In this study involving nearly 3400 patients with venous thromboembolism, both prophylactic and therapeutic doses of rivaroxaban were superior to aspirin in reducing the risk of recurrent ...thromboembolism with a similar risk of bleeding.
Venous thromboembolism, which includes deep-vein thrombosis and pulmonary embolism, is the third most common cause of vascular death after myocardial infarction and stroke.
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The mainstay of treatment is anticoagulation,
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and in patients without active cancer, guidelines suggest the use of direct oral anticoagulant agents such as rivaroxaban over vitamin K antagonists such as warfarin.
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Anticoagulation therapy is administered for 3 months or longer, depending on the balance between the risk of recurrent venous thromboembolism and the risk of bleeding.
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In patients without reversible risk factors, the risk of recurrent venous thromboembolism is as much as 10% in the first . . .
Background: Prophylaxis of venous thromboembolism (VTE) in hospitalized medical patients is largely underused. We sought to assess the value of a simple risk assessment model (RAM) for the ...identification of patients at risk of VTE. Methods: In a prospective cohort study, 1180 consecutive patients admitted to a department of internal medicine in a 2‐year period were classified as having a high or low risk of VTE according to a predefined RAM. They were followed‐up for up to 90 days to assess the occurrence of symptomatic VTE complications. The primary study outcome was to assess the adjusted hazard ratio (HR) of VTE in high‐risk patients who had adequate in‐hospital thromboprophylaxis in comparison with those who did not, and that of VTE in the latter group in comparison with low‐risk patients. Results: Four hundred and sixty‐nine patients (39.7%) were labelled as having a high risk of thrombosis. VTE developed in four of the 186 (2.2%) who received thromboprophylaxis, and in 31 of the 283 (11.0%) who did not (HR of VTE, 0.13; 95% CI, 0.04–0.40). VTE developed also in two of the 711 (0.3%) low‐risk patients (HR of VTE in high‐risk patients without prophylaxis as compared with low‐risk patients, 32.0; 95% CI, 4.1–251.0). Bleeding occurred in three of the 186 (1.6%) high‐risk patients who had thromboprophylaxis. Conclusions: Our RAM can help discriminate between medical patients at high and low risk of VTE. The adoption of adequate thromboprophylaxis in high‐risk patients during hospitalization leads to longstanding protection against thromboembolic events with a low risk of bleeding.
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An increasing body of evidence suggests the likelihood of a link between arterial and venous disease. According to the results of recent studies, atherosclerosis and venous thromboembolism (VTE) ...share common risk factors, including age, obesity, diabetes mellitus and metabolic syndrome. Atherosclerosis has the potential to promote the development of thrombotic disorders in the venous system. Another scenario assumes that the two clinical conditions are simultaneously triggered by biological stimuli responsible for activating coagulation and inflammatory pathways in both the arterial and the venous system. Several recent studies have consistently shown that patients with VTE of unknown origin are at a higher risk of cardiovascular diseases, including atherosclerotic complications, than patients with secondary VTE and matched control individuals. Future studies are needed to clarify the nature of this association, to assess its extent and to evaluate its implications for clinical practice.
The post‐thrombotic syndrome (PTS) is increasingly recognized to be a common and important complication of deep venous thrombosis (DVT). Because there is no ‘gold standard’ objective test to ...establish its presence, PTS is diagnosed primarily on the basis of the presence of typical symptoms and clinical signs in a limb that was affected by DVT. As a wide variety of definitions of PTS have been used by researchers, it is difficult to compare data across studies and to formally combine data in meta‐analyses. In a step towards standardization of the measurement of PTS in clinical studies, available scales and evidence to support their utility to diagnose PTS and to classify its severity were reviewed and discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis (Vienna, July 2008).
After the initial demonstration provided 4 years ago by a case–control study in the New England Journal of Medicine, numerous investigations have addressed the association between venous and arterial ...thrombotic disorders. According to the results of recent studies, the two conditions are likely to share common risk factors, including age, obesity, cigarette smoking, diabetes mellitus, arterial hypertension, hyperlipemia and metabolic syndrome. The nature of this association is unclear. On the one hand, atherosclerosis has the potential to promote the development of thrombotic disorders in the venous system. On the other hand, the two clinical conditions can be simultaneously triggered by biological stimuli responsible for activating coagulation and inflammatory pathways in both the arterial and the venous system. Based on the results of two population‐based studies carried out in the USA, atherosclerosis is unlikely to constitute a risk factor for venous thromboembolic (VTE) disorders. Several recent studies have consistently shown that subjects with VTE of unknown origin are at a higher risk of subsequent arterial cardiovascular events than subjects with secondary VTE and matched control individuals. In conclusion, the separate nature of arterial and venous disorders has been challenged. Future studies are needed to clarify the nature of this association, to assess its extent, and to evaluate its implications for clinical practice.
