Deferred Stenting in Patients With Anterior Wall STEMI

Summary

Trial Name) Impact of Immediate SteNt ImplaNtatiOn Versus Deferred Stent ImplAntaTION on Clinical Outcomes in Patients with AnteRior Wall ST-segment Elevation Myocardial Infarction (INNOVATION-CORE)

Objectives) To evaluate the impact of deferred versus immediate stenting in patients with acute ST-segment elevation anterior wall myocardial infarction (STEMI) on

1. the clinical efficacy and safety
2. the microvascular obstruction using Cardiac magnetic resonance (MR)
3. the structural and functional cardiac remodeling using conventional echocardiography and strain imaging
4. the intravascular findings using optical coherence tomography (OCT)

Study Design) A multicenter, prospective, randomized, controlled, open-label clinical trial for anterior wall STEMI patients

Patient Enrollment) 460 patients will be enrolled at 20 centers in South-Korea

Patient Follow-Up) Clinical follow-up will occur at 1, 6, 12 months, 2, 3 years and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint) Composite of all-cause death, hospitalization due to heart failure, recurrent myocardial infarction (MI), target vessel revascularization (TVR) at 2 years.

Secondary Endpoints)

1. Clinical events A. All-cause death B. Cardiac death C. Hospitalization due to heart failure D. Recurrent MI E. TVR F. Stent thrombosis
2. Imaging parameters A. Echocardiographic parameters i. Left ventricle (LV) remodeling index ii. %LV strain iii. Regional wall motion abnormality B. Cardiac MR parameters (optional) i. Infarct size ii. Microvascular obstruction (MVO) size iii. MVO incidence iv. MVO to infarct ratio C. OCT parameters (optional) i. Plaque morphology ii. Lipid index iii. Minimal scaffold area and area stenosis iv. Stent malapposition

Conditions

• Acute Myocardial Infarction With ST Elevation
• Anterior Wall Myocardial Infarction

Interventions

PROCEDURE

Immediate stenting

Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.

PROCEDURE

Deferred stenting

Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 3 to 7 days after TIMI Ⅲ flow has achieved.

Sponsors & Collaborators

• Abbott

  collaborator INDUSTRY

• Samjin Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Korea University Anam Hospital

  lead OTHER

Principal Investigators

• Cheol Woong Yu, M.D.,Ph.D. · Cardiovascular center, Korea University Anam Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-03

Primary Completion

2025-04-03

Completion

2025-11-30

Countries

• South Korea

Study Locations