Comparative effectiveness of initial computed tomography and invasive coronary angiography in women and men with stable chest pain and suspected coronary artery disease: multicentre randomised trial

To assess the comparative effectiveness of computed tomography and invasive coronary angiography in women and men with stable chest pain suspected to be caused by coronary artery disease

Treatment of post-biopsy arteriovenous fistula of a renal graft by selective embolization

The development of an arteriovenous fistula (AVF) after renal graft biopsy is a rare complication, it is associated in most cases with spontaneous resolution. However, interventional therapies are required in some cases, to prevent graft loss. Selective embolization has been described as an alternative treatment. In the present study, we describes our experience on AVF after biopsy in kidney transplant patients, which was managed with selective embolization. From 2005 to 2015, a total of 452 kidney transplant biopsies were performed, 12 had an AVF requiring embolization. In 92% of cases, this was successful. Beforehand, mean serum creatinine levels were 2.45 mg/dL, after the procedure, that increased to 3.05, however, 3 months later, mean creatinine levels dropped to 1.85 mg/dL. Graft survival after 2 follow-up years was 72%. Our experience demonstrates that selective embolization of the AVF after kidney transplant biopsy is a safe procedure, and that transplant function can be maintained in patients with this complication

Plasmaféresis en rechazo agudo del injerto renal mediado por anticuerpos: Estudio realizado en el Hospital Pablo Tobón Uribe, Medellín, Colombia. Año 2005-2015

Introducción: el rechazo agudo mediado por anticuerpos es una complicación que se presenta luego del trasplante renal y es una causa importante de pérdida del injerto. La plasmaféresis es una de las terapias utilizadas para su tratamiento, algunos estudios sugieren mejor supervivencia del injerto renal con el uso de plasmaféresis; sin embargo su evidencia es débil. Objetivo: este estudio tiene como objetivo describir la experiencia del uso de plasmaféresis en el rechazo agudo mediado por anticuerpos. Materiales y Métodos: estudio descriptivo retrospectivo realizado en el Hospital Pablo Tobón Uribe entre agosto de 2005 y junio de 2015 en pacientes con diagnóstico de rechazo agudo mediado por anticuerpos, quienes recibieron entre tres y nueve sesiones de plasmaféresis. Resultados: se realizaron un total de 769 trasplantes renales; de los cuales 26 pacientes presentaron rechazo agudo mediado por anticuerpos y recibieron plasmaféresis como parte del tratamiento. Todos los pacientes recibieron terapia de inducción al momento del trasplante y en el 80,8% la terapia de mantenimiento utilizada fue tacrolimus-micofenolato-prednisolona. El rechazo mediado por anticuerpos se presentó en forma temprana en el 61,5% de los pacientes. A seis y doce meses el 44% y 53,8% de los pacientes respectivamente presentaron pérdida del injerto renal; las complicaciones se presentaron en el 53,8%  de los pacientes, las cuales fueron hipocalcemia, hipotensión y anailaxia. Conclusión: en esta cohorte el uso de plasmaféresis en el rechazo agudo mediado por anticuerpos no logró evitar la pérdida del injerto renal en el 50% de los pacientes; se sugiere adicionar a esta terapia otras alternativas de tratamiento entre ellas, la inmunoglobulinas intravenosas, rituximab, eculizumab y bortezomib

Medición del NGAL urinario en el donante para detectar función retardada del injerto renal en el receptor