Background: Fatal bleeding is a serious consequence of anticoagulant therapy, but factors associated with fatal bleeding during the first 3 months of treatment of venous thromboembolism (VTE) are ...uncertain. Methods: Using data from RIETE, an ongoing registry of consecutive patients with acute VTE, we assessed risk factors for fatal bleeding among all patients. We then used this information to derive a clinical model that would stratify a patient’s risk of fatal bleeding during the first 3 months of treatment. Results: Of 24 395 patients, 546 (2.24%) had a major bleed and 135 (0.55%) had a fatal bleed. The gastrointestinal tract was the most common site (40% of fatal bleeds), followed by intracranial bleeding (25%). Fatal bleeding was independently associated with the following factors at the time of VTE diagnosis: age >75 years (OR, 2.16), metastatic cancer (OR, 3.80), immobility ≥ 4 days (OR, 1.99), a major bleed within the past 30 days (OR, 2.64), an abnormal prothrombin time (OR, 2.09), a platelet count < 100 × 109 L−1 (OR, 2.23), creatinine clearance < 30 mL min−1 (OR, 2.27), anemia (OR, 1.54), and distal deep vein thrombosis (OR, 0.39). INR at the time of bleeding is not known. A clinical prediction rule for risk of fatal bleeding that included nine baseline factors was derived. Fatal bleeding occurred in 0.16% (95% CI, 0.11–0.23) of the low‐risk, 1.06% (95% CI, 0.85–1.30) of the moderate‐risk, and 4.24% (95% CI, 2.76–6.27) of the high‐risk category. Conclusions: Patient characteristics and laboratory variables can identify patients at high risk for fatal bleeding during treatment of VTE.
Background: Guidelines addressing the management of venous thromboembolism (VTE) in cancer patients are heterogeneous and their implementation has been suboptimal worldwide. Objectives: To establish ...a common international consensus addressing practical, clinically relevant questions in this setting. Methods: An international consensus working group of experts was set up to develop guidelines according to an evidence‐based medicine approach, using the GRADE system. Results: For the initial treatment of established VTE: low‐molecular‐weight heparin (LMWH) is recommended 1B; fondaparinux and unfractionated heparin (UFH) can be also used 2D; thrombolysis may only be considered on a case‐by‐case basis Best clinical practice (Guidance); vena cava filters (VCF) may be considered if contraindication to anticoagulation or pulmonary embolism recurrence under optimal anticoagulation; periodic reassessment of contraindications to anticoagulation is recommended and anticoagulation should be resumed when safe; VCF are not recommended for primary VTE prophylaxis in cancer patients Guidance. For the early maintenance (10 days to 3 months) and long‐term (beyond 3 months) treatment of established VTE, LMWH for a minimum of 3 months is preferred over vitamin K antagonists (VKA) 1A; idraparinux is not recommended 2C; after 3–6 months, LMWH or VKA continuation should be based on individual evaluation of the benefit‐risk ratio, tolerability, patient preference and cancer activity Guidance. For the treatment of VTE recurrence in cancer patients under anticoagulation, three options can be considered: (i) switch from VKA to LMWH when treated with VKA; (ii) increase in LMWH dose when treated with LMWH, and (iii) VCF insertion Guidance. For the prophylaxis of postoperative VTE in surgical cancer patients, use of LMWH o.d. or low dose of UFH t.i.d. is recommended; pharmacological prophylaxis should be started 12–2 h preoperatively and continued for at least 7–10 days; there are no data allowing conclusion that one type of LMWH is superior to another 1A; there is no evidence to support fondaparinux as an alternative to LMWH 2C; use of the highest prophylactic dose of LMWH is recommended 1A; extended prophylaxis (4 weeks) after major laparotomy may be indicated in cancer patients with a high risk of VTE and low risk of bleeding 2B; the use of LMWH for VTE prevention in cancer patients undergoing laparoscopic surgery may be recommended as for laparotomy Guidance; mechanical methods are not recommended as monotherapy except when pharmacological methods are contraindicated 2C. For the prophylaxis of VTE in hospitalized medical patients with cancer and reduced mobility, we recommend prophylaxis with LMWH, UFH or fondaparinux 1B; for children and adults with acute lymphocytic leukemia treated with l‐asparaginase, depending on local policy and patient characteristics, prophylaxis may be considered in some patients Guidance; in patients receiving chemotherapy, prophylaxis is not recommended routinely 1B; primary pharmacological prophylaxis of VTE may be indicated in patients with locally advanced or metastatic pancreatic 1B or lung 2B cancer treated with chemotherapy and having a low risk of bleeding; in patients treated with thalidomide or lenalidomide combined with steroids and/or chemotherapy, VTE prophylaxis is recommended; in this setting, VKA at low or therapeutic doses, LMWH at prophylactic doses and low‐dose aspirin have shown similar effects; however, the efficacy of these regimens remains unclear 2C. Special situations include brain tumors, severe renal failure (CrCl < 30 mL min−1), thrombocytopenia and pregnancy. Guidances are provided in these contexts. Conclusions: Dissemination and implementation of good clinical practice for the management of VTE, the second cause of death in cancer patients, is a major public health priority.
