Trattamento del tromboembolismo venoso con anticoagulanti tradizionali e di nuova generazione.

The paradigm of treatment of acute venous thromboembolism (VTE) has been recently challenged by the new direct oral anticoagulants (DOACs). The aim of the research project was to evaluate the impact of DOACs on the management of pulmonary embolism (PE), isolated distal deep vein thrombosis (IDDVT) and bleeding. The approval process of DOACs was delayed in Italy and did not include IDDVT and, until 2015, PE. Therefore, the projects underwent some changes, with the aim of building solid bases for subsequent studies that will adopt DOACs. The project on PE was focused on the prognostic stratification, by applying the Pulmonary Embolism Severity Index (PESI). The results of the study showed a 2 days significant difference of the median duration of hospital stay between low risk vs. high risk patients, as identified retrospectively by PESI. However, this difference has little clinical significance and led to hypothesize that prospectively adopting PESI may have a significant impact. With regards to IDDVT, a retrospective study was performed on 321 patients, who were treated with a short course of anticoagulation. The results showed a non negligible 15% rate of recurrent VTE events. Therefore, many cases of IDDVT should be considered in the context of major VTE and may benefit from an extended treatment. Finally, the management of anticoagulant-associated bleeding was explored in a literature review and includes general resuscitation, diagnosis and local treatment of the bleeding source, as well as transfusion of red cells, clotting factor replacements and administration of antidotes and other prohaemostatic agents. Reversal strategies for the ‘conventional’ anticoagulants are based on clinical evidence, whereas evidence on DOACs is emergin

Trattamento del tromboembolismo venoso con anticoagulanti tradizionali e di nuova generazione.

The paradigm of treatment of acute venous thromboembolism (VTE) has been recently challenged by the new direct oral anticoagulants (DOACs). The aim of the research project was to evaluate the impact of DOACs on the management of pulmonary embolism (PE), isolated distal deep vein thrombosis (IDDVT) and bleeding. The approval process of DOACs was delayed in Italy and did not include IDDVT and, until 2015, PE. Therefore, the projects underwent some changes, with the aim of building solid bases for subsequent studies that will adopt DOACs. The project on PE was focused on the prognostic stratification, by applying the Pulmonary Embolism Severity Index (PESI). The results of the study showed a 2 days significant difference of the median duration of hospital stay between low risk vs. high risk patients, as identified retrospectively by PESI. However, this difference has little clinical significance and led to hypothesize that prospectively adopting PESI may have a significant impact. With regards to IDDVT, a retrospective study was performed on 321 patients, who were treated with a short course of anticoagulation. The results showed a non negligible 15% rate of recurrent VTE events. Therefore, many cases of IDDVT should be considered in the context of major VTE and may benefit from an extended treatment. Finally, the management of anticoagulant-associated bleeding was explored in a literature review and includes general resuscitation, diagnosis and local treatment of the bleeding source, as well as transfusion of red cells, clotting factor replacements and administration of antidotes and other prohaemostatic agents. Reversal strategies for the \u2018conventional\u2019 anticoagulants are based on clinical evidence, whereas evidence on DOACs is emergin

Antithrombotic treatment of retinal vein occlusion: a position statement from the Italian Society on Thrombosis and Haemostasis (SISET)

Retinal vein occlusion (RVO) represents a common cause of visual impairment and blindness. RVO may be associated with both local (e.g., hyperopia, glaucoma) and systemic (e.g., hypertension, diabetes, smoking, obesity, and dyslipidaemia) risk factors. The association with thrombophilia remains controversial. Data on the use of antithrombotic therapy for RVO are poor and inconsistent with most of the information being derived from observational studies. Here we provide a position statement from the Italian Society on Thrombosis and Haemostasis (SISET) to guide the clinical and therapeutic management of patients with RVO based on the available evidence and expert opinion

The Clinical Impact of the Pulmonary Embolism Severity Index on the Length of Hospital Stay of Patients with Pulmonary Embolism: A Randomized Controlled Trial.

