COMMAND VTE Registry Research Articles

Initial hemodynamic status and Acute Mortality in Cancer patients with Acute Pulmonary Embolism: from the COMMAND VTE Registry.

Initial hemodynamic status in patients with acute pulmonary embolism (PE) concerns their acute clinical outcomes. Nevertheless, the characteristics of initial hemodynamic dysfunction and acute mortality in PE patients with active cancer is still controversial. We analyzed the data of 1715 PE patients in the COMMAND VTE Registry to compare initial hemodynamic dysfunction, management strategies, and mortality outcomes at 30 days after PE diagnosis between patients with and without active cancer (N = 393 and N = 1322). The patients with active cancer showed lower prevalence of right ventricular dysfunction (35.4% vs. 49.5%, P < 0.001), shock (6.4% vs. 11.6%, P = 0.003), and cardiac arrest (1.8% vs. 5.5%, P = 0.002) at PE diagnosis, compared with those without. The patients with active cancer less frequently received systemic thrombolysis (4.1% vs. 12.6%, P < 0.001) than those without. There was no significant difference in the cumulative 30-day incidence of PE-related death between patients with and without active cancer (4.1% vs. 4.2%, P = 0.89). The cumulative 30-day incidence of all-cause death was significantly higher in patients with active cancer than in those without (11.5% vs. 4.9%, P < 0.001). PE patients with active cancer less frequently present with initial hemodynamic dysfunction at PE diagnosis, compared with those without. Nevertheless, PE patients with active cancer still show a similar risk of PE-related death and a higher risk of all-cause death at 30 days after PE diagnosis, suggesting the importance of prudent management for this patient population even if their initial hemodynamic status are not compromised.

Abstract 14258: Are Anticoagulants Necessary for Isolated Distal Deep Vein Thrombosis? From COMMAND VTE Registry 1 and 2

Background: Anticoagulation for isolated distal deep vein thrombosis (DVT) remains controversial and is rarely recommended; however, all available data are from the warfarin era, and the effects of DOACs remain unknown. Objective and Methods: A large cohort of patients with acute venous thrombosis in the Contemporary Management and Outcomes in Patients with Venous Thromboembolism Registry (COMMAND VTE Registry 1 and 2) in Japan were included for analysis. We then evaluated the patient characteristics, clinical outcomes of symptomatic isolated distal DVT, and the risk-benefit of anticoagulation therapy by comparing direct oral anticoagulant (DOAC) and warfarin. Results: From a total of 8224 patients in the COMMAND registry, we excluded those with isolated distal DVT who had an event within 30 days of the initial venous thrombosis, leaving 1054 patients for the study. Among the 1054 patients included, 599, 312 and 143 were on DOACs, warfarin and no anticoagulant respectively. Overall, Kaplan-Meier analysis during a median follow-up of 988 days showed that anticoagulation significantly prevented recurrent VTE (P = 0.011), with no difference between warfarin and DOACs (P = 0.862). No clear increase in bleeding events were observed regardless of anticoagulation status (P = 0.327). Subsequent analysis stratified entries into transient (N = 318), Persistent (N = 353), and Unprovoked (N = 383) groups according to risk of venous thrombosis. In the persistent group, anticoagulation significantly prevented recurrent VTE (P = 0.025), with no difference between DOAC and warfarin (P = 0.939). In the transient group, anticoagulation was not effective in preventing recurrent VTE, with warfarin use significantly increasing bleeding events compared to those with DOAC or no anticoagulation (P = 0.030). Multivariate analysis showed that anticoagulation was independently associated with decreased incidence of venous thrombosis in the persistent group [HR: 0.262 (0.094-0.727), P = 0.010]. Conclusion: In symptomatic isolated distal DVT, anticoagulation is effective in preventing exacerbation of venous thrombosis; however, warfarin may increase bleeding events among the patients with transient DVT risk.

