36-month clinical outcomes of patients with venous thromboembolism:GARFIELD-VTE

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.</p

Characterization of Incidental Renal Mass With Dual-Energy CT: Diagnostic Accuracy of Effective Atomic Number Maps for Discriminating Nonenhancing Cysts From Enhancing Masses.

OBJECTIVE The purpose of this study was to assess the diagnostic accuracy of effective atomic number maps reconstructed from dual-energy contrast-enhanced data for discriminating between nonenhancing renal cysts and enhancing masses. MATERIALS AND METHODS Two hundred six patients (128 men, 78 women; mean age, 64 years) underwent a CT renal mass protocol (single-energy unenhanced and dual-energy contrast-enhanced nephrographic imaging) at two different hospitals. For each set of patients, two blinded, independent observers performed measurements on effective atomic number maps from contrast-enhanced dual-energy data. Renal mass assessment on unenhanced and nephrographic images, corroborated by imaging and medical records, was the reference standard. The diagnostic accuracy of effective atomic number maps was assessed with ROC analysis. RESULTS Significant differences in mean effective atomic numbers (Zeff) were observed between nonenhancing and enhancing masses (set A, 8.19 vs 9.59 Zeff; set B, 8.05 vs 9.19 Zeff; sets combined, 8.13 vs 9.37 Zeff) (p < 0.0001). An effective atomic number value of 8.36 Zeff was the optimal threshold, rendering an AUC of 0.92 (95% CI, 0.89-0.94), sensitivity of 90.8% (158/174 [95% CI, 85.5-94.7%]), specificity of 85.2% (445/522 [95% CI, 81.9-88.2%]), and overall diagnostic accuracy of 86.6% (603/696 [95% CI, 83.9-89.1%]). CONCLUSION Nonenhancing renal cysts, including hyperattenuating cysts, can be discriminated from enhancing masses on effective atomic number maps generated from dual-energy contrast-enhanced CT data. This technique may be of clinical usefulness when a CT protocol for comprehensive assessment of renal masses is not available

Virtual unenhanced images at Dual-Energy CT: Influence on renal lesion characterization

Background: Dual-energy (DE) CT allows reconstruction of virtual noncontrast (VNC) images from a single-phase contrast agent- enhanced examination, potentially reducing the need for multiphasic CT to characterize renal lesions. However, data regarding diagnostic performance of VNC images for the characterization of renal lesions are limited. Purpose: To determine whether renal mass CT performed by using VNC images allows for reliable identification of renal lesions and differentiation of contrast-enhanced from unenhanced lesions, compared with unenhanced images. Materials and Methods: This is a retrospective study of 293 patients (105 women [mean age, 65 years; age range, 18-91 years] and 188 men [mean age, 66 years; age range, 23-90 years] with 379 renal lesions [craniocaudal diameter, 1.0-4.0 cm]) who underwent a single-energy unenhanced CT examination followed by a nephrographic-phase DE CT between June 2013 and October 2017 by using one of four different DE CT platforms from two vendors. VNC images were calculated by using vendor-specific algorithms. Each lesion was classified in a blinded and independent fashion by using the VNC or unenhanced image in combination with the nephrographic images. Attenuation measurements were obtained on the VNC, unenhanced, and nephrographic images. Unenhanced images and pathologic or imaging follow-up for more than 24 months served as reference standard. Results: There was strong overall agreement between VNC and unenhanced images for renal lesion characterization (Cramer V = 0.85). VNC images yielded a high diagnostic performance (area under the receiver operating characteristic curve, 0.91; 95% confidence interval: 0.86, 0.95) for facilitation of differentiation of contrast-enhanced from unenhanced renal lesions. However, there was a reduction in diagnostic performance for depicting contrast-enhanced renal lesions by using VNC compared with unenhanced images (area under the receiver operating characteristic curve, 0.91 [95% confidence interval: 0.86, 0.95] vs 0.96 [95% confidence interval: 0.93, 0.99]; P &lt;.001). Mean absolute difference between the VNC and unenhanced attenuation was 9.2 HU ± 8.7. Conclusion: Virtual noncontrast images enabled accurate renal lesion characterization, albeit with a reduction in diagnostic performance for contrast-enhanced lesion characterization

Venous thromboembolism in Asia and worldwide: Emerging insights from GARFIELD-VTE

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\u201317.3] vs. 5.9 [5.4\u20136.5]). Adjusted hazard ratios indicated a higher risk of all-cause mortality in Asian patients than the ROW (1.32 [1.08\u20131.62]). 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

Management strategies and clinical outcomes in patients with inferior vena cava thrombosis: Data from GARFIELD-VTE

