Residual Vein Thrombosis After Deep Vein Thrombosis in Patients Treated with DOACs: Incidence and Associated Factors
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
- ▪
- Male or female aged ≥ 18 years old;
- ▪
- A recent, radiologically confirmed, uni- or bilateral lower-limb DVT involving the common femoral vein and/or the popliteal vein (the presence of PE did not preclude enrolment);
- ▪
- At least 2 years elapsed since the previous DVT, if the current episode was an ipsilateral recurrence;
- ▪
- Indication for anticoagulation treatment;
- ▪
- Eligibility for DOACs therapy, initiated within 45 days of diagnosis;
- ▪
- Enrolment within 3 months of diagnosis.
2.2. Baseline Assessment
2.3. Ultrasonographic Assessment
- The common femoral vein at the groin level, from the confluence of the deep and superficial femoral veins to the great saphenous vein;
- The popliteal vein, from its proximal tract to the confluence of the calf veins.
2.4. Clinical Outcomes
2.5. Statistical Analysis
3. Results
3.1. Primary Endpoint
3.2. Therapeutic Decisions
3.3. Safety Outcomes
3.4. Predictors of RVT
3.5. Drugs Comparison
3.6. Multivariable Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
READ | Residual vein thrombosis and DOACs |
RVT | Residual vein thrombosis |
RVO | Residual vein obstruction |
DOACs | Direct oral anticoagulants |
VKAs | Vitamin K antagonists |
VTE | Venous thromboembolism |
DVT | Deep vein thrombosis |
PE | Pulmonary embolism |
CUS | Compression ultrasonography |
References
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Total number of enrolled patients | 113 |
Patients included in the statistical analysis | 96 |
Gender, n. (%) | M 63 (65.6%); F 33 (34.4%) |
Age, years old (mean ± SD) | 61.9 ± 16.9 |
Age > 60 y.o., n. (%) | 55 (57.3%) |
Weight, Kg (mean ± SD) | 78.6 ± 16.5 |
BMI, Kg/m2 (mean ± SD) | 26.4 ± 5.1 |
Obese patients with BMI ≥ 30, n. (%) | 19 (19.8%) |
Weight in obese patients, Kg (mean ± SD) | 95.6 ± 15.1 |
BMI in obese patients, Kg/m2 (mean ± SD) | 33.8 ± 3.7 |
Personal history of VTE, n. (%) | 10 (10.4%) |
Family history of VTE, n. (%) | 17 (17.7%) |
Site of DVT, n. (%) |
|
Associated PE, n. (%) | 36 (37.5%) |
Nature of DVT |
|
Time between symptoms onset and diagnosis, n. (%) |
|
Mean time to start DOACs | 10 days |
Full-dose DOACs, n. (%) | 95 (99.0%) |
Loading dose of DOACs, n. (%) | 47 (49.0%) |
Apixaban, n. (%) | 50 (52.1%) |
Rivaroxaban, n. (%) | 42 (43.8%) |
Edoxaban, n. (%) | 3 (3.1%) |
Dabigatran, n. (%) | 1 (1.0%) |
Inherited thrombophilia 1, n. (%) | 22 (40.0%) 2 |
Smoke, n. (%) | 20 (20.8%) |
Alcohol abuse, n. (%) | 20 (20.8%) |
Active cancer, n. (%) | 9 (9.4%) |
Diabetes, n. (%) | 7 (7.3%) |
Recent surgery, n. (%) | 4 (4.0%) |
Bleeding history, n. (%) | 7 (7.3%) |
Chronic liver disease, n. (%) | 3 (3.1%) |
Renal failure, n. (%) | 17 (17.7%) |
Hypertension, n. (%) | 47 (48.9%) |
Previous stroke, n. (%) | 5 (5.2%) |
Frequent falls, n. (%) | 0 (0%) |
Chronic use of NSAIDs, n. (%) | 8 (8.3%) |
Patients with T1, n. (%) | 85 (88.5%) |
Patients with T2, n. (%) | 96 (100%) |
Patients with T3, n. (%) | 77 (80.2%) |
RVT ≥ 4 mm, n. (%) |
|
Overall therapeutic decision, n. (%) |
|
Therapeutic decision at T3, n. (%) 2 |
|
Thrombotic recurrence during the study, n. (%) | 0 (0%) |
Bleedings, n. (%) |
|
RVT < 4 mm N = 46 | RVT ≥ 4 mm N = 50 | p-Value | |
---|---|---|---|
