Background: The risk of thromboembolic events is increased in patients with non-valvular atrial fibrillation (NVAF) and renal impairment. The risk of bleeding events is increased if these patients are treated with anticoagulants and further increased in those with active cancer.
Methods: RELOAD, a retrospective database study, assessed the outcomes of patients with NVAF prescribed rivaroxaban versus phenprocoumon. Here, we present a subgroup analysis evaluating effectiveness and safety of rivaroxaban versus phenprocoumon in patients with NVAF and renal impairment. Analyses were additionally stratified by patients with and without evidence of cancer at baseline.
Results: When using the 'one tablet per day' definition of estimating drug exposure time, the incidence of the primary endpoint of ischaemic stroke was significantly lower in patients (without evidence of cancer at baseline) receiving rivaroxaban 15 mg or 20 mg once daily versus those receiving phenprocoumon (2.40 vs 3.51 events per 100 patient-years, respectively; hazard ratio [HR] = 0.72, 95% confidence interval [CI] 0.55-0.94, p = 0.015); with the incidence of the primary safety outcome of intracranial haemorrhage being numerically lower (0.57 vs 0.89 events per 100 patient-years, respectively; HR = 0.66, 95% CI 0.38-1.14, p = 0.14). Similar results were observed when using the 'empirical defined daily dose' definition to estimate drug exposure time and when including patients with evidence of cancer.
Conclusion: The prescription of rivaroxaban in patients with NVAF and renal impairment was associated with a lower incidence of ischaemic stroke and intracranial haemorrhage versus phenprocoumon in patients without evidence of cancer.
Keywords: AF, atrial fibrillation; CHA2DS2-VASc, Congestive heart failure, Hypertension, Age ≥ 75 years (2 points), Diabetes mellitus, Stroke or transient ischaemic attack (2 points), Vascular disease, Age 65–74, Sex category (female); CHADS2, Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, Stroke or transient ischaemic attack (2 points); CI, confidence interval; DOAC, direct oral anticoagulant; HAS-BLED, Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalised ratio, Elderly, Drugs/alcohol concomitantly; HR, hazard ratio; ICD-10, International Classification of Diseases Tenth Revision; ICH, intracranial haemorrhage; NVAF, non-valvular atrial fibrillation; Non-valvular atrial fibrillation; PY, patient-years; Phenprocoumon; RELOAD study; Renal impairment; Rivaroxaban; TIA, transient ischaemic attack; VKA, vitamin K antagonist; eDDD, empirical defined daily dose; od, once daily; pPDD, personalised prescribed daily dose.