Introducción: en el trasplante renal de donante fallecido es importante tener marcadores tempranos que ayuden a predecir la funcionalidad adecuada del injerto renal. La medición de creatinina continúa siendo el marcador de elección para definir si los riñones de un posible donante son aptos para ser trasplantados. La lipocalina asociada a la gelatinasa delneutrófilo urinaria (NGALu) es un biomarcador que ha sido utilizado para el diagnóstico temprano de lesión renal aguda, pero su comportamiento es incierto en el donante fallecido. Este estudio tiene como objetivo determinar si los niveles de NGALu del donante pueden predecir la función retardada del injerto (FRI) en los receptores. Metodología: cohorte prospectiva en la que se evaluaron los niveles de NGALu del donante al momentode la extracción renal; se aplicó estadística descriptiva y pruebasno paramétricas. Se exploró el comportamiento de este  biomarcador en el donante del injerto renal para determinar si es un factor predictivo de función retardada del injerto. Resultados: se evaluaron 27 donantes de criterios óptimos; el 74,1 % eran hombres, la edad tuvo una mediana de 27 años (rango: 18,8-43,3); la principal causa de muerte fue trauma encefalocraneano, seguido por el accidente cerebrovascular. La creatinina tuvo una mediana de 0,8 mg/dl y los valores de NGALu tuvieron una mediana de 11,1ng/ml (4,2-33,6). En total se realizaron 46 trasplantes, de los cuales el 15,2 % presentaron función retardada del injerto y dos pacientes necesitaron terapia de reemplazo renal en la primera semana luego del trasplante.Los valores de NGALu agrupados de acuerdo a presencia o no de función retardada del injerto fueron de 11,1 ng/ml (3-17,3) en los pacientes sin función retardada del injerto y 11,2 ng/ml en los pacientes con dicha función (7,7-39,4) (p=0,40). En el análisis multivariado no se encontró ningún factor asociado al desarrollo de función retardada del injerto. Conclusión: en este estudio la medición de uNGAL en donantes fallecidos de criteriosóptimos no predijo función retardada del injerto

Development and internal validation of the Comprehensive ALPPS Preoperative Risk Assessment (CAPRA) score: is the patient suitable for Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)?

Background Preoperative patient selection in Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) is not always reliable with currently available scores, particularly in patients with primary liver tumor. This study aims to (I) to determine whether comorbidities and patients characteristics are a risk factor in ALPPS and (II) to create a score predicting 90-day mortality preoperatively. Methods Thirteen high-volume centers participated in this retrospective multicentric study. A risk analysis based on patient characteristics, underlying disease and procedure type was performed to identify risk factors and model the Comprehensive ALPPS Preoperative Risk Assessment (CAPRA) score. A nonparametric receiver operating characteristic analysis was performed to estimate the predictive ability of our score against the Charlson Comorbidity Index (CCI), the age-adjusted CCI (aCCI), the ALPPS risk score before Stage 1 (ALPPS-RS1) and Stage 2 (ALPPS-RS2). The model was internally validated applying bootstrapping. Results A total of 451 patients were included. Mortality was 14.4%. The CAPRA score is calculated based on the following formula: (0.1 × age) - (2 × BSA) + 1 (in the presence of primary liver tumor) + 1 (in the presence of severe cardiovascular disease) + 2 (in the presence of moderate or severe diabetes) + 2 (in the presence of renal disease) + 2 (if classic ALPPS is planned). The predictive ability was 0.837 for the CAPRA score, 0.443 for CCI, 0.519 for aCCI, 0.693 for ALPPS-RS1 and 0.807 for ALPPS-RS2. After 1,000 cycles of bootstrapping the C statistic was 0.793. The accuracy plot revealed a cut-off for optimal prediction of postoperative mortality of 4.70. Conclusions Comorbidities play an important role in ALPPS and should be carefully considered when planning the procedure. By assessing the patient's preoperative condition in relation to ALPPS, the CAPRA score has a very good ability to predict postoperative mortality

Additional file 1 of Planning preclinical confirmatory multicenter trials to strengthen translation from basic to clinical research – a multi-stakeholder workshop report

Additional file 1: Figure S 1. Composition of workshop participants as per field of expertise. The organizing team mainly consists of meta-researchers with a clinical or preclinical background. Other refers to e.g., stakeholders from funding agencies that also attended the workshop. Methods S1. Multi-stakeholder workshop method-Workshop design. Glossary. Glossary of terms

Computed Tomography Versus Invasive Coronary Angiography in Patients With Diabetes and Suspected Coronary Artery Disease

