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BACKGROUND: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide. METHODS: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries. FINDINGS: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE ± DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0-8.1), 5.4 (4.9-5.9) and 2.7 (2.4-3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2-4.7), 3.5 (3.2-2.7) and 1.4 (1.3-1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up was cancer (n = 565, 48.6 %), followed by cardiac (n = 94, 8.1 %), and VTE (n = 38, 3.2 %). Most recurrent VTE events were DVT alone (n = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %). INTERPRETATION: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population. ispartof: THROMBOSIS RESEARCH vol:222 pages:31-39 ispartof: location:United States status: published

Thrombopoietin receptor agonists (TPO-RAs) are a reliable second-line immune thrombocytopenia (ITP) treatment. Despite an increase in use of TPO-RAs, the treatment pattern among adults with ITP is not well understood.From January 2015 to December 2018, ITP patients were identified using the Korean Health Insurance Review and Assessment Service database.Of the total 3885 adult patients with ITP, 1745 (44.9%) required treatment, with a median follow-up duration of 31.4 months (range, 0.1-59.8 months). Of these, 46.5% and 36.6% continued treatment for more than 6 months and more than 12 months, respectively. Corticosteroids were the most common first-line therapy. Of the treated patients, 83 (4.8%) received TPO-RAs (eltrombopag, 86.7%; romiplostim, 13.3%). The median age of the group treated with TPO-RAs was 62 years, 62.6% were female, and the median time from first diagnosis to initial TPO-RA treatment was 12.5 months (range, 0.4-48.0 months). A total of 52 (62.7%) patients received TPO-RAs as a second-line treatment for ITP. Splenectomy was performed in 19 patients (22.9%) before initiation of TPO-RAs. When clinical efficacy was analyzed before and during TPO-RA use, there was a significant decrease in platelet transfusion and a tendency toward reduced bleeding events.This population-based study is the first to describe the treatment pattern of TPO-RAs for ITP among patients in Korea.

Introduction Direct oral anticoagulants (DOACs) have the potential to increase bleeding due to drug-drug interactions (DDIs). In the present study, the risk of bleeding was evaluated when drugs with potential DDIs were simultaneously prescribed with DOACs. Materials and methods The present study included patients with non-valvular atrial fibrillation (AF) and venous thromboembolism (VTE) who were newly prescribed DOACs between January 2014 and December 2016. Results The study included 115,362 patients with AF or VTE who were newly administered DOACs (median age, 73 years, range, 19–108 years; males, 53.0%; AF, 81.9%). A total of 7001 any bleeding (6.1%) and 2283 major bleeding (2.0%) events occurred with DOAC prescriptions. Based on multiple logistic regression analysis, the number of DDIs was significantly associated with bleeding events independent of CHA2DS2-VASc score and Charlson Comorbidity Index (CCI). The rates of exposure to DDI drugs associated with any bleeding and major bleeding were 56.7% and 66.1%, respectively. The most common DDI drugs showed similar distributions in any or major bleeding; non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, diltiazem, and amiodarone were frequently prescribed. Conclusions Physicians prescribing DOACs for AF or VTE should be aware of the increasing risk of bleeding associated with drugs having potential DDIs regardless of comorbidities.

Venous thromboembolism (VTE) may lead to diminished quality of life and ultimately worse prognosis in cancer patients, but there is limited data on the incidence, risk factors and mortality impact of VTE in Asian primary central nervous system lymphoma (PCNSL) patients.To report the incidence, risk factors and mortality impact of VTE in Asian PCNSL patients.From 7 academic centers in Korea, 235 newly diagnosed PCNSL patients undergoing chemotherapy were retrospectively identified during period of January 2004 to September 2018.All patients but 12 (6 T-cell, 6 other B-cell) had diffuse large B-cell lymphoma. During the median follow-up of 21 months, 33 patient (14.0%) developed VTE. Of the VTE events, 11 (33.3%) were deep vein thrombosis (DVT), 15 (45.5%) were pulmonary thromboembolism (PTE), and 7 (21.2%) were DVT with PTE. The median time to VTE was 2 months and the one-year actuarial incidence was 11.7%. On multivariate analysis, ECOG performance ≥2, age60 years, female sex, and Hb10 g/dL were independently associated with VTE. The patients with VTE were associated with shorter disease specific survival (P = 0.046) and overall survival (P = 0.022).Overall, the incidence of VTE in Asian PCNSL seems to be lower compared to Western population. As VTE development is associated with overall survival and indicative of relapse, careful close monitoring is warranted.

