Predictors of thrombo-embolic events in Covid-19 Ambulatory Patients: Insights from the TUNACOV Study

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Rania Hammami
Aymen Dammak
Faiza Safi
Nouha Ktata
Hanen Maamri
Mouna Baklouti
Fadhila Issaoui
Nejah Ben Halima
Olfa Chakroun
jihen Jdidi

Abstract

Introduction: There are no clear data on the incidence and predictors of arterial and venous thromboembolic (TE) events in COVID-19 ambulatory patients.


Aim: We conducted this study to analyze thromboembolic complications in this setting and to compare the efficacy and safety of Rivaroxaban to LMWHs as a thromboprophylaxis treatment.


 Methods: This is an observational study including COVID-19 patients treated on an outpatient basis. We analysed the predictors of thromboembolic events.


Results: We included 2089 patients with COVID19 managed on an outpatient basis during the period from October 01, 2020 to December 31, 2021. The mean age of our patients was 43±16 years. The incidence of venous and arterial TE complications was 0.9%. Predictive factors for arteriovenous thromboembolic complications were hormonal contraception (OR=23), moderate clinical form (OR=3.5), recent surgery or miscarriage in the month preceding COVID-19 (OR=9.2) and CT signs of COVID-19 (OR=4.9). In contrast, physical activity proved to be a protective factor. Thromboprophylaxis was prescribed in 22.5% of cases: LMWH in 18.1%, Rivaroxaban in 3.7% and a combination of the two molecules successively in 0.6% of patients. There was no statistical difference in thromboembolic or major bleeding complications between the Rivaroxaban and LMWH groups.


Conclusion: Our study showed that the incidence of thromboembolic complications is very low in Covid-19 ambulatory patients. 

Keywords:

COVID-19, thromboembolic events, hemorrhagic events, Rivaroxaban, Low Molecular Weight Heparin.

