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| Name | Class |
|---|---|
| Spanish Society of Cardiology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOFREEDOM | Active Comparator | Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction. |
|
| COMBO | Experimental | Implantation of Bioactive coronary stent in patients with myocardial infarction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction | Procedure | The 6-month scheduled coronary angiography will perform 3 interventions:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional flow reserve | To compare the fractional flow reserve (FFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients | At 6 months of the stent implantation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Gomez Lara, MD PhD | Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain | Principal Investigator |
| Neus Salvatella, MD | Hospital del Mar, Barcelona, Spain | Principal Investigator |
| Salvatore Brugaletta, MD PhD | Hospital Clinic, Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33640311 | Derived | Gomez-Lara J, Oyarzabal L, Brugaletta S, Salvatella N, Romaguera R, Roura G, Fuentes L, Perez Fuentes P, Ortega-Paz L, Ferreiro JL, Teruel L, Gracida M, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary endothelial and microvascular function distal to polymer-free and endothelial cell-capturing drug-eluting stents. The randomized FUNCOMBO trial. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1013-1022. doi: 10.1016/j.rec.2021.01.007. Epub 2021 Feb 24. English, Spanish. |
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|
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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 |
| ID | Term |
|---|---|
| D017566 | Microvascular Angina |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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