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1. Utilidad de la estrategia de corregistro con iFR en lesiones coronarias largas o difusas (iLARDI): protocolo del estudio

Author

Francisco Hidalgo, Soledad Ojeda, Javier Suárez de Lezo, Miguel Romero, Adrián Lostalob, Rafael González, Cristina Pericet, Nick Paredes, Juan C. Elizalde, Aurora Luque, Francisco Mazuelos, José Segura, and Manuel Pan

Subjects
Lesiones coronarias difusas, Lesiones coronarias largas, Relación en el periodo instantáneo libre de ondas, Software SyncVision, Internal medicine, RC31-1245
Abstract

RESUMEN Introducción y objetivos: Los pacientes con lesiones coronarias largas, secuenciales o difusas tratadas percutáneamente continúan presentando un riesgo alto de eventos cardiovasculares a pesar de la mejoría de la seguridad y de la eficacia de los nuevos stents liberadores de fármacos. El objetivo de este estudio es analizar la utilidad del software SyncVision /iFR (SyncVision versión 4.1.0.5, Philips Volcano, Bélgica) para guiar la revascularización en este tipo de lesiones. Métodos: Estudio aleatorizado, multicéntrico, controlado y abierto para comparar la revascularización guiada por SyncVision /iFR respecto a la revascularización guiada por angiografía en pacientes con lesiones coronarias largas, secuenciales o difusas (identificador de ClinicalTrials.gov: NCT04283734). Se incluirá a 100 pacientes (aleatorización 1:1 no estratificada). El objetivo primario es la longitud total del stent implantado. Como objetivo secundario se ha establecido un combinado de muerte cardiaca, infarto de miocardio, trombosis definitiva o probable del stent, nueva revascularización de la lesión tratada en el procedimiento basal o nueva revascularización de la lesión analizada en el procedimiento basal, y la presencia de isquemia residual evaluada por tomografía computarizada por emisión de fotón simple a los 6 meses de seguimiento. El tiempo de seguimiento será de 12 meses tras el procedimiento índice. Resultados: El estudio se encuentra actualmente en fase de reclutamiento, con los primeros 7 pacientes ya incluidos. Esperamos completar el reclutamiento en febrero de 2021 y el seguimiento en febrero de 2022. Conclusiones: El estudio iLARDI es el primer estudio aleatorizado para la evaluación de la potencial utilidad de la revascularización guiada por Syncvision en lesiones coronarias largas, secuenciales y difusas.

Published
2021
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2. Utilidad de la valoración fisiológica coronaria con iFR en la práctica diaria y en todo tipo de pacientes: resultados inmediatos y en el seguimiento

Author

Cristina Pericet-Rodríguez, Francisco José Hidalgo-Lesmes, Rafael González-Manzanares, Soledad Ojeda-Pineda, Aurora Luque-Moreno, Javier Suárez de Lezo, Miguel Ángel Romero-Moreno, Francisco Mazuelos-Bellido, José María Segura Saint-Gerons, Ana Fernández-Ruiz, María Guisela Flores-Vergara, and Manuel Pan Álvarez-Ossorio

Subjects
Evaluación fisiológica, Todo tipo de pacientes, Software Syncvision/iFR, Internal medicine, RC31-1245
Abstract

RESUMEN Introducción y objetivos: El propósito del estudio fue describir nuestra experiencia con el uso del índice diastólico instantáneo sin ondas (iFR) para la evaluación fisiológica coronaria o el uso del software Syncvision/iFR (Syncvision versión 4.1.0.5, Philips Volcano, Bélgica) en todo tipo de pacientes. Métodos: Se incluyeron todos los pacientes consecutivos a quienes, entre enero de 2017 y diciembre de 2019, se realizó en nuestro centro una evaluación fisiológica coronaria con iFR o con Syncvision/iFR. El valor de corte establecido para el iFR fue 0,89. El objetivo primario fue un compuesto de muerte cardiaca, infarto de miocardio, trombosis de stent probable o definitiva y nueva revascularización de la lesión evaluada. Resultados: Se incluyeron 277 pacientes con 433 lesiones evaluadas. La edad media fue de 65 ± 10 años y el 74% eran varones. El 41% tenía antecedente de diabetes mellitus. La presentación clínica fue angina estable en 160 pacientes (58%) y síndrome coronario agudo en 117 pacientes (42%). Se obtuvo un iFR > 0,89 en 266 lesiones (61,4%), en las cuales la intervención coronaria percutánea fue diferida. Las lesiones restantes se revascularizaron. El software Syncvision/iFR se usó en 155 lesiones (36%) para guiar la toma de decisiones, principalmente lesiones largas, difusas o secuenciales (91 lesiones, 58,7%) y lesiones intermedias (52 lesiones, 33,5%). Tras un periodo de seguimiento de 18 meses, el objetivo primario se observó en 17 pacientes (6,1%), sin diferencias en función del iFR basal (≤ 0,89 o > 0,89) (4,2 frente a 3,8%; p = 0,9) ni de la presentación clínica (angina estable o síndrome coronario agudo) (4,4 frente a 8,5%; p = 0,1). Conclusiones: La evaluación fisiológica coronaria con iFR y el software Syncvision/iFR en la práctica diaria y en todo tipo de pacientes parece ser segura, con un bajo porcentaje de eventos cardiacos adversos mayores a medio plazo.