Autoimmune disorders and venous thromboembolism: a report from the COMMAND VTE Registry

Abstract Background/Introduction Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. Several studies reported that autoimmune disorder is one of important risk factors for development of VTE. Furthermore, autoimmune disorder is thought to be a relatively strong risk factor for VTE recurrence, and extended anticoagulation therapy are recommended for prevention of VTE recurrence in patients with autoimmune disorders. However, it remains controversial whether patients with autoimmune disorders have higher risk for clinical events after VTE than those without. Purpose We sought to evaluate the clinical characteristics, management strategies, and long-term outcomes of patients with autoimmune disorders after excluding patients with active cancer in a large observational database in Japan. Methods The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic VTE. After excluding patients with active cancer, the current study population consisted of 2332 patients, who were divided into 2 groups: patients with autoimmune disorders and those without. We estimated the cumulative incidences of the clinical outcomes. To adjust for the clinically relevant confounders, we used the multivariable Cox proportional hazard model to estimate the hazard ratio (HR) and their 95% confidence interval (CI) for the risk of patients with autoimmune disorders relative to those without for the clinical outcome measures. Furthermore, we added corticosteroids use at discharge to explore the effect of corticosteroids use. Results There were 188 patients (8.1%) with autoimmune disorders and 2144 patients (92%) without autoimmune disorders. Patients with autoimmune disorders were more often women (74%), and more often received corticosteroids at discharge (69%). The discontinuation rate of anticoagulation therapy was not significantly different between patients with autoimmune disorders and those without (38.0% vs. 39.7% at 3-year, P=0.35). The cumulative 5-year incidences of recurrent VTE and major bleeding were significantly higher in patients with autoimmune disorders than in those without (recurrent VTE: 14.3% vs. 8.3%, P=0.01; major bleeding: 14.9% vs. 8.8%, P=0.02). Even after adjusting confounders of patient characteristic, the excess risk of patients with autoimmune disorders relative to those without remained significant for recurrent VTE (HR 1.81, 95% CI 1.08–2.88, P=0.03) and major bleeding (HR 1.70, 95% CI 1.05–2.63, P=0.03). However, after adjusting for corticosteroids use at discharge, the excess risk was no longer significant for recurrent VTE (HR 1.42, 95% CI 0.75–2.61, P=0.27) nor major bleeding (HR 1.53, 95% CI 0.84–2.69, P=0.16). Conclusions Patients with autoimmune disorders had a higher risk for recurrent VTE and major bleeding than those without, and the excess risk could at least partly be attributable to corticosteroids use. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Research Institute for Production Development, Mitsubishi Tanabe Pharma Corporation

Periprocedural management and clinical outcomes of invasive procedures after venous thromboembolism: from the COMMAND VTE registry.

Anticoagulation therapy is prescribed for the prevention of recurrence in patients with venous thromboembolism, which could be temporarily interrupted during invasive procedures. The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic VTE in Japan between January 2010 and August 2014. We identified patients who underwent invasive procedures during the entire follow-up period and evaluated periprocedural managements and clinical outcomes at 30days after invasive procedures. During a median follow-up period of 1213 (IQR: 847-1764) days, 518 patients underwent invasive procedures with the cumulative incidences of 5.8% at 3months, 11.1% at 1year, and 24.0% at 5years. Among 382 patients in high bleeding-risk category of invasive procedures, anticoagulation therapy had been discontinued already in 62 patients (16%) and interrupted temporarily in 288 patients (75%) during the invasive procedures with bridging anticoagulation therapy with heparin in 214 patients (56%). Among 80 patients in low bleeding-risk category, anticoagulation therapy had been already discontinued in 15 patients (19%) and interrupted temporarily in 31 patients (39%) during invasive procedure with bridging anticoagulation therapy with heparin in 17 patients (21%). At 30days after the invasive procedures, 14 patients (2.7%) experienced recurrent VTE, while 28 patients (5.4%) had major bleeding. This study elucidated the real-world features of peri-procedural management and prognosis in patients with VTE who underwent invasive procedures during follow-up in the large multicenter VTE registry. The 30-day incidence rates of recurrent VTE and major bleeding events were 2.7% and 5.4%.

