GARFIELD-VTE: how does renal impairment affect VTE patients’ risk of major adverse outcomes?
GARFIELD-VTE: how does renal impairment affect VTE patients’ risk of major adverse outcomes?
Take-home messages
- Patients with moderate-to-severe CKD were at an increased risk of all-cause mortality, major bleeding and recurrent VTE versus those with normal-to-mild CKD
- Impairment was more likely in female patients
- There were no clinically meaningful differences in anticoagulation use between the two patient groups over 12 months
Professor Shinya Goto, Professor of Medicine, Department of Medicine, Tokai University School of Medicine, Japan.
Managing patients with venous thromboembolism (VTE) and chronic kidney disease (CKD) is complex, as patients are simultaneously at an increased risk of bleeding and thromboembolic events. The majority of anticoagulants are excreted by the kidney, which further complicates treatment decisions.
New real-world findings from the ongoing, prospective, non-interventional, real-world study Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE were released at this year's International Society on Thrombosis and Haemostasis (ISTH) Congress, focusing on renal impairment.
Professor Shinya Goto, Professor of Medicine, Department of Medicine, Tokai University School of Medicine, Japan, presented the results. "So, the aim of this analysis is [to] compare the baseline characteristics, treatment patterns and 12-month outcomes in patients newly diagnosed with VTE with moderate-to-severe CKD [stages 3-5] or mild to no CKD [stages 1-2]."
Of the 10,685 patients enrolled between 2014 and 2017, n=2,042 had moderate-to-severe CKD and n=6,897 had normal-to-mild CKD (n=8,939 eligible patients).
There were no clinically meaningful differences in treatment patterns between the two patient groups over 12 months. "The use of oral anticoagulation decreased over time," Professor Goto added. The use of direct oral anticoagulants (DOACs) was similar between the two groups at 3, 6 and 12 months.
Distribution of VTE events was also comparable between groups. In moderate-to-severe CKD, 57.1% of patients had deep vein thrombosis (DVT) alone, 42.9% with pulmonary embolism (PE) ± DVT; in normal-to-mild CKD patients, 58.9% had DVT alone, 41.1% with PE ± DVT.
In terms of comorbidities, patients with moderate-to-severe CKD were more likely to have chronic heart failure (6.8% vs 2.2%), chronic immobilisation (7.1% vs 5.3%) and a history of cancer (17.2% vs 12.9%) compared with patients with normal-to-mild CKD.
"Moderate-to-severe CKD patients were at an increased risk of death," noted Professor Goto, speculating that this may be due to increased age. "Recurrent VTE and major bleeding [was] also high in patients with moderate-to-severe CKD."
Event rates at 12 months:
| Moderate-to-severe CKD (n=2,042) | Normal-to-mild CKD (n=6,897) | |||||
|---|---|---|---|---|---|---|
| Event | n | Rate per 100 person-years (95% CI) | n | Rate per 100 person-years (95% CI) | HR (95% CI) | P-value |
| All-cause mortality | 164 | 17.3 (14.9-20.2) | 290 | 8.8 (7.9-9.9) | 1.96 (1.62-2.37) | <0.0001 |
| Recurrent VTE | 84 | 9.2 (7.4-11.3) | 216 | 6.7 (5.9-7.7) | 1.35 (1.05-1.73) | 0.0211 |
| Any bleeding | 191 | 21.4 (18.6-24.7) | 524 | 16.8 (15.4-18.3) | 1.27 (1.07-1.49) | 0.0053 |
| Major bleeding | 43 | 4.6 (3.4-6.2) | 81 | 2.5 (2.0-3.1) | 1.84 (1.27-2.66) | 0.0013 |
| Cancer | 39 | 4.2 (3.0-5.7) | 95 | 2.9 (2.4-3.6) | 1.43 (0.99-2.08) | 0.0581 |
| MI/ACS | 17 | 1.8 (1.1-2.9) | 30 | 0.9 (0.6-1.3) | 1.96 (1.08-3.56) | 0.0263 |
| Stroke/TIA | 12 | 1.3 (0.7-2.2) | 25 | 0.8 (0.5-1.1) | 1.67 (0.84-3.32) | 0.1459 |
ACS: acute coronary syndrome; CI: confidence interval; HR: hazard ratio; MI: myocardial infarction; TIA: transient ischaemic attack. Data were unavailable for 20 patients with moderate-to-severe CKD and 37 patients with normal-to-mild CKD
. "Moderate-to-severe CKD was more common in females… we don't know the reason," continued Professor Goto. 57.0% vs 47.0% of patients were female (moderate-to-severe vs normal-to-mild CKD, respectively). Patients were more likely to be older (median age at diagnosis: 70.1 vs 57.2), but body mass index (BMI) was similar between the two arms (mean BMI 29.2 kg/m2 vs 28.1 kg/m2).Overall, the results show that patients with VTE and moderate-to-severe CKD are at an increased risk of major adverse outcomes versus those with normal-to-mild CKD. "We want to share our current data with all of you, and to start considering what should be the next step to improve the care of patients with VTE and moderate-to-severe CKD, which is difficult in an aging society."
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Based on Goto S, Turpie A G G et al. The influence of renal impairment on clinical outcomes in venous thromboembolism patients enrolled in GARFIELD-VTE (abstract OC 24.1). Presented on 7 July 2019.
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