Residual Thrombosis on Ultrasonography to Guide the Duration of Anticoagulation in Patients With Deep Venous Thrombosis: A Randomized Trial

The decision on treatment after a first venous thromboembolism (VTE) to prevent recurrences may be influenced by many factors. The prospective, observational, WHITE study aimed to analyze how this issue was tackled in every-day clinical practice in various countries, which have sensibly different socio-economic conditions and healthcare systems. Doctors active in 79 Internal or Vascular clinical centers in 7 countries (China, Czechia, Poland, Portugal, Russia, Slovakia, and Tunisia) enrolled VTE patients after the maintenance treatment phase. The present report analyzed information, collected in the central database, regarding the baseline characteristics, index events, type and duration of anticoagulant therapy and decision on post-maintenance treatment. From April 2018 to December 2020, 1240 patients were enrolled, 58% with an unprovoked index event. Direct oral anticoagulants (DOACs) were used in > 85% of all cases in China, Poland, Portugal, Russia and Czechia, in 52% in Slovakia and in no patient in Tunisia. The maintenance anticoagulation lasted in average approximately 6 months. Altogether, anticoagulation was stopped in 20%, extended in about 50%, regardless of whether the event was unprovoked or provoked and shifted to antithrombotics (mainly sulodexide or aspirin) in the remaining patients. In conclusion, some differences in VTE patient management were found between countries. The provoked/unprovoked nature of the index event, instead, was not the prevalent criterion to drive the decision on extension of anticoagulation, without large variations between countries. DOACs were the most widely used anticoagulant drugs, whereas > 25% of patients received antithrombotic drugs instead of anticoagulants as extended treatment.

/pdf/unprovoked-or-provoked-venous-thromboembolism-not-the-1ajmhos0rl.pdf

Unprovoked or provoked venous thromboembolism: not the prevalent criterion to decide on anticoagulation extension in clinical practice of various countries-the prospective, international, observational WHITE study.

Background Despite evidence of ongoing epidemiological changes in deaths from venous thromboembolism in high-income countries, little recent information is available on the time trends in mortality related to pulmonary embolism (PE) as underlying or concomitant cause of death in Europe. Methods We accessed the regional database of death certificates of Veneto Region (Northern Italy, population 4,900,000) from 2008 to 2019. We analyzed the trends in crude and age-adjusted annual rates of mortality related to PE (reported either as underlying cause or in any position in the death certificate) using Joinpoint regression; in the contribution of PE to mortality (proportionate mortality); and, using logistic regression, in the association between PE and cancer at death. Results Between 2008 and 2019, the annual age-standardized mortality rate related to PE in Veneto decreased from 20.7 to 12.6 deaths per 100,000 population for PE in any position of the death certificate, and from 4.6 to 2.2 deaths per 100,000 population for PE as underlying cause of death. PE-related proportionate mortality remained up to twice as high in women. The age- and sex-adjusted odds ratio for cancer in deaths with versus without PE constantly increased from 1.01 (95% confidence interval [CI]: 0.88–1.16) in 2008 to 1.58 (95% CI: 1.35–1.83) in 2019. Conclusion The descending trends in PE-related mortality reported for Europe up to 2015 for both sexes continued thereafter in this high-income region of Northern Italy. However, sex differences in proportionate mortality persist. The increasing strength in the association between cancer and PE may indicate a change in risk factor distribution, calling for tailored management practices in this patient group.

Decline in Overall Pulmonary Embolism-Related Mortality and Increasing Prevalence of Cancer-Associated Events in the Veneto Region (Italy), 2008-2019.

Background International guidelines recommend at least three months anticoagulation in all patients after acute venous thromboembolism (VTE) and suggest those with unprovoked events be considered for indefinite anticoagulation if the risk of recurrence is high and the risk of bleeding during treatment non-high. Other authors have recently argued against using a dichotomy unprovoked/provoked events to decide on anticoagulation duration and suggest instead using overall risk factors present in each patient as the basis for deciding. Aim This sub-analysis of the WHITE study aimed at assessing the reasons for the treatment decisions taken by doctors in different countries. Results 1240 patients were recruited in 7 countries (China, Czechia, Poland, Portugal, Russia, Slovakia, and Tunisia). Anticoagulation was extended in 51.7% and 49.3% of patients with unprovoked or provoked events (n.s.); stopped in 15.4% versus 28.9% (P 83% of cases) given to continue anticoagulation, regardless of nature and site of the index events, followed by risk of bleeding and presence of PTS signs. Conclusion On average, attending physicians estimated the risk of recurrence in real life conditions, and the consequent therapeutic decision, using all the information available, not limiting to the location or nature of the index event.

https://journals.sagepub.com/doi/pdf/10.1177/10760296211049402

Anticoagulation Duration After First Venous Thromboembolism: Real-Life Data From the International, Observational WHITE Study.

Little data are available on real-life long-term treatments after a venous thromboembolism (VTE), and on recurrent VTE or bleeds events during treatments.We investigated the complications occurring during follow-up (FU) in VTE patients who had received the treatment decisions given by the clinical centers, active in 7 countries (China, Czechia, Poland, Portugal, Russia, Slovakia, Tunisia), which participated in the international, prospective, observational WHITE study.FU information was collected in 1004 patients, recruited by 62 clinical centers (17 centers did not participate in FU collection). Extended treatments were proposed to 811 patients: direct oral anticoagulants (DOACs) (475), sulodexide (202), antiplatelet agents (73), vitamin K antagonists (VKAs) (45), low molecular weight heparin (LMWH) (16). All specific treatments were stopped in the remaining 193 patients. Patients who during FU used treatments different than those prescribed by the local investigators (263) or for other causes (26) were excluded from analysis. 50 primary events occurred throughout 1044 years FU in 715 patients, 4.8 incidence (×100 patient-years) [3.8 for recurrences, and 0.96 for bleeding (major or clinically relevant)]. Primary event incidence differed according to treatments (LMWH=33.3, antiplatelets =7.6, VKAs = 6.1, DOACs = 4.7, sulodexide = 4.2, all treatment stopped = 2.5), and differed across the involved countries.DOACs were the most used drugs for extended treatments. Overall, the rate of primary events during FU was low. The investigators identified patients at low risk of recurrence and high bleeding risk. Sulodexide use for secondary prevention deserves further studies. 

Recurrences and bleeding during extended treatment of patients with venous thromboembolism: results of the international, prospective, observational WHITE study

Patients with venous thromboembolism (VTE) should receive a decision on the duration of anticoagulant treatment (AT) that is often not easy to make. Sixteen Italian clinical centers included patients with recent VTE in the START2-POST-VTE register and reported the decisions taken on duration of AT in each patient and the reasons for them. At the moment of this report, 472 (66.9%) of the 705 patients included in the registry were told to stop AT in 59.3% and to extend it in 40.7% of patients. Anticoagulant treatment lasted ≥3 months in >90% of patients and was extended in patients with proximal deep vein thrombosis because considered at high risk of recurrence or had thrombophilic abnormalities. d-dimer testing, assessment of residual thrombus, and patient preference were also indicated among the criteria influencing the decision. In conclusion, Italian doctors stuck to the minimum 3 months AT after VTE, while the secondary or unprovoked nature of the event was not seen as the prevalent factor influencing AT duration which instead was the result of a complex and multifactorial evaluation of each patient.

Treatment Decision-Making of Secondary Prevention After Venous Thromboembolism: Data From the Real-Life START2-POST-VTE Register.

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Treatment Decision-Making of Secondary Prevention After Venous Thromboembolism: Data From the Real-Life START2-POST-VTE Register.