Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Sponsor

Fundación EPIC (Other)

Overall Status

Recruiting

CT.gov ID

NCT05599061

Collaborator

Abbott (Industry)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Disease Ischemic Heart Disease	Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque	N/A

Detailed Description

STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR > 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

Actual Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optimal Medical Treatment (OMT) + PCI	Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
Active Comparator: Optimal Medical Treatment (OMT)	Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque OPTIMAL MEDICAL TREATMENT (OMT)

Arm

Intervention/Treatment

Experimental: Optimal Medical Treatment (OMT) + PCI

Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque

Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

Active Comparator: Optimal Medical Treatment (OMT)

Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque

OPTIMAL MEDICAL TREATMENT (OMT)

Outcome Measures

Primary Outcome Measures

Target Vessel Failure (TVF) [4 Years]
TVF as a composite of : Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization

Secondary Outcome Measures

Cardiac death [4 Years]
To compare Cardiac death between both groups in the randomized arm death.
All-cause Death [4 Years]
To compare all death between both groups in the randomized arm death.
All Myocardial Infarctions [4 Years]
To compare Myocardial Infarctions between both groups in the randomized arm death. death
Target-Vessel Myocardial Infarction [4 Years]
To compare target-vessel myocardial infarction between both groups in the randomized arm.
Revascularizations [4 Years]
To compare all revascularizations between both groups in the randomized arm.
Ischemic-driven target vessel revascularization [4 Years]
To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
Patient-oriented endpoint of major adverse cardiac events [4 Years]
To compare the patient-oriented endpoint of major adverse cardiac events, a composite of all-cause death, myocardial infarction, and revascularization between both groups in the randomized arm.
Target Vessel Failure (TVF) [4 Years]
To compare the TVF rate between patients included in the OMT group of the randomized arm (presenting with vulnerable plaque) vs. patients included in the OMT registry (without vulnerable plaque).
Fractional Flow Reserve (FFR) [4 years]
To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).
Minimal lumen area by Optical Coherence Tomography (OCT) [4 years]
To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.
Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT) [4 years]
To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients > 18 years.
Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (> 1mm in > 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads) in the first 72 hours of the symptom's onset.
Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (>24 hours and <60 days after PCI of the culprit lesion).
Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ).
Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study.
Informed consent signed.

Exclusion Criteria:

Inability to provide informed consent.
Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
Known intolerance to aspirin, heparin, everolimus, contrast material.
Unresolved mechanical complication or cardiogenic shock at the staged procedure.
Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion.
Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation.
Asthma or known history of bronchial hyper-reactivity.
Chronic renal dysfunction with creatinine clearance < 45 ml/min.
Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy < 4 years.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.