Background: Inferior vena cava (IVC) thrombosis is a rare form of venous thromboembolism (VTE). The optimal treatment strategies and outcomes are unclear in patients with this presentation. Objective: We aimed to compare baseline characteristics, treatment patterns and 24-month outcomes in IVC thrombosis patients (n&nbsp;=&nbsp;100) with lower extremity deep vein thrombosis (LEDVT) patients (n&nbsp;=&nbsp;7629). Methods: GARFIELD\u2013VTE is a prospective, observational registry of 10&nbsp;868 patients with objectively diagnosed VTE from 415&nbsp;sites in 28 countries. Results: IVC thrombosis patients were younger (51.9 vs. 59.8&nbsp;years), more frequently had active cancer (26.0% vs. 8.9%) or history of cancer (21.0% vs. 12.2%), and less frequently had recent trauma or surgery than LEDVT patients. IVC thrombosis was more frequently treated with parenteral anticoagulants alone (35.1% vs. 15.9%), whereas patients with LEDVT more commonly received vitamin K antagonists (32.0% vs. 25.8%) or direct oral anticoagulants (49.0% vs. 35.1%). Thrombolysis (11.0% vs. 3.6%) and surgical/mechanical interventions (4.0% vs. 1.4%) were more frequent in IVC thrombosis. At 24-months, the rate per 100 person-years (95% confidence interval) of all-cause mortality was higher in patients with IVC thrombosis than LEDVT (13.28 [8.57\u201320.58] vs. 4.91 [4.55\u20135.3]); the incidence of cancer-associated mortality was comparable as was the incidence of VTE recurrence (4.11 [1.85\u20139.15] vs. 4.18 [3.84\u20134.55]). Major bleeding was slightly higher in IVC thrombosis (2.03 [0.66\u20136.31] vs. 1.66 [1.45\u20131.89]). Conclusion: In summary, IVC thrombosis patients have higher all-cause mortality rates than those with LEDVT, a finding only partly attributable to malignancy

Upper Extremity DVT versus Lower Extremity DVT: Perspectives from the GARFIELD-VTE Registry

Upper extremity deep vein thrombosis (UEDVT) is less common than lower extremity DVT (LEDVT) and consequently less well characterized. This study compared clinical characteristics and 1-year outcomes between 438 UEDVT patients and 7,602 LEDVT patients recruited in the GARFIELD-VTE registry. UEDVT patients were significantly more likely to have a central venous catheter than those with LEDVT (11.5% vs. 0.5%; p &lt; 0.0001), and had a higher rate of active cancer (16.2%) or recent hospitalization (19.4%) compared with LEDVT patients (8.7% and 11.2%, respectively). Nearly all patients with UEDVT and LEDVT were initiated on anticoagulant therapy, which was a direct oral anticoagulant in one-third individuals in both groups. At 3, 6, and 12 months, the proportion of UEDVT and LEDVT patients who were receiving anticoagulant therapy was 82.6 and 87.4%, 66.0 and 72.6%, and 45.7 and 54.6%, respectively. In the UEDVT and LEDVT groups, VTE recurrence rate was 4.0 (95% confidence interval [CI], 2.4-6.7) and 5.5 (95% CI, 4.9-6.1) per 100 person-years, respectively; major bleed was noted in 1.3 (95% CI, 0.6-3.2) and 1.6 (95% CI, 1.3-1.9) per 100 person-years and all-cause mortality in 9.7 (95% CI, 7.1-13.4) and 6.7 (95% CI, 6.1-7.3) per 100 person-years, respectively. Hence, risk of recurrence was similar in the two groups whereas all-cause mortality was significantly higher in the UEDVT group than the LEDVT group (p = 0.0338). This latter finding was likely due to the high prevalence of cancer in the UEDVT group

Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE

Venous thromboembolism (VTE) is common in cancer patients and is an important cause of morbidity and mortality. The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE (ClinicalTrials.gov: NCT02155491) is a prospective, observational study of 10,684 patients with objectively diagnosed VTE from 415 sites in 28 countries. We compared baseline characteristics, VTE treatment patterns, and 1-year outcomes (mortality, recurrent VTE and major bleeding) in 1075 patients with active cancer, 674 patients with a history of cancer, and 8935 patients without cancer. Patients with active cancer and history of cancer were older than cancer-free patients, with median ages of 64.8, 68.9, and 58.4&nbsp;years, respectively. The most common sites of active cancer were lung (14.5%), colorectal (11.0%), breast (10.6%), and gynaecological (10.3%). Active cancer patients had a higher incidence of upper limb and vena cava thrombosis than cancer-free patients (9.0% vs 4.8% and 5.1% vs 1.4%, respectively), and were more likely to receive parenteral anticoagulation as monotherapy than cancer-free patients (57.8% vs 12.1%), and less likely to receive DOACs (14.2% vs 50.6%). Rates of death, recurrent VTE, and major bleeding were higher in active cancer patients than in cancer-free patients, with hazard ratios (95% confidence intervals) of 14.2 (12.1-16.6), 1.6 (1.2-2.0) and 3.8 (2.9-5.0), respectively. VTE was the second most common cause of death in patients with active cancer or history of cancer. In patients with VTE, those with active cancer are at higher risk of death, recurrence, and major bleeding than those without cancer