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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    784
  • sponsor
    Chonnam National University Hospital
Updated on 26 January 2021

Summary

Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% 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.

Description

Study objectives:

To determine the optimal timing of non-infarct related artery (IRA) percutaneous coronary intervention (PCI) with the aid of FFR (fractional flow reserve) (immediate complete revascularization during primary angioplasty vs. staged procedure for non-IRA PCI) in patients with ST-segment elevation myocardial infarction with multivessel disease (MVD).

Study hypothesis:

Complete revascularization (CR) at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA.

Background

Multivessel coronary artery disease (MVD) is a common clinical condition, about 40-65% of all primary angioplasty, encountered by interventional cardiologists in ST-segment elevation myocardial infarction (STEMI), and it is associated with poorer clinical outcomes than single-vessel disease. Older guidelines recommended culprit-vessel only revascularization (CVR) during primary angioplasty, except in patient that are hemodynamically unstable. Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention (PCI), and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery (non-IRA) with significant stenosis. However, there has been no consensus of optimal revascularization strategy in this circumstance.

Recently, several large-scaled randomized controlled trials were conducted about this issue, and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR. Furthermore, fractional flow reserve (FFR)-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials.

Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI). Timing of non-IRA PCI is also uncertain. After promising results of above-mentioned randomized trials, current guideline recommendation of multivessel PCI (immediate or staged) was upgraded. However, current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy.

Therefore, the investigators planned to perform prospective, open-label, multicenter, non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during primary angioplasty) compared to staged PCI strategy of non-IRA (primary angioplasty for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 70% should be conducted with the aid of FFR, and non-IRA with diameter stenosis 70% will be revascularized without FFR.

Study procedure:

Patients will be randomized after primary PCI for 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 50-70% 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.

Details
Condition Acute Myocardial Infarction, Multi-Vessel Coronary Artery Stenosis, Multi-Vessel Coronary Artery Stenosis, Multi-Vessel Coronary Artery Stenosis, Multi-Vessel Coronary Artery Stenosis, Multi-Vessel Coronary Artery Stenosis
Treatment Staged in-hospital or Immediate complete revascularization
Clinical Study IdentifierNCT04626882
SponsorChonnam National University Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 19 years old
ST-segment elevation myocardial infarction
ST-segment elevation in at least 2 contiguous leads or
New onset left bundle branch block
Primary PCI within 12 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

Exclusion Criteria

Cardiogenic shock at initial presentation or after treatment of IRA
Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
TIMI (Thrombolysis in Myocardial Infarction) 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 (coronary artery bypass graft), or planned CABG
Fibrinolysis before admission
Severe asthma
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note