Published
2021
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3. Usefulness of physiological coronary assessment with iFR in daily practice and all-comer patients: immediate and follow-up results

Author

Cristina Pericet-Rodríguez, Francisco José Hidalgo-Lesmes, Rafael González-Manzanares, Soledad Ojeda-Pineda, Aurora Luque-Moreno, Javier Suárez de Lezo, Miguel Ángel Romero-Moreno, Francisco Mazuelos-Bellido, José María Segura Saint-Gerons, Ana Fernández-Ruiz, María Guisela Flores-Vergara, and Manuel Pan Álvarez-Ossorio

Subjects
Physiological assessment, All-comer patients, Syncvision-guided iFR-pullback study, Medicine
Abstract

ABSTRACT Introduction and objectives: The objective of this study was to describe our experience with coronary physiology assessment using the instantaneous wave-free ratio (iFR) and/or a Syncvision-guided iFR-pullback study [Syncvision version 4.1.0.5, Philips Volcano, Belgium] in all-comer patients. Methods: Consecutive patients undergoing coronary physiology assessment with the iFR (and/or a Syncvision-guided iFR-pullback study) at our center between January 2017 and December 2019 were included. The iFR cut-off value was 0.89. The primary endpoint was a composite of cardiac death, myocardial infarction, probable or definitive stent thrombosis, and target lesion revascularization. Results: A total of 277 patients with 433 lesions evaluated were included. The mean age was 65 ± 10 years and 74% were men. Personal history of diabetes mellitus was present in 41% of patients. Clinical presentation was stable angina in 160 patients (58%), and acute coronary syndrome in 117 patients (42%). iFRs > 0.89 were obtained in 266 lesions (61.4%) on which the PCI was postponed. The remaining lesions were revascularized. The Syncvision software was used to guide the iFR-pullback study in 155 lesions (36%) and the decision-making process, mainly in long, diffuse or sequential lesions (91 lesions, 58.7%), and intermediate lesions (52 lesions, 33.5%). After a median follow-up of 18 months, the primary endpoint occurred in 17 patients (6.1%) without differences regarding the baseline iFR (≤ 0.89 or > 0.89) (4.2% vs 3.8%; P = .9) or the clinical presentation (stable angina or acute coronary syndrome) (4.4% vs 8.5%; P = .1) Conclusions: The use of coronary physiology assessment with the iFR and the Syncvision-guided iFR-pullback study in the routine daily practice and in all-comer patients seems safe with a low percentage of major adverse cardiovascular events at the mid-term follow-up.

Published
2021
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4. Usefulness of a co-registration strategy with iFR in long and/or diffuse coronary lesions (iLARDI): study protocol

Author

Francisco Hidalgo, Soledad Ojeda, Javier Suárez de Lezo, Miguel Romero, Adrián Lostalo, Rafael González, Cristina Pericet, Nick Paredes, Juan C. Elizalde, Aurora Luque, Francisco Mazuelos, José Segura, and Manuel Pan

Subjects
Diffuse coronary artery disease, Long coronary artery disease, Instantaneous wave-free ratio, SyncVision software, Medicine
Abstract

ABSTRACT Introduction and objectives: patients with long, sequential and diffuse coronary lesions who undergo a percutaneous coronary intervention remain at a high risk of suffering cardiovascular events despite the improved safety and efficacy of the new drug-eluting stents. The objective of this study was to analyze the utility of SyncVision/iFR-guided revascularization (SyncVision version 4.1.0.5, Philips Volcano, Belgium) in this type of lesions. Methods: Randomized, multicenter, controlled, and open-label trial designed to compare SyncVision/iFR-guided and angiography-guided revascularizations in patients with long, sequential or diffuse significant angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). A total of 100 patients will be randomized (1:1, no stratification). The primary endpoint is the average length of the stent implanted. The secondary endpoint is a composite of cardiac death, myocardial infarction, definitive or probable stent thrombosis, new target lesion revascularization or new target lesion failure; and the presence of residual ischemia as seen on single-photon emission computed tomography at the 6-month follow-up. Patients will be followed for 12 months after the procedure. Results: The trial is currently in the recruitment phase, and it has already recruited the first 7 patients. We expect to complete the recruitment phase by February 2021 and the follow-up by February 2022. Conclusions: The iLARDI study is the first randomized trial to assess the potential utility of SyncVision-guided revascularization in long, sequential and diffuse coronary lesions.

