Behnood Bikdeli1,2,3, Azita H Talasaz4, Farid Rashidi5, Hooman Bakhshandeh6,7, Farnaz Rafiee7, Parisa Rezaeifar5, Elahe Baghizadeh7, Samira Matin5, Sepehr Jamalkhani8, Ouria Tahamtan5, Babak Sharif-Kashani9,10, Mohammad Taghi Beigmohammadi11, Mohsen Farrokhpour12, Seyed Hashem Sezavar13, Pooya Payandemehr14, Ali Dabbagh15, Keivan Gohari Moghadam16, Hossein Khalili17, Mahdi Yadollahzadeh12, Taghi Riahi18, Atefeh Abedini19, Somayeh Lookzadeh19, Hamid Rahmani20, Elnaz Zoghi21, Keyhan Mohammadi21, Pardis Sadeghipour12, Homa Abri12, Sanaz Tabrizi18, Seyed Masoud Mousavian18, Shaghayegh Shahmirzaei14, Ahmad Amin7, Bahram Mohebbi22, Seyed Ehsan Parhizgar7, Rasoul Aliannejad23,24, Vahid Eslami25, Alireza Kashefizadeh26, Paul P Dobesh27, Hessam Kakavand21, Seyed Hossein Hosseini21, Shadi Shafaghi10, Samrand Fattah Ghazi11, Atabak Najafi14, David Jimenez28,29,30, Aakriti Gupta2,3,31, Mahesh V Madhavan3,31, Sanjum S Sethi3,31, Sahil A Parikh3,31, Manuel Monreal32,33, Naser Hadavand7, Alireza Hajighasemi4, Majid Maleki7, Saeed Sadeghian4, Gregory Piazza1, Ajay J Kirtane3,31, Benjamin W Van Tassell34,35, Gregg W Stone3,36, Gregory Y H Lip37,38, Harlan M Krumholz2,39,40, Samuel Z Goldhaber1, Parham Sadeghipour6,7,21. 1. Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States. 2. Yale/YNHH Center for Outcomes Research and Evaluation, New Haven, Connecticut, United States. 3. Cardiovascular Research Foundation, New York, New York, United States. 4. Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran. 5. Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 6. Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran. 7. Rajaie Cardiovascular Medical and Research Center, Iran university of Medical Sciences, Tehran, Iran. 8. Student Research Committee, Iran University of Medical Sciences, Tehran, Iran. 9. Tobacoo Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 10. Department of Cardiology, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 11. Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. 12. Department of Internal Medicine, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran. 13. Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran. 14. Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. 15. Department of Anesthesiology, School of Medicine Anesthesiology Research Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 16. Department of Internal Medicine, School of Medicine, Shariati Hospital, Tehran, Iran. 17. Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. 18. Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran. 19. Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 20. Department of Pharmacotherapy, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran. 21. School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. 22. Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran. 23. Department of Pulmonary and Critical Care, School of Medicine, Shariati Hospital, Tehran, Iran. 24. Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran. 25. Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 26. Shahid Dr. Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 27. College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska, United States. 28. Respiratory Department, Hospital Ramón y Cajal, Madrid, Spain. 29. Medicine Department, Universidad de Alcalá, Madrid, Spain. 30. CIBER Enfermedades Respiratorias, Madrid, Spain. 31. Division of Cardiology, Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States. 32. Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. 33. Universidad Católica de Murcia, Murcia, Spain. 34. Department of Pharmacotherapy and Outcome Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, United States. 35. Division of Cardiology, Department of Internal Medicine, Pauley Heart Center, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, United States. 36. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States. 37. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. 38. Aalborg University, Aalborg, Denmark. 39. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States. 40. Department of Health Policy and Administration, Yale School of Public Health, New Haven, Connecticut, United States.
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. Thieme. All rights reserved.
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. Thieme. All rights reserved.
Authors: Ronald Lg Flumignan; Vinicius T Civile; Jéssica Dantas de Sá Tinôco; Patricia If Pascoal; Libnah L Areias; Charbel F Matar; Britta Tendal; Virginia Fm Trevisani; Álvaro N Atallah; Luis Cu Nakano Journal: Cochrane Database Syst Rev Date: 2022-03-04
Authors: Azita H Talasaz; Parham Sadeghipour; Maryam Aghakouchakzadeh; Hessam Kakavand; Hamid Ariannejad; Jean M Connors; Beverley J Hunt; Jeffrey S Berger; Benjamin W Van Tassell; Saskia Middeldorp; Gregory Piazza; Jeffrey I Weitz; Mary Cushman; Gregory Y H Lip; Samuel Z Goldhaber; Behnood Bikdeli Journal: J Thromb Haemost Date: 2021-09-30 Impact factor: 5.824
Authors: Sam Schulman; Michelle Sholzberg; Alex C Spyropoulos; Ryan Zarychanski; Helaine E Resnick; Charlotte A Bradbury; Lisa Broxmeyer; Jean Marie Connors; Anna Falanga; Toshiaki Iba; Scott Kaatz; Jerrold H Levy; Saskia Middeldorp; Tracy Minichiello; Eduardo Ramacciotti; Charles Marc Samama; Jecko Thachil Journal: J Thromb Haemost Date: 2022-07-29 Impact factor: 16.036
Authors: Innocent G Asiimwe; Sudeep P Pushpakom; Richard M Turner; Ruwanthi Kolamunnage-Dona; Andrea L Jorgensen; Munir Pirmohamed Journal: Br J Clin Pharmacol Date: 2022-04-25 Impact factor: 3.716