Abstract Number: PB2210
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » Post-thrombotic Syndrome
Background: Studies suggest that the direct factor Xa inhibitor rivaroxaban reduces the risk of post-thrombotic syndrome (PTS) 2-5 years after deep vein thrombosis (DVT) compared to warfarin, but this has not been evaluated for oral direct thrombin inhibitors.
Aims: To compare the long-term prevalence of PTS and health-related quality of life (HRQoL) in acute DVT and pulmonary embolism (PE) patients randomized to treatment with dabigatran or warfarin.
Methods: In the RE-COVER studies, patients with DVT and/or PE were randomized to 6 months of dabigatran or warfarin. We did a long-term cross-sectional follow-up study in patients from Canada, Sweden, and Norway. The primary outcome was PTS assessed by the patient-reported Villalta scale (PRV). PTS was defined as PRV ≥ 5 in the leg with DVT or the leg with the highest PRV in patients with PE only. HRQoL was assessed with EQ-5D. The study was approved by the research ethics committees and informed consent was obtained from all patients.
Results: A total of 349 patients were included between December 2015 and November 2018, of which 166 were treated with dabigatran and 183 with warfarin. Baseline variables were balanced between treatment groups (Table 1). Mean time from index event to follow-up was 8.7 (SD 1.4) years. 255 patients had DVT (+/- PE) as index event and 94 had PE only. Two DVT patients and 4 with PE were excluded due to missing PRV. PTS was diagnosed in 155/253 (61.3%) patients with DVT and in 40/90 (44.4%) patients with PE only. The prevalence of PTS and HRQoL scores did not differ between treatment groups in patients with DVT or patients with PE only (Table 2).
Conclusions: In this long-term cross-sectional study, the prevalence of PTS and HRQoL were similar in patients treated with dabigatran and warfarin.
| Variable | Dabigatran N=166 |
Warfarin N=183 |
P-value Chi-square or t-test |
| Study, n(%) RE-COVER 1 RE-COVER 2 |
88 (53.0) 78 (47.0) |
90 (49.2) 93 (50.8) |
0.5 |
| Age, index, years, mean (SD) |
52.0 (13.5) | 53.3 (13.6) | 0.8 |
| BMI, index, kg/m2, mean (SD) |
29.1 (6.4) | 30.1 (6.1) | 0.6 |
| Female sex, n (%) | 63 (38.0) | 71 (38.8) | 0.9 |
| Race, white, n (%) | 162 (97.6) | 173 (94.5) | 0.2 |
| Type of index event, n (%) DVT only PE only DVT and PE |
107 (64.5) |
113 (61.7) |
0.9 |
| Cancer at baseline, n (%) |
6 (3.6) | 7 (3.8) | 0.9 |
| Country, n(%) Canada Norway Sweden |
137 (83.7) 13 (7.8) 16 (9.6) |
150 (82.0) 16 (8.7) 17 (9.3) |
1.0 |
[Baseline characteristics of patients in the original RE-COVER studies]
| Variable | N | Dabigatran | Warfarin | p-value Chi-square or t-test |
|
| Time from index event to follow-up, years, mean (SD) | 348 | 8.8 (1.4) | 8.6 (1.5) | 0.7 | |
| DVT (+/- PE) | PTS, n (%) | 253 | 77 (63.1) | 78 (59.5) | 0.6 |
| DVT (+/- PE) | EQ VAS, mean (SD) |
243 | 76.6 (18.1) | 75.9 (19.1) | 0.9 |
| PE only | PTS, n (%) | 90 | 20 (48.8) | 20 (40.8) | 0.4 |
| PE only | EQ VAS, mean (SD) |
92 | 78.3 (15.8) | 74.9 (14.7) | 0.5 |
[Post-thrombotic syndrome and health-related quality of life after venous thromboembolism]
To cite this abstract in AMA style:
Wik HS, Sandset PM, Eriksson H, Ghanima W, Kahn SR, Morrison D, Schulman S. Post-Thrombotic Syndrome in Patients with Venous Thromboembolism Treated with Dabigatran or Warfarin – a Long-Term Cross-Sectional Follow-up of RE-COVER Study Patients [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/post-thrombotic-syndrome-in-patients-with-venous-thromboembolism-treated-with-dabigatran-or-warfarin-a-long-term-cross-sectional-follow-up-of-re-cover-study-patients/. Accessed September 21, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/post-thrombotic-syndrome-in-patients-with-venous-thromboembolism-treated-with-dabigatran-or-warfarin-a-long-term-cross-sectional-follow-up-of-re-cover-study-patients/