Refinement of a modified simplified Pulmonary Embolism Severity Index for elderly patients with acute pulmonary embolism

ObjectiveTo evaluate the utility of a modified (i.e., without the variable “Age >80 years”) simplified Pulmonary Embolism Severity Index (sPESI) in elderly patients with acute symptomatic pulmonary embolism (PE), and to derive and validate a refined version of the sPESI for identification of elderly patients at low risk of adverse events. MethodsThe study included normotensive patients aged >80 years with acute PE enrolled in the RIETE registry. We used multivariable logistic regression analysis to create a new risk score to predict 30-day all-cause mortality. We externally validated the new risk score in elderly patients from the COMMAND VTE registry. ResultsMultivariable logistic regression identified four predictors for mortality: high-risk sPESI, immobilization, coexisting deep vein thrombosis (DVT), and plasma creatinine >2 mg/dL. In the RIETE derivation cohort, the new model classified fewer patients as low risk (4.0% [401/10,106]) compared to the modified sPESI (35% [3522/10,106]). Low-risk patients based on the new model had a lower 30-day mortality than those based on the modified sPESI (1.2% [95% CI, 0.4–2.9%] versus 4.7% [95% CI, 4.0–5.4%]). In the COMMAND VTE validation cohort, 1.5% (3/206) of patients were classified as having low risk of death according to the new model, and the overall 30-day mortality of this group was 0% (95% CI, 0–71%), compared to 5.9% (95% CI, 3.1–10.1%) in the high-risk group. ConclusionsFor predicting short-term mortality among elderly patients with acute PE, this study suggests that the new model has a substantially higher sensitivity than the modified sPESI. A minority of these patients might benefit from safe outpatient therapy of their disease.

Неблагоприятное течение тромбоэмболии легочной артерии в течение года наблюдения

Цель исследования: изучение частоты и причины неблагоприятных исходов, а также факторов, с ними связанных, в течение года наблюдения у пациентов с тромбоэмболией легочной артерии (ТЭЛА). Материалы и методы: В одноцентровый регистр проспективного наблюдения методом сплошного включения включены 185 пациентов с ТЭЛА. Проводилось стандартное обследование пациентов, диагноз подтверждался по результатам мультиспиральной компьютерной томографии. Период наблюдения составил 12 мес, в течение которого отслеживали исходы пациентов, выписанных под амбулаторное наблюдение. Конечными точками являлись все случаи смерти и рецидивов ТЭЛА. Статистическую обработку результатов осуществляли с помощью пакета программ MedCalc Version 16.2.1 (Softwa, Бельгия). Результаты: Годовые исходы были определены у 161 пациента. Фатальный исход в течение года после выписки из стационара наступил у 22 (13,6%) больных ТЭЛА: у 45,5% по причине рецидива ТЭЛА, у 22,7% — онкологической патологии, у 13,6% — из-за острого нарушения мозгового кровообращения (ОНМК). Развитие летальных исходов было ассоциировано с такими факторами, как пожилой возраст, наличие ишемической болезни сердца, злокачественных новообразований, застойной сердечной недостаточности, ОНМК, а также со снижением глобальной сократимости миокарда левого желудочка, высоким риском по шкале PESI (англ. Pulmonary Embolism Severity Index) и отказом от антикоагулянтной терапии в течение первых 6 мес. Рецидив ТЭЛА в течение года наблюдения выявлен в 11,2% случаев и был связан с наличием тромбоза глубоких вен нижних конечностей, нижней полой вены и подвздошных вен, застойной сердечной недостаточностью и дилатацией правых отделов сердца. Установлено, что отказ от антикоагулянтной терапии в течение 11 мес после первичного эпизода повышает риск развития рецидива ТЭЛА. Заключение: У пациентов с ТЭЛА в течение первого года наблюдения летальный исход развился в 13,6% случаев, а рецидив ТЭЛА — в 11,2%. Наиболее значимым неблагоприятным фактором, связанным с данными конечными точками, являлся отказ от антикоагулянтной терапии ранее 6 мес после эпизода ТЭЛА. Objectives: to study the incidence, causes and factors associated with adverse outcomes in patients with pulmonary embolism (PE) during the year of observation. Patients/Methods: The single-center prospective follow-up register included 185 patients with PE. Standard examination was carried out; the diagnosis was confirmed by multispiral computed tomography. During follow-up period of 12 months we tracked outpatient outcomes. The endpoints were all-cause mortality and PE relapses. Statistical analysis was performed by MedCalc Version 16.2.1 software package (Softwa, Belgium). Results: Twelve-month outcomes were determined in 161 patients. Post-discharge fatal outcome within a year occurred in 22 (13.6%) patients with PE: in 45.5% due to PE relapse, in 22.7% due to oncological pathology, in 13.6% because of acute stroke. Lethal outcomes were associated with elderly age, ischemic heart disease, malignant neoplasms, congestive heart failure, stroke, reduction of left ventricular global myocardial contractility, a high risk according to PESI (Pulmonary Embolism Severity Index) scale and the refusal of anticoagulant therapy during the first 6 months. Within a year of observation PE relapse was detected in 11.2% of patients and was associated with deep vein thrombosis of the lower limbs, inferior vena cava and iliac veins, congestive heart failure and dilatation of right heart compartments. Refusal of anticoagulant therapy within 11 months after the initial episode increased the risk of PE relapse. Conclusions: In patients with PE during the first year of observation a fatal outcome occurred in 13.6% patients with PE and PE relapse — in 11.2%. Refusal of anticoagulant therapy earlier than 6 months after the episode of PE was the most significant adverse factor associated with these endpoints.

