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.
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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, Maleki Majid, Sadeghian Saeed, Piazza Gregory, Kirtane Ajay J, Van Tassell Benjamin W, Stone Gregg W, Lip Gregory Y H, Krumholz Harlan M, Goldhaber Samuel Z, Sadeghipour Parham
Аннотация
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.