Background: Low-molecular-weight heparin is the guideline-endorsed treatment for cancer-associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, limited data support its use in cancer patients. Objectives:The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding (CRNMB). Patients/Methods:Patients with cancer-associated VTE were randomly assigned to receive either apixaban 10 mg twice daily for seven days followed by 5 mg twice daily for six months or subcutaneous dalteparin (200 IU/kg for one month followed by 150 IU/kg once daily). Results:Of 300 patients randomized, 287 were included in the primary analysis.Metastatic disease was present in 66% of subjects; 74% were receiving concurrent chemotherapy. Major bleeding occurred in 0% of 145 patients receiving apixaban,
A higher risk of thrombosis has been described as a prominent feature of COVID-19. This systematic review synthesizes current data on thrombosis risk, prognostic implications, and anticoagulation effects in COVID-19. We included 37 studies from 4,070 unique citations. Meta-analysis was performed when feasible. Coagulopathy and thrombotic events were frequent among patients with COVID-19, and further increased in those with more severe forms of the disease. We also present guidance on the prevention and management of thrombosis from a multidisciplinary panel of specialists from the Mayo Clinic. The current certainty of evidence is generally very low, and continues to evolve.
To provide direct comparison between apixaban and rivaroxaban in patients with acute cancer‐associated venous thromboembolism (Ca‐VTE), consecutive patients treated with apixaban, rivaroxaban, or enoxaparin at Mayo Thrombophilia Clinic (March 1, 2013 to January 31, 2018)) were followed prospectively. The primary effectiveness outcome was venous thromboembolism (VTE) recurrence, and the secondary was mortality. The primary safety outcome was major bleeding, the secondary clinically relevant safety outcome was non‐major bleeding (CRNMB), and the third a composite of major and CRNMB. There were 750 patients treated for acute Ca‐VTE with apixaban (n = 224), rivaroxaban (n = 163), and enoxaparin (n = 363) within 14 days of diagnosis and for at least 3 months, or until study event. Recurrent VTE was diagnosed in 11 receiving apixaban, 7 receiving rivaroxaban (apixaban vs rivaroxaban hazard ratio (HR) 1.31, 95% confidence interval (95% CI) 0.51‐3.36) and 17 in the enoxaparin receiving group (apixaban vs enoxaparin HR 1.14, 95% CI: 0.54, 2.42 and rivaroxaban vs enoxaparin HR 0.85, 95% Cl: 0.36, 2.06). There were 82 deaths in apixaban, 74 rivaroxaban (apixaban vs rivaroxaban HR 1.67, 95% Cl: 1.20, 2.33) and 171 in enoxaparin group (rivaroxaban vs enoxaparin HR 0.73, 95% Cl: 0.56, 0.96). Major bleeding occurred in 11 apixaban, 12 rivaroxaban (apixaban vs rivaroxaban HR 0.73, 95% Cl: 0.32, 1.66) and 21 enoxaparin group (apixaban vs enoxaparin HR 0.89, 95% Cl: 0.43, 1.84 and rivaroxaban vs enoxaparin HR 1.23, 95% Cl: 0.61, 2.50). The CRNMB rate was higher in rivaroxaban compared to apixaban (P = .03) and LMWH (P = .01) groups. Recurrence of VTE and major bleeding were similar in apixaban, rivaroxaban, and enoxaparin groups. Rivaroxaban was associated with higher CRNMB but lower mortality compared to apixaban and enoxaparin.
Objective To evaluate differences in thrombo-inflammatory biomarkers between patients with severe COVID-19 infection/death and mild infection. Patients and Methods Medline, Cochrane Central Register of Controlled Trials, Embase, EBSCO, Web of Science, and CINAHL databases were searched for studies comparing thrombo-inflammatory biomarkers in COVID-19 among severe/non-survivors and non-severe/survivors from January 1, 2020 through July 11, 2020. Inclusion criteria: (1) hospitalized patients ≥18 years comparing severe/non-survivors vs. non-severe/survivors; (2) biomarkers of inflammation and/or thrombosis. A random-effects model was used to estimate the weighted mean difference (WMD) between the two groups of COVID-19 severity. Results Seventy-five studies were included (17,052 patients). Patients with severe COVID-19/non-survivors were older, a greater proportion were men, had a higher prevalence of hypertension, diabetes, cardiac or cerebrovascular disease, chronic kidney disease, malignancy, and COPD. The thrombo-inflammatory biomarkers were significantly higher in patients with severe disease including D-dimer (WMD 0.60, 0.49-0.71, I 2 =83.85%), fibrinogen (WMD 0.42, 0.18-0.67, I 2 =61.88%, p<0.001), CRP (WMD 35.74, 30.16-41.31, I 2 =85.27%), high sensitivity-CRP (WMD 62.68, 45.27-80.09, I 2 =0%), Interleukin-6 (WMD 22.81, 17.90-27.72, I 2 =90.42%) and, ferritin (WMD 506.15, 356.24-656.06, I 2 =52.02%). Moderate to significant heterogeneity was observed for all parameters. Sub-analysis based on disease severity, mortality, and geographic region of studies demonstrated similar inferences. Conclusions Thrombo-inflammatory biomarkers (D-dimer, Fibrinogen, CRP, hs-CRP, ferritin, and IL-6) and marker of end-organ damage (hs-Troponin I) are associated with increased severity and mortality in COVID-19 infection.
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