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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChonnam National University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Staged in-hospital complete revascularization
  • Immediate complete revascularization

Treatment groups

1,014 Participants
are divided into 2 treatment groups