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. 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.

Keywords: Anticoagulation; Elderly; Nonvitamin K antagonist oral anticoagulant; Renal function; Vitamin K antagonist.

Conflict of interest statement

Dr. Ageno has participated in advisory boards for Bayer, Portola, Aspen, Sanofi, Daiichi Sankyo, Boehringer Ingelheim, and has received travel or research support from Bayer, Portola, Aspen, Janssen, Sanofi, Daiichi Sankyo, Bristol-Myers Squibb, Pfizer, and Boehringer Ingelheim. Dr. Casella has received speaker and/or consultancy fees from Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer, and Amgen. Dr. Chee has received speaker fees from Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer. Dr. Schellong has received speaker fees from Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Sanofi, and LEO Pharma. He has received consultancy fees from Bayer HealthCare, Boehringer Ingelheim, Daiichi Sankyo, GlaxoSmithKline, and Sanofi. Dr. Schulman has received honoraria from Alnylam, Boehringer Ingelheim, Bayer HealthCare, Daiichi Sankyo, Pfizer, and Sanofi, and research support from Boehringer Ingelheim and Octapharma. Dr. Singer has received honoraria from Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Johnson & Johnson, and Pfizer, and research support from Boehringer Ingelheim and Bristol-Myers Squibb. Dr. Desch, Dr. Tang, Dr. Voccia, and Dr. Zint are employees of Boehringer Ingelheim. Dr. Goldhaber has received research support from Boehringer Ingelheim, Bristol-Myers Squibb, Boston Scientific BTG, Daiichi Sankyo, Janssen, and the US National Heart Lung and Blood Institute. He is a consultant for Bayer and Boehringer Ingelheim.

Figures

Fig. 1

Pattern of anticoagulant use at hospital discharge or 14 days after diagnosis (whichever was later) according to a age or b renal function. aCrCl creatinine clearance, NOAC non-VKA oral anticoagulant, VKA vitamin K antagonist. aCrCl data missing for 1892 patients. CrCl estimated using the Cockcroft–Gault formula: < 30 mL/min represents severe impairment, 30 to < 50 mL/min moderate impairment, 50 to < 80 mL/min mild impairment, and ≥ 80 mL/min normal. b“Other” includes catheter-directed or systemic thrombolytic therapy

Fig. 2

Pattern of anticoagulant use in 4203 patients with age and renal function data available (a). CrCl creatinine clearance, NOAC non-VKA oral anticoagulant, VKA vitamin K antagonist. aCrCl data missing for 1892 patients: 1389 patients aged < 75 years and 503 patients aged ≥ 75 years. CrCl estimated using the Cockcroft–Gault formula: < 30 mL/min represents severe impairment, 30 to < 50 mL/min moderate impairment, 50 to < 80 mL/min mild impairment, and ≥ 80 mL/min normal. b“Other” includes catheter-directed or systemic thrombolytic therapy