Overall Hemostatic Potential Assay Detects Risk of Progression to Post-Thrombotic Syndrome in Anticoagulated Patients following Deep Vein Thrombosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Participants
2.2. Follow Up
2.3. Laboratory Procedure
2.4. Healthy Controls
2.5. Modified Overall Hemostatic Potential (OHP) Assay
2.6. Statistical Analysis
3. Results
No PTS | PTS | p-Value * | Mild PTS | Moderate/ Severe PTS | p-Value ** | |
---|---|---|---|---|---|---|
n | 128 | 62 | 46 | 16 | ||
Age (years), mean (SD) | 56.6 (14.2) | 57.4 (11.2) | 0.72 | 58.2 (11.1) | 54.9 (11.6) | 0.32 |
Male | 72 (56.2%) | 30 (48.4%) | 0.31 | 19 (41.3%) | 11 (68.8%) | 0.06 |
Female | 56 (43.8%) | 32 (51.6%) | 27 (58.7%) | 5 (31.2%) | ||
Weight (kg) | 92.0 [81.0, 104.0] | 100.0 [85.0, 120.0] | 0.016 | 97.0 [80.0, 116.0] | 110.0 [88.5, 129.0] | 0.07 |
Unprovoked DVT | 77 (60.2%) | 43 (69.4%) | 0.22 | 30 (65.2%) | 13 (81.2%) | 0.23 |
Proximal DVT | 56 (43.8%) | 39 (62.9%) | 0.013 | 27 (58.7%) | 12 (75.0%) | 0.24 |
Previous DVT history | 32 (25.0%) | 14 (22.6%) | 0.72 | 12 (26.1%) | 2 (12.5%) | 0.26 |
Family history DVT/PE | 22 (17.2%) | 15 (24.2%) | 0.25 | 12 (26.1%) | 3 (18.8%) | 0.56 |
Malignancy | 10 (7.8%) | 2 (3.2%) | 0.22 | 2 (4.3%) | 0 (0.0%) | 0.40 |
Smoker | 17 (13.6%) | 13 (21.0%) | 0.20 | 11 (23.9%) | 2 (12.5%) | 0.33 |
History of varicose veins | 6 (4.7%) | 14 (22.6%) | <0.001 | 11 (23.9%) | 3 (18.8%) | 0.67 |
Length of follow up (days) | 480.5 [261.0, 1072.0] | 815.0 [368.0, 1127.0] | 0.07 | 820.5 [357.0, 1119.0] | 761.0 [405.5, 1127.5] | 1.00 |
Anticoagulation | ||||||
DOAC | 110 (85.9%) | 46 (74.2) | 0.048 | 37 (80.4%) | 9 (56.2%) | 0.06 |
Warfarin | 14 (10.9%) | 14 (22.6%) | 0.034 | 8 (17.4%) | 6 (37.5%) | 0.10 |
Enoxaparin | 4 (3.1%) | 2 (3.2%) | 0.97 | 1 (2.2%) | 1 (6.2%) | 0.43 |
Residual thrombus on repeat imaging | 50 (42.4%) | 26 (43.3%) | 0.90 | 18 (40.9%) | 8 (50.0%) | 0.53 |
Inherited thrombophilia # | 25 (19.7%) | 10 (16.4%) | 0.59 | 7 (15.6%) | 3 (18.8%) | 0.77 |
Antiphospholipid syndrome ^ | 3 (2.4%) | 1 (1.6%) | 0.75 | 1 (2.2%) | 0 (0.0%) | 0.55 |
Recurrent VTE during follow-up | 12 (9.4%) | 6 (9.7%) | 0.95 | 4 (8.7%) | 2 (12.5%) | 0.66 |
Recurrent ipsilateral leg DVT during follow-up | 5 (3.9%) | 4 (6.5%) | 0.44 | 3 (6.5%) | 1 (6.2%) | 0.97 |
Healthy Controls (HC) | No PTS | PTS | p-Value HC vs. No PTS | p-Value HC vs. PTS | |
