RÉSUMÉ
BACKGROUND AND HYPOTHESIS: Clinical trials of direct oral anticoagulants (DOAC) are scarce and inconclusive in patients who are receiving dialysis, for whom DOAC are not labelled in Europe. In a French nationwide registry study of patients on chronic dialysis, we compared the effectiveness and safety of off-label DOAC use vs. approved vitamin K antagonist (VKA). METHODS: Data on patients on dialysis were extracted from the French Renal Epidemiology and Information Network (REIN) registry and merged with data from the French national healthcare system database (Système National des Données de Santé, SNDS). Patients on dialysis who had initiated treatment with an oral anticoagulant between January 1st, 2012, and December 31st, 2020, were eligible for inclusion. The primary safety outcome was the occurrence of major bleeding events and the primary effectiveness outcome was the occurrence of thrombotic events. Using propensity-score-weighted cause-specific Cox regression, we compared the safety and effectiveness outcomes for DOAC and VKA. RESULTS: 8,954 patients received an oral anticoagulant (483 DOAC and 8,471 VKA) for the first time after the initiation of dialysis. Over a median [interquartile range] follow-up period of 1.7 [0.8-3.2] years, 2,567 patients presented a first thromboembolic event and 1,254 patients had a bleeding event. After propensity score adjustment, the risk of a thromboembolic event was significantly lower in patients treated with a DOAC than in patients treated with a VKA (weighted hazard ratio (wHR) [95% confidence interval (CI)]: 0.66 [0.46; 0.94]. A non-significant trend toward a lower risk of major bleeding events was found in DOAC-treated patients, relative to VKA-treated patients (wHR [95%CI]: 0.68 [0.41; 1.12]). The results were consistent across subgroups and in sensitivity analyses. CONCLUSIONS: In a large group of dialysis patients initiating an oral anticoagulant, the off-label use of DOACs was associated with a significantly lower risk of thromboembolic events and a non-significantly lower risk of bleeding, relative to VKA use. This provides reassurance regarding the off-label use of DOACs in people on dialysis.
RÉSUMÉ
Ectopia renal é uma das mais comuns anormalidades de desenvolvimento renal. Contudo, somente poucos casos de ectopia renal cruzada com fusão têm sido relatados na literatura. Ectopia renal cruzada, geralmente, é uma entidade clinicamente silenciosa, mas algumas vezes complica com infecção urinária de repetição e nefrolitíase e pode ser associada com uma alta incidência de obstrução da junção ureteropélvica, refluxo vesicoureteral e displasia renal multicística. Os autores relatam dois novos casos de ectopia renal cruzada com fusão diagnosticados em um contexto de infecção urinária e nefrolitíase e fazem uma revisão dos mecanismos e características clínicas desta anormalidade. O nefrologista deve estar familiarizado com esta alteração do desenvolvimento renal, uma vez que muitas complicações podem ocorrer durante o seguimento destes pacientes.
Renal ectopia is one of the most common renal abnormalities of kidney development. However, only a few cases of crossed fused renal ectopia have been reported in the literature. Although crossed renal ectopia is usually clinically silent, they is sometime responsible for infection and urinary stones and may be associated with a high incidence of ureteropelvic junction obstruction, vesicoureteral reflux and renal multicystic dysplasia. We report two new cases of crossed renal ectopia with fusion diagnosed in a context of kidney stones and urinary tract infection and review the mechanism and clinical features of this abnormality. We believe that Nephrologist must be familiar with this abnormality of kidney development, as a number of complications may appear during follow-up.