To evaluate the effect of hospitalization on deep venous thrombosis (DVT) rate by the cumulative incidence of DVT in the proximal venous tract of the lower limbs at admission and discharge.
The ...AURELIO (rAte of venoUs thRombosis in acutEly iLl patIents hOspitalized in internal medicine wards) multicenter observational study was carried out in hospital-university internal medicine wards including consecutive acutely ill medical patients. Patients underwent compression ultrasonography (CUS) of proximal lower limb veins at admission and discharge. The occurrence of DVT was the primary end point of the study.
Among 1340 patients, 26 (1.9%; 95% CI, 1.3%-2.8%) had asymptomatic DVT at admission and were excluded. During the follow-up, 144 patients were excluded because of hospitalization less than 5 days. The remaining 1170 patients underwent a CUS at discharge. Two hundred fifty (21%) underwent prophylaxis with parenteral anticoagulants; the remaining 920 (79%) were not treated with anticoagulants. The mean length of hospitalization was 13±8 days. Compared with patients without prophylaxis, those treated with parenteral anticoagulants had a higher incidence of active cancer, heart and respiratory failure, pneumonia, renal failure, previous venous thromboembolism, reduced mobility, and elderly age. During the hospital stay, 3 patients with a negative CUS at admission experienced DVT in the proximal tract (0.025%, rate of 1 per 5017 patient-days); 2 of them were in prophylaxis with parenteral anticoagulants.
We provide evidence that in the real world acutely ill medical patients display more than 90% (1.9%) asymptomatic DVT at admission, whereas the intrahospital DVT occurrence is very low. This suggests a novel diagnostic workup and a careful reanalysis of anticoagulant prophylaxis.
Acutely ill medical patients experience deep venous thrombosis (DVT) during the hospitalization, however the time course of DVT is still unclear.
To evaluate risk factors in acutely ill hospitalized ...medical patients for proximal asymptomatic DVT (ADVT) and symptomatic DVT (SDVT) at admission and discharge.
In this prospective observational study, consecutive acutely ill medical patients (hospitalized mainly for acute medical disease as infections, neoplasm, anemia, heart failure) underwent compression ultrasonography (CUS) of proximal lower limb veins within 48 h from admission and at discharge to diagnose ADVT and SDVT. Covid-19 patients, anticoagulant therapy, surgical procedures, acute SDVT, and acute pulmonary embolism, were exclusion criteria. Biographical characteristics at hospitalization, D-Dimer (assessed by ELISA)) and DD-improve score.
Of 2,100 patients (1002 females, 998 males, age 71 ± 16 years) 58 (2.7%) had proximal ADVT at admission. Logistic regression analysis showed that age, and active cancer were independently associated with ADVT at admission. The median length of hospitalization was 10 days interquartile range: 6-15. During the hospital stay, 6 patients (0.3%) with a negative CUS at admission experienced DVT (2 SDVT and 4 ADVT). In the subgroup of patients (n = 1118), in whom D-dimer was measured at admission, D-Dimer and IMPROVE-DD score were associated with ADVT at admission (n = 37) and with all DVT (n = 42) at discharge. ROC curve defined an IMPROVE-DD score of 2.5 as the optimal cut-off for discriminating patients with and without thrombotic events.
We provide evidence of early development of ADVT in unselected acutely ill medical patients suggesting the need of investigating patients by CUS immediately after hospital admission (within 48 h). Advanced age, active cancer, known thrombophilia and increased IMPROVE-DD score may identify patients at risk. The benefit of anticoagulation needs to be investigated in patients with these specific risk factors and negative CUS at admission.
NCT03157843.
•A relationship between high baseline DOAC levels and early bleeding events in 1-year follow-up was found.•Early measurement allows to identify patients with high DOAC levels and, hopefully, to ...adjust treatment to reduce bleeding events.
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Treatment with direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) is effective and safe. However, bleeding complications still occur. Whether DOAC level measurement may further improve treatment efficacy and safety is still an open issue. In the "Measure and See" Study venous blood was collected 15-30 days after DOAC initiation in AF patients who were then followed-up for 1 year to record the occurrence of major and clinically relevant nonmajor bleeding. DOAC plasma levels were measured in 1 laboratory, and results were kept blind to patients and treating doctors. Trough DOAC levels were assessed in 1657 patients (957 57.7% and 700 patients treated with standard and low-dose, respectively). Fifty bleeding events were recorded during 1606 years of follow-up (3.11% pt/yrs). Fifteen bleeding events (4.97% pt/yrs) occurred in patients with C-trough standardized values in the highest activity class (>0.50); whereas 35 events (2.69% pt/yrs) occurred in those with values in the 2 lower classes (≤0.50, P = .0401). Increasing DOAC levels and low-dose DOAC use were associated with increased bleeding risk in the first 3 months of treatment. Overall, 19% of patients receiving low doses had standardized values in the highest class. More bleeding occurred in patients on low (4.3% pt/yrs) vs standard (2.2% pt/yrs; P = .0160) dose DOAC. Early measurement of DOAC levels in AF patients identified many individuals with high levels despite the low doses use and had more bleeding risk during the first 3 months of treatment. This trial was registered at www.ClinicalTrials.gov as #NCT03803579.
•A relationship between low baseline DOAC levels and thrombotic events in 1-year follow-up was found.•Early measurement allows the identification of patients with low DOAC levels and treatment ...adjustment to avoid future thrombotic events.
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Although effective and safe, treatment with direct oral anticoagulants (DOAC) in atrial fibrillation (AF) is still associated with thrombotic complications. Whether the measurement of DOAC levels may improve treatment efficacy is an open issue. We carried out the observational, prospective, multicenter Measure and See (MAS) study. Blood was collected 15 to 30 days after starting DOAC treatment in patients with AF who were followed-up for 1 year. Plasma samples were centralized for DOAC level measurement. Patients’ DOAC levels were converted into drug/dosage standardized values to allow a pooled analysis in a time-dependent, competitive-risk model. The measured values were transformed into standardized values (representing the distance of each value from the overall mean) by subtracting the DOAC-specific mean value from the original values and dividing by the standard deviation. Trough and peak DOAC levels were assessed in 1657 and 1303 patients, respectively. In total, 21 thrombotic complications were recorded during 1606 years of follow-up (incidence of 1.31% of patients per year). Of 21 thrombotic events, 17 occurred in patients whose standardized activity levels were below the mean of each DOAC (0); the incidence was the highest (4.82% of patients per year) in patients whose standardized values were in the lowest class (−1.00 or less). Early measurement of DOAC levels in patients with AF allowed us to identify most of the patients who, having low baseline DOAC levels, subsequently developed thrombotic complications. Further studies are warranted to assess whether thrombotic complications may be reduced by measuring baseline DOAC levels and modifying treatment when indicated. This trial was registered at www.ClinicalTrials.gov as #NCT03803579.
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