Prognostication of Patients with Pulmonary Thromboembolism with and without Residual Deep Vein Thrombosis: A Subanalysis of the J’xactly Study
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SUBMITTER: Yamada N
PROVIDER: S-EPMC10539124 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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Project description:Background: The efficacy and safety of direct oral anticoagulants (DOACs) in patients with unprovoked venous thromboembolism (VTE) remain unclear. Methods and Results: In this subanalysis of the J'xactly study, a multicenter prospective observational study, we evaluated the safety and effectiveness of rivaroxaban in patients with acute VTE according to unprovoked (n=388) or provoked (n=557) VTE status. Median follow-up was 21.2 months. Compared with patients in the provoked group, patients in the unprovoked group were younger, less likely to be female, and had higher body weight. The incidence of symptomatic VTE recurrence was significantly higher in the unprovoked than provoked VTE group (3.54% vs. 1.77% per patient-year; P=0.032). There was no significant difference in the incidence of major bleeding events between rivaroxaban-treated patients with unprovoked and provoked VTE (2.31% vs. 3.75% per patient-year; P=0.289). Although the proportion of patients with a body mass index (BMI) ≥25 kg/m2 who were non-users of antiplatelet agents was higher in the unprovoked VTE group, there was no interaction effect (BMI: 4.58% vs. 1.55% per patient-year [P=0.040; P for interaction=0.361]; concomitant antiplatelet agent non-users: 3.65% vs. 1.72% per patient-year [P=0.028; P for interaction=0.627]). Conclusions: This subanalysis suggests the safety and effectiveness of rivaroxaban in patients with unprovoked VTE. In such patients, DOAC discontinuation should be considered carefully, particularly in those not using antiplatelet agents and those with a high BMI.
| S-EPMC9535131 | biostudies-literature
Project description:Studies on the association between aortic aneurysm (AA) and the subsequent risk of venous thromboembolism (VTE) are limited to a few case reports and investigations which only focused on surgical effects. Therefore, we used the National Health Insurance Research Database to clarify whether patients with AAs have a heightened risk of subsequent VTEs, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Our retrospective cohort study comprised patients aged ≥ 18 years who received a diagnosis of an AA and were hospitalized at any point during 2000-2010 (n = 16,630). Each AA patient was frequency-matched to 4 non-AA hospitalized patients based on age, sex, and index year (n = 66,453). The Cox proportional hazard regressions model was used to estimate the adjusted effect of AAs on VTE risk. The overall incidence of DVT and PE was higher in the patients with AA than in the non-AA group patients (23.5 versus 13.2 and 13.5 versus 7.98/1,000 person-years). After adjustment for age, sex, duration of hospitalization in the study period, and comorbidities, patients with AAs were associated with a 1.88-fold higher risk of DVT and 1.90-fold higher risk of PE compared to the non-AA cohort. Patients with abdominal AAs were more likely to develop DVT, whereas thoracic AA patients were more likely to develop PE. A diagnosis of a ruptured AA was associated with a substantially increased risk of DVT. Surgical treatment of AAs was associated with a heightened risk of VTE within 6-months post-operation. Our study demonstrates that AAs are associated with an increased risk of subsequent VTE. Future investigations are encouraged to delineate the mechanisms underlying this association and to evaluate the cost-effectiveness of screening for VTEs in patients with AAs.
| S-EPMC5462404 | biostudies-literature
Project description:Background: Rivaroxaban, a direct oral anticoagulant, is used as a first-line treatment to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, whether 21 days is optimal for the initial treatment duration has not been investigated. Methods and Results: In this subanalysis of the prospective multicenter observational J'xactly study, which included 1,039 Japanese patients with acute symptomatic/asymptomatic DVT/PE who were prescribed rivaroxaban, the VTE recurrence rate and incidence of bleeding complications were assessed in 667 patients who underwent intensive rivaroxaban treatment (15 mg, twice daily) for a short (1-8 days), intermediate (9-16), or standard (17-24) duration. The short treatment duration group showed a tendency for increased VTE recurrence/aggravation compared with the standard treatment duration group (6.10% vs. 2.60% per patient-year). The intermediate treatment duration group showed a higher incidence of bleeding events than the standard treatment duration group (9.34% vs. 2.16% per patient-year), without major differences in patient characteristics between the groups. Conclusions: In this subanalysis of the real-world observational J'xactly study of VTE treatment and prevention in Japanese patients with acute symptomatic/asymptomatic DVT/PE, the standard initial intensive rivaroxaban treatment duration (17-24 days) appeared to be safe and effective, providing important insights into the clinical outcomes of the initial rivaroxaban treatment duration in this population.
