Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial
- Conditions
- Coronary DiseaseIschemic Heart DiseaseCoronary Artery Disease
- Interventions
- Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
- Registration Number
- NCT05599061
- Lead Sponsor
- Fundación EPIC
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal Medical Treatment (OMT) + PCI FFR>0.80+ OCT with findings indicative of vulnerable plaque - Optimal Medical Treatment (OMT) FFR>0.80+ OCT with findings indicative of vulnerable plaque -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Cardiac death 4 Years To compare Cardiac 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.
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.
Revascularizations 4 Years To compare all revascularizations 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.
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).
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).
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.
All-cause Death 4 Years To compare all death between both groups in the randomized arm death.
Ischemic-driven target vessel revascularization 4 Years To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
Trial Locations
- Locations (44)
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital General Universitario de Albacete
🇪🇸Albacete, Spain
Hospital General Universitario Dr.Balmis
🇪🇸Alicante, Spain
Hospital Universitari Sant Joan D'Alacant
🇪🇸Alicante, Spain
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital de Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Vall Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
Hospital General Universitario de Castellón
🇪🇸Castellón De La Plana, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario A Coruña
🇪🇸Coruña, Spain
Hospital Universitario Reina Sofia de Cordoba
🇪🇸Córdoba, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Spain
Hospital Universitario de Girona Dr Trueta
🇪🇸Girona, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario de Leon
🇪🇸León, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital de Manises
🇪🇸Manises, Spain
Hospital Universitario Virgen Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario de Donostia
🇪🇸San Sebastián, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clinico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari Joan Xxiii
🇪🇸Tarragona, Spain
Hospital Universitario Nuestra Señora de La Candelaria
🇪🇸Tenerife, Spain
Hospital Universitario de Torrevieja
🇪🇸Torrevieja, Spain
Hospital Universitario 12 Octubre
🇪🇸Usera, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari I Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitari Miquel Servet
🇪🇸Zaragoza, Spain