Objective: To compare cardiac computed tomography (CT) with invasive coronary angiography (ICA) as the initial strategy in patients with diabetes and stable chest pain. Research design and methods: This prespecified analysis of the multicenter DISCHARGE trial in 16 European countries was performed in patients with stable chest pain and intermediate pretest probability of coronary artery disease. The primary end point was a major adverse cardiac event (MACE) (cardiovascular death, nonfatal myocardial infarction, or stroke), and the secondary end point was expanded MACE (including transient ischemic attacks and major procedure-related complications). Results: Follow-up at a median of 3.5 years was available in 3,541 patients of whom 557 (CT group n = 263 vs. ICA group n = 294) had diabetes and 2,984 (CT group n = 1,536 vs. ICA group n = 1,448) did not. No statistically significant diabetes interaction was found for MACE (P = 0.45), expanded MACE (P = 0.35), or major procedure-related complications (P = 0.49). In both patients with and without diabetes, the rate of MACE did not differ between CT and ICA groups. In patients with diabetes, the expanded MACE end point occurred less frequently in the CT group than in the ICA group (3.8% [10 of 263] vs. 8.2% [24 of 294], hazard ratio [HR] 0.45 [95% CI 0.22-0.95]), as did the major procedure-related complication rate (0.4% [1 of 263] vs. 2.7% [8 of 294], HR 0.30 [95% CI 0.13 - 0.63]). Conclusions: In patients with diabetes referred for ICA for the investigation of stable chest pain, a CT-first strategy compared with an ICA-first strategy showed no difference in MACE and may potentially be associated with a lower rate of expanded MACE and major procedure-related complications

CT or invasive coronary angiography in stable chest pain

Background: In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain. Methods: We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris. Results: Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P=0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48). Conclusions: Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229

Age and computed tomography and invasive coronary angiography in stable chest pain: a prespecified secondary analysis of the discharge randomized clinical trial

Importance: The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown. Objective: To determine the association of age with outcomes of CT and ICA in patients with stable chest pain. Design, Setting, and Participants: The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023. Interventions: Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy. Main Outcomes and Measures: MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years. Results: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients. Conclusions and Relevance: Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effect on major procedure-related complications. Results suggest that CT was associated with a lower risk of major procedure-related complications in younger patients

Effect of body mass index on effectiveness of CT versus invasive coronary angiography in stable chest pain: The DISCHARGE trial

Background Recent trials support the role of cardiac CT in the evaluation of symptomatic patients suspected of having coronary artery disease (CAD); however, body mass index (BMI) has been reported to negatively impact CT image quality. Purpose To compare initial use of CT versus invasive coronary angiography (ICA) on clinical outcomes in patients with stable chest pain stratified by BMI category. Materials and Methods This prospective study represents a prespecified BMI subgroup analysis of the multicenter Diagnostic Imaging Strategies for Patients with Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) trial conducted between October 2015 and April 2019. Adult patients with stable chest pain and a CAD pretest probability of 10%–60% were randomly assigned to undergo initial CT or ICA. The primary end point was major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, or stroke. The secondary end point was an expanded MACE composite, including transient ischemic attack, and major procedure-related complications. Competing risk analyses were performed using the Fine and Gray subdistribution Cox proportional hazard model to assess the impact of the relationship between BMI and initial management with CT or ICA on the study outcomes, whereas noncardiovascular death and unknown causes of death were considered competing risk events. Results Among the 3457 participants included, 831 (24.0%), 1358 (39.3%), and 1268 (36.7%) had a BMI of less than 25, between 25 and 30, and greater than 30 kg/m2, respectively. No interaction was found between CT or ICA and BMI for MACE (P = .29), the expanded MACE composite (P = .38), or major procedure-related complications (P = .49). Across all BMI subgroups, expanded MACE composite events (CT, 10 of 409 [2.4%] to 23 of 697 [3.3%]; ICA, 26 of 661 [3.9%] to 21 of 422 [5.1%]) and major procedure-related complications during initial management (CT, one of 638 [0.2%] to five of 697 [0.7%]; ICA, nine of 630 [1.4%] to 12 of 422 [2.9%]) were less frequent in the CT versus ICA group. Participants with a BMI exceeding 30 kg/m² exhibited a higher nondiagnostic CT rate (7.1%, P = .044) compared to participants with lower BMI. Conclusion There was no evidence of a difference in outcomes between CT and ICA across the three BMI subgroups