Abstract Number: PB/LB03
Meeting: ISTH 2020 Congress
Background: Subgroup analyses of patients with atrial fibrillation (AF) and chronic kidney disease (CKD) in randomised controlled trials may not reflect real-world outcomes.
Aims: Our aims were to evaluate the incidence and risk of adverse events in a ‘real-world’ vs ‘clinical trial’ cohort of AF patients with CKD.
Methods: We studied vitamin K antagonist-treated AF patients with a creatinine clearance of below 60 mL/min from the real-world Murcia AF Project and AMADEUS clinical trial. The primary study endpoint was a composite of first ischaemic stroke, major bleeding and all-cause mortality. Secondary endpoints were ischaemic stroke, major bleeding, all-cause mortality, cardiovascular mortality, non-cardiovascular mortality, myocardial infarction and intracranial haemorrhage.
Results: This study included 1,108 AF patients with CKD: 365 (32.9%) real-world and 743 (67.1%) clinical trial patients. Median age was 77 (IQR 73-81) years with 616 (55.6%) females. Both cohorts had similar renal function (p=0.889). In comparison to the AMADEUS trial, real-world patients were older, more likely to be females and suffering from multiple comorbidities. These characteristics were reflected by higher CHA2DS2-VASc (5 [IQR 4-6] vs. 4 [IQR 3-5], p=0.005) and HAS-BLED (3 [IQR 2-3] vs 2 [IQR 2-3], p< 0.001) scores in the real-world cohort. Annual rate of the composite study outcome was significantly higher in the real-world cohort (13.4% vs 6.6%) with an incidence rate ratio of 2.04 (95% CI 1.34-3.09), p< 0.001 (Table). Furthermore, the individual annual rates of major bleeding, all-cause mortality and non-cardiovascular mortality were significantly greater in the real-world cohort, even after multivariable adjustment for other risk factors (Figure).
Conclusions: Vitamin K antagonist-treated AF patients with CKD are exposed to significant annual rates of major adverse events including all-cause mortality. Furthermore, this risk may be under-appreciated in the idealised environment of randomised controlled trials. Therefore, treatment decisions in this real-world cohort of patients should focus on a holistic approach.
|n||Annual event rate (%)||95% CI||n||Annual event rate (%)||95% CI||Incidence rate ratio||95% CI||p value|
|Composite of ischaemic stroke/major bleeding/all-cause mortality||49||13.43||9.93 – 17.75||49||6.59||4.88 – 8.71||2.04||1.34 – 3.09||<0.001|
|Ischaemic stroke||7||1.92||0.77 – 3.95||11||1.48||0.74 – 2.65||1.29||0.43 – 3.66||0.591|
|Major bleeding||17||4.66||2.71 – 7.45||14||1.88||1.03 – 3.16||2.47||1.15 – 5.42||0.010|
|All-cause mortality||37||10.14||7.14 – 13.97||31||4.17||2.83 – 5.92||2.43||1.47 – 4.05||<0.001|
|Cardiovascular mortality||12||3.29||1.70 – 5.74||13||1.75||0.93 – 2.99||1.88||0.78 – 4.47||0.109|
|Non-cardiovascular mortality||25||6.84||4.43 – 10.11||18||2.42||1.44 – 3.83||2.83||1.48 – 5.50||<0.001|
|Myocardial infarction||6||1.64||0.60 – 3.58||8||1.08||0.46 – 2.12||1.53||0.44 – 5.02||0.430|
|Intracranial haemorrhage||4||1.10||0.30 – 2.80||2||0.26||0.03 – 0.97||4.07||0.58 – 45.00||0.079|
[Major adverse events at 1-year among the CKD cohort in Real-World vs Clinical Trial]
To cite this abstract in AMA style:Ding WY, Caravaca JMR, Roldán V, Lip GYH. Differences in Outcomes between Real-World vs Clinical Trial in Atrial Fibrillation and Chronic Kidney Disease [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/differences-in-outcomes-between-real-world-vs-clinical-trial-in-atrial-fibrillation-and-chronic-kidney-disease/. Accessed January 23, 2022.
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