Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)

Study Overview
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Brief Summary
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A total of 50 patients with ST-elevation myocardial infarction (STEMI) undergoing primary-percutaneous coronary intervention (PPCI) will be randomized to two different coronary stents: BIOFREEDOM vs. COMBO stent. All patients will undergo to 6-month scheduled coronary angiography to evaluate the endothelial function response of the distal coronary segment and other functional parameters.

Detailed Description
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The bioengineered COMBO stent (Orbus Neich, Fort Lauderdale, Florida, United States) has a dual-therapy strategy, which combines a sirolimus-eluting coating with an anti-CD34 antibody layer to promote vessel healing. Sirolimus release (5 μg/mm) is completed in 30 days, and the biodegradable polymer disappears within 90 days. CD34 antibodies are immobilized on the surface of the stent and capture circulating endothelial progenitor cells (EPCs). The captured EPCs are triggered by sheer stress from the circulating blood and other cell signals to differentiate and mature into endothelial cells. COMBO Plus is the only stent with a biological coating that actively repairs the vessel morphology. However, little is known regarding the endothelial function after stent implantation.

Official Title
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Six-month Endothelial and Microcirculatory Function of the Bioactive Sirolimus-eluting Combo Stent Versus the Polymer-free Biolimus-eluting Biofreedom Stent in Patients With ST-segment Elevation Myocardial Infarction

Conditions
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Endothelial Dysfunction, Coronary Microvascular Disease, Myocardial Infarction

Intervention / Treatment
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* Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI < 12 hours undergoing primary PCI. ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads. Presence of at least one acute infarct artery target vessel with one or more de-novo coronary artery stenosis in a native coronary artery within 2.75 - 3.75 mm reference vessel diameter and < 24 mm length (visually estimated). 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, PLLA, everolimus, contrast material Cardiogenic Shock Unprotected left main coronary artery stenosis Distal occlusion of target vessel Acute myocardial infarction secondary to stent thrombosis Mechanical complications of acute myocardial infarction Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication in the follow-up procedure Active bleeding or coagulopathy or patients at chronic anticoagulation therapy Chronic renal dysfunction with creatinine clearance < 45 ml/minm2 Subject is currently participating in another clinical trial that has not yet completed its primary endpoint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIOFREEDOM<br>Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction. | Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction<br>* The 6-month scheduled coronary angiography will perform 3 interventions: Endothelial function assessment with intracoronary acetyl-choline infusion. Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion. Stent healing assessment using optical coherence tomography<br>* Other names: All patients will undergo to 6-month coronary angiography after stent implantation in order to assess the endothelial and microvascular function of the infarct related artery;|
| Experimental: COMBO<br>Implantation of Bioactive coronary stent in patients with myocardial infarction. | Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction<br>* The 6-month scheduled coronary angiography will perform 3 interventions: Endothelial function assessment with intracoronary acetyl-choline infusion. Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion. Stent healing assessment using optical coherence tomography<br>* Other names: All patients will undergo to 6-month coronary angiography after stent implantation in order to assess the endothelial and microvascular function of the infarct related artery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents | To compare the mean lumen diameter changes to intracoronary acetyl-choline infusion of the distal coronary segment by quantitative coronary angiography between the COMBO stent vs. the BIOFREEDOM stent in STEMI patients. Endothelial dysfunction is defined as >4% vasoconstriction to intracoronary acetylcholine compared to the 6-month baseline mean lumen diameter of the matched segment. | At 6 months of the stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of microcirculatory resistance | To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients. | At 6 months of the stent implantation | 
| Coronary flow reserve | To compare the coronary flow reserve (CFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients | At 6 months of the stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function