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

Myocardial Infarction, Acute Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04626882
• Other study ID #: CNUH-2019-318
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 994
• Est. completion date: December 31, 2029
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Stenosis
• Infarction
• Multi-Vessel Coronary Artery Stenosis
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Procedure:
• Staged in-hospital or Immediate complete revascularization
Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients 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 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.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheon
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Yeongnam University Medical Center	Daegu
Korea, Republic of	GangNeung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Koera University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	St. Carollo General Hospital	Suncheon
Korea, Republic of	The Catholic University of Korea, Uijeongbu St. Mary's Hospital	Uijeongbu
Korea, Republic of	Yonsei University, Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline	Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention	Index admission to 12 months
Secondary	Rate of contrast-induced nephropathy during index admission	Rate of contrast-induced nephropathy during index admission	During index admission
Secondary	Cumulative incidence rate of all unplanned revascularization at each visit	Cumulative incidence rate of all unplanned revascularization at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of target-lesion revascularization at each visit	Cumulative incidence rate of target-lesion revascularization at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of target-vessel revascularization at each visit	Cumulative incidence rate of target-vessel revascularization at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of non-target vessel revascularization at each visit	Cumulative incidence rate of non-target vessel revascularization at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of all-cause death at each visit	Cumulative incidence rate of all-cause death at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of cardiac death at each visit	Cumulative incidence rate of cardiac death at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of non-cardiac death at each visit	Cumulative incidence rate of non-cardiac death at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of non-fatal myocardial infarction at each visit	Cumulative incidence rate of non-fatal myocardial infarction at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of hospitalization for unstable angina at each visit	Cumulative incidence rate of hospitalization for unstable angina at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of hospitalization for heart failure at each visit	Cumulative incidence rate of hospitalization for heart failure at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of definite or probable stent thrombosis at each visit	Cumulative incidence rate of definite or probable stent thrombosis at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit	Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit	Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline	Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention	Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months