---|---|---|---|---|---|
n | 144 | 128 | 62 | ||
Age (years) | 42.0 [24.5, 57.0] | 57.0 [46.0, 67.0] | 58.5 [51.0, 65.0] | <0.001 | <0.001 |
Male | 50 (34.7%) | 72 (56.2%) | 30 (48.4%) | <0.001 | 0.065 |
Fibrinogen (g/L) | 2.9 [2.5, 3.5] | 3.5 [3.0, 4.2] | 3.9 [3.4, 4.6] | <0.001 | <0.001 |
D-dimer (mg/L FEU) | 0.2 [0.1, 0.3] | 0.3 [0.3, 0.5] | 0.3 [0.3, 0.5] | <0.001 | <0.001 |
Factor VIII (%) | 106.0 [86.0, 145.0] | 148.0 [112.5, 190.5] | 162.0 [121.5, 202.5] | <0.001 | <0.001 |
von-Willebrand antigen (%) | 102.0 [87.0, 142.5] | 148.5 [101.0, 192.0] | 159.5 [118.5, 200.0] | 0.005 | <0.001 |
OCP (units) | 34.5 [29.0, 43.3] | 38.8 [32.1, 48.1] | 45.8 [39.3, 52.8] | 0.004 | <0.001 |
OHP (units) | 6.4 [4.8, 9.5] | 9.2 [6.9, 13.2] | 12.8 [8.8, 17.2] | <0.001 | <0.001 |
OFP (%) | 81.1 [77.5, 84.1] | 75.6 [71.0, 80.5] | 74.1 [64.9, 77.3] | <0.001 | <0.001 |
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A
Symptoms and Signs | None | Mild | Moderate | Severe |
---|---|---|---|---|
Symptoms | ||||
Pain | 0 | 1 | 2 | 3 |
Cramps | 0 | 1 | 2 | 3 |
Heaviness | 0 | 1 | 2 | 3 |
Paresthesia | 0 | 1 | 2 | 3 |
Pruritus | 0 | 1 | 2 | 3 |
Clinical signs | ||||
Pretibial edema | 0 | 1 | 2 | 3 |
Skin induration | 0 | 1 | 2 | 3 |
Hyperpigmentation | 0 | 1 | 2 | 3 |
Redness | 0 | 1 | 2 | 3 |
Venous ectasia | 0 | 1 | 2 | 3 |
Pain on calf compression | 0 | 1 | 2 | 3 |
Venous ulceration | Absent | Present |
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No PTS | PTS | p-Value * | Mild PTS | Moderate/Severe PTS | p-Value ** | |
---|---|---|---|---|---|---|
n | 128 | 62 | 46 | 16 | ||
Days from DVT diagnosis to blood sample | 90.0 [46.0, 112.0] | 80.0 [55.0, 105.0] | 0.76 | 82.0 [63.0, 105.0] | 67.0 [50.0, 108.0] | 0.38 |
Hemoglobin (g/L) | 146.0 [136.0, 155.0] | 144.0 [135.0, 154.0] | 0.44 | 140.0 [135.0, 154.0] | 148.5 [140.0, 154.5] | 0.25 |
Neutrophils (×109/L) | 3.9 (3.3, 5.2] | 4.4 [3.5, 5.4] | 0.23 | 4.2 [3.5, 5.4] | 4.8 [3.9, 5.8] | 0.25 |
Lymphocytes (×109/L) | 2.2 [1.8, 2.8] | 1.8 [1.5, 2.3] | 0.007 | 1.8 [1.6, 2.3] | 1.7 [1.4, 2.3] | 0.65 |
Neutrophil/lymphocyte ratio | 1.9 [1.4, 2.4] | 2.3 [1.6, 3.0] | 0.007 | 2.2 [1.5, 3.0] | 2.3 [1.8, 3.9] | 0.55 |
Platelets (×109/L) | 256.0 [226.0, 316.5] | 259.0 [217.0, 311.0] | 0.66 | 255.0 [231.0, 296.0] | 272.0 [214.5, 337.5] | 0.48 |
