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Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial
Josep Gómez-Lara1,2, Ramón López-Palop3, Eva Rúmiz2,4
1Servicio de Cardiología, Hospital Universitari de Bellvitge, Grupo de Investigación en Enfermedades Cardiovasculares (BIO-HEART), Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, España Servicio de Cardiología, Hospital Universitari de Bellvitge Grupo de Investigación en Enfermedades Cardiovasculares (BIO-HEART) L'Hospitalet de Llobregat Barcelona España.
Insights
This study investigates preventive stenting for vulnerable nonculprit lesions in ST-segment elevation myocardial infarction (STEMI) patients. It compares stenting plus optimal medical therapy against optimal medical therapy alone to reduce adverse cardiac events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- Optimal treatment for nonculprit intermediate lesions (40%-69% stenosis) in ST-segment elevation myocardial infarction (STEMI) remains unclear.
- While lesions with fractional flow reserve (FFR) ≤ 0.80 indicate ischemia and benefit from revascularization, those with FFR > 0.80 but showing plaque vulnerability on optical coherence tomography (OCT) may still pose risks.
- Identifying and managing these vulnerable plaques is crucial for improving patient outcomes.
Purpose of the Study:
- To compare the efficacy of preventive stent implantation plus optimal medical therapy versus optimal medical therapy alone in STEMI patients with nonculprit intermediate lesions.
- To evaluate outcomes in lesions with FFR > 0.80 and OCT-identified plaque vulnerability at 4-year follow-up.
- To assess the role of OCT-guided management of vulnerable plaques in STEMI.
Main Methods:
- A 1:1 randomized, parallel-group, multicenter, controlled, single-blind trial enrolling 600 STEMI patients.
- Inclusion criteria: ≥ 1 intermediate nonculprit lesion with FFR > 0.80 and OCT findings of plaque vulnerability (lipid-rich, ≥70% burden, thin fibrous cap ≤80 μm).
- Primary endpoint: Target vessel failure (cardiac death, target vessel MI, or target vessel revascularization). A parallel registry will include patients with FFR > 0.80 but no OCT vulnerability.
Main Results:
- The VULNERABLE trial is designed to determine the clinical impact of preventive stenting in STEMI patients.
- It will assess whether stenting functionally non-significant but morphologically vulnerable plaques reduces adverse events.
- Results will provide insights into the management of nonculprit lesions in the context of STEMI.
Conclusions:
- This is the first randomized trial specifically evaluating OCT-guided treatment for vulnerable plaques in STEMI.
- The findings will clarify the benefit of preventive revascularization for nonculprit intermediate lesions with FFR > 0.80 but OCT-defined vulnerability.
- The study aims to refine treatment strategies for STEMI patients with complex nonculprit lesions.
Introduction And Objectives:
The optimal treatment of nonculprit angiographic intermediate lesions (diameter stenosis 40%-69%) in patients with ST-segment elevation myocardial infarction (STEMI) is still unknown. Lesions with fractional flow reserve (FFR) ≤ 0.80 are indicative of ischemia and benefit from revascularization. However, lesions with FFR > 0.80 and optical coherence tomography (OCT) findings of vulnerability have been hypothesized to cause adverse events during follow-up. The study aims to compare the efficacy of a preventive treatment with stent implantation plus optimal medical therapy vs optimal medical therapy alone for nonculprit intermediate lesions with FFR > 0.80 and OCT findings of plaque vulnerability in STEMI patients at 4 years of follow-up.
Methods:
This parallel-group, multicenter, controlled, single-blind, and 1:1 randomized trial will enroll a total of 600 STEMI patients with ≥ 1 intermediate nonculprit lesions with FFR > 0.80 and OCT findings of plaque vulnerability. The primary endpoint is target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. The study will include a parallel registry of patients with FFR > 0.80 but without OCT findings of vulnerability. Vulnerable plaques are defined as lipid-rich fibroathermas with plaque burden ≥ 70% and a thin fibrous cap (≤ 80 mm).
Results:
The VULNERABLE trial will reveal the role of preventive treatment with stent implantation for nonculprit and functionally nonsignificant vulnerable plaques in STEMI patients.
Conclusions:
This is the first randomized trial of OCT-guided treatment of vulnerables plaques. Registered at ClinicalTrials.gov (NCT05599061).
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