Background Although epidemiological studies report a lower risk of venous thromboembolism (VTE) than in the Western world, VTE rates in Asia may be underestimated. Furthermore, it is uncertain whether VTE outcomes differ in Asia and the rest of the world (ROW). Methods GARFIELD-VTE is a global, prospective, non-interventional study of real-world treatment practices. In this study, we compared baseline characteristics, treatment patterns, and 12-month outcomes in Asia and ROW. Results Of the 10,684 enrolled patients, 1822 (17.1%) were Asian (China n = 420, Hong Kong n = 98, Japan n = 148, Malaysia n = 244, South Korea n = 343, Taiwan n = 232, Thailand n = 337). Compared with ROW patients, those from Asia were more often female (57.4% vs. 48.0%), non-smokers (74.0% vs. 58.9%) and had a lower BMI (24.8 kg/m2 vs. 29.1 kg/m2). Asian patients were more likely to be managed in the hospital (86.9% vs. 70.4%) and to have active cancer (19.8% vs. 8.1%) or a history of cancer (19.1% vs. 12.0%). Asian patients received no anticoagulation more frequently than ROW patients (6.5% vs. 2.1%). Over 12-months follow-up, the rate of all-cause mortality (per 100 person-years [95% confidence interval]) was higher in Asians (15.2 [13.4–17.3] vs. 5.9 [5.4–6.5]). Adjusted hazard ratios indicated a higher risk of all-cause mortality in Asian patients than the ROW (1.32 [1.08–1.62]). The frequencies of major bleeding and recurrent VTE were similar. Conclusion Asian patients have different risk profiles, treatment patterns and a higher risk of mortality compared with the ROW.

Introduction The epidemiology of immune thrombocytopenia (ITP) is not well characterized in an Asian population. Materials and methods From July 2010 to June 2014, ITP patients were identified using the Korean Health Insurance Review and Assessment Service database. Results The overall incidence rate of ITP was 5.3 per 100,000 person-years (95% CI: 5.1–5.5). The overall incidence rate ratios of children under 15 years old to adults and females to males were 3.8 (95% CI: 3.7–3.9) and 1.3 (95% CI: 1.2–1.4), respectively. Of the total 10,814 patients, 3388 patients (31%) needed treatment for ITP; of these, 54% continued treatment for more than three months. First-line therapy consisted of corticosteroids (CS) in 42%, immunoglobulin (IVIg) in 35%, CS with IVIg in 19%, and other immunosuppressive agents (ISA) in 4%. Among treated patients, 75% of adults and 33% of children continued treatment for more than three months. After three months, the most frequently used drug was CS alone in 63% of patients. Only 104 patients underwent splenectomy; of these, 51% received salvage treatment after a median of one month after surgery (range: 0–27). The proportion of patients who received platelet transfusions of 12 units or more per month for at least two consecutive months was significantly higher among patients treated for more than three months compared with patients who completed treatment within three months. Conclusions This population-based study is the first to describe the incidence of ITP and its treatment reality for patients in Korea.

Background Evidences suggest an association between leukocytosis and thrombotic or hemorrhagic complication in polycythemia vera (PV) and essential thrombocythemia (ET), but clinical implication is not well known. Objective To evaluate whether leukocyte burden during follow-up is related to thrombotic or hemorrhagic events in PV and ET. Patients/Methods We retrospectively analyzed patients with PV or ET treated at Seoul National University Bundang Hospital, Korea. Time-weighted averages of leukocytes during the follow-up period were defined as leukocyte burden and were calculated for each patient and compared between patient subgroups. In each patient with events, leukocyte burden for the 3-month period before the event was compared with that for the entire follow-up period. Results In 102 patients with PV or ET, 35 events (16 thrombotic, 19 hemorrhagic) occurred in 29 patients (median follow-up, 54months). Leukocyte burden were significantly higher in patients with events than in event-free patients (12,015×10 3 /μL vs. 9,567×10 3 /μL, P =0.003). The difference was more prominent in ET patients than in PV patients, and in patients with hemorrhagic events than in those with thrombotic events. In patients with events, the leukocyte burden in the pre-event period was higher than in the entire follow-up period (16,767×10 3 /μL vs. 12,015×10 3 /μL, P =0.002). In all patients, leukocyte burden during entire follow-up period of 11,000×10 3 /μL or higher was an independent risk factor for vascular events. Conclusion In PV or ET patients, leukocyte burden during disease course is related to increased incidence of thrombotic or hemorrhagic events.

