Your browser doesn't support javascript.
loading
Outcomes in VKA-treated patients with atrial fibrillation and chronic kidney disease: Clinical trials vs 'real-world'.
Ding, Wern Yew; Rivera-Caravaca, José Miguel; Shantsila, Alena; Marin, Francisco; Gupta, Dhiraj; Roldán, Vanessa; Lip, Gregory Y H.
Afiliación
  • Ding WY; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
  • Rivera-Caravaca JM; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
  • Shantsila A; Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
  • Marin F; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
  • Gupta D; Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca), CIBERCV, Murcia, Spain.
  • Roldán V; Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
  • Lip GYH; Department of Hematology and Clinical Oncology, Hospital General Universitario Morales Meseguer, University of Murcia, Murcia, Spain.
Int J Clin Pract ; 75(4): e13888, 2021 Apr.
Article en En | MEDLINE | ID: mdl-33283377
ABSTRACT

BACKGROUND:

Our objectives were to evaluate the risk of adverse events in a 'real-world' vs 'clinical trial' cohort of atrial fibrillation (AF) patients with chronic kidney disease (CKD).

METHODS:

We studied patient-level data for vitamin K antagonist-treated AF patients with a creatinine clearance <60 mL/min from the Murcia AF Project and AMADEUS trial. The study end-points were ischaemic stroke, major bleeding, all-cause mortality, myocardial infarction and intracranial haemorrhage.

RESULTS:

This study included 1,108 AF patients with CKD. The annual rate of the composite study outcome of ischaemic stroke, major bleeding and all-cause mortality was higher in the real-world (13.4%) vs AMADEUS (6.6%) cohort with an IRR of 2.04 (95% CI,1.34-3.09), P < .001. Individual annual rates of major bleeding, all-cause mortality and non-cardiovascular mortality were significantly greater in the real-world cohort. Similar findings were demonstrated even after multivariable adjustment, with the composite outcome HR of 2.85 (95% CI,1.74-4.66), P < .001. In a propensity score matched cohort, this risk remained significantly higher in the real-world cohort (IRR 2.95 [95% CI,1.03-10.28], P = .027), as did the risk of major bleeding and all-cause mortality.

CONCLUSION:

Vitamin K antagonist-treated AF patients with CKD are exposed to significant annual rates of major adverse events including all-cause mortality. This risk may be under-appreciated in the idealised environment of randomised controlled trials.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Fibrilación Atrial / Isquemia Encefálica / Accidente Cerebrovascular / Insuficiencia Renal Crónica Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Int J Clin Pract Asunto de la revista: MEDICINA Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Fibrilación Atrial / Isquemia Encefálica / Accidente Cerebrovascular / Insuficiencia Renal Crónica Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Int J Clin Pract Asunto de la revista: MEDICINA Año: 2021 Tipo del documento: Article País de afiliación: Reino Unido