| S-EPMC10072900 | biostudies-literature
Project description:BackgroundVenous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in ∼1 to 2 individuals per 1000 each year, corresponding to ∼300 000 to 600 000 events in the United States annually.ObjectiveThese evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about treatment of VTE.MethodsASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.ResultsThe panel agreed on 28 recommendations for the initial management of VTE, primary treatment, secondary prevention, and treatment of recurrent VTE events.ConclusionsStrong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. Conditional recommendations include the preference for home treatment over hospital-based treatment for uncomplicated DVT and PE at low risk for complications and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.
| S-EPMC7556153 | biostudies-literature
Project description:INTRODUCTION:Rivaroxaban, a factor Xa inhibitor used as a direct oral anticoagulant, is beneficial over warfarin in terms of food-drug interactions and the need for therapeutic monitoring in patients with acute venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. Because there is little data regarding VTE treatment in Japan, a real-world survey of Japanese patients being treated with rivaroxaban for VTE is needed. METHODS AND ANALYSIS:The Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients with Deep Vein Thrombosis and Pulmonary Embolism has been established to investigate the clinical outcomes of rivaroxaban for the initial treatment and prevention of symptomatic recurrent VTE in Japanese patients with acute symptomatic/asymptomatic VTE. 150 institutions in Japan will enrol patients in the study; the target enrolment is 1000. All patients will be followed up two times a year for at least 18 months and up to 3 years after their enrolment. The primary outcome is symptomatic recurrent VTE occurring during the study period. The principal safety outcome is clinically relevant bleeding (ie, major bleeding or clinically relevant non-major bleeding) occurring during treatment. A clinical events committee will adjudicate all outcomes. ETHICS AND DISSEMINATION:The study protocol has been approved by the Nihon University Itabashi Hospital, Clinical Research Ethics Committee and all local institutional ethics committees of the participating hospitals. Findings of the study will be presented in scientific sessions and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03091621,UMIN000025072; Pre-results.
| S-EPMC6020936 | biostudies-literature
Project description:An improved understanding of which patients are at higher risk of recurrent venous thromboembolism (VTE) is important to designing interventions to reduce degraded quality of life after VTE. Although metabolic syndrome (MetS), the clustering of hypertension, hyperlipidemia, diabetes mellitus, and obesity has been associated with a hypofibrinolytic state, data linking VTE recurrence with MetS remain limited. The purpose of this study was to measure the prevalence of MetS in patients with deep vein thrombosis (DVT) across a large population and determine its effect on VTE recurrence. This was a retrospective analysis of a large statewide database from 2004 to 2017. We measured the frequency with which patients with DVT carried a comorbid International Coding of Diseases diagnosis of MetS components. Association of MetS with VTE recurrence was tested with a multiple logistic regression model and VTE recurrence as the dependent variable. Risk of VTE recurrence conferred by each MetS component was assessed by Kaplan-Meier curves with the log-rank statistic. A total of 151 054 patients with DVT were included in this analysis. Recurrence of VTE occurred in 17% overall and increased stepwise with each criterion for MetS. All 4 components of MetS had significant adjusted odds ratios (OR) for VTE recurrence, with hyperlipidemia having the largest (OR, 1.8), representing the 4 largest ORs of all possible explanatory variables. All 4 MetS variables were significant on Kaplan-Meier analysis for recurrence of VTE. These data imply a role for appropriate therapies to reduce the effects of MetS as a way to reduce risk of VTE recurrence.
| S-EPMC6960475 | biostudies-literature
Project description:BACKGROUND:The prognostic significance of coexisting deep vein thrombosis (DVT) in acute pulmonary embolism (PE) is controversial. This study aimed to provide routine patient care data on the impact of this association on PE severity and 3-month outcomes in a population presenting with symptomatic venous thromboembolism (VTE) from the REMOTEV registry. METHODS AND RESULTS:REMOTEV is a prospective, non-interventional study of patients with acute symptomatic VTE, treated with direct oral anticoagulants (DOACs) or standard anticoagulation (vitamin K antagonists (VKA) or parenteral heparin/fondaparinux alone) for at least 3 months. From 1 November 2013 to 28 February 2018, among 1241 consecutive patients included, 1192 had a follow-up of at least 3 months and, among them, 1037 had PE with (727) or without DVT (310). The median age was 69 (55-80, 25th-75th percentiles). Patients with PE-associated DVT had more severe forms of PE (p < 0.0001) and, when DVT was present, proximal location was significantly correlated to PE severity (p < 0.01). However, no difference in all-cause mortality rate (hazard ratio (HR) 1.36 (CI 95% 0.69-2.92)), nor in the composite criterion of all-cause mortality and recurrence rate (HR 1.56 (CI 95% 0.83-3.10)) was noted at 3 months of follow-up. CONCLUSION:In REMOTEV, coexisting DVT was associated with a higher severity of PE, with no impact on short-term prognosis.