Platelet/lymphocyte ratio | 120.5 [96.3, 148.4] | 141.8 [110.0, 184.2] | 0.07 | 138.7 [109.5, 164.4] | 150.1 [114.5, 201.6] | 0.43 |
Fibrinogen (g/L) | 3.5 [3.0, 4.2] | 3.9 [3.4, 4.6] | 0.06 | 3.7 [3.4, 4.6] | 4.3 [3.8, 5.0] | 0.08 |
Fibrinogen/lymphocyte ratio | 1.6 [1.2, 2.1] | 1.9 [1.7, 2.8] | 0.001 | 1.9 [1.6, 2.7] | 2.3 [1.7, 3.7] | 0.47 |
D-dimer (mg/L FEU) | 0.3 [0.3, 0.5] | 0.3 [0.3, 0.5] | 0.73 | 0.3 [0.3, 0.4] | 0.4 [0.3, 0.7] | 0.33 |
Factor VIII (%) | 148.0 [112.5, 190.5] | 162.0 [121.5, 202.5] | 0.21 | 158.0 [128.0, 198.0] | 166.0 [113.0, 214.0] | 0.76 |
von-Willebrand antigen (%) | 148.5 (101.0, 192.0] | 159.5 (118.5, 200.0] | 0.51 | 162.0 (122.0, 200.0] | 147.0 (100.0, 200.0] | 0.56 |
OCP (units) | 38.8 [32.1, 48.1] | 45.8 [39.3, 52.8] | 0.010 | 44.3 [40.5, 55.8] | 49.3 [32.8, 52.5] | 0.71 |
OHP (units) | 9.2 [6.9, 13.2] | 12.8 [8.8, 17.2] | 0.005 | 12.3 [8.8, 16.8] | 13.7 [9.2, 17.2] | 0.61 |
OFP (%) | 75.6 [71.0, 80.5] | 74.1 [64.9, 77.3] | 0.050 | 75.2 [64.9, 77.3] | 72.7 [65.7, 76.9] | 0.46 |
Odds Ratio | Standard Error | p-Value | 95% Confidence Interval of Odds Ratio | |
---|---|---|---|---|
Proximal DVT | 2.22 | 0.79 | 0.026 | 1.10–4.47 |
History of varicose veins | 7.51 | 4.28 | <0.001 | 2.46–22.96 |
NLR ≥ 2.6 | 2.35 | 0.95 | 0.035 | 1.06–5.18 |
OHP > 13.0 units | 2.17 | 0.79 | 0.033 | 1.06–4.43 |
Weight > 108 kg | 2.86 | 1.11 | 0.007 | 1.34–6.11 |
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McLeod, B.; Lim, H.Y.; Nandurkar, H.; Ho, P.; Wang, J. Overall Hemostatic Potential Assay Detects Risk of Progression to Post-Thrombotic Syndrome in Anticoagulated Patients following Deep Vein Thrombosis. Diagnostics 2022, 12, 3165. https://doi.org/10.3390/diagnostics12123165
McLeod B, Lim HY, Nandurkar H, Ho P, Wang J. Overall Hemostatic Potential Assay Detects Risk of Progression to Post-Thrombotic Syndrome in Anticoagulated Patients following Deep Vein Thrombosis. Diagnostics. 2022; 12(12):3165. https://doi.org/10.3390/diagnostics12123165
Chicago/Turabian StyleMcLeod, Blake, Hui Yin Lim, Harshal Nandurkar, Prahlad Ho, and Julie Wang. 2022. "Overall Hemostatic Potential Assay Detects Risk of Progression to Post-Thrombotic Syndrome in Anticoagulated Patients following Deep Vein Thrombosis" Diagnostics 12, no. 12: 3165. https://doi.org/10.3390/diagnostics12123165