ABSTRACT
BACKGROUND: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). METHODS/DESIGN: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. SUMMARY: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Coronary Angiography , Coronary Artery Disease/therapy , Humans , Percutaneous Coronary Intervention/methods , Prospective Studies , Stents , Ticagrelor/therapeutic use , Treatment OutcomeABSTRACT
Risk stratification of patients with ischemic heart disease (IHD) still depends mainly on the left ventricular ejection fraction (LVEF). LV inward displacement (InD) is a novel parameter of LV systolic function, derived from feature tracking cardiac magnetic resonance (CMR) imaging. We aimed to investigate the prognostic impact of InD in patients with IHD and prior myocardial infarction. A total of 111 patients (mean age 57 ± 10, 86% male) with a history of myocardial infarction who underwent CMR were included. LV InD was quantified by measuring the displacement of endocardially tracked points towards the centreline of the LV during systole with feature tracking CMR. The endpoint was a composite of all-cause mortality, heart failure hospitalization and arrhythmic events. During a median follow-up of 142 (IQR 107-159) months, 31 (27.9%) combined events occurred. Kaplan-Meier analysis demonstrated that patients with LV InD below the study population median value (23.0%) had a significantly lower event-free survival (P < 0.001). LV InD remained independently associated with outcomes (HR 0.90, 95% CI 0.84-0.98, P = 0.010) on multivariate Cox regression analysis. InD also provided incremental prognostic value to LVEF, LV global radial strain and CMR scar burden. LV InD, measured with feature tracking CMR, was independently associated with outcomes in patients with IHD and prior myocardial infarction. LV InD also provided incremental prognostic value, in addition to LVEF and LV global radial strain. LV InD holds promise as a pragmatic imaging biomarker for post-infarct risk stratification.
Subject(s)
Myocardial Infarction , ST Elevation Myocardial Infarction , Humans , Male , Middle Aged , Aged , Female , Prognosis , Stroke Volume , Ventricular Function, Left , Magnetic Resonance Imaging, Cine/methods , Predictive Value of Tests , Magnetic Resonance Imaging/methods , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/therapyABSTRACT
BACKGROUND: Advances in coronary computed tomography angiography (CCTA) reconstruction algorithms are expected to enhance the accuracy of CCTA plaque quantification. We aim to evaluate different CCTA reconstruction approaches in assessing vessel characteristics in coronary atheroma using intravascular ultrasound (IVUS) as the reference standard. METHODS: Matched cross-sections (n â= â7241) from 50 vessels in 15 participants with chronic coronary syndrome who prospectively underwent CCTA and 3-vessel near-infrared spectroscopy-IVUS were included. Twelve CCTA datasets per patient were reconstructed using two different kernels, two slice thicknesses (0.75 âmm and 0.50 âmm) and three different strengths of advanced model-based iterative reconstruction (IR) algorithms. Lumen and vessel wall borders were manually annotated in every IVUS and CCTA cross-section which were co-registered using dedicated software. Image quality was sub-optimal in the reconstructions with a sharper kernel, so these were excluded. Intraclass correlation coefficient (ICC) and repeatability coefficient (RC) were used to compare the estimations of the 6 CT reconstruction approaches with those derived by IVUS. RESULTS: Segment-level analysis showed good agreement between CCTA and IVUS for assessing atheroma volume with approach 0.50/5 (slice thickness 0.50 âmm and highest strength 5 ADMIRE IR) being the best (total atheroma volume ICC: 0.91, RC: 0.67, p â< â0.001 and percentage atheroma volume ICC: 0.64, RC: 14.06, p â< â0.001). At lesion-level, there was no difference between the CCTA reconstructions for detecting plaques (accuracy range: 0.64-0.67; p â= â0.23); however, approach 0.50/5 was superior in assessing IVUS-derived lesion characteristics associated with plaque vulnerability (minimum lumen area ICC: 0.64, RC: 1.31, p â< â0.001 and plaque burden ICC: 0.45, RC: 32.0, p â< â0.001). CONCLUSION: CCTA reconstruction with thinner slice thickness, smooth kernel and highest strength advanced IR enabled more accurate quantification of the lumen and plaque at a segment-, and lesion-level analysis in coronary atheroma when validated against intravascular ultrasound. CLINICALTRIALS: gov (NCT03556644).
