Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study.

Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3-20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5-4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2-4.2). No patient died of recurrent PE (0%, 95% CI: 0-7.6%). Subgroup analyses showed that patients with diagnosis in 2021-2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45-5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19-4.49) had significantly higher rates of VTE recurrences. Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

Clinical Presentation and Outcomes of Patients With Cancer-Associated Isolated Distal Deep Vein Thrombosis.

PURPOSE: Patients with isolated distal deep vein thrombosis (DVT) have lower rates of adverse outcomes (death, venous thromboembolism [VTE] recurrence or major bleeding) than those with proximal DVT. It is uncertain if such findings are also observed in patients with cancer. METHODS: Using data from the international Registro Informatizado de la Enfermedad TromboEmbolica venosa registry, we compared the risks of adverse outcomes at 90 days (adjusted odds ratio [aOR]; 95% CI) and 1 year (adjusted hazard ratio [aHR; 95% CI]) in 886 patients with cancer-associated distal DVT versus 5,196 patients with cancer-associated proximal DVT and 5,974 patients with non-cancer-associated distal DVT. RESULTS: More than 90% of patients in each group were treated with anticoagulants for at least 90 days. At 90 days, the adjusted risks of death, VTE recurrence, or major bleeding were lower in patients with non-cancer-associated distal DVT than in patients with cancer-associated distal DVT (reference): aOR = 0.16 (0.11-0.22), aOR = 0.34 (0.22-0.54), and aOR = 0.47 (0.27-0.80), respectively. The results were similar at 1-year follow-up: aHR = 0.12 (0.09-0.15), aHR = 0.39 (0.28-0.55), and aHR = 0.51 (0.32-0.82), respectively. Risks of death, VTE recurrence, and major bleeding were not statistically different between patients with cancer-associated proximal versus distal DVT, both at 90 days: aOR = 1.11 (0.91-1.36), aOR = 1.10 (0.76-1.62), and aOR = 1.18 (0.76-1.83), respectively, and 1 year: aHR = 1.01 (0.89-1.15), aHR = 1.02 (0.76-1.35), and aHR = 1.10 (0.76-1.61), respectively. However, more patients with cancer-associated proximal DVT, compared with cancer-associated distal DVT, developed fatal pulmonary embolism (PE) during follow-up: The risk difference was 0.40% (95% CI, 0.23 to 0.58). CONCLUSION: Cancer-associated distal DVT has serious and relatively comparable outcomes compared with cancer-associated proximal DVT. The lower risk of fatal PE from cancer-associated distal DVT needs further investigation.

Prognostic Impact of Obstructive Sleep Apnea in Patients Presenting with Acute Symptomatic Pulmonary Embolism.

BACKGROUND: In patients with pulmonary embolism (PE), there is a lack of comprehensive data on the prevalence and prognostic significance of pre-existing obstructive sleep apnea (OSA). METHODS: In this study of patients with PE from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry, we assessed the prevalence of OSA, and the association between pre-existing OSA and the outcomes of all-cause mortality, PE-related mortality, recurrences, and major bleeding over 30 days after initiation of PE treatment. Additionally, we also examined rates of outcomes within 90 days and 1 year following the diagnosis of PE. RESULTS: Of 4,153 patients diagnosed with PE, 241 (5.8%; 95% confidence interval [CI]: 5.1-6.6%) had pre-existing OSA. Overall, 166 (4.0%; 95% CI: 3.4-4.6%) died during the first 30 days of follow-up. In multivariable analysis, the OSA syndrome was not a significant predictor of death from any cause (odds ratio [OR]: 1.5; 95% CI: 0.8-2.9; p = 0.19). However, patients with pre-existing OSA had an increased PE-specific mortality (adjusted OR: 3.0; 95% CI: 1.3-6.8; p = 0.01) compared with those without OSA. OSA was not significantly associated with 30-day recurrent venous thromboembolism (adjusted OR: 0.6; 95% CI: 0.1-4.7; p = 0.65) or major bleeds (adjusted OR: 1.0; 95% CI: 0.4-2.2; p = 1.0). Findings were similar at 90-day and 1-year follow-ups. CONCLUSION: In patients presenting with PE, pre-existing OSA is relatively infrequent. Patients with OSA were at increased risk of PE-related mortality when compared with those without OSA.

Salivary and serum beta2-microglobulin and gamma-glutamyl-transferase in patients with primary Sjögren syndrome and Sjögren syndrome secondary to systemic lupus erythematosus.

BACKGROUND: Sialochemistry has been proposed as a simple and useful tool for the diagnosis of Sjögren syndrome (SS). Although many changes have been detected in several constituents of saliva from patients with SS, none are individually sensitive or specific enough for diagnosing SS. The aim of this study was to assess the value of the combined determination of beta2-microglobulin (beta2m) and gamma-glutamyl-transferase (GGT) activity in serum and saliva as a diagnostic instrument for differentiating primary and secondary [to systemic lupus erythematosus (SLE)] SS patients from normal subjects. METHODS: Nineteen primary SS (pSS) patients, 15 patients with SS secondary to SLE, and 25 SLE patients without SS were studied. Thirty healthy subjects were included in the study as control group. RESULTS: By means of a mathematical model, (a) 84.1%, (b) 85.7%, and (c) 87.0% of patients were correctly classified as SS or normal when (a) salivary beta2m and GGT values, (b) serum beta2m and salivary GGT values, and (c) salivary beta2m and GGT along with serum beta2m values, respectively, were considered. To differentiate between pSS and sSS by means of the mathematical model, the combination of serum beta2m and salivary GGT values achieved that 81.8% of the patients were correctly classified. CONCLUSION: Since sialochemistry is an easy, safe and reliable test, the combined determination of beta2m and GGT in saliva and serum was useful for differentiating SS patients from normal subjects, but not excessively good for differentiating pSS from sSS patients.