Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
SummaryVenous thromboembolism is a leading cause of in-hospital postoperative morbidity and mortality. Postoperative deep vein thrombosis (DVT) is usually asymptomatic. A number of studies have consistently shown that the non invasive diagnostic methods are inaccurate in the screening of asymptomatic DVT. Failure of non invasive diagnostic methods to detect thrombi in asymptomatic patients has been suggested to be due to the features of thrombi in these patients. The aim of this study was to assess the distribution and the occlusiveness of thrombi in a series of 321 asymptomatic hip surgery patients with adequate bilateral venography of the lower limbs.Venography was performed 10 ± 1 days after hip surgery. DVT was found in 180 limbs (28.0%). The distribution of thrombi was as follows: 26 (14.4%) isolated proximal thrombi, 55 (30.6%) proximal and distal thrombi, 99 (55.0%) isolated calf thrombi. We found that 14 of the 81 proximal trombi (17.3%) involved the superficial femoral vein either as exclusive location or in association with calf veins. An involvement of common femoral, superficial femoral and popliteal vein was observed in 37 (45.7%), 39 (48.1%) and 44 (54.3%) cases of the 91 proximal DVT. These thrombi were non occlusive in 25 (67.6%), 22 (56.4%) and 26 (59.1%) limbs, respectively. An involvement of at least one peroneal, anterior tibial and posterior tibial veins was observed in 118,13 and 89 cases of the 220 distal thrombi. These thrombi were non occlusive in 61 (51.7%), 10 (76.9%) and 30 (33.7%) of the cases.We conclude that the majority of thrombi found in asymptomatic hip surgery patients are non occlusive. In view of this, non invasive diagnostic methods based upon venous flow measurement will be unlikely to improve the diagnosis of asymptomatic DVT. The high incidence of isolated superficial femoral vein thrombosis necessitates that real-time B-mode ultrasonography should be performed examining the entire proximal venous system.
The novel SARS-CoV-2 virus has led to a severe pandemic, starting from early 2020. Intensive care (ICU) management of the COVID-19 disease is difficult with high morbidity and mortality. Early nutritional support, especially with whey protein, seems to be crucial in this medical case. Thus, we aimed to assess the effects of an adequate nutritional protocol rich in whey protein on nutritional and inflammatory status, extubating time, and mortality of critically ill COVID-19 patients (CICP). Methods: A prospective single-center exploratory observational study was undertaken on 32 consecutive CICP admitted to the ICU of Santa Maria Hospital, Terni, Italy, and treated with whey protein-enriched formula. Patients’ demographics, nutritional status, indexes of inflammation, daily pre-albumin serum levels, duration of mechanical ventilation, and mortality were recorded. Results: Thirty-two patients were enrolled. Ninety-five percent of them showed a gradual reduction in C-reactive protein (CRP) values and increase in pre-albumin levels after the whey protein-enriched formula. Prealbumin levels were not correlated with a better nutritional status but with a shorter extubating time and better survival. Conclusions: An adequate administration of whey protein during COVID-19 patients’ ICU stays can provide fast achievement of protein targets, reducing the duration of mechanical ventilation, and improving inflammatory status and ICU survival. Further prospective and large-scale, controlled studies are needed to confirm these results.
Background The accuracy of currently available bleeding scores in patients on treatment with direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) is undefined. Purpose In a prospective cohort of patients with VTE treated with DOACs, we evaluated the accuracy of the ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED risk scores in predicting major bleeding (according to ISTH definition). Methods The accuracy of different scores to correctly classify subjects into a defined risk category was assessed by the c-statistic. Results Overall, 1141 patients were evaluated and 1034 included in the study. The index event was pulmonary embolism in 509 patients (49.2%) and proximal deep vein thrombosis in the remaining patients (50.8%). During the 12-month study period, 26 major bleedings occurred in 25 patients (2.8% patient-year): 14 major bleedings occurred in the first 6 months of treatment and 12 from 6 to 12 months in the 654 patients remained on treatment. In the 12-month study period, the VTE-BLEED score showed the best predictive value for bleeding complications (c-statistics 0.674, 95% CI 0.593–0.755). The lowest incidence of major bleeding (0.3%) was observed in the low risk category of VTE-BLEED which includes 38% of patients. The highest incidence of major bleeding (7.1%) was observed in the high-risk category of ORBIT which includes 10.9% of patients. Conclusions The VTE-BLEED score had the best accuracy in predicting major bleeding during treatment with DOACs for VTE. Whether the VTE-BLEED score can be used for decision making on anticoagulation should be tested in a management study.
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