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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.
Bikdeli, Behnood; Talasaz, Azita H; Rashidi, Farid; Bakhshandeh, Hooman; Rafiee, Farnaz; Rezaeifar, Parisa; Baghizadeh, Elahe; Matin, Samira; Jamalkhani, Sepehr; Tahamtan, Ouria; Sharif-Kashani, Babak; Beigmohammadi, Mohammad Taghi; Farrokhpour, Mohsen; Sezavar, Seyed Hashem; Payandemehr, Pooya; Dabbagh, Ali; Moghadam, Keivan Gohari; Khalili, Hossein; Yadollahzadeh, Mahdi; Riahi, Taghi; Abedini, Atefeh; Lookzadeh, Somayeh; Rahmani, Hamid; Zoghi, Elnaz; Mohammadi, Keyhan; Sadeghipour, Pardis; Abri, Homa; Tabrizi, Sanaz; Mousavian, Seyed Masoud; Shahmirzaei, Shaghayegh; Amin, Ahmad; Mohebbi, Bahram; Parhizgar, Seyed Ehsan; Aliannejad, Rasoul; Eslami, Vahid; Kashefizadeh, Alireza; Dobesh, Paul P; Kakavand, Hessam; Hosseini, Seyed Hossein; Shafaghi, Shadi; Ghazi, Samrand Fattah; Najafi, Atabak; Jimenez, David; Gupta, Aakriti; Madhavan, Mahesh V; Sethi, Sanjum S; Parikh, Sahil A; Monreal, Manuel; Hadavand, Naser; Hajighasemi, Alireza.
  • Bikdeli B; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.
  • Talasaz AH; Yale/YNHH Center for Outcomes Research and Evaluation, New Haven, Connecticut, United States.
  • Rashidi F; Cardiovascular Research Foundation, New York, New York, United States.
  • Bakhshandeh H; Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Rafiee F; Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Rezaeifar P; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.
  • Baghizadeh E; Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran.
  • Matin S; Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran.
  • Jamalkhani S; Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Tahamtan O; Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran.
  • Sharif-Kashani B; Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Beigmohammadi MT; Student Research Committee, Iran University of Medical Sciences, Tehran, Iran.
  • Farrokhpour M; Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Sezavar SH; Tobacoo Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Payandemehr P; Department of Cardiology, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Dabbagh A; Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Moghadam KG; Department of Internal Medicine, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Khalili H; Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
  • Yadollahzadeh M; Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Riahi T; Department of Anesthesiology, School of Medicine Anesthesiology Research Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Abedini A; Department of Internal Medicine, School of Medicine, Shariati Hospital, Tehran, Iran.
  • Lookzadeh S; Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Rahmani H; Department of Internal Medicine, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Zoghi E; Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Mohammadi K; Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Sadeghipour P; Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Abri H; Department of Pharmacotherapy, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.
  • Tabrizi S; School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Mousavian SM; School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Shahmirzaei S; Department of Internal Medicine, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Amin A; Department of Internal Medicine, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Mohebbi B; Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Parhizgar SE; Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Aliannejad R; Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Eslami V; Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran.
  • Kashefizadeh A; Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.
  • Dobesh PP; Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran.
  • Kakavand H; Department of Pulmonary and Critical Care, School of Medicine, Shariati Hospital, Tehran, Iran.
  • Hosseini SH; Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Shafaghi S; Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Ghazi SF; Shahid Dr. Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Najafi A; College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska, United States.
  • Jimenez D; School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Gupta A; School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Madhavan MV; Department of Cardiology, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Sethi SS; Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Parikh SA; Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Monreal M; Respiratory Department, Hospital Ramón y Cajal, Madrid, Spain.
  • Hadavand N; Medicine Department, Universidad de Alcalá, Madrid, Spain.
  • Hajighasemi A; CIBER Enfermedades Respiratorias, Madrid, Spain.
Thromb Haemost ; 122(1): 131-141, 2022 01.
Article in English | MEDLINE | ID: covidwho-1258614
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / Enoxaparin / SARS-CoV-2 / COVID-19 Drug Treatment / Anticoagulants Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: Thromb Haemost Year: 2022 Document Type: Article Affiliation country: A-1485-2372

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / Enoxaparin / SARS-CoV-2 / COVID-19 Drug Treatment / Anticoagulants Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: Thromb Haemost Year: 2022 Document Type: Article Affiliation country: A-1485-2372