Derivation and validation of a clinical prediction rule for thrombolysis-associated major bleeding in patients with acute pulmonary embolism: the BACS score.

Improved prediction of the risk of major bleeding in patients with acute pulmonary embolism (PE) receiving systemic thrombolysis is crucial to guide the choice of therapy. The study included consecutive patients with acute PE who received systemic thrombolysis in the RIETE registry. We used multivariable logistic regression analysis to create a risk score to predict 30-day major bleeding episodes. We externally validated the risk score in patients from the COMMAND VTE registry. We also compared the newly created risk score against the Kuijer and RIETE scores. Multivariable logistic regression identified four predictors for major bleeding: recent major Bleeding (3 points), Age >75 years (1 point), active Cancer (1 point), and Syncope (1 point) (BACS). Among 1172 patients receiving thrombolytic therapy in RIETE, 446 (38%) were classified as having low-risk (none of the variables present, 0 points) of major bleeding according to the BACS score, and the overall 30-day major bleeding rate of this group was 2.9% (95% CI, 1.6-4.9%), compared with 44% (95% CI, 14-79%) in the high-risk group (>3 points). In the validation cohort, 51% (149/290) of patients were classified as having low-risk, and the overall 30-day major bleeding rate of this group was 1.3%. In RIETE, the 30-day major bleeding event rates in the Kuijer and RIETE low-risk stratum were 5.3% and 4.4%, respectively. The BACS score is an easily applicable aid for prediction of the risk of major bleeding in the population of PE patients who receive systemic thrombolysis.

Usefulness of Simplified Pulmonary Embolism Severity Index Score for Identification of Patients With Low-Risk Pulmonary Embolism and Active Cancer: From the COMMAND VTE Registry

The simplified Pulmonary Embolism Severity Index (sPESI) score is a practical score for identification of patients with low-risk pulmonary embolism (PE), although it has not been applied in patients with active cancer. The current study aimed to evaluate the usefulness of the sPESI score in patients with PE and active cancer. The COMMAND VTE Registry is a multicenter registry enrolling consecutive patients with acute symptomatic VTE. The current study population consisted of 368 patients with PE and active cancer. The 30-day clinical outcomes were compared between patients with sPESI score= 1 and patients with sPESI scores≥2. Overall, 37 patients (10%) died during the 30days after diagnosis. The cumulative 30-day incidences of mortality, and PE-related death, were lower in patients with sPESI score= 1 than in patients with sPESI scores≥ 2 (6.3%vs13.1%; log-rank P= .03; and 0.7%vs3.9%; log-rank P= .046). Among patients with sPESI score= 1, the predominant cause of death was cancer. There were no significant differences in the cumulative 30-day incidence of recurrent VTE and major bleeding between the two groups (3.9%vs5.6%; log-rank P= .46; and 6.4%vs4.5%; log-rank P= .45). Among patients with PE and active cancer, patients with sPESI score= 1 had a lower 30-day mortality rate compared with patients with sPESI scores≥ 2, and they showed very low PE-related mortality risk, although the overall mortality rate remained high because of cancer-related mortality. They also showed relatively high risks for recurrence and major bleeding, suggesting the need for careful follow-up. UMIN Clinical Trials Registry; No.: UMIN000021132; URL: http://www.umin.ac.jp/ctr/index.htm.