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References

  1. Piazza G, Campia U, Hurwitz S, Snyder JE, Rizzo SM, Pfeferman MB, et al. Registry of Arterial and Venous Thromboembolic Complications in Patients With COVID-19. J Am Coll Cardiol. 2020 Nov 3;76(18):2060–72.
  2. Elbadawi A, Elgendy IY, Sahai A, Bhandari R, McCarthy M, Gomes M, et al. Incidence and Outcomes of Thrombotic Events in Symptomatic Patients with COVID-19. Arterioscler Thromb Vasc Biol. 2020;41(1):545–7.
  3. Cui S, Chen S, Li X, Liu S, Wang F. Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia. J Thromb Haemost. 2020 Jun 6;18(6):1421–4.
  4. Aktaa S, Wu J, Nadarajah R, Rashid M, de Belder M, Deanfield J, et al. Incidence and mortality due to thromboembolic events during the COVID-19 pandemic: Multi-sourced population-based health records cohort study. Thromb Res. 2021 Jun 1;202:17–23.
  5. Souissi S, Ben Turkia H, Saad S, Keskes S, Jeddi C, Ghazali H. Predictive factors of mortality in patients admitted to the emergency department for SARS-Cov2 pneumonia. Tunis Med. 2024 Feb 5;102(2):78-82.
  6. Krittanawong C, Virk HUH, Narasimhan B, Wang Z, Narasimhan H, Zhang HJ, et al. Coronavirus disease 2019 (COVID-19) and cardiovascular risk: A meta-analysis. Prog Cardiovasc Dis. 2020 Jul 1;63(4):527–8.
  7. Giannis D, Allen S, Tsang J, Flint S, Pinhasov T, Williams S, et al. Post-Discharge Thromboembolic Outcomes and Mortality of Hospitalized COVID-19 Patients: The CORE-19 Registry. Blood. 2021 Apr 6;
  8. Bikdeli B, Madhavan M V., Jimenez D, Chuich T, Dreyfus I, Driggin E, et al. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950–73.
  9. Gerotziafas GT, Catalano M, Colgan MP, Pecsvarady Z, Wautrecht JC, Fazeli B, et al. Guidance for the Management of Patients with Vascular Disease or Cardiovascular Risk Factors and COVID-19: Position Paper from VAS-European Independent Foundation in Angiology/Vascular Medicine. Thromb Haemost. 2020 Dec 1;120(12):1597–628.
  10. Vanassche T, Orlando C, Vandenbosch K, Gadisseur A, Hermans C, Jochmans K, et al. Belgian clinical guidance on anticoagulation management in hospitalised and ambulatory patients with COVID-19. Acta Clin Belgica Int J Clin Lab Med. 2020 Oct 3;1–6.
  11. Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534–44.
  12. Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, et al. Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients. N Engl J Med. 2013 Feb 7;368(6):513–23.
  13. Spyropoulos AC, Lipardi C, Xu J, Lu W, Suh E, Yuan Z, et al. Improved Benefit Risk Profile of Rivaroxaban in a Subpopulation of the MAGELLAN Study. Clin Appl Thromb. 2019;25.
  14. NIH. COVID-19 Treatment Guidelines. Nih. 2021.
  15. Cuker A, Tseng EK, Nieuwlaat R, Angchaisuksiri P, Blair C, Dane K, et al. American Society of Hematology 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19. Blood Adv. 2021 Feb 9;5(3):872–88.
  16. NORDSTRÖM M, LINDBLAD B, BERGQVIST D, KJELLSTRÖM T. A prospective study of the incidence of deep-vein thrombosis within a defined urban population. J Intern Med. 1992 Aug 1;232(2):155–60.
  17. Khorana AA, Dalal M, Lin J, Connolly GC. Incidence and predictors of venous thromboembolism (VTE) among ambulatory high-risk cancer patients undergoing chemotherapy in the United States. Cancer. 2013 Feb 1;119(3):648–55.
  18. Nopp S, Moik F, Jilma B, Pabinger I, Ay C. Risk of venous thromboembolism in patients with COVID‐19: A systematic review and meta‐analysis. Res Pract Thromb Haemost. 2020 Oct;4(7):1178–91.
  19. Al-Samkari H. Finding the Optimal Thromboprophylaxis Dose in Patients with COVID-19. JAMA - Journal of the American Medical Association. American Medical Association; 2021.
  20. Moores LK, Tritschler T, Brosnahan S, Carrier M, Collen JF, Doerschug K, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020 Sep 1;158(3):1143–63.
  21. Zhai Z, Li C, Chen Y, Gerotziafas G, Zhang Z, Wan J, et al. Prevention and Treatment of Venous Thromboembolism Associated with Coronavirus Disease 2019 Infection: A Consensus Statement before Guidelines. Vol. 120, Thrombosis and Haemostasis. Georg Thieme Verlag; 2020. p. 937–48.
  22. Barnes GD, Burnett A, Allen A, Blumenstein M, Clark NP, Cuker A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020 Jul 1;50(1):72–81.
  23. Rosenberg D, Eichorn A, Alarcon M, McCullagh L, McGinn T, Spyropoulos AC. External validation of the risk assessment model of the international medical prevention registry on venous thromboembolism (IMPROVE) for medical patients in a tertiary health system. J Am Heart Assoc. 2014;3(6).
  24. Spyropoulos AC, Cohen SL, Gianos E, Kohn N, Giannis D, Chatterjee S, et al. Validation of the IMPROVE-DD risk assessment model for venous thromboembolism among hospitalized patients with COVID-19. Res Pract Thromb Haemost. 2021 Feb 1;5(2):296–300.
  25. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373(9676):1673–80.
  26. Papadaki S, Tselepis AD. Nonhemostatic Activities of Factor Xa: Are There Pleiotropic Effects of Anti-FXa Direct Oral Anticoagulants? Vol. 70, Angiology. SAGE Publications Inc.; 2019. p. 896–907.