Patient and graft survival in pancreas transplant recipients: The EFISPAN study / Supervivencia del paciente y del injerto en receptores de trasplante de páncreas: estudio EFISPAN

Introduction and objectives: Graft outcomes in pancreas transplantation have improved in recent decades, but data are mainly derived from registries or prospective single-centre studies. This large epidemiological study was undertaken to investigate the impact of clinical and demographic factors on graft and patient survival in pancreas transplant recipients in Spain, and to provide robust, country-wide, practice-based data to complement registry findings. Patients and methods: We conducted a retrospective, longitudinal, epidemiological study to assess risk factors impacting patient and graft survival in pancreas transplant recipients in eight centres in Spain. All patients transplanted between 1 January 2008 and 31 December 2012 were included; data were collected until 31 December 2015. The Kaplan–Meier method was used for all time-to-event analyses, including patient survival, graft survival, acute rejection, and BPAR. For graft survival analysis, in cases of death with functioning graft, patients were censored without any event on the date of death. For acute rejection and BPAR, patients were censored without any event on the date of death or graft loss. Univariable and multivariable analyses (Cox proportional hazards model) were conducted to assess the association between baseline clinical and demographic characteristics and patient/graft survival. (AU)

Introducción y objetivos: Los resultados del injerto en el trasplante de páncreas han mejorado en las últimas décadas, pero los datos provienen principalmente de registros o estudios prospectivos unicéntricos. Este estudio epidemiológico se llevó a cabo para investigar el impacto de los factores clínicos y demográficos en la supervivencia del injerto y del paciente en receptores de trasplante de páncreas en España, y proporcionar datos sólidos, basados en la práctica a nivel nacional, para complementar los hallazgos de los registros. Pacientes y métodos: Realizamos un estudio epidemiológico longitudinal, retrospectivo, para evaluar los factores de riesgo que influyen en la supervivencia del paciente y del injerto en receptores de trasplante de páncreas en 8 centros de España. Se incluyeron todos los pacientes trasplantados entre el 1 de enero de 2008 y el 31 de diciembre de 2012; los datos se recogieron hasta el 31 de diciembre de 2015. Se utilizó el método de Kaplan-Meier para todos los análisis del tiempo transcurrido hasta el evento, incluida la supervivencia del paciente, la supervivencia del injerto, el rechazo agudo y el BPAR. Para el análisis de la supervivencia del injerto, en los casos de muerte con injerto funcionante, los pacientes fueron censurados sin ningún evento en la fecha de la muerte. Para el rechazo agudo y BPAR, los pacientes fueron censurados sin ningún evento en la fecha de la muerte o pérdida del injerto. Se realizaron análisis univariables y multivariables (modelo de riesgos proporcionales de Cox) para evaluar la asociación entre las características clínicas y demográficas basales y la supervivencia del paciente/injerto. (AU)

Patient and graft survival in pancreas transplant recipients: The EFISPAN study.

INTRODUCTION AND OBJECTIVES: Graft outcomes in pancreas transplantation have improved in recent decades, but data are mainly derived from registries or prospective single-centre studies. This large epidemiological study was undertaken to investigate the impact of clinical and demographic factors on graft and patient survival in pancreas transplant recipients in Spain, and to provide robust, country-wide, practice-based data to complement registry findings. PATIENTS AND METHODS: We conducted a retrospective, longitudinal, epidemiological study to assess risk factors impacting patient and graft survival in pancreas transplant recipients in eight centres in Spain. All patients transplanted between 1 January 2008 and 31 December 2012 were included; data were collected until 31 December 2015. The Kaplan-Meier method was used for all time-to-event analyses, including patient survival, graft survival, acute rejection, and BPAR. For graft survival analysis, in cases of death with functioning graft, patients were censored without any event on the date of death. For acute rejection and BPAR, patients were censored without any event on the date of death or graft loss. Univariable and multivariable analyses (Cox proportional hazards model) were conducted to assess the association between baseline clinical and demographic characteristics and patient/graft survival. RESULTS: Data were included for 241 (80.1%) simultaneous pancreas-kidney transplants, 56 (18.6%) pancreas-after-kidney transplants and 4 (1.3%) pancreas transplants alone. Mean±standard deviation time from diagnosis until transplantation was 26.1±7.5 years. Nineteen patients died, mainly due to infections (n=10); the remaining 282 patients (93.7%) survived from transplantation until the end of the study. Among 55 patients (18.3%) with pancreas graft loss, the main reasons were vascular thrombosis (n=19), chronic rejection (n=10), acute rejection (n=6) and death with a functioning graft (n=5). The overall rate of vascular-related death was 1.3% at 5 years post transplant. Univariable analysis showed that patient age and weight, donor age, previous kidney transplantation, previous cardiovascular events and need for insulin more than 48h post transplantation were significantly associated with pancreas graft survival. Of these, in multivariable analyses pancreas graft survival was inferior in patients who had received a previous kidney transplant prior to pancreas transplantation (log-rank test, p=0.0002). Glucose metabolism, renal function and cardiovascular risk factors were generally stable following transplantation. CONCLUSIONS: The results of this multicentre study highlight the excellent patient and graft outcomes following pancreas transplantation, with a notably low incidence of cardiovascular events.