BACKGROUND The Pulmonary Embolism Severity Index (PESI) is an extensively validated prognostic score, but impact analyses of the PESI on management strategies, outcomes and health care costs are lacking. Our aim was to assess whether the adoption of the PESI for patients admitted to an internal medicine ward has the potential to safely reduce the length of hospital stay (LOS). METHODS We carried out a multicenter randomized controlled trial, enrolling consecutive adult outpatients diagnosed with acute PE and admitted to an internal medicine ward. Within 48 h after diagnosis, the treating physicians were randomized, for every patient, to calculate and report the PESI in the clinical record form on top of the standard of care (experimental arm) or to continue routine clinical practice (standard of care). The ClinicalTrials.gov identifier is NCT03002467. RESULTS This study was prematurely stopped due to slow recruitment. A total of 118 patients were enrolled at six internal medicine units from 2016 to 2019. The treating physicians were randomized to the use of the PESI for 59 patients or to the standard of care for 59 patients. No difference in the median LOS was found between the experimental arm (8, IQR 6-12) and the standard-of-care arm (8, IQR 6-12) (p = 0.63). A pre-specified secondary analysis showed that the LOS was significantly shorter among the patients who were treated with DOACs (median of 8 days, IQR 5-11) compared to VKAs or heparin (median of 9 days, IQR 7-12) (p = 0.04). CONCLUSIONS The formal calculation of the PESI in the patients already admitted to internal medicine units did not impact the length of hospital stay

Rivaroxaban for the treatment of noncirrhotic splanchnic vein thrombosis: an interventional prospective cohort study.

Heparins and vitamin K antagonists are the mainstay of treatment of splanchnic vein thrombosis (SVT). Rivaroxaban is a potential alternative, but data to support its use are limited. We aimed to evaluate the safety and efficacy of rivaroxaban for the treatment of acute SVT. In an international, single-arm clinical trial, adult patients with a first episode of noncirrhotic, symptomatic, objectively diagnosed SVT received rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg daily for an intended duration of 3 months. Patients with Budd-Chiari syndrome and those receiving full-dose anticoagulation for >7 days prior to enrollment were excluded. Primary outcome was major bleeding; secondary outcomes included death, recurrent SVT, and complete vein recanalization within 3 months. Patients were followed for a total of 6 months. A total of 103 patients were enrolled; 100 were eligible for the analysis. Mean age was 54.4 years; 64% were men. SVT risk factors included abdominal inflammation/infection (28%), solid cancer (9%), myeloproliferative neoplasms (9%), and hormonal therapy (9%); 43% of cases were unprovoked. JAK2 V617F mutation was detected in 26% of 50 tested patients. At 3 months, 2 patients (2.1%; 95% confidence interval, 0.6-7.2) had major bleeding events (both gastrointestinal). One (1.0%) patient died due to a non-SVT-related cause, 2 had recurrent SVT (2.1%). Complete recanalization was documented in 47.3% of patients. One additional major bleeding event and 1 recurrent SVT occurred at 6 months. Rivaroxaban appears as a potential alternative to standard anticoagulation for the treatment of SVT in non-cirrhotic patients. This trial was registered at www.clinicaltrials.gov as #NCT02627053 and at eudract.ema.europa.eu as #2014-005162-29-36

Prediction Scores Do Not Correlate with Clinically Adjudicated Categories of Pulmonary Embolism in Critically Ill Patients

Copyright © 2014 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.BACKGROUND: Prediction scores for pretest probability of pulmonary embolism (PE) validated in outpatient settings are occasionally used in the intensive care unit (ICU).OBJECTIVE: To evaluate the correlation of Geneva and Wells scores with adjudicated categories of PE in ICU patients.METHODS: In a randomized trial of thromboprophylaxis, patients with suspected PE were adjudicated as possible, probable or definite PE. Data were then retrospectively abstracted for the Geneva Diagnostic PE score, Wells, Modified Wells and Simplified Wells Diagnostic scores. The chance-corrected agreement between adjudicated categories and each score was calculated. ANOVA was used to compare values across the three adjudicated PE categories.RESULTS: Among 70 patients with suspected PE, agreement was poor between adjudicated categories and Geneva pretest probabilities (kappa 0.01 [95% CI −0.0643 to 0.0941]) or Wells pretest probabilities (kappa −0.03 [95% CI −0.1462 to 0.0914]). Among four possible, 16 probable and 50 definite PEs, there were no significant differences in Geneva scores (possible = 4.0, probable = 4.7, definite = 4.5; P=0.90), Wells scores (possible = 2.8, probable = 4.9, definite = 4.1; P=0.37), Modified Wells (possible = 2.0, probable = 3.4, definite = 2.9; P=0.34) or Simplified Wells (possible = 1.8, probable = 2.8, definite = 2.4; P=0.30).CONCLUSIONS: Pretest probability scores developed outside the ICU do not correlate with adjudicated PE categories in critically ill patients. Research is needed to develop prediction scores for this population