Subject(s)
Coronary Artery Disease , Plaque, Atherosclerotic , Humans , Algorithms , Computed Tomography Angiography/methods , Coronary Angiography/methods , Coronary Vessels/diagnostic imaging , Predictive Value of Tests , Tomography, X-Ray Computed/methods , Ultrasonography, Interventional/methodsSubject(s)
Artificial Intelligence , Deep Learning , Humans , X-Rays , Predictive Value of Tests , Angiography , Coronary AngiographyABSTRACT
OBJECTIVES: To determine the most relevant aerodynamic characteristic of the oropharynx related to the collapse of the upper airway in obstructive sleep apnea (OSA) patients; and to determine the correlation between the most relevant aerodynamic characteristic(s) of the oropharynx and anatomical characteristics of the oropharynx in OSA patients. METHODS: 31 mild to moderate OSA patients (mean ± SD age = 43.5 ± 9.7 years) and 13 control subjects (mean ± SD age = 48.5 ± 16.2 years) were included in this prospective study. The diagnosis of OSA patients was based on an overnight polysomnographic recording. To exclude the presence of OSA in the control subjects, they were asked to fill out a validated questionnaire to determine the risk of OSA. NewTom5G cone beam CT (CBCT) scans were obtained from both OSA patients and control subjects. Computational models of the oropharynx were reconstructed based on CBCT images. The aerodynamic characteristics of the oropharynx were calculated based on these computational models. Pearson correlation analysis was used to analyse the correlation between the most relevant aerodynamic characteristic(s) and anatomical characteristics of the oropharynx in OSA patients. RESULTS: Compared with controls, the airway resistance during expiration (Rex) of the OSA patients was significantly higher (p = 0.04). There was a significant negative correlation between Rex and the minimum cross-sectional area (CSAmin) of the oropharynx (r = -0.41, p = 0.02), and between Rex and the volume of the oropharynx (r = -0.48, p = 0.01) in OSA patients. After excluding an outlier, there is only significant correlation between Rex and the CSAmin of the oropharynx (r = -0.45, p = 0.01). CONCLUSIONS: Within the limitations of this study, we concluded that the most relevant aerodynamic characteristic of the oropharynx in the collapse of the upper airway in OSA patients is Rex. Therefore, the repetitive collapse of the upper airway in OSA patients may be explained by a high Rex, which is related to the CSAmin of the oropharynx.
Subject(s)
Cone-Beam Computed Tomography/methods , Oropharynx/diagnostic imaging , Oropharynx/physiopathology , Sleep Apnea, Obstructive/diagnostic imaging , Sleep Apnea, Obstructive/physiopathology , Adult , Case-Control Studies , Female , Humans , Male , Middle Aged , Polysomnography , Prospective Studies , Surveys and QuestionnairesABSTRACT
Introducción y objetivos: Se ha demostrado que el armazón vascular bioabsorbible Absorb produce una disminución del área total de las placas en el segmento tratado. Sin embargo, no se sabe si el tamaño de la placa se modifica tan solo en los segmentos tratados con armazones o si la modificación se extiende también a otros segmentos coronarios. Métodos: El Absorb Cohort A es un estudio prospectivo de un solo grupo, en el que se evalúan variables de valoración de seguridad y de resultados en exploraciones de imagen en 30 pacientes tratados mediante intervención coronaria percutánea con el armazón vascular bioabsorbible Absorb de primera generación. Se utilizaron exploraciones de tomografía computarizada multicorte no invasivas de 18 pacientes a los 18 meses y a los 5 años de seguimiento. El presente estudio es una comparación intraindividual de segmentos de características comparables (normalizados respecto a la longitud del segmento) de la región tratada con armazones frente a segmentos no tratados, en la que se evaluó el volumen de la luz vascular, el volumen del vaso, el volumen de las placas, la carga de placa y el cambio porcentual en el volumen de ateroma de las placas. Resultados: Se pudo analizar los 18 segmentos tratados con armazones. De los segmentos a los que no se aplicó la intervención, 1 de un total de 72 presentó un artefacto de movimiento y fue excluido. La comparación de exploraciones secuenciales puso de manifiesto que los segmentos tratados con armazones no presentaban un cambio significativo de la carga media de placas, el volumen total de ateroma, el volumen total de la luz o el volumen del vaso entre los 18 meses y los 5 años. En cambio, los segmentos no tratados mostraban un aumento significativo de la carga de placa (2,7 ± 6,5%; p < 0,01) y los volúmenes de placas normalizados (8,0 ± 22,8 mm3; p < 0,01). Esto dio lugar a una diferencia significativa en la carga de placa entre los segmentos tratados con armazones y los no tratados (p = 0,03). Conclusiones: En esta pequeña serie, el armazón vascular bioabsorbible Absorb mostró potencial de aportar un beneficio adicional al del tratamiento farmacológico en cuanto a la reducción local de la progresión en el porcentaje de carga de placa. Se deberá confirmar estos resultados en estudios más amplios (AU)
Introduction and objectives: The Absorb bioresorbable vascular scaffold has been shown to decrease total plaque areas in the treated segment. However, it is unknown whether plaque size is modified in scaffolded segments only or whether the modification extends to other coronary segments. Methods: Absorb Cohort A is a single-arm, prospective study, with safety and imaging endpoints, in which 30 patients underwent percutaneous coronary intervention with the first generation Absorb bioresorbable vascular scaffold. Noninvasive multislice computed tomography imaging was performed in 18 patients at 18 months and 5 years of follow-up. The present study was an intrapatient comparison of matched segments (normalized by the segment length) of the scaffolded region with nonintervened segments for lumen volume, vessel volume, plaque volume, plaque burden, and percent change in plaque atheroma volume. Results: All 18 scaffolded segments could be analyzed. In the nonintervened segments, 1 of 72 segments had a motion artifact and was excluded. Serial comparison showed that the scaffolded segments showed no significant change in the mean plaque burden, total atheroma volume, total lumen volume, or vessel volume between 18 months and 5 years. Conversely, the untreated segments showed a significant increase in plaque burden (2.7 ± 6.5%; P < .01) and normalized plaque volumes (8.0 ± 22.8 mm3; P < .01). This resulted in a significant difference in plaque burden between scaffolded and nonintervened segments (P = .03). Conclusions: In this small series, the Absorb bioresorbable vascular scaffold showed the potential to provide an additional benefit to pharmacological therapy in locally reducing progression of percent plaque burden. These findings need to be confirmed in larger studies (AU)