ABSTRACT
BACKGROUND: In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days. METHODS: This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale. RESULTS: In the primary analysis, 587 patients were included (age: 57 [Q1-Q3: 45-68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60-1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42-0.86, p interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal: 0.64, 95% CI: 0.41-1.01, p = 0.05). CONCLUSION: Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset (NCT04486508).
Subject(s)
COVID-19 , Thrombosis , Adult , Humans , Female , Middle Aged , Male , Atorvastatin/therapeutic use , Treatment Outcome , Thrombosis/drug therapy , Intensive Care Units , Double-Blind MethodABSTRACT
BACKGROUND: Recent studies have utilized MRI to determine the extent to which COVID-19 survivors may experience cardiac sequels after recovery. PURPOSE: To systematically review the main cardiac MRI findings in COVID-19 adult survivors. STUDY TYPE: Systematic review. SUBJECTS: A total of 2954 COVID-19 adult survivors from 16 studies. FIELD STRENGTH/SEQUENCE: Late gadolinium enhancement (LGE), parametric mapping (T1-native, T2, T1-post (extracellular volume fraction [ECV]), T2-weighted sequences (myocardium/pericardium), at 1.5 T and 3 T. ASSESSMENT: A systematic search was performed on PubMed, Embase, and Google scholar databases using Boolean operators and the relevant key terms covering COVID-19, cardiac injury, CMR, and follow-up. MRI data, including (if available) T1, T2, extra cellular volume, presence of myocardial or pericardial late gadolinium enhancement (LGE) and left and right ventricular ejection fraction were extracted. STATISTICAL TESTS: The main results of the included studies are summarized. No additional statistical analysis was performed. RESULTS: Of 1601 articles retrieved from the initial search, 12 cohorts and 10 case series met our eligibility criteria. The rate of raised T1 in COVID-19 adult survivors varied across studies from 0% to 73%. Raised T2 was detected in none of patients in 4 out of 15 studies, and in the remaining studies, its rate ranged from 2% to 60%. In most studies, LGE (myocardial or pericardial) was observed in COVID-19 survivors, the rate ranging from 4% to 100%. Myocardial LGE mainly had nonischemic patterns. None of the cohort studies observed myocardial LGE in "healthy" controls. Most studies found that patients who recovered from COVID-19 had a significantly greater T1 and T2 compared to participants in the corresponding control group. DATA CONCLUSION: Findings of MRI studies suggest the presence of myocardial and pericardial involvement in a notable number of patients recovered from COVID-19. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 3.