Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study

Abstract

In randomized clinical trials (RCTs) of nonvitamin K antagonist oral anticoagulants (NOACs) for acute venous thromboembolism (VTE), ~ 12–13% of patients were elderly and ~ 26% had mild-to-moderate renal impairment. Observational studies are not restricted by the selection and treatment criteria of RCTs. In this ancillary analysis of the RE-COVERY DVT/PE global observational study, we aimed to describe patient characteristics, comorbidities, and anticoagulant therapy for subgroups of age (< or ≥ 75 years) and renal impairment (creatinine clearance [CrCl; estimated with Cockcroft–Gault formula] < 30 [severe], 30 to < 50 [moderate], 50 to < 80 [mild], ≥ 80 [normal] mL/min). Of 6095 eligible patients, 25.3% were aged ≥ 75 years; 38.2% (1605/4203 with CrCl values) had mild-to-moderate renal impairment. Comorbidities were more common in older patients (73.9% aged ≥ 75 vs. 58.1% < 75 years) and in those with mild or moderate versus no renal impairment (75.9%, 80.9%, and 59.3%, respectively). At hospital discharge or 14 days after diagnosis (whichever was later), most patients (53.7% and 55.1%, respectively) in both age groups received NOACs; 20.8% and 23.4%, respectively, received vitamin K antagonists, 19.0% and 21.8% parenteral therapy, 2.3% and 3.8% other anticoagulant treatments. Use of NOACs decreased with worsening renal impairment (none 58.5%, moderate 49.6%, severe 25.7%) and, in younger versus older patients with moderate renal impairment (33.1% vs. 56.1%). In routine practice, there are more elderly and renally impaired patients with VTE than represented in RCTs. Decreasing renal function, but not older age, was associated with less NOAC use. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02596230. Graphic abstract Decreasing renal function, particularly in the subgroup with CrCl < 30 mL/min, but not older age, was associated with less use of nonvitamin K antagonist oral anticoagulants (NOACs). Nevertheless, more than half of the older patients with moderate renal impairment received a NOAC as their oral anticoagulant.

Efficacy and Safety of Rivaroxaban for Extremely Aged Patients with Venous Thromboembolism: A Retrospective, Cross-Sectional Real-World Study

“… 19 The initial and maintenance doses of rivaroxaban are usually lower in elderly VTE patients, and the recommended standard rivaroxaban starting dose of 15mg twice daily for 3 weeks, followed by 20mg once daily may be too high for patients aged over 80 years. 18 , 28 Because of the age-related physiological changes, comorbidities, and concomitant medications, the anticoagulation in elderly patients is challenging and associated with an increased risk of adverse events. 15 , 17 Many clinical trials of anticoagulant therapy have excluded older patients, and it is controversial whether older patients are at higher risk for bleeding during anticoagulant therapy than are younger patients.…”

“…Previous studies showed that renal impairment did not increase the risk of bleeding in rivaroxaban-treated patients. 28 , 35 However, clinicians are desirous of knowing the influence of renal insufficiency on the efficacy and safety of rivaroxaban in extremely old VTE patients in order to minimize the risk of hemorrhage while ensuring the optimal anticoagulation effect. In this study, we observed 12 bleeding events (10.81%) in patients with an eGFR value higher than or equal to 30mL/min/1.73m 2 , while no bleeding event was observed in patients with severe renal insufficiency (eGFR<30mL/min/1.73m 2 ).…”