Key result
Real-world VKA-treated AF patients with CKD had a significantly higher annual rate of ischaemic stroke, major bleeding, and mortality compared to a clinical trial cohort (13.4% vs 6.6%; IRR 2.04; P<.001).
Why the study?
The study was conducted to evaluate the risk of adverse events in a real-world versus a clinical trial cohort of patients with AF and chronic kidney disease.
Are adverse event rates higher in a 'real-world' cohort compared to a 'clinical trial' cohort among VKA-treated AF patients with CKD?
Cohort (n=1,108)
Are adverse event rates higher in a 'real-world' cohort compared to a 'clinical trial' cohort among VKA-treated AF patients with CKD?
VKA-treated AF patients with CKD face significantly higher risks of major adverse events in real-world settings compared to the idealized environment of randomized controlled trials.
Higher adverse events in real-world vs trial VKA-treated AF with CKD warrant caution applying trial data; leaves open generalizability to routine care.
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.
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Ding et al. (2020) conducted a cohort in Atrial fibrillation and chronic kidney disease (n=1,108). Real-world clinical setting vs. Clinical trial setting (AMADEUS trial) was evaluated on Composite of ischaemic stroke, major bleeding and all-cause mortality (IRR 2.04, 95% CI 1.34-3.09, p=< .001). Real-world VKA-treated AF patients with CKD had a significantly higher annual rate of ischaemic stroke, major bleeding, and mortality compared to a clinical trial cohort (13.4% vs 6.6%; IRR 2.04; P<.001).
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