Gender: F M | 24 (52.2%) 22 (47.8%) | 9 (18.0%) 41 (82.0%) | 0.001 |
Age, years: | 61.5 [47.0; 73.8] | 64.0 [55.5; 74.8] | 0.346 |
Smoking habit: No Yes | 36 (78.3%) 10 (21.7%) | 40 (80.0%) 10 (20.0%) | 1.000 |
Diabetes: No Yes | 44 (95.7%) 2 (4.3%) | 45 (90.0%) 5 (10.0%) | 0.438 |
Hypertension: No Yes | 22 (47.8%) 24 (52.2%) | 27 (54.0%) 23 (46.0%) | 0.689 |
BMI, kg/m2 | 26.7 [23.1; 31.1] | 26.1 [23.2; 27.6] | 0.215 |
Thrombophilia: Absent Inherited, low risk 1 Inherited, high risk 2 APS Not tested | 16 (34.8%) 8 (17.4%) 1 (2.2%) 1 (2.2%) 20 (43.4%) | 17 (34.0%) 8 (16.0%) 3 (6.0%) 1 (2.0%) 21 (42.0%) | 0.942 |
VTE familiar history: No Yes | 43 (93.5%) 3 (6.5%) | 36 (72.0%) 14 (28.0%) | 0.013 |
VTE personal history: No Yes | 41 (89.1%) 5 (10.9%) | 45 (90.0%) 5 (10.0%) | 1.000 |
Popliteal vein involvement: No Yes | 5 (10.9%) 41 (89.1%) | 3 (6.0%) 47 (94.0%) | 0.474 |
Femoral vein involvement: No Yes | 30 (65.2%) 16 (34.8%) | 20 (40.0%) 30 (60.0%) | 0.023 |
Femoropopliteal involvement: No Yes | 35 (76.1%) 11 (23.9%) | 23 (46.0%) 27 (54.0%) | 0.005 |
Iliac vein involvement: No Yes | 40 (87.0%) 6 (13.0%) | 38 (76.0%) 12 (24.0%) | 0.266 |
Bilateral involvement: No Yes | 43 (93.5%) 3 (6.5%) | 46 (92.0%) 4 (8.0%) | 1.000 |
Nature of DVT: Idiopathic Associated with weak risk factors Associated with strong risk factors Cancer associated | 17 (37.0%) 15 (32.6%) 8 (17.4%) 6 (13.0%) | 27 (54.0%) 16 (32.0%) 4 (8.0%) 3 (6.0%) | 0.217 |
Pulmonary embolism: No Yes | 26 (56.5%) 20 (43.5%) | 34 (68.0%) 16 (32.0%) | 0.342 |
Drugs: Apixaban Rivaroxaban | 25 (58.1%) 18 (41.9%) | 25 (51.0%) 24 (49.0%) | 0.635 |
Loading dose: No Yes | 20 (43.6%) 23 (50.0%) | 25 (50.0%) 24 (48.0%) | 0.922 |
Characteristic | OR | 95% CI | p-Value |
---|---|---|---|
Gender: | |||
M | — | — | |
F | 0.20 | 0.07, 0.52 | 0.002 |
Femoropopliteal involvement: | |||
No | — | — | |
Yes | 4.13 | 1.58, 11.7 | 0.005 |
VTE familiar history: | |||
No | — | — | |
Yes | 4.58 | 1.18, 23.5 | 0.040 |
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Bardetta, M.; Simoncini, M.; Valeri, F.; Pizzuto, A.; Dainese, C.; Sella, C.; Porreca, A.; Bruno, B.; Borchiellini, A. Residual Vein Thrombosis After Deep Vein Thrombosis in Patients Treated with DOACs: Incidence and Associated Factors. J. Clin. Med. 2025, 14, 5991. https://doi.org/10.3390/jcm14175991
Bardetta M, Simoncini M, Valeri F, Pizzuto A, Dainese C, Sella C, Porreca A, Bruno B, Borchiellini A. Residual Vein Thrombosis After Deep Vein Thrombosis in Patients Treated with DOACs: Incidence and Associated Factors. Journal of Clinical Medicine. 2025; 14(17):5991. https://doi.org/10.3390/jcm14175991
Chicago/Turabian StyleBardetta, Marco, Matteo Simoncini, Federica Valeri, Andrea Pizzuto, Cristina Dainese, Carola Sella, Annamaria Porreca, Benedetto Bruno, and Alessandra Borchiellini. 2025. "Residual Vein Thrombosis After Deep Vein Thrombosis in Patients Treated with DOACs: Incidence and Associated Factors" Journal of Clinical Medicine 14, no. 17: 5991. https://doi.org/10.3390/jcm14175991
APA StyleBardetta, M., Simoncini, M., Valeri, F., Pizzuto, A., Dainese, C., Sella, C., Porreca, A., Bruno, B., & Borchiellini, A. (2025). Residual Vein Thrombosis After Deep Vein Thrombosis in Patients Treated with DOACs: Incidence and Associated Factors. Journal of Clinical Medicine, 14(17), 5991. https://doi.org/10.3390/jcm14175991