Published
2021
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5. Utilidad de la estrategia de corregistro con iFR en lesiones coronarias largas o difusas (iLARDI): protocolo del estudio

Author

Miguel Ángel Romero Moreno, Soledad Ojeda, Francisco Mazuelos Bellido, Francisco Hidalgo Lesmes, Rafael Gonzalez Manzanares, Javier Suárez de Lezo Rodríguez de Tejada, Nick Paredes, Adrián Lostalo, Manuel Pan Álvarez-Osorio, Cristina Pericet, José Segura, Juan Carlos Elizalde Joza, and Aurora Luque

Subjects
Target lesion, Relación en el periodo instantáneo libre de ondas, business.industry, medicine.medical_treatment, General Engineering, Stent, Coronary stenosis, RC31-1245, Lesiones coronarias difusas, Software SyncVision, Lesiones coronarias largas, Medicine, In patient, Stent thrombosis, Nuclear medicine, business, Internal medicine, Target lesion revascularization
Abstract

espanolIntroduccion y objetivos: Los pacientes con lesiones coronarias largas, secuenciales o difusas tratadas percutaneamente continuan presentando un riesgo alto de eventos cardiovasculares a pesar de la mejoria de la seguridad y de la eficacia de los nuevos stents liberadores de farmacos. El objetivo de este estudio es analizar la utilidad del software SyncVision /iFR (SyncVision version 4.1.0.5, Philips Volcano, Belgica) para guiar la revascularizacion en este tipo de lesiones. Metodos: Estudio aleatorizado, multicentrico, controlado y abierto para comparar la revascularizacion guiada por SyncVision /iFR respecto a la revascularizacion guiada por angiografia en pacientes con lesiones coronarias largas, secuenciales o difusas (identificador de ClinicalTrials.gov: NCT04283734). Se incluira a 100 pacientes (aleatorizacion 1:1 no estratificada). El objetivo primario es la longitud total del stent implantado. Como objetivo secundario se ha establecido un combinado de muerte cardiaca, infarto de miocardio, trombosis definitiva o probable del stent, nueva revascularizacion de la lesion tratada en el procedimiento basal o nueva revascularizacion de la lesion analizada en el procedimiento basal, y la presencia de isquemia residual evaluada por tomografia computarizada por emision de foton simple a los 6 meses de seguimiento. El tiempo de seguimiento sera de 12 meses tras el procedimiento indice. Resultados: El estudio se encuentra actualmente en fase de reclutamiento, con los primeros 7 pacientes ya incluidos. Esperamos completar el reclutamiento en febrero de 2021 y el seguimiento en febrero de 2022. Conclusiones: El estudio iLARDI es el primer estudio aleatorizado para la evaluacion de la potencial utilidad de la revascularizacion guiada por Syncvision en lesiones coronarias largas, secuenciales y difusas. EnglishIntroduction and objectives: patients with long, sequential and diffuse coronary lesions who undergo a percutaneous coronary intervention remain at a high risk of suffering cardiovascular events despite the improved safety and efficacy of the new drug-eluting stents. The objective of this study was to analyze the utility of SyncVision/iFR-guided revascularization (SyncVision version 4.1.0.5, Philips Volcano, Belgium) in this type of lesions. Methods: Randomized, multicenter, controlled, and open-label trial designed to compare SyncVision/iFR-guided and angiography-guided revascularizations in patients with long, sequential or diffuse significant angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). A total of 100 patients will be randomized (1:1, no stratification). The primary endpoint is the average length of the stent implanted. The secondary endpoint is a composite of cardiac death, myocardial infarction, definitive or probable stent thrombosis, new target lesion revascularization or new target lesion failure; and the presence of residual ischemia as seen on single-photon emission computed tomography at the 6-month follow-up. Patients will be followed for 12 months after the procedure. Results: The trial is currently in the recruitment phase, and it has already recruited the first 7 patients. We expect to complete the recruitment phase by February 2021 and the follow-up by February 2022. Conclusions:The iLARDI study is the first randomized trial to assess the potential utility of SyncVision-guided revascularization in long, sequential and diffuse coronary lesions.

