Shamir Mehta

Program Manager

Susan Chrolavicius, Brandi Meeks

Research Coordinator

Emilija Makaji