Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn's Disease (Versus-CD): Data from the ENEIDA Registry.

BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.

Complicaciones cardio-respiratorias graves derivadas de la sedación con propofol controlado por endoscopista / Severe cardiorespiratory complications derived from propofol sedation monitored by an endoscopist

Introducción: la sedación profunda con propofol controlada por endoscopista en las diferentes unidades de endoscopia ha sido un tema de continua controversia a lo largo de los últimos años, origen de conflictos de intereses entre las distintas sociedades científicas de Anestesiología y Gastroenterología. Numerosos estudios han demostrado ya la eficacia, eficiencia y escasa aparición de complicaciones en la sedación controlada por un endoscopista formado frente al anestesiólogo. Material y métodos: hemos revisado en nuestra base de datos el porcentaje de complicaciones cardio-respiratorias graves en nuestra unidad, en el periodo comprendido entre 2011 y 2016, en las distintas exploraciones endoscópicas que realizamos (gastroscopia, colonoscopia, colangiopancreatografía retrógrada endoscópica [CPRE] y ecoendoscopia [USE]) y cuya sedación es controlada por un endoscopista. Resultados: se llevó a cabo el análisis de 33.195 exploraciones durante el periodo de estudio. Obtuvimos un 0,13% de complicaciones cardio-respiratorias, la mayor parte de ellas desaturaciones graves (la mayoría respondieron a la apertura de la vía aérea asociada a la interrupción de la infusión del fármaco, precisando la necesidad de ambú en contadas ocasiones). No existieron diferencias estadísticamente significativas entre los diferentes grupos excepto en edad media, riesgo por tipo de exploración y riesgo ASA, donde la CPRE presentó una p < 0,01 frente al resto de exploraciones. Conclusión: con los datos de los que disponemos hasta la actualidad, existen numerosas evidencias en la literatura científica para divulgar que la sedación de las endoscopias controlada por un endoscopista formado es segura, eficaz y eficiente. No obstante, deben realizarse más estudios prospectivos que confirmen estas suposiciones, ya que hasta el momento la mayoría de los estudios son retrospectivos

Introduction: deep sedation with propofol monitored by an endoscopist in different endoscopy units is a controversial subject and the source of conflicts of interest between the various scientific societies of Anesthesiology and Gastroenterology. Many studies have already demonstrated the efficacy, efficiency and low incidence of complications associated with sedation when under the control of a trained endoscopist vs an anesthesiologist. Material and methods: the rate of severe cardiorespiratory complications during various endoscopic examinations (gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography [ERCP] and endoscopic ultrasound [EUS]) where sedation was controlled by an endoscopist within our unit, from 2011 to 2016, was reviewed. Results: during the study period, 33,195 examinations were analyzed. The rate of cardiorespiratory complications was 0.13% and the majority were severe desaturations. Most cases responded to an opening in the airway associated with the interruption of drug infusion and an ambu bag was required in a few cases. There were no statistically significant differences between the different groups, except for mean age, risk by type of examination and ASA risk, where the difference between ERCP and the rest of examinations was statistically significant. Conclusion: there is a high level of evidence in the scientific literature suggesting that sedation controlled by a trained endoscopist is safe, effective and efficient. However, further prospective studies are required in order to confirm this conclusion due to the fact that the majority of studies to date are retrospective

Severe cardiorespiratory complications derived from propofol sedation monitored by an endoscopist.

INTRODUCTION: deep sedation with propofol monitored by an endoscopist in different endoscopy units is a controversial subject and the source of conflicts of interest between the various scientific societies of Anesthesiology and Gastroenterology. Many studies have already demonstrated the efficacy, efficiency and low incidence of complications associated with sedation when under the control of a trained endoscopist vs an anesthesiologist. MATERIAL AND METHODS: the rate of severe cardiorespiratory complications during various endoscopic examinations (gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography [ERCP] and endoscopic ultrasound [EUS]) where sedation was controlled by an endoscopist within our unit, from 2011 to 2016, was reviewed. RESULTS: during the study period, 33,195 examinations were analyzed. The rate of cardiorespiratory complications was 0.13% and the majority were severe desaturations. Most cases responded to an opening in the airway associated with the interruption of drug infusion and an ambu bag was required in a few cases. There were no statistically significant differences between the different groups, except for mean age, risk by type of examination and ASA risk, where the difference between ERCP and the rest of examinations was statistically significant. CONCLUSION: there is a high level of evidence in the scientific literature suggesting that sedation controlled by a trained endoscopist is safe, effective and efficient. However, further prospective studies are required in order to confirm this conclusion due to the fact that the majority of studies to date are retrospective.

Fístula gastrocólica por adenocarcinoma gástrico / Gastrocolonic fistula due to gastric adenocarcinoma

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