Essentials
The risk of bleeding influences the duration of anticoagulation (AC) after venous thromboembolism.
We assessed the ACCP bleeding risk score in an inception‐cohort of patients receiving AC.
...53% were categorized at high‐risk, but their bleeding rate was low during long‐term AC.
ACCP score had low predictive value for bleeding.
Summary
Background
The American College of Chest Physicians (ACCP) guideline proposes a score to decide on extended anticoagulation after an unprovoked venous thromboembolism (VTE).
Methods
We investigated the ACCP score to predict bleeding risk in an inception cohort of 2263 patients on long‐term anticoagulation (1522 treated with vitamin K antagonists VKAs and the remaining with direct oral anticoagulants DOACs) belonging to the Italian START2 Register.
Results
More than half the patients were categorized as high risk; nevertheless, a higher proportion received anticoagulation for > 1 year compared with those in the low‐risk category. For 3130 years (median 12 interquartile range 6, 24 months), 48 bleeding outcomes occurred (1.53%/year) in the cohort (1.7%/year and 0.95%/year in high‐ and low‐risk categories, respectively). The c‐statistic of the ACCP score was 0.55 (0.48–0.63), 0.50 (0.42–0.58) and 0.56 (0.48–0.64) in low‐, moderate‐ and high‐risk categories, respectively. The bleeding incidence was higher during the first 90 days of treatment (3.0%/year) than afterwards (1.2%/year; relative risk (RR), 2.5 1.3–4.7), and similar among the three categories. The bleeding rate was not different during the initial 3 months of treatment in patients receiving VKAs or DOACs; it was, however, lower in the latter patients in the subsequent period (0.5%/year vs. 1.4%/year, respectively).
Conclusion
The bleeding rate during extended treatment was rather low in our patients. ACCP score had insufficiently predictive value for bleeding and cannot be used to guide decisions on extended treatment. New prediction tools for bleeding risk during anticoagulant treatments (including DOACs) are required.
We recently proposed a scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE). Further development of this post-VTE functional status ...(PVFS) scale is still needed.
Guided by the input of VTE experts and patients, we refined the PVFS scale and its accompanying manual, and attempted to acquire broad consensus on its use.
A Delphi analysis was performed involving 53 international VTE experts with diverse scientific and clinical backgrounds. In this process, the number of scale grades of the originally proposed PVFS scale was reduced and descriptions of the grades were improved. After these changes, a consensus was reached on the number/definitions of the grades, and method/timing of the scale assessment. The relevance and potential impact of the scale was confirmed in three focus groups totaling 18 VTE patients, who suggested additional changes to the manual, but not to the scale itself. Using the improved manual, the κ-statistics between PVFS scale self-reporting and its assessment via the structured interview was 0.75 (95%CI 0.58–1.0), and 1.0 (95%CI 0.83–1.0) between independent raters of the recorded interview of 16 focus groups members.
We improved the PVFS scale and demonstrated broad consensus on its relevance, optimal grades, and methods of assessing among international VTE experts and patients. The interobserver agreement of scale grade assignment was shown to be good-to-excellent. The PVFS scale may become an important outcome measure of functional impairment for quality of patient care and in future VTE trials.
•Functional limitations are frequent after venous thromboembolism (VTE).•We evaluated the previously proposed post-VTE functional status scale (PVFS scale).•After modifications, 53 VTE experts reached consensus on all scale aspects.•The goal and use of the scale were fully endorsed by patient focus groups.•Interobserver agreement of PVFS scale assessment was shown to be good to excellent.
COVID-19 is still a global challenge in regard for management and therapy. Pulmonary embolism (PE) seems to have a higher prevalence in COVID-19 instead of non-COVID patients. Clinical and laboratory ...parameters related with PE are still unknown.
We conducted a retrospective unicentre study in Alto Vicentino Hospital between March 1st, 2020, and January 31st, 2021 in patients admitted for COVID-19 tested with a RT-PCR nasal swab. Data about patients studied with computed tomography pulmonary angiogram (CTPA) because of PE suspicion were collected, as their clinical and laboratory parameters too.
2621 patients were admitted for COVID-19 in Alto Vicentino Hospital between March 1st, 2020, and January 31st, 2021 and in 267 of them a CTPA was performed finding 50 PE (18.7%). Only non-Caucasian race (OR = 5.44; 95% CI 1.22–24.35; p = 0.027) and previous VTE (OR = 5.3; 95% CI 1.09–26.17; p = 0.039) were found to be independently associated with PE.
PE is a frequent complication of COVID-19 and clinician need high degree of suspicion because clinical and laboratoristic parameters cannot drive diagnosis.
•This study tries to find a correlation between COVID-19 and pulmonary embolism.•COVID-19 infection appears to be most correlated with thromboembolic events.•Unfortunately, clinical and laboratoristic parameters cannot drive diagnosis of pulmonary embolism in COVID-19 patients.
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