| S-EPMC6617259 | biostudies-literature
Project description:Isolated distal deep vein thrombosis (IDDVT) is presumed to be more benign than proximal DVT (PDVT) or pulmonary embolism (PE), suggesting a need for different management approaches. This subgroup analysis of the RE-COVERY DVT/PE global, observational study investigated patient characteristics, hospitalization details, and anticoagulant therapy in patients with IDDVT in real-world settings in 34 countries enrolled from January 2016 to May 2017. Data were analyzed descriptively according to the type and location of the index venous thromboembolism (VTE): IDDVT, PDVT ± distal DVT (DDVT), and PE ± DVT. Of the 6,095 eligible patients, 323 with DVT located outside the lower limb and no PE were excluded. Of the remaining 5,772 patients, 17.6% had IDDVT, 39.9% had PDVT ± DDVT, and 42.5% had PE ± DVT. IDDVT patients were younger and had fewer risk factors for VTE than the other groups. Other comorbidities were less frequent in the IDDVT group, except for varicose veins, superficial thrombophlebitis, and venous insufficiency. IDDVT patients were less likely to be diagnosed in an emergency department (22.3 vs. 29.7% for PDVT ± DDVT and 45.4% for PE ± DVT) or hospitalized for VTE (29.2 vs. 48.5% for PDVT ± DDVT and 75.0% for PE ± DVT). At hospital discharge or 14 days after diagnosis (whichever was later), non-vitamin K antagonist oral anticoagulants were the most commonly used anticoagulants (55.6% for IDDVT, 54.7% for PDVT ± DDVT, and 52.8% for PE ± DVT). Although differences in patient characteristics, risk factors, and clinical management were identified, anticoagulant treatment of IDDVT was almost equal to that of PDVT or PE. Prospective studies should investigate whether, in a global perspective, this is an appropriate use of anticoagulants.
| S-EPMC9246482 | biostudies-literature
Project description:INTRODUCTION: A 45-year-old female presented with 8 hours of right lower extremity pain and dyspnea. She was tachycardic and her right lower extremity was dusky, cold, and pulseless. DISCUSSION: Computerized tomography of the venous and arterial systems revealed massive pulmonary embolism and right lower extremity arterial and left lower extremity venous thromboses. Management included intra-arterial thrombolytics, right lower extremity arterial embolectomy, and anticoagulation. Echocardiogram revealed a patent foramen ovale (PFO) with a right-to-left shunt. CONCLUSION: We hypothesize that our patient developed deep venous thrombosis that led to major pulmonary embolization and increased right-sided pressures. In the setting of a patent foramen ovale, a later venous embolus transversed the PFO and lodged in the femoral artery. Our case illustrates the importance of a high index of suspicion for a paradoxical embolus in patients with arterial thrombosis.
| S-EPMC2219736 | biostudies-other
Project description:Incidental venous thromboembolism (VTE) is common in cancer patients and identifying factors associated with these events can improve the management plan. We studied the characteristics of concomitant deep vein thrombosis (C-DVT) in cancer patients presenting with unsuspected pulmonary embolism (PE) and the association of C-DVT with VTE recurrence and survival outcomes. Patients presenting to our emergency department with confirmed unsuspected/incidental PE between 1 January 2006 and 1 January 2016, were identified. Radiologic reports were reviewed to confirm the presence or absence of C-DVT. Logistic regression analyses and cox regression modeling were used to determine the effect of C-DVT on VTE recurrence and survival outcomes. Of 904 eligible patients, 189 (20.9%) had C-DVT. Patients with C-DVT had twice the odds of developing VTE recurrence (odds ratio 2.07, 95% confidence interval 1.21-3.48, p = 0.007). The mortality rates among C-DVT were significantly higher than in patients without. C-DVT was associated with reduced overall survival in patients with unsuspected PE (hazard ratio 1.33, 95% confidence interval 1.09-1.63, p = 0.005). In conclusion, C-DVT in cancer patients who present with unsuspected PE is common and is associated with an increased risk of VTE recurrence and poor short- and long-term survival. Identifying other venous thrombi in cancer patients presenting with unsuspected PE is recommended and can guide the management plan. For patients with isolated incidental subsegmental pulmonary embolism and concomitant deep vein thrombosis, initiating anticoagulants if no contraindications exist is recommended.
| S-EPMC9496711 | biostudies-literature