Published
2021

6. Usefulness of physiological coronary assessment with iFR in daily practice and all-comer patients: immediate and follow-up results

Author

Rafael González-Manzanares, María Guisela Flores-Vergara, Francisco José Hidalgo-Lesmes, Ana Fernández-Ruiz, and Manuel Pan Álvarez-Ossorio, Javier Suárez de Lezo, Francisco Mazuelos-Bellido, Cristina Pericet-Rodríguez, Aurora Luque-Moreno, Miguel Ángel Romero-Moreno, Soledad Ojeda-Pineda, and José María Segura Saint-Gerons

Subjects
medicine.medical_specialty, Physiological assessment, business.industry, Daily practice, Physical therapy, Medicine, Follow up results, Cardiology and Cardiovascular Medicine, business, All-comer patients, Syncvision-guided iFR-pullback study
Abstract

Introduction and objectives: The objective of this study was to describe our experience with coronary physiology assessment using the instantaneous wave-free ratio (iFR) and/or a Syncvision-guided iFR-pullback study [Syncvision version 4.1.0.5, Philips Volcano, Belgium] in all-comer patients. Methods: Consecutive patients undergoing coronary physiology assessment with the iFR (and/or a Syncvision-guided iFR-pullback study) at our center between January 2017 and December 2019 were included. The iFR cut-off value was 0.89. The primary endpoint was a composite of cardiac death, myocardial infarction, probable or definitive stent thrombosis, and target lesion revascularization. Results: A total of 277 patients with 433 lesions evaluated were included. The mean age was 65 ± 10 years and 74% were men. Personal history of diabetes mellitus was present in 41% of patients. Clinical presentation was stable angina in 160 patients (58%), and acute coronary syndrome in 117 patients (42%). iFRs > 0.89 were obtained in 266 lesions (61.4%) on which the PCI was postponed. The remaining lesions were revascularized. The Syncvision software was used to guide the iFR-pullback study in 155 lesions (36%) and the decision-making process, mainly in long, diffuse or sequential lesions (91 lesions, 58.7%), and intermediate lesions (52 lesions, 33.5%). After a median follow-up of 18 months, the primary endpoint occurred in 17 patients (6.1%) without differences regarding the baseline iFR (≤ 0.89 or > 0.89) (4.2% vs 3.8%; P = .9) or the clinical presentation (stable angina or acute coronary syndrome) (4.4% vs 8.5%; P = .1) Conclusions: The use of coronary physiology assessment with the iFR and the Syncvision-guided iFR-pullback study in the routine daily practice and in all-comer patients seems safe with a low percentage of major adverse cardiovascular events at the mid-term follow-up.

Published
2021

7. Usefulness of a co-registration strategy with iFR in long and/or diffuse coronary lesions (iLARDI): study protocol

Author

Cristina Pericet, Miguel Romero, Francisco Mazuelos, Soledad Ojeda, Adrián Lostalo, Javier Suárez de Lezo, Nick Paredes, Francisco Hidalgo, José Segura, Juan C. Elizalde, Rafael González, Aurora Luque, and Manuel Pan

Subjects
Protocol (science), Long coronary artery disease, Instantaneous wave-free ratio, medicine.medical_specialty, business.industry, Co registration, Medicine, Radiology, Cardiology and Cardiovascular Medicine, business, SyncVision software, Diffuse coronary artery disease
Abstract

Introduction and objectives: patients with long, sequential and diffuse coronary lesions who undergo a percutaneous coronary intervention remain at a high risk of suffering cardiovascular events despite the improved safety and efficacy of the new drug-eluting stents. The objective of this study was to analyze the utility of SyncVision/iFR-guided revascularization (SyncVision version 4.1.0.5, Philips Volcano, Belgium) in this type of lesions. Methods: Randomized, multicenter, controlled, and open-label trial designed to compare SyncVision/iFR-guided and angiography-guided revascularizations in patients with long, sequential or diffuse significant angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). A total of 100 patients will be randomized (1:1, no stratification). The primary endpoint is the average length of the stent implanted. The secondary endpoint is a composite of cardiac death, myocardial infarction, definitive or probable stent thrombosis, new target lesion revascularization or new target lesion failure; and the presence of residual ischemia as seen on single-photon emission computed tomography at the 6-month follow-up. Patients will be followed for 12 months after the procedure. Results: The trial is currently in the recruitment phase, and it has already recruited the first 7 patients. We expect to complete the recruitment phase by February 2021 and the follow-up by February 2022. Conclusions: The iLARDI study is the first randomized trial to assess the potential utility of SyncVision-guided revascularization in long, sequential and diffuse coronary lesions.