P5593The association of recurrence and bleeding events with mortality after venous thromboembolism: from the COMMAND VTE Registry

Abstract Background/Introduction Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), has a long-term risk for recurrence, which can be prevented by anticoagulation therapy. The duration of anticoagulation therapy after VTE should be based on the balance between risks of recurrent VTE and bleeding. However, there is uncertainty about the impact of these events on subsequent mortality. Purpose We sought to evaluate the impact of recurrent VTE events and bleeding events on subsequent mortality in patients with VTE in a large retrospective observational database in Japan. Methods We evaluated the association of recurrent VTE and major bleeding with mortality among 3026 patients in the COMMAND VTE Registry. We estimated the risks of recurrent VTE events and major bleeding events for subsequent all-cause death with the multivariable Cox proportional hazard model. We incorporated the recurrent VTE events and major bleeding events during follow-up into the multivariable Cox model as time-updated covariates together with the clinically-relevant 16 risk-adjusting factors. We expressed the adjusted risks of each covariate as hazard ratios (HR) and their 95%confidence intervals (CI). Furthermore, to assess the risks of recurrent PE and recurrent DVT events for subsequent all-cause death respectively, we divided recurrent VTE events into recurrent PE (PE with or without DVT) and recurrent DVT (DVT only), and incorporated these events as well as major bleeding events into the multivariable Cox model as time-updated covariates. Results In the current study population, the mean age was 67 years, 61% were women, and mean body weight and body mass index were 57.9 kg and 23.2 kg/m2, respectively. During the median follow-up period of 1,218 days, 763 patients died, 225 patients developed recurrent VTE events, and 274 patients developed major bleeding events. The time-updated multivariable Cox proportional hazard model revealed that both the recurrent VTE events and the major bleeding events were strongly associated with subsequent mortality risk (recurrent VTE events: HR 3.24, 95% CI 2.57–4.08, P&lt;0.001; major bleeding events: HR 3.53, 95% CI 2.88–4.31, P&lt;0.001). Both the recurrent PE events and the recurrent DVT events were associated with subsequent mortality risk with the numerically greater magnitude of effect with the recurrent PE events than with the recurrent DVT events (recurrent PE events: HR 4.42, 95% CI 3.28–5.95, P&lt;0.001; recurrent DVT events: HR 2.42, 95% CI 1.75–3.36, P&lt;0.001). Conclusions In the real-world patients with VTE, both recurrent VTE events and major bleeding events were strongly associated with subsequent mortality risk with the comparable effect size. Recurrent PE and recurrent DVT events were also associated with increased risks for mortality, although the magnitude of the effect on mortality was numerically greater with the recurrent PE events than with the recurrent DVT events. Acknowledgement/Funding Research Institute for Production Development, Mitsubishi Tanabe Pharma Corporation

P5592Thrombolysis with tissue plasminogen activator for patients with acute pulmonary embolisms in the real world: from the COMMAND VTE Registry

