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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The 6-month scheduled coronary angiography will perform 3 interventions: 1. Endothelial function assessment with intracoronary acetyl-choline infusion. 2. Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion. 3. Stent healing assessment using optical coherence tomography
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
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.
Time frame: At 6 months of the stent implantation
Index of microcirculatory resistance
To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients.
Time frame: 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
Time frame: At 6 months of the stent implantation
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