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Original article
DOI: 10.1016/j.rec.2021.01.007
Available online 25 February 2021
Coronary endothelial and microvascular function distal to polymer-free and endothelial cell-capturing drug-eluting stents. The randomized FUNCOMBO trial
Función endotelial y microvascular distal a stents farmacoactivos sin polímero y captadores de células endoteliales. Estudio aleatorizado FUNCOMBO
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Josep Gómez-Laraa,b,
Corresponding author
gomezjosep@hotmail.com

Corresponding author: Department of Interventional Cardiology, Hospital Universitari de Bellvitge, Carrer de la Feixa Llarga s/n, 08907 L’Hospitalet de Llobregat, Barcelona, Spain.
, Loreto Oyarzabala,b, Salvatore Brugalettac,d, Neus Salvatellae,f, Rafael Romagueraa,b, Gerard Rouraa,b, Lara Fuentesa,b, Pedro Pérez Fuentesc,d, Luis Ortega-Pazc,d, José L. Ferreiroa,b, Luis Teruela,b, Montserrat Gracidaa,b, Beatriz Vaquerizoe,f, Manel Sabatéc,d, Josep Comín-Coleta,b, Joan-Antoni Gómez-Hospitala,b
a Departament de Cardiologia Intervencionista, Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
b Institut d’Investigació Biomèdica de Bellvitge (IDIBELL), L’Hospitalet de Llobregat, Barcelona, Spain
c Departament de Cardiologia Intervencionista, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain
d Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
e Departament de Cardiologia Intervencionista, Hospital del Mar, Barcelona, Spain
f Institut Hospital del Mar d’Investigacions Mèdiques (IMIM), Barcelona, Spain
Related content
10.1016/j.rec.2021.06.006
Benjamin Beska, Daniell Edward Raharjo, Vijay Kunadian
Received 07 November 2020. Accepted 11 January 2021
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Tables (5)
Table 1. Baseline clinical and procedural characteristics
Table 2. Quantitative coronary angiography analysis of the stent segment
Table 3. Distal coronary segment vasomotor test results
Table 4. Microcirculatory function results
Table 5. Optical coherence tomography findings
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Additional material (1)
Abstract
Introduction and objectives

The vasomotor function of new-generation drug-eluting stents designed to enhance stent healing and reendothelialization is unknown. This study aimed to compare the endothelial function of the infarct-related artery (IRA) treated with bioactive circulating endothelial progenitor cell-capturing sirolimus-eluting stents (COMBO) vs polymer-free biolimus-eluting stents (BioFreedom) in ST-segment elevation myocardial infarction patients at 6 months. Secondary objectives were to compare the microcirculatory function of the IRA and stent healing at 6 months.

Methods

Sixty patients were randomized to bioactive sirolimus-eluting stent vs polymer-free biolimus-eluting stents implantation. At 6 months, patients underwent coronary angiography with vasomotor, microcirculatory and optical coherence tomography examinations. Endothelial dysfunction of the distal coronary segment was defined as ≥ 4% vasoconstriction to intracoronary acetylcholine infusion.

Results

Endothelial dysfunction was similarly observed between groups (64.0% vs 62.5%, respectively; P=.913). Mean lumen diameter decreased by 16.0 ±20.2% vs 16.1 ±21.6% during acetylcholine infusion (P=.983). Microcirculatory function was similar in the 2 groups: coronary flow reserve was 3.23 ±1.77 vs 3.23±1.62 (P=.992) and the index of microcirculatory resistance was 24.8±16.8 vs 21.3±12.0 (P=.440). Optical coherence tomography findings were similar: uncovered struts (2.3% vs 3.2%; P=.466), malapposed struts (0.1% vs 0.3%; P=.519) and major evaginations (7.1% vs 5.6%; P=.708) were observed in few cases.

Conclusions

Endothelial dysfunction of the IRA was frequent and was similarly observed with new-generation drug-eluting stents designed to enhance stent reendothelialization at 6 months. Endothelial dysfunction was observed despite almost preserved microcirculatory function and complete stent coverage. Larger and clinically powered studies are needed to assess the role of residual endothelial dysfunction in ST-segment elevation myocardial infarction patients.

Registered in ClinicalTrials.gov: NCT04202172

Keywords:
Drug-eluting stents
Endothelial dysfunction
Optical coherence tomography
ST-segment elevation myocardial infarction
Abbreviations:
BES
BMS
DES
IRA
SES
STEMI
Resumen
Introducción y objetivos

Aún no se conoce la función endotelial de los nuevos stents farmacoactivos diseñados para promover el recubrimiento y la reendotelización. El objetivo principal es comparar la función endotelial de la arteria responsable del infarto (ARI) tratada con stents bioactivos liberadores de sirolimus captadores de células progenitoras endoteliales circulantes (SES; COMBO) frente a la tratada con stents sin polímero liberadores de biolimus (BES; Biofreedom), así como comparar la función microvascular de la ARI y el grado de cicatrización de ambos dispositivos a los 6 meses.

Métodos

Se aleatorizó a 60 pacientes con infarto agudo de miocardio con elevación del ST (IAMCEST) a tratamiento con SES o BES. Tras 6 meses, todos los pacientes se sometieron a pruebas vasomotora mediante acetilcolina y nitroglicerina y de función microvascular mediante técnicas de termodilución y exploración con tomografía de coherencia óptica (OCT). Una respuesta vasoconstrictora a la acetilcolina ≥ 4% se definió como disfunción endotelial.

Resultados

Ambos grupos presentaron similares porcentajes de disfunción endotelial (el 64,0 frente al 62,5%; p=0,913) y función microvascular. La reserva coronaria de flujo fue de 3,23±1,77 frente a 3,23±1,62 (p=0,992) y el índice de resistencia microvascular, 24,8±16,8 frente a 21,3±12,0 (p=0,440). Los hallazgos de la OCT fueron parecidos e indicaban una cicatrización avanzada: proporciones de struts sin recubrir (el 2,3 frente al 3,2%; p=0,466), con mala aposición (el 0,1 frente al 0,3%; p=0,519) y de evaginaciones coronarias mayores (el 7,1 frente al 5,6%; p=0,708).

Conclusiones

Tras 6 meses, los nuevos stents farmacoactivos presentaron con frecuencia parecidas disfunciones endoteliales de la ARI. La disfunción endotelial se observó a pesar de la adecuada función microvascular y la cicatrización avanzada.

Registrado en ClinicalTrials.gov: NCT04202172

Palabras clave:
Stents farmacoactivos
Disfunción endotelial
Tomografía de coherencia óptica
Infarto agudo de miocardio con elevación del segmento ST

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