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Intermediate-Dose Versus Standard-Dose Prophylactic Anticoagulation in Patients With Covid-19 Admitted to the Intensive Care Unit: 90-Day Results From the Inspiration Randomized Trial Publisher Pubmed



Bikdeli B1, 2, 3 ; Talasaz AH4 ; Rashidi F5 ; Bakhshandeh H6, 7 ; Rafiee F7 ; Rezaeifar P5 ; Baghizadeh E7 ; Matin S5 ; Jamalkhani S8 ; Tahamtan O5 ; Sharifkashani B9, 10 ; Beigmohammadi MT11 ; Farrokhpour M12 ; Sezavar SH13 Show All Authors
Authors
  1. Bikdeli B1, 2, 3
  2. Talasaz AH4
  3. Rashidi F5
  4. Bakhshandeh H6, 7
  5. Rafiee F7
  6. Rezaeifar P5
  7. Baghizadeh E7
  8. Matin S5
  9. Jamalkhani S8
  10. Tahamtan O5
  11. Sharifkashani B9, 10
  12. Beigmohammadi MT11
  13. Farrokhpour M12
  14. Sezavar SH13
  15. Payandemehr P14
  16. Dabbagh A15
  17. Moghadam KG16
  18. Khalili H17
  19. Yadollahzadeh M12
  20. Riahi T18
  21. Abedini A19
  22. Lookzadeh S19
  23. Rahmani H20
  24. Zoghi E21
  25. Mohammadi K21
  26. Sadeghipour P12
  27. Abri H12
  28. Tabrizi S18
  29. Mousavian SM18
  30. Shahmirzaei S14
  31. Amin A7
  32. Mohebbi B22
  33. Parhizgar SE7
  34. Aliannejad R23, 24
  35. Eslami V25
  36. Kashefizadeh A26
  37. Dobesh PP27
  38. Kakavand H21
  39. Hosseini SH21
  40. Shafaghi S10
  41. Ghazi SF11
  42. Najafi A14
  43. Jimenez D28, 29, 30
  44. Gupta A2, 3, 31
  45. Madhavan MV3, 31
  46. Sethi SS3, 31
  47. Parikh SA3, 31
  48. Monreal M32, 33
  49. Hadavand N7
  50. Hajighasemi A4
  51. Maleki M7
  52. Sadeghian S4
  53. Piazza G1
  54. Kirtane AJ3, 31
  55. Van Tassell BW34, 35
  56. Stone GW3, 36
  57. Lip GYH37, 38
  58. Krumholz HM2, 39, 40
  59. Goldhaber SZ1
  60. Sadeghipour P12

Source: Thrombosis and Haemostasis Published:2021


Abstract

Background  Thrombotic complications are considered among the main extrapulmonary manifestations of coronavirus disease 2019 (COVID-19). The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods  This article reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results  Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]: 62 [50, 71] years; 237 [42.2%] women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, p = 0.11). Findings were similar for other efficacy outcomes, and in the landmark analysis from days 31 to 90 (HR: 1.59, 95% CI: 0.45-5.06). There were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24). Conclusion  Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up. © 2021. Thieme. All rights reserved.
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