Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

NCT04968808 | Recruiting DMC

• 1 other identifier: CNUH-2021-223
• Study Type: interventional
• Target: 1,014
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention \[PCI\] for both infarct-related artery \[IRA\] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.

Conditions

Myocardial Infarction, Acute; Multi-Vessel Coronary Artery Stenosis; Multi Vessel Coronary Artery Disease

Keywords

Non-ST-Segment Elevation Myocardial Infarction; Multi-Vessel Coronary Artery Disease; Multi-Vessel Coronary Artery Stenosis; Culprit-Only; Multi-Vessel Percutaneous Coronary Intervention; Percutaneous Coronary Intervention; Complete Revascularization; Timing; Staged Percutaneous Coronary Intervention; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization

  Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline

  Up to 12 months

Secondary Outcomes (14)

• Rate of contrast-induced nephropathy

  Up to 12 months

• Cumulative incidence rate of all unplanned revascularization

  Up to 12 months

• Cumulative incidence rate of target-lesion revascularization

  Up to 12 months

• Cumulative incidence rate of target-vessel revascularization

  Up to 12 months

• Cumulative incidence rate of non-target vessel revascularization

  Up to 12 months

Study Arms (2)

Staged in-hospital CR (complete revascularization)

ACTIVE COMPARATOR

Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after percutaneous coronary intervention (PCI) for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: Staged in-hospital complete revascularization

Immediate CR (complete revascularization)

EXPERIMENTAL

Non-infarct related artery (IRA) will be revascularized immediately after percutaneous coronary intervention (PCI) for IRA (during index PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Procedure: Immediate complete revascularization

Interventions

Staged in-hospital complete revascularization PROCEDURE

Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Staged in-hospital complete revascularization group will receive staged PCI for non-IRA in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Staged in-hospital CR (complete revascularization)

Immediate complete revascularization PROCEDURE

Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Immediate complete revascularization group will receive simultaneous PCI for both IRA and non-IRA during index PCI. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Immediate CR (complete revascularization)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years old
• Non-ST-segment elevation myocardial infarction
• Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
• occurs at rest, usually lasting \> 10 minutes
• severe and new onset (within the prior 4-6 weeks)
• crescendo pattern
• Elevated cardiac biomarkers and,
• ≥ 99% value of high-sensitivity cardiac troponin
• No ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
• PCI within 72 hours after symptom development
• Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
• Patient's or protector's agreement about study design and the risk of PCI

You may not qualify if:

• Cardiogenic shock at initial presentation or after treatment of IRA
• TIMI flow at non-IRA ≤ 2
• Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
• Non-IRA lesion not suitable for PCI treatment by operators' decision
• Chronic total occlusion at non-IRA
• History of anaphylaxis to contrast agent
• Pregnancy and lactation
• Life expectancy \< 1-year
• Severe valvular disease
• History of CABG, or planned CABG
• Fibrinolysis before admission

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Min Chul Kim, MD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chul Kim, MD

CONTACT

82-62-220-6578; kmc3242@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)