Clinical trial NCT04626882: Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
Official title: OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Infarction, Acute
Multi-Vessel Coronary Artery Stenosis
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 994
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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
* Patient's refusal to participate in study

Primary outcomes:
measure: Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
timeFrame: Index admission to 12 months
Secondary outcomes:
measure: Rate of contrast-induced nephropathy during index admission
timeFrame: During index admission
measure: Cumulative incidence rate of all unplanned revascularization at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of target-lesion revascularization at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of target-vessel revascularization at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of non-target vessel revascularization at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of all-cause death at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of cardiac death at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of non-cardiac death at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of non-fatal myocardial infarction at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of hospitalization for unstable angina at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of hospitalization for heart failure at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of definite or probable stent thrombosis at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
timeFrame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Medical Center
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Koera University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St. Carollo General Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Youngkeun Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: