Impact of pre-admission physical activity on benefits of physiology-guided complete revascularization in older patients with myocardial infarction: insights from the FIRE trial.

AIMS: The present analysis from the Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial aims to explore the significance of pre-admission physical activity and assess whether the benefits of physiology-guided complete revascularization apply consistently to sedentary and active older patients. METHODS AND RESULTS: Patients aged 75 years or more with myocardial infarction (MI) and multivessel disease were randomized to receive physiology-guided complete revascularization or culprit-only strategy. The primary outcome was a composite of death, MI, stroke, or any revascularization within a year. Secondary endpoints included the composite of cardiovascular death or MI, as well as single components of the primary endpoint. Pre-admission physical activity was categorized into three groups: (i) absent (sedentary), (ii) light, and (iii) vigorous. Among 1445 patients, 692 (48%) were sedentary, whereas 560 (39%) and 193 (13%) performed light and vigorous physical activity, respectively. Patients engaging in light or vigorous pre-admission physical activity exhibited a reduced risk of the primary outcome compared with sedentary individuals [light hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.55-0.91 and vigorous HR 0.14, 95% CI 0.07-0.91, respectively]. These trends were also observed for death, cardiovascular death, or MI. When comparing physiology-guided complete revascularization vs. culprit-only strategy, no significant interaction was observed for primary and secondary endpoints when stratified by sedentary or active status. CONCLUSION: In older patients with MI, pre-admission physical activity emerges as a robust and independent prognostic determinant. Physiology-guided complete revascularization stands out an effective strategy in reducing ischaemic adverse events, irrespective of pre-admission physical activity status. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03772743.

The Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial has shown that physiology-guided complete revascularization reduces ischaemic adverse events in older patients with myocardial infarction (MI) and multivessel disease. Older patients who engage in light or vigorous physical activity before hospitalization for MI have a reduced risk of the primary composite outcome of death, MI, stroke, or ischaemia-driven revascularization. These benefits extend to all secondary cardiovascular outcomes as well. In the present subanalysis of the FIRE trial, we find that the positive prognosis associated with physiology-guided complete revascularization holds true even for patients with a sedentary lifestyle. This means that this type of revascularization can effectively reduce ischaemic adverse events in older patients with MI and multivessel disease, regardless of their physical activity levels.

Association of cyclophilins and cardiovascular risk factors in coronary artery disease.

Cyclophilins are chaperone proteins that play important roles in signal transduction. Among them, cyclophilins A, B, C, and D were widely associated with inflammation and cardiovascular diseases. Cyclophilins A and C have been proposed as coronary artery disease biomarkers. However, less is known about their relationship with cardiovascular risk factors. Therefore, this study aimed to determine the association between cyclophilin A, B, C, and D and cardiovascular risk factors in coronary artery disease. Serum levels of cyclophilins were measured in 167 subjects (subdivided according to cardiovascular risk factors presence). This study reveals that cyclophilin A and C are elevated in patients regardless of the risk factors presence. Moreover, cyclophilin B is elevated in male patients with hypertension, type 2 diabetes, or high glucose levels. In addition, cyclophilins A, B, and C were significantly correlated with cardiovascular risk factors, but only cyclophilin B was associated with type 2 diabetes. The multivariate analysis strengthens the predictive value for coronary artery disease presence of cyclophilin A (>8.2 ng/mL) and cyclophilin C (>17.5 pg/mL) along with the cardiovascular risk factors tobacco, hypertension, dyslipidemia, and high glucose and cholesterol levels. Moreover, the risk of coronary artery disease is increased in presence of cyclophilin B levels above 63.26 pg/mL and with hypertension or dyslipidemia in male patients. Consequently, cyclophilins A and C serum levels are reinforced as useful coronary artery disease biomarkers, meanwhile, cyclophilin B is a valuable biomarker in the male population when patients are also suffering from hypertension or dyslipidemia.

Ajustando a RFR por Preditores de Discordância, "A RFR Ajustada": Uma Metodologia Alternativa para Melhorar a Capacidade Diagnóstica dos Índices Coronarianos / Adjusting RFR by Predictors of Disagreement, "The Adjusted RFR": An Alternative Methodology to Improve the Diagnostic Capacity of Coronary Indices

Resumo Fundamento Os limiares de corte para a "relação do ciclo completo de repouso" (RFR) oscilam em diferentes séries, sugerindo que as características da população podem influenciá-los. Da mesma forma, foram documentados preditores de discordância entre a RFR e a reserva de fluxo fracionado (FFR). O Estudo RECOPA, mostrou que a capacidade diagnóstica está reduzida na "zona cinzenta" da RFR, tornando necessária a realização de FFR para descartar ou confirmar isquemia. Objetivos Determinar os preditores de discordância, integrar as informações que eles fornecem em um índice clínico-fisiológico: a "RFR Ajustada", e comparar sua concordância com o FFR. Métodos Usando dados do Estudo RECOPA, os preditores de discordância em relação à FFR foram determinados na "zona cinzenta" da RFR (0,86 a 0,92) para construir um índice ("RFR Ajustada") que pesaria a RFR juntamente com os preditores de discordância e avaliar sua concordância com a FFR. Resultados Foram avaliadas 156 lesões em 141 pacientes. Os preditores de discordância foram: doença renal crônica, cardiopatia isquêmica prévia, lesões não envolvendo a artéria descendente anterior esquerda e síndrome coronariana aguda. Embora limitada, a "RFR Ajustada" melhorou a capacidade diagnóstica em comparação com a RFR na "zona cinzenta" (AUC-RFR = 0,651 versus AUC-"RFR Ajustada" = 0,749), mostrando também uma melhora em todos os índices diagnósticos quando foram estabelecidos limiares de corte otimizados (sensibilidade: 59% a 68%; especificidade: 62% a 75%; acurácia diagnóstica: 60% a 71%; razão de verossimilhança positiva: 1,51 a 2,34; razão de verossimilhança negativa: 0,64 a 0,37). Conclusões Ajustar a RFR integrando as informações fornecidas pelos preditores de discordância para obter a "RFR Ajustada" melhorou a capacidade diagnóstica em nossa população. Mais estudos são necessários para avaliar se os índices clínico-fisiológicos melhoram a capacidade diagnóstica da RFR ou de outros índices coronarianos.

Abstract Background Cutoff thresholds for the "resting full-cycle ratio" (RFR) oscillate in different series, suggesting that population characteristics may influence them. Likewise, predictors of discordance between the RFR and fractional flow reserve (FFR) have been documented. The RECOPA Study showed that diagnostic capacity is reduced in the RFR "grey zone", requiring the performance of FFR to rule out or confirm ischemia. Objectives To determine predictors of discordance, integrate the information they provide in a clinical-physiological index, the "Adjusted RFR", and compare its agreement with the FFR. Methods Using data from the RECOPA Study, predictors of discordance with respect to FFR were determined in the RFR "grey zone" (0.86 to 0.92) to construct an index ("Adjusted RFR") that would weigh RFR together with predictors of discordance and evaluate its agreement with FFR. Results A total of 156 lesions were evaluated in 141 patients. Predictors of discordance were: chronic kidney disease, previous ischemic heart disease, lesions not involving the anterior descending artery, and acute coronary syndrome. Though limited, the "Adjusted RFR" improved the diagnostic capacity compared to the RFR in the "grey zone" (AUC-RFR = 0.651 versus AUC-"Adjusted RFR" = 0.749), also showing an improvement in all diagnostic indices when optimal cutoff thresholds were established (sensitivity: 59% to 68%; specificity: 62% to 75%; diagnostic accuracy: 60% to 71%; positive likelihood ratio: 1.51 to 2.34; negative likelihood ratio: 0.64 to 0.37). Conclusions Adjusting the RFR by integrating the information provided by predictors of discordance to obtain the "Adjusted RFR" improved the diagnostic capacity in our population. Further studies are required to evaluate whether clinical-physiological indices improve the diagnostic capacity of RFR or other coronary indices.

Adjusting RFR by Predictors of Disagreement, "The Adjusted RFR": An Alternative Methodology to Improve the Diagnostic Capacity of Coronary Indices. / Ajustando a RFR por Preditores de Discordância, "A RFR Ajustada": Uma Metodologia Alternativa para Melhorar a Capacidade Diagnóstica dos Índices Coronarianos.

BACKGROUND: Cutoff thresholds for the "resting full-cycle ratio" (RFR) oscillate in different series, suggesting that population characteristics may influence them. Likewise, predictors of discordance between the RFR and fractional flow reserve (FFR) have been documented. The RECOPA Study showed that diagnostic capacity is reduced in the RFR "grey zone", requiring the performance of FFR to rule out or confirm ischemia. OBJECTIVES: To determine predictors of discordance, integrate the information they provide in a clinical-physiological index, the "Adjusted RFR", and compare its agreement with the FFR. METHODS: Using data from the RECOPA Study, predictors of discordance with respect to FFR were determined in the RFR "grey zone" (0.86 to 0.92) to construct an index ("Adjusted RFR") that would weigh RFR together with predictors of discordance and evaluate its agreement with FFR. RESULTS: A total of 156 lesions were evaluated in 141 patients. Predictors of discordance were: chronic kidney disease, previous ischemic heart disease, lesions not involving the anterior descending artery, and acute coronary syndrome. Though limited, the "Adjusted RFR" improved the diagnostic capacity compared to the RFR in the "grey zone" (AUC-RFR = 0.651 versus AUC-"Adjusted RFR" = 0.749), also showing an improvement in all diagnostic indices when optimal cutoff thresholds were established (sensitivity: 59% to 68%; specificity: 62% to 75%; diagnostic accuracy: 60% to 71%; positive likelihood ratio: 1.51 to 2.34; negative likelihood ratio: 0.64 to 0.37). CONCLUSIONS: Adjusting the RFR by integrating the information provided by predictors of discordance to obtain the "Adjusted RFR" improved the diagnostic capacity in our population. Further studies are required to evaluate whether clinical-physiological indices improve the diagnostic capacity of RFR or other coronary indices.

FUNDAMENTO: Os limiares de corte para a "relação do ciclo completo de repouso" (RFR) oscilam em diferentes séries, sugerindo que as características da população podem influenciá-los. Da mesma forma, foram documentados preditores de discordância entre a RFR e a reserva de fluxo fracionado (FFR). O Estudo RECOPA, mostrou que a capacidade diagnóstica está reduzida na "zona cinzenta" da RFR, tornando necessária a realização de FFR para descartar ou confirmar isquemia. OBJETIVOS: Determinar os preditores de discordância, integrar as informações que eles fornecem em um índice clínico-fisiológico: a "RFR Ajustada", e comparar sua concordância com o FFR. MÉTODOS: Usando dados do Estudo RECOPA, os preditores de discordância em relação à FFR foram determinados na "zona cinzenta" da RFR (0,86 a 0,92) para construir um índice ("RFR Ajustada") que pesaria a RFR juntamente com os preditores de discordância e avaliar sua concordância com a FFR. RESULTADOS: Foram avaliadas 156 lesões em 141 pacientes. Os preditores de discordância foram: doença renal crônica, cardiopatia isquêmica prévia, lesões não envolvendo a artéria descendente anterior esquerda e síndrome coronariana aguda. Embora limitada, a "RFR Ajustada" melhorou a capacidade diagnóstica em comparação com a RFR na "zona cinzenta" (AUC-RFR = 0,651 versus AUC-"RFR Ajustada" = 0,749), mostrando também uma melhora em todos os índices diagnósticos quando foram estabelecidos limiares de corte otimizados (sensibilidade: 59% a 68%; especificidade: 62% a 75%; acurácia diagnóstica: 60% a 71%; razão de verossimilhança positiva: 1,51 a 2,34; razão de verossimilhança negativa: 0,64 a 0,37). CONCLUSÕES: Ajustar a RFR integrando as informações fornecidas pelos preditores de discordância para obter a "RFR Ajustada" melhorou a capacidade diagnóstica em nossa população. Mais estudos são necessários para avaliar se os índices clínico-fisiológicos melhoram a capacidade diagnóstica da RFR ou de outros índices coronarianos.

Increase of serum cyclophilin C levels in the follow-up of coronary artery disease: A biomarker and possible clinical predictor. / Aumento de niveles séricos de Ciclofilina C en el seguimiento de la enfermedad arterial coronaria: un biomarcador y posible predictor clínico

OBJECTIVE: This study is aimed at investigating the changes in serum CypC levels and their relationship with cardiovascular events at 12 months of follow-up in coronary artery disease (CAD) patients. METHODS: The study included a total of 125 subjects (40 patients with acute CAD, 40 patients with chronic CAD, and 45 control volunteers) and we analyzed plasma CypC levels from baseline to 6 and 12 months for a better understanding of its behavior in atherosclerosis. RESULTS: Serum CypC levels were shown to be gradually increased in CAD patients (30.63 pg/mL ± 3.77 at baseline, 38.70 pg/mL ± 6.41 at 6 months [p = 0.25], and 47.27 pg/mL ± 5.65 at 12 months [p = 0.007]). In addition, serum CypC levels during the follow-up were a significant predictor of CAD (c-statistic 0.76 at 6 months and 0.89 at 12 months; p < 0.001). Despite it, there was no significant association between CypC and cardiovascular events, but serum CypC levels tended to be higher in patients suffering cardiovascular events during the follow-up (29.02 pg/mL ± 6.39 vs. 79.96 pg/mL ± 22.18; p = 0.029). In this regard, plasma levels of high-sensitivity C-reactive protein (hsCRP) > 2.3 mg/L plus NT-proBNP > 300 pg/mL together were significant predictors of cardiovascular events during the follow-up in CAD patients with CypC levels >17.5 pg/mL (p = 0.048). CONCLUSIONS: Taken together, our results suggest that serum CypC levels increase during the follow-up in CAD patients and could be a novel biomarker with a possible prognostic value in combination with hsCRP and NT-proBNP.

OBJETIVO: Este estudio tiene como objetivo investigar los cambios en los niveles séricos de CypC y su relación con eventos cardiovasculares a los 12 meses de seguimiento en pacientes con EAC. MÉTODO: El estudio incluyó un total de 125 sujetos (40 pacientes con EAC aguda, 40 pacientes con EAC crónica y 45 voluntarios de control) y se analizaron los niveles ­plasmáticos de CypC desde el inicio hasta los 6 y 12 meses para comprender mejor su comportamiento en la aterosclerosis. RESULTADOS: Se demostró que los niveles séricos de CypC aumentaron gradualmente en pacientes con CAD [(30.63 pg/ml ± 3.77 al inicio del estudio, 38.70 pg/ml ± 6.41 a los 6 meses (p = 0.25) y 47.27 pg/ml ± 5.65 a los 12 meses (p = 0,007)]. Además, los niveles séricos de CypC durante el seguimiento fueron un predictor significativo de EAC (estadístico c 0.76 a los 6 meses y 0.89 a los 12 meses; p < 0.001). A pesar de ello, no hubo asociación significativa entre CypC y eventos cardiovasculares, pero los niveles séricos de CypC tendieron a ser más altos en los pacientes que sufrieron eventos cardiovasculares durante el seguimiento (29.02 pg/mL ± 6.39 vs. 79.96 pg/mL ± 22.18; p = 0.029). En este sentido, los niveles plasmáticos de hsCRP > 2.3 mg/L más NT-proBNP> 300 pg/ml juntos fueron predictores significativos de eventos cardiovasculares durante el seguimiento en pacientes con EAC con niveles de CypC > 17.5 pg/ml (p = 0.048). CONCLUSIONES: Tomados en conjunto, nuestros resultados sugieren que los niveles séricos de CypC aumentan durante el seguimiento en pacientes con EAC y podría ser un nuevo biomarcador con un posible valor pronóstico en combinación con hsCRP y NT-proBNP.

The role of invasive coronary physiology in Takotsubo Syndrome.

The pathophysiology of Takotsubo Syndrome has not yet been precisely defined. Different hypotheses have been proposed, including cardiotoxicity due to catecholaminergic hormone release, metabolic disorders, coronary microvascular dysfunction and epicardial coronary artery spasm. Invasive coronary physiology is considered the cornerstone to understand physiological assessment of coronary blood flow in this setting. We have reviewed most important studies in coronary invasive physiology in this field to update the state of the art in TakoTsubo Syndrome.

Usefulness of the Hybrid RFR-FFR Approach: Results of a Prospective and Multicenter Analysis of Diagnostic Agreement between RFR and FFR-The RECOPA (REsting Full-Cycle Ratio Comparation versus Fractional Flow Reserve (A Prospective Validation)) Study.

BACKGROUND: The resting full-cycle ratio (RFR) is a novel resting index which in contrast to the gold standard (fractional flow reserve (FFR)) does not require maximum hyperemia induction. The objectives of this study were to evaluate the agreement between RFR and FFR with the currently recommended thresholds and to design a hybrid RFR-FFR ischemia detection strategy, allowing a reduction of coronary vasodilator use. MATERIALS AND METHODS: Patients subjected to invasive physiological study in 9 Spanish centers were prospectively recruited between April 2019 and March 2020. Sensitivity and specificity studies were made to assess diagnostic accuracy between the recommended levels of RFR ≤0.89 and FFR ≤0.80 (primary objective) and to determine the RFR "grey zone" in order to define a hybrid strategy with FFR affording 95% global agreement compared with FFR alone (secondary objective). RESULTS: A total of 380 lesions were evaluated in 311 patients. Significant correlation was observed (R 2 = 0.81; P < 0.001) between the two techniques, with 79% agreement between RFR ≤ 0.89 and FFR ≤ 0.80 (positive predictive value, 68%, and negative predictive value, 80%). The hybrid RFR-FFR strategy, administering only adenosine in the "grey zone" (RFR: 0.86 to 0.92), exhibited an agreement of over 95% with FFR, with high predictive values (positive predictive value, 91%, and negative predictive value, 92%), reducing the need for vasodilators by 58%. CONCLUSIONS: Dichotomous agreement between RFR and FFR with the recommended thresholds is significant but limited. The adoption of a hybrid RFR-FFR strategy affords very high agreement, with minimization of vasodilator use.

Comparison of One-Year Outcomes Between the ihtDEStiny BD Stent and the Durable-Polymer Everolimus- and Zotarolimus-Eluting Stents: A Propensity-Score-Matched Analysis.

OBJECTIVES: We sought to evaluate clinical outcomes in patients treated with the drug-eluting stent ihtDEStiny BD. BACKGROUND: The ihtDEStiny BD stent is a metallic sirolimus eluting stent with a biodegradable polymer with both drug and polymer coating the abluminal surface of the stent and balloon. METHODS: In this study, the clinical outcomes of a multicenter prospective registry of patients treated with this stent (DEStiny group) were analyzed and compared with those of a control group of patients treated with durable polymer everolimus or zotarolimus eluting stents (CONTROL group) paired by propensity score matching. Primary outcome was the target vessel failure (TVF) at 12 months defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel revascularization (TVR). RESULTS: A total of 350 patients were included in the DESTtiny group. The control group consisted initially of 1368 patients, but after matching (1:1) 350 patients were selected as CONTROL group. The baseline clinical, angiographic and procedural characteristics were quite comparable in both groups. At 12 months follow up the TVF was 6.6% in DEStiny group and 6.3% in CONTROL group (p = 0.8). No differences were observed for any of the individual components of the primary endpoint: cardiac death 1.1% vs. 1.4%, TV-MI 3.4% vs. 3.7% and TVR 2.6% vs. 2.3% respectively. CONCLUSIONS: The use of ihtDEStiny stent in real practice is associated with a clinical performance at 12 months follow up that appears to be non-inferior to the most widely used and largely evidence supported durable polymer drug eluting stents. A longer follow up is warranted.

12-month clinical outcomes after Magmaris percutaneous coronary intervention in a real-world cohort of patients: Results from the CardioHULA registry.

INTRODUCTION AND OBJECTIVES: Clinical evidence on the bioresorbable magnesium scaffolds (BRS) is still scarce. We aim to assess clinical outcomes after magnesium BRS deployment in a real-world cohort of patients. METHODS: We included in a non-randomized, prospective, single-center registry of all patients treated with at least one Magmaris device in our cath lab. Pre and postdilatation with optical coherence tomography guidance, as part of the 4Ps strategy, were performed in all cases. The primary endpoint was target lesion failure (TLF) at 12 months. RESULTS: 42 patients (with 42 lesions) underwent Magmaris percutaneous coronary intervention (PCI) between June 2016 to April 2017. PCI was performed in an acute setting in 54.76% cases; the most treated vessel was the anterior descending artery, with a mean diameter of 3.30±0.25 mm. All lesions underwent predilatation and postdilatation, with a mean postdilatation pressure of 19.2 atm. Procedural success rate was 100%. TLF rate was 4.7% at 12 months. None of our patients died or suffered myocardial infarction. Two patients (4.7%) underwent clinically-driven target lesion revascularization due to in-stent restenosis. No stent thrombosis was detected. CONCLUSION: 12-months clinical outcomes after Magmaris PCI demonstrate its safety and feasibility when deployed in a 4Ps strategy.

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance / Andamiajes bioresorbibles de magnesio versus poliméricos: comparación in vivo de su comportamiento mecánico por OCT

Abstract Background: Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris® scaffold in comparison to Absorb®. Materials and Methods: Two groups of 10 coronary lesions treated with Magmaris® and Absorb® 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations. Results: No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb® and 3.52 ± 0.19mm in Magmaris® groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris® group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris® devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris® scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up. Conclusion: Mechanical properties of Magmaris® scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

Resumen Introducción: Se ha sugerido la presencia de un distinto comportamiento mecánico entre los dos grupos principales de dispositivos bioresorbibles: metálicos y poliméricos. En este estudio evaluamos el comportamiento mecánico agudo del andamiaje bioresorbible metálico Magmaris® frente al del polimérico Absorb®. Métodos: Se compararon dos grupos de 10 lesiones coronarias tratadas con Magmaris® y Absorb® 1.1 (20584 vs. 21016 struts). En todos los casos se realizó estudio postimplante del dispositivo mediante tomografia de coherencia óptica (OCT). Se compararon las características basales clínicas y angiográficas, así como aspectos del procedimiento (incluídos los estudios de OCT) entre ambos grupos. Resultados: No se encontraron diferencias clínicas o angiográficas estadísticamente significativas entre ambos grupos. La indicación más frecuente de revascularización coronaria fué la presencia de angina de esfuerzo (60% vs. 70% p = 0.45), sin incluirse casos de IAMCEST. La arteria descendente anterior fué el principal vaso diana, con un diámetro medio de 3.46 ± 0.23 mm en el grupo de Absorb® y de 3.52 ± 0.19mm en el grupo de Magmaris® (p = 0.56). En todos los casos se realizó pre y postdilatación, con una tasa de éxito del procedimiento del 100%. Los estudios mediante OCT demostraron un mayor diámetro de stent y del vaso en el grupo de Magmaris®: 3.11 ± 0.38mm versus 3.07 ± 0.36 mm, p = 0.03 y 4.12 ± 0.51mm versus 4.04 ± 0.46mm, p = 0.04. A pesar de someter a los dispositivos Magmaris® a presiones de postdilatación ligeramente superiores (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), se identificó un menor porcentaje estadísticamente significativo de struts rotos o malapuestos en dicho grupo (0.15% vs. 0.27 %, p = 0.03 y 1.06 % vs. 1.46% p = 0.01). En un seguimiento a 30 días no se registraron eventos mayores: muerte cardíaca, IM relacionado con vaso diana o TLR. Conclusión: Las propiedades mecánicas del scaffold metálico bioresorbible Magmaris® permiten alcanzar mayores diámetros de stent y vaso de forma segura tras su implante, con una baja tasa de malaposición y disrupción.

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance.

Background: Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris® scaffold in comparison to Absorb®. Materials and Methods: Two groups of 10 coronary lesions treated with Magmaris® and Absorb® 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations. Results: No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb® and 3.52 ± 0.19mm in Magmaris® groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris® group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris® devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris® scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up. Conclusion: Mechanical properties of Magmaris® scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

Introducción: Se ha sugerido la presencia de un distinto comportamiento mecánico entre los dos grupos principales de dispositivos bioresorbibles: metálicos y poliméricos. En este estudio evaluamos el comportamiento mecánico agudo del andamiaje bioresorbible metálico Magmaris® frente al del polimérico Absorb®. Métodos: Se compararon dos grupos de 10 lesiones coronarias tratadas con Magmaris® y Absorb® 1.1 (20584 vs. 21016 struts). En todos los casos se realizó estudio postimplante del dispositivo mediante tomografia de coherencia óptica (OCT). Se compararon las características basales clínicas y angiográficas, así como aspectos del procedimiento (incluídos los estudios de OCT) entre ambos grupos. Resultados: No se encontraron diferencias clínicas o angiográficas estadísticamente significativas entre ambos grupos. La indicación más frecuente de revascularización coronaria fué la presencia de angina de esfuerzo (60% vs. 70% p = 0.45), sin incluirse casos de IAMCEST. La arteria descendente anterior fué el principal vaso diana, con un diámetro medio de 3.46 ± 0.23 mm en el grupo de Absorb® y de 3.52 ± 0.19mm en el grupo de Magmaris® (p = 0.56). En todos los casos se realizó pre y postdilatación, con una tasa de éxito del procedimiento del 100%. Los estudios mediante OCT demostraron un mayor diámetro de stent y del vaso en el grupo de Magmaris®: 3.11 ± 0.38mm versus 3.07 ± 0.36 mm, p = 0.03 y 4.12 ± 0.51mm versus 4.04 ± 0.46mm, p = 0.04. A pesar de someter a los dispositivos Magmaris® a presiones de postdilatación ligeramente superiores (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), se identificó un menor porcentaje estadísticamente significativo de struts rotos o malapuestos en dicho grupo (0.15% vs. 0.27 %, p = 0.03 y 1.06 % vs. 1.46% p = 0.01). En un seguimiento a 30 días no se registraron eventos mayores: muerte cardíaca, IM relacionado con vaso diana o TLR. Conclusión: Las propiedades mecánicas del scaffold metálico bioresorbible Magmaris® permiten alcanzar mayores diámetros de stent y vaso de forma segura tras su implante, con una baja tasa de malaposición y disrupción.

Magmaris very late in-scaffold restenosis: Has the "black boxes" nightmare come back?

Magnesium Bioresorbable Scaffold (Magmaris, Biotronik) is a device with promising outcomes at 24 months of follow up. Previous studies with first generation, everolimus-eluting Bioresorbable Vascular Scaffold (Absorb, Abbott) showed that very late restenosis seems to be attributed to pure intrascaffold tissue growth but very late. Magmaris very late restenosis has not been previously published, probably because of the 95% of resorption at 12 months. We present in-scaffold very late restenosis within Magmaris, with Optical Coherence Tomography, highlighting mechanism of degradation and in scaffold "neo-tissue" growth.

Carotid plaque is a predictor of major adverse cardiac and cerebrovascular events in patients undergoing coronary angiography.

Background: Carotid disease, measured as carotid intima-media thickness (CIMT) and carotid plaque (CP), is associated with major adverse cardiac and cerebrovascular events (MACCE) in people without the previous atherosclerotic disease; however, there are few published data in patients undergoing coronary angiography. The aim of the study is to determinate if the carotid disease is associated with MACCE after coronary angiography. Methods: A total of 390 consecutive patients underwent coronary angiography after exercise echocardiography and carotid ultrasonography between 2002 and 2013. MACCE was defined as stroke, myocardial infarction due to atherosclerosis progression or death due to a stroke or cardiac event. Results: Two patients were lost (0.5%). During a mean follow-up of 6.0 years (standard deviation of 2.9), 52 patients (13.4%) suffered MACCE. 1, 5, and 10 years, event-free survival was 96.4% (1.0), 88.7% (1.7), and 81.4% (2.8), respectively. Event rates at 10 years were higher in the CP group (23.2% vs. 10.2%, p = 0.013) and in the CIMT > 0.9 mm group (25.9% vs. 13.3%, p = 0.023). Multivariate analysis showed smoking habit (hazard ratio [HR] 2.51, 95% confidence interval [CI] 1.36-4.62, p = 0.003), glomerular filtration rate (HR 0.98, 95% CI 0.98-0.99), aortic stenosis (HR 2.99, 95% CI 1.24-7.21, p = 0.014), incomplete/no coronary revascularization (HR 1.97, 95% CI 1.06-3.67, p = 0.033), insulin treatment (HR 2.63, 95% CI 1.30-5.31, p = 0.006), and CP (HR 2.36, 95% CI 1.02-5.44, p = 0.044) as predictors of MACCE. Conclusions: CP is an independent predictor of MACCE in patients undergoing coronary angiography.

Introducción: La enfermedad carotídea, definida como grosor de íntima media (GIMC) y placa (PC), se asocia con eventos adversos cardiacos y cerebrovasculares (EACC) en sujetos sin aterosclerosis previa; sin embargo hay pocos datos en pacientes sometidos a coronariografía. El objetivo del estudio es determinar si la enfermedad carotídea se asocia a EACC en pacientes remitidos a coronariografía. Métodos: Entre 2002 y 2013 390 pacientes fueron sometidos a coronariografía tras ecocardiograma de esfuerzo y ecografía carotídea. Se definió EACC como accidente cerebrovascular, infarto de miocardio por progresión aterosclerótica o muerte por accidente cerebrovascular o causa cardiaca. Resultados: Durante un seguimiento medio de 6 años (desviación estándar 2, 9) se registraron 2 pérdidas y 52 eventos (13,4%). La supervivencia media libre de eventos a uno, cinco y diez años fue 96.4% (1.0), 88.7% (1.7) y 81.4% (2.8). Hubo mayor número de eventos a 10 años en el grupo de PC (23.2% frente 10.2%, p = 0.013) y GIMC > 0.9 mm (25,9% frente 13.3%, p = 0.023). En el análisis multivariado los predictores de EACC fueron tabaquismo (hazard ratio [HR] 2.51, intervalo de confianza [IC] al 95% 1.36-4.62, p = 0.003), filtrado glomerular renal (HR 0.98 IC95% 0.98-0.99), estenosis aórtica (HR 2.99, IC 95% 1.24-7.21, p = 0.014), revascularización incompleta/no revascularización (HR 1.97, IC 95% 1.06-3.67, p = 0.033), tratamiento con insulina (HR 2.63, IC 95% 1.30-5.31, p = 0.006) y PC (HR 2.36, 95%CI 1.02-5.44, p = 0.044). Conclusiones: La PC es un predictor independiente de EACC en pacientes sometidos a coronariografía.