Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
Abstract
:1. Introduction
2. Study Design
3. Statistical Analysis
4. Results
4.1. Primary Efficacy Endpoint
4.2. Primary Safety Endpoint
5. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Index Event | n | % |
---|---|---|
Deep-vein thrombosis | ||
Proximal | 163 * | 36.3 |
Distal | 195 † | 43.3 |
Pulmonary embolism | 21 | 4.7 |
Deep-vein thrombosis and pulmonary embolism | 71 | 15.7 |
Medical conditions | n. | % |
Hypertension (>140 mmHg or in therapy) | 240 | 53.6 |
Diabetes | 39 | 8.7 |
COPD | 14 | 3.1 |
Recent infection (<3 months) | 18 | 4.0 |
Previous stroke | 18 | 4.0 |
Congestive heart failure | 9 | 2.0 |
Peripheral arterial disease | 33 | 7.4 |
Varicose veins | 160 | 35.6 |
Previous venous thromboembolism | 233 | 52.0 |
Renal dysfunction (eGFR <30 mL/min) | 15 | 3.3 |
Dislipidemia | 80 | 17.8 |
Active cancer | 28 | 6.2 |
Autoimmune disease | 36 | 8.0 |
Esophagitis, gastritis, inflammatory bowel disease | 50 | 11.1 |
Hormone therapy | 4 | 0.9 |
Active smoking | 63 | 14.0 |
Known thrombophilia | 76 | 16.9 |
Protein c deficiency | 9 | 2.0 |
Protein s deficiency | 6 | 1.3 |
Factor V leiden. Apc resistenza | 43 | 9.5 |
Prothrombin variant G20210A | 13 | 2.9 |
Antiphospholipid syndrome | 4 | 0.9 |
Previous hemorrhagic events | 15 | 3.3 |
Intracranial | 5 | 1.1 |
Gastro-intestinal | 4 | 0.7 |
Medication Use | n. | % |
Low-dose aspirin | 46 | 11.2 |
P2Y12 inhibitor | 6 | 1.3 |
Double antiaggregation | 3 | 0.7 |
Antihypertensive treatment | 61 | 13.6 |
Oral antidiabetics | 34 | 7.6 |
Hypolipidemic drugs | 86 | 19.1 |
NSAIDS | 6 | 1.3 |
Laboratory values | mean | SD |
Hemoglobin g/L | 138.1 | 44.7 |
Platelets 100 × 106/L | 229.8 | 67.5 |
Serum creatinine (mL/min) | 38.9 | 44.7p |
Creatinine clearance (Cockcroft–Gault formula) mL/min | 75.9 | 32.8 |
HAS-BLED score | n | % |
0 | 146 | 32.4 |
1 | 214 | 47.6 |
2 | 68 | 15.1 |
3–4 | 22 | 4.9 |
Recurrent VTE | Bleeding | |||||||
---|---|---|---|---|---|---|---|---|
Basal Risk Factors | No. | n. (%) | IR (95% C.I.) | Logrank p | n. (%) | IR (95% C.I.) | Logrank p | |
Age | <65a | 193 | 20 (10.4) | 5.5 (3.3–8.4) | 0.673 | 13 (6.7) | 3.5 (1.8–5.9) | 0.762 |
≥65a | 257 | 25 (9.7) | 4.7 (3.1–7.0) | 20 (7.8) | 3.8 (2.3–5.8) | |||
Gender | Male | 234 | 23 (9.8) | 4.9 (3.1–7.3) | 0.786 | 6 (2.6) | 1.2 (0.5–2.7) | <0.001 |
Female | 216 | 22 (10.2) | 5.3 (3.3–7.9) | 27 (12.5) | 6.5 (4.3–9.4) | |||
Cancer | With | 28 | 2 (7.1) | 3.2 (0.4–11.4) | 0.471 | 0 | - | 0.111 |
Without | 422 | 43 (10.2) | 5.2 (3.8–7.0) | 33 (7.8) | 3.9 (2.7–5.5) | |||
VTE type | Proximal + PE | 232 | 24 (10.3) | 4.7 (3.0–7.0) | 0.698 | 24 (10.3) | 4.8 (3.1–7.1) | 0.085 |
Distal | 89 | 8 (9.0) | 6.4 (2.8–12.6) | 2 (2.2) | 1.6 (0.2–5.6) | |||
Antiplatelet therapy | With | 46 | 7 (15.2) | 9.6 (3.8–19.7) | 0.107 | 6 (13) | 8.1 (3.0–17.7) | 0.048 |
Without | 404 | 38 (9.4) | 4.6 (3.3–6.4) | 27 (6.7) | 3.3 (2.1–4.7) | |||
Previous Bleeding | With | 15 | 1 (6.7) | 2.9 (0.1–16.3) | 0.505 | 6 (40) | 27.1 (9.9–59.1) | <0.001 |
Without | 435 | 44 (10.1) | 5.1 (3.7–6.9) | 27 (6.2) | 3.1 (2.0–4.5) | |||
Anemia (HB < 110 gr/L) | With | 22 | 3 (13.6) | 7.1 (1.5–20.8) | 0.553 | 5 (22.7) | 11.9 (3.8–27.7) | 0.004 |
Without | 400 | 38 (9.5) | 4.5 (3.2–6.2) | 26 (6.5) | 3.1 (2.0–4.5) |
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Bortoluzzi, C.; Bernardi, E.; Camporese, G.; Noventa, F.; Ceccato, D.; Tonello, C.; Vo Hong, N.; Campello, E.; Simion, C.; Imbalzano, E.; et al. Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project. Life 2022, 12, 1657. https://doi.org/10.3390/life12101657
Bortoluzzi C, Bernardi E, Camporese G, Noventa F, Ceccato D, Tonello C, Vo Hong N, Campello E, Simion C, Imbalzano E, et al. Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project. Life. 2022; 12(10):1657. https://doi.org/10.3390/life12101657
Chicago/Turabian StyleBortoluzzi, Cristiano, Enrico Bernardi, Giuseppe Camporese, Franco Noventa, Davide Ceccato, Chiara Tonello, Ngoc Vo Hong, Elena Campello, Chiara Simion, Egidio Imbalzano, and et al. 2022. "Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project" Life 12, no. 10: 1657. https://doi.org/10.3390/life12101657