Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChonnam National University Hospital

About this trial

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥19 years

ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)

Primary PCI within 12 h after symptom development

At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation

Disqualifiers

Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment

Thrombolysis in myocardial infarction flow at non-IRA ≤ 2

Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment

Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • In-hospital staged complete revascularization

    Procedure/Surgery

    PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without 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 will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

  • Out-of-hospital staged complete revascularization

    Procedure/Surgery

    PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without 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 will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Treatment groups

1,252 Participants
are divided into 2 treatment groups
Group A: In-hospital staged complete revascularizationExperimental treatment 1 intervention
Group B: Out-of-hospital staged complete revascularizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

Time frame
At 12 months after randomization

Secondary outcomes

1

Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

Time frame
At 1, 6, 24, 36, 48, and 60 months after randomization
2

All-cause death

Time frame
At 1, 6, 12, 24, 36, 48, and 60 months after randomization
3

Nonfatal myocardial infarction

Time frame
At 1, 6, 12, 24, 36, 48, and 60 months after randomization
4

All unplanned revascularization

Time frame
At 1, 6, 12, 24, 36, 48, and 60 months after randomization

Other outcomes

Sponsors and contacts

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