Acute Delta Hepatitis in Italy spanning three decades (1991–2019): Evidence for the effectiveness of the hepatitis B vaccination campaign

Updated incidence data of acute Delta virus hepatitis (HDV) are lacking worldwide. Our aim was to evaluate incidence of and risk factors for acute HDV in Italy after the introduction of the compulsory vaccination against hepatitis B virus (HBV) in 1991. Data were obtained from the National Surveillance System of acute viral hepatitis (SEIEVA). Independent predictors of HDV were assessed by logistic-regression analysis. The incidence of acute HDV per 1-million population declined from 3.2 cases in 1987 to 0.04 in 2019, parallel to that of acute HBV per 100,000 from 10.0 to 0.39 cases during the same period. The median age of cases increased from 27 years in the decade 1991-1999 to 44 years in the decade 2010-2019 (p < .001). Over the same period, the male/female ratio decreased from 3.8 to 2.1, the proportion of coinfections increased from 55% to 75% (p = .003) and that of HBsAg positive acute hepatitis tested for by IgM anti-HDV linearly decreased from 50.1% to 34.1% (p < .001). People born abroad accounted for 24.6% of cases in 2004-2010 and 32.1% in 2011-2019. In the period 2010-2019, risky sexual behaviour (O.R. 4.2; 95%CI: 1.4-12.8) was the sole independent predictor of acute HDV; conversely intravenous drug use was no longer associated (O.R. 1.25; 95%CI: 0.15-10.22) with this. In conclusion, HBV vaccination was an effective measure to control acute HDV. Intravenous drug use is no longer an efficient mode of HDV spread. Testing for IgM-anti HDV is a grey area requiring alert. Acute HDV in foreigners should be monitored in the years to come

Treating patients with cancer and acute venous thromboembolism

Introduction: Cancer and venous thromboembolism (VTE) are closely related, with a high risk of VTE associated with cancer and a strong impact of VTE on cancer prognosis. The management and treatment of cancer-associated VTE are particularly challenging and, in many cases, are not guided by a high level of evidence.Areas covered: In this review, we present the best therapeutic approach to acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and to some controversial issues, such as home treatment, optimal duration of anticoagulation, management of VTE recurrence during anticoagulant treatment, and of unsuspected PE. Then, the available evidence on other cancer-related VTE manifestations is presented, such as catheter-related thrombosis and splanchnic vein thrombosis.Expert opinion: While solid evidence exists on the advantage of low molecular weight heparin (LMWH) over vitamin K antagonists (VKAs) during the first 3 to 6 months after acute DVT and/or PE, several issues have not been sufficiently investigated yet. These include the role of LMWH beyond the first 3 to 6 months, whether it is still more effective than VKA and if its intensity could be safely reduced, the strategies to identifying accurate predictors of VTE recurrence and the role of direct oral anticoagulants

Management of bleeding in patients receiving conventional or new anticoagulants: a practical and case-based approach

Anticoagulant drugs are highly effective for the prevention and treatment of venous and arterial thromboembolism. However, their use is also associated with an increased risk for bleeding, with an associated ∼10 case-fatality rate. Appropriate strategies for the management and reversal of anticoagulant-associated bleeding are clinically important and, ideally, should be standardized. These include general resuscitation, and diagnosis and local treatment of the bleeding source, and one or more of the following interventions: transfusion of red cells; transfusion of clotting factor replacements; and administration of anticoagulant antidotes and other prohaemostatic agents. Reversal strategies for the 'conventional' anticoagulants are based largely on clinical evidence, whereas evidence to guide the management of bleeding associated with 'new' anticoagulants is emerging. This review provides an evidence-based, but practical, patient-focused approach for the management of bleeding associated with the old and new anticoagulants