Published
2021

8. Impact of Canagliflozin in Patients with Type 2 Diabetes after Hospitalization for Acute Heart Failure: A Cohort Study

Author

Nick Paredes, Jesús Oneto, Manuel Anguita, José López-Aguilera, Jorge Perea, Guillermo Gutiérrez, Juan C. Castillo, Rafael González-Manzanares, Ernesto San Martín, Aurora Luque, [Martín,E, López-Aguilera,J, González-Manzanares,R, Anguita,M, Gutiérrez,G, Luque,A, Paredes,N, Oneto,J, Perea,J, Castillo,JC] Department of Cardiology, Hospital Universitario Reina Sofía, Córdoba, Spain. [Martín,E, and Castillo,JC] Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain

Subjects
sodium glucose co-transporter 2 inhibitor, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective Studies [Medical Subject Headings], heart failure, lcsh:Medicine, Type 2 diabetes, 030204 cardiovascular system & hematology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Confidence Intervals [Medical Subject Headings], readmissions, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Medicine, 030212 general & internal medicine, canagliflozin, Sodium glucose co-transporter 2 inhibitor, Canagliflozin, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Membrane Proteins::Membrane Transport Proteins::Ion Pumps::Symporters::Sodium-Glucose Transport Proteins::Sodium-Glucose Transporter 2 [Medical Subject Headings], N-terminal pro-B-type natriuretic peptide, Hazard ratio, Insuficiencia cardíaca, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization::Patient Readmission [Medical Subject Headings], General Medicine, Readmissions, Diabetes mellitus tipo 2, Cohort, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Glucose Metabolism Disorders::Diabetes Mellitus::Diabetes Mellitus, Type 2 [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Control Groups [Medical Subject Headings], medicine.drug, Cohort study, medicine.medical_specialty, Canagliflozina, Readmisión del paciente, Heart failure, Lower risk, Article, Péptidos natriuréticos, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies [Medical Subject Headings], Type 2 diabetes mellitus, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings], Contraindication, business.industry, lcsh:R, Diseases::Cardiovascular Diseases::Heart Diseases::Heart Failure [Medical Subject Headings], Inhibidores del cotransportador de sodio-glucosa 2, medicine.disease, Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Natriuretic Peptides::Natriuretic Peptide, Brain [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization::Patient Discharge [Medical Subject Headings], business, Health Care::Health Care Facilities, Manpower, and Services::Health Services::Pharmaceutical Services::Prescriptions [Medical Subject Headings]
Abstract

Background: Heart failure (HF) is one of the mayor contributors to cardiovascular morbidity and mortality in patients with diabetes. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated to reduce the risk of hospitalization for HF in patients with type 2 diabetes mellitus (T2D). We aimed to assess the risk for re-hospitalization in a cohort of patients hospitalized for HF according to whether or not they received canagliflozin at discharge, as well as changes in N-terminal pro–B-type natriuretic peptide (NT-ProBNP) concentration during follow-up. Methods: We conducted a retrospective longitudinal study at a tertiary centre including 102 consecutive T2D patients discharged for acute HF without contraindication for SGLT2 inhibitors. We compared adverse clinical events (HF rehospitalization and cardiovascular death) and NT-ProBNP changes according to canagliflozin prescription at discharge. Results: Among the 102 patients included, 45 patients (44.1%) were prescribed canagliflozin and the remaining 57 (55.9%) were not prescribed any SGLT2 inhibitors (control group). After a median follow-up of 22 months, 45 patients (44.1%) were hospitalized for HF. Most of the rehospitalizations occurred during the first year (37.3%). HF readmission at first year occurred in 10 patients (22.2%) in the canagliflozin group and 29 patients (49.1%) in the control group (hazard ratio (HR): 0.45, 95% confidence interval (CI): 0.21–0.96, p &lt, 0.039). A composite outcome of hospitalization for HF or death from cardiovascular causes was lower in the canagliflozin group (37.8%) than in the control group (70.2%) (HR: 0.51, 95% CI: 0.27–0.95, 0.035). Analysis of NT-ProBNP concentration showed an interaction between canagliflozin therapy and follow-up time (p = 0.002). Conclusions: Canagliflozin therapy at discharge was associated with a lower risk of readmission for HF and a reduction in NT-ProBNP concentration in patients with diabetes after hospitalization for HF.

Published
2021

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