Patients with cancer have been associated with increased risk of recurrent venous thromboembolism (VTE). However, data on recurrent VTE in Asian patients with advanced solid cancers are limited. Methods This study was conducted using data from the Korean VTE registry, which is an ongoing, prospective database. Patients were eligible if they had diagnosed with recurrent/metastatic solid cancers and initiated anticoagulation therapy following index VTE diagnosis. A total of 449 patients were included in this analysis. The 6-month and 12-month cumulative incidences of recurrent VTE were 20.6% and 27.0%, respectively. Isolated pulmonary embolism (PE) (51%) was the most predominant recurrence type. Pancreas as the primary tumor site, poor Eastern Cooperative Oncology Group performance status at the time of index VTE diagnosis, and initial presentation with PE were independent risk factors for developing recurrent VTE. With a median follow-up of 29.1 months (range, 1.0-91.2), the median overall survival (OS) was 11.9 months. Patients with recurrent VTE had a significantly worse OS than those without recurrent VTE (median, 8.4 vs. 13.0 months, respectively; P = 0.001). In conclusion, the incidence of recurrent VTE in Korean patients with advanced solid cancers is comparable with Caucasian patients. Pancreas as the primary tumor site, poor performance status, and initial presentation with PE are independent recurrent VTE risk factors in advanced cancer VTE patients. Additionally, OS is adversely affected by recurrent VTE.

There have been conflicting results on seasonal variation in the occurrence of venous thromboembolism (VTE). It also has never been studied in Asian population. To address these issues, we investigated seasonal changes of the incidence of VTE in Korean population using 1,495 patients with VTE between January 2001 and December 2010. VTE occurred most frequently in the winter and least frequently in the summer (χ2 = 11.83, P = 0.008). In the subset analyses, the same trend was shown in the PE ± DVT group, the unprovoked VTE group, and the VTE without malignancy group. The monthly occurrence rate peaked in December and was at its lowest in July (P = 0.004). In conclusion, our study provides evidence that there is an increased risk for VTE in Korean population in the winter season.

Background Pancreatic adenocarcinoma is one of the cancers most frequently associated with venous thromboembolism (VTE), with the varying incidences of 10%–20% reported in Western countries. Asians are known to have a lower risk for VTE than Caucasians, but few studies have been conducted regarding the incidence of VTE in Asian cancer patients. Materials and methods Incidence of radiologically confirmed VTE was assessed by review of medical records of all patients histologically diagnosed with advanced pancreatic adenocarcinoma, with follow-up conducted at a regional teaching hospital from Jun 2003 to Dec 2005. Results Seventy five patients with advanced pancreatic adenocarcinoma were identified for evaluation (M:F = 44:31, locally advanced:metastatic = 25:50, median age:67 years). Four patients (5.3%) developed VTE during median follow-up period of 124 days. Three of four patients had metastatic disease and were receiving chemotherapy when VTE developed. The mean time from cancer diagnosis to the detection of VTE was 160 days. No episodes of peripheral arterial thrombosis were detected, but three multiple cerebral infarctions occurred, which proved fatal in all three. Median survival time was shorter in patients with VTE than those without, but the difference was not statistically significant (4.3 vs 6.6 months). Conclusion The incidence of VTE complications in Korean patients with advanced pancreatic cancer was 5.3%, which is lower than that observed in other ethnic groups. Our study warrants further prospective investigations on the incidence and mechanism of VTE and cerebral infarctions in cancer patients of different ethnic groups.