Abstract Background/Introduction There is still uncertainty about the optimal usage of thrombolysis for acute pulmonary embolisms (PEs), leading to widely varying usage of thrombolysis in the real world. However, these have not been fully evaluated yet. Purpose We sought to evaluate the management strategies and clinical outcomes of thrombolysis for acute PEs in the real world. Methods The COMMAND VTE Registry is a multicenter registry enrolling 3,027 consecutive patients with acute symptomatic venous thromboembolisms in Japan between January 2010 and August 2014. The present study population consisted of 1,549 patients with PEs who received tissue plasminogen activator (t-PA) thrombolysis (N=180, 12%), or those who did not (N=1,369). The effectiveness outcome was all-cause death. The safety outcome was major bleeding. We used a multivariable logistic regression analysis to estimate the odds ratio (OR) and 95% confidence intervals (CI), to adjust clinically relevant confounders (age, sex, history of major bleeding, active cancer, and anemia). Additionally, we conducted stratified analysis by clinical severity, and we also evaluated clinical outcomes according to dosages of t-PA. Results Patients with t-PA thrombolysis were younger, and more frequently had higher body weight, but less frequently had active cancer, history of major bleeding, and anemia. More than half of patients with t-PA thrombolysis were patients with mild PEs, and the proportions of t-PA thrombolysis varied widely across the participating centers. More than half of patients received low-dose of t-PA (&lt;20,000 IU/kg). As for the effectiveness, 9 (5.0%) patients in the t-PA thrombolysis group and 95 (6.9%) patients in the non t-PA thrombolysis group died at 30 days (Crude OR, 0.71; 95% CI 0.35–1.42, P=0.33). As for the safety, 7 (3.9%) patients in the t-PA thrombolysis group and 22 (1.6%) patients in the non t-PA thrombolysis group experienced major bleeding events at 10 days (Crude OR, 2.48; 95% CI 1.04–5.88, P=0.04). T-PA thrombolysis group had a significantly higher risk for 10-day major bleeding (Adjusted OR, 4.01; 95% CI 1.57–10.2, P=0.004), but not a lower risk for 30-day mortality (Adjusted OR, 1.10; 95% CI 0.53–2.28, P=0.79), although the risk for 30-day mortality was significantly lower in those with severe PEs (Adjusted OR, 0.36; 95% CI 0.15–0.88, P=0.02). After adjusting confounders, the 10-day major bleeding risk of the low-dose of t-PA group relative to the standard-dose of t-PA group tended to be lower (Adjusted OR, 0.07; 95% CI 0.004–1.05, P=0.05). Conclusions In the present real-world registry, relatively large number of patients received t-PA thrombolysis with wide variation across the participating centers. T-PA thrombolysis was significantly associated with a higher risk for major bleeding, but not a lower risk for mortality, although there appeared to be a benefit of t-PA thrombolysis in decreasing the risk for mortality in patients with severe PEs. Acknowledgement/Funding Research Institute for Production Development, Mitsubishi Tanabe Pharma Corporation

P6461The long-term clinical comparisons of symptomatic patients of pulmonary embolism with and those without deep vein thrombosis: from the COMMAND VTE Registry

Abstract Background Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), has significant morbidity and mortality. Acute PE, in particular, is fatal if we miss it, and symptomatic patients of PE sometimes have concomitant DVT. Purpose This study compared the risk of mortality in symptomatic patients of PE with and those without DVT in the long term. Methods The COMMAND VTE Registry is a multicenter registry enrolling consecutive 3027 patients with acute symptomatic VTE objectively confirmed by imaging examination or by autopsy among 29 centers in Japan between January 2010 and August 2014. Patients with both PE and DVT (N=1334) were regarded as PE patients, and the current study population consisted of 1715 PE patients and 1312 DVT patients. Results There were 1203 symptomatic patients of PE, including 381 without and 822 with DVT. In our cohort, the mean age was 67.9±14.9 years, 63% was female, 44% had hypertension, 12% diabetes mellitus, 5% history of VTE. There were 20% of active cancer. Baseline characteristics were well matched except for dyslipidemia (18% vs. 23%, p=0.021) and atrial fibrillation (8% vs. 5%, p=0.045). Patients without DVT had a more severe clinical presentation compared to those with DVT, including hypoxemia, shock and arrest. Moreover, Initial parenteral anticoagulation therapy in the acute phase was administered less frequently in patients without DVT (89% vs. 96%, P=0.0001). Two groups received thrombolysis (20% vs. 26%, P=0.18) and mechanical supports (Ventilator 14% vs. 5%, p&lt;0.001, PCPS 5% vs. 3%, p&lt;0.001, respectively). During follow-up, 93 (8%) patients experienced recurrent VTE events and 98 (8%) major bleeding events, and 323 (27%) patients died. The most frequent cause of death was cancer (11%). There were a significant differences in the cumulative incidences of all-cause death between the groups (32% vs. 24%, P=0.006), whereas there was significant difference in VTE-related death (13% vs. 4%, p&lt;0.001). Estimated freedom rates from death for patients of PE without and those with DVT were as follows: 88% vs 99% at 10-day, 86% vs 95% at 1-month, 75% vs 83% at 1-year, and 64% vs 71% at 5-year, respectively. Landmark analysis Conclusions In symptomatic patients of PE, there was a difference in mortality between groups, but no difference in recurrent VTE. Patients without DVT had a more severe clinical presentation compared to those with DVT, and many VTE-related deaths in the acute phase. The one-month mortality rate differed statistically between groups, but there was no significant difference in long-term survival beyond one month. Most of deaths were due to underlying diseases, mainly cancer, and less commonly due to VTE in the long term. Acknowledgement/Funding Research Institute for Production Development, Mitsubishi Tanabe Pharma Corporation

Validation of simplified PESI score for identification of low-risk patients with pulmonary embolism: From the COMMAND VTE Registry.

The simplified pulmonary embolism severity index (sPESI) score has been reported to be useful in predicting 30-day mortality for patients with pulmonary embolism, which helps the identification of low-risk patients for early hospital discharge or home treatment. However, therapeutic decision-making should also be based on the risks of adverse events other than mortality. The COMMAND VTE Registry is a multicentre registry enrolling consecutive patients with acute symptomatic venous thromboembolism in Japan between January 2010 and August 2014, and the current study population consisted of 1715 patients with pulmonary embolism. We calculated the sPESI score for each patient, and compared 30-day rates of mortality, recurrent venous thromboembolism and major bleeding between sPESI scores of 0 and 1 or greater. Patients with a sPESI score of 0 accounted for 383 (22%) patients, and 110 (6.4%) patients died within 30 days. The cumulative 30-day incidence of mortality was lower in patients with a sPESI score of 0 than those with a sPESI score of 1 or greater (0.5% vs. 8.1%, log rank P<0.001). There was no significant difference in the cumulative 30-day incidence of recurrent venous thromboembolism between patients with a sPESI score of 0 and 1 or greater (1.3% vs. 2.8%, log rank P=0.11). The cumulative 30-day incidence of major bleeding was lower in patients with a sPESI score of 0 than those with a sPESI score of 1 or greater (1.1% vs. 4.0%, log rank P=0.005). In patients with a sPESI score of 0, the 30-day mortality, recurrent venous thromboembolism and major bleeding rates were reasonably low. The sPESI score could be useful to identify candidates for early hospital discharge or home treatment.

P252Sex differences in the clinical characteristics and outcomes of patients with venous thromboembolism: from the COMMAND VTE Registry

P252Sex differences in the clinical characteristics and outcomes of patients with venous thromboembolism: from the COMMAND VTE Registry

P2609The long-term clinical outcomes of patients with pulmonary embolism and deep vein thrombosis: From the COMMAND VTE Registry

P2609The long-term clinical outcomes of patients with pulmonary embolism and deep vein thrombosis: From the COMMAND VTE Registry

P3563Risk factors for bleeding in patients with venous thromboembolism during long-term anticoagulation therapy: From the COMMAND VTE Registry

P3563Risk factors for bleeding in patients with venous thromboembolism during long-term anticoagulation therapy: From the COMMAND VTE Registry

P1622Risk factors for development of postthrombotic syndrome in patients with deep venous thrombosis: from the COMMAND VTE Registry

P1622Risk factors for development of postthrombotic syndrome in patients with deep venous thrombosis: from the COMMAND VTE Registry

P6024The clinical characteristics and outcomes of venous thromboembolism in patients with renal dysfunction: from the COMMAND VTE Registry

P6024The clinical characteristics and outcomes of venous thromboembolism in patients with renal dysfunction: from the COMMAND VTE Registry