scholarly journals Predicting recurrence after unprovoked venous thromboembolism: prospective validation of the updated Vienna Prediction Model

Blood ◽  
2015 ◽  
Vol 126 (16) ◽  
pp. 1949-1951 ◽  
Author(s):  
Tobias Tritschler ◽  
Marie Méan ◽  
Andreas Limacher ◽  
Nicolas Rodondi ◽  
Drahomir Aujesky

Key Points The updated Vienna Prediction Model was developed to identify patients with unprovoked VTE who are at low risk of recurrence. In elderly patients with unprovoked VTE, the model does not discriminate between patients who develop recurrent VTE and those who do not.

Author(s):  
Jeffrey A. Kline ◽  
David H. Adler ◽  
Naomi Alanis ◽  
Joseph R. Bledsoe ◽  
Daniel M. Courtney ◽  
...  

BACKGROUND: The objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial. METHODS: This was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes. RESULTS: We enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%–1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%–1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%–0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%–9.5%) and was associated with a risk ratio of 6.0 (2.3–15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled. CONCLUSIONS: Monotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03404635


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giustozzi ◽  
S Barco ◽  
L Valerio ◽  
F A Klok ◽  
M C Vedovati ◽  
...  

Abstract Introduction The interaction between sex and specific provoking risk factors for venous thromboembolism (VTE) may influence initial presentation and prognosis. Purpose We investigated the impact of sex on the risk of recurrence across subgroups of patients with first VTE classified according to baseline risk factors. Methods PREFER in VTE was an international, non-interventional registry (2013–2015) including patients with a first episode of acute symptomatic objectively diagnosed VTE. We studied the risk of recurrence in patients classified according to baseline provoking risk factors for VTE consisted of i) major transient (major surgery/trauma, >5 days in bed), ii) minor transient (pregnancy or puerperium, estroprogestinic therapy, prolonged immobilization, current infection or bone fracture/soft tissue trauma); iii) unprovoked events, iv) active cancer-associated VTE. Results A total of 3,455 patients diagnosed with first acute VTE were identified, of whom 1,623 (47%) were women. The percentage of patients with a major transient risk factor was 22.2% among women and 19.7% among men. Minor transient risk factors were present in 21.3% and 12.4%, unprovoked VTE in 51.6% and 61.6%, cancer-associated VTE in 4.9% of women and 6.3% of men, respectively. The proportions of cases treated with Vitamin-K antagonists (VKAs) and direct oral anticoagulants (DOACs) were similar between sexes. Median length of treatment of VKAs was 181.5 and 182.0 days and of DOACs was 113.0 and 155.0 days in women and men, respectively. At 12-months of follow-up, VTE recurrence was reported in 74 (4.8%) women and 80 (4.5%) men. Table 1 shows the sex-specific proportion of recurrences by VTE risk factor categories. Table 1 Major Transient (n=722) Minor transient (n=573) Cancer-associated (n=195) Unprovoked (1965) Women (361) Men (361) OR (95% CI) Women (346) Men (227) OR (95% CI) Women (79) Men (116) OR (95% CI) Women (837) Men (1128) OR (95% CI) One-year follow-up, n (N%)   Recurrent VTE, 21 (6.2) 10 (2.9) 0.46 (0.2; 0.9) 9 (2.7) 12 (5.4) 2.09 (0.9; 5.0) 6 (8.0) 5 (4.5) 0.54 (0.2; 1.9) 38 (4.7) 53 (4.7) 1.03 (0.7; 1.6)   Major bleeding, 6 (1.8) 5 (1.5) 0.83 (0.3; 2.7) 5 (1.5) 1 (0.5) 0.30 (0.1; 2.6) 1 (1.3) 3 (2.7) 2.07 (0.2; 20) 10 (1.2) 15 (1.4) 1.11 (0.6; 2.4)   All-cause death, 37 (10.2) 31 (8.5) 0.82 (0.5; 1.4) 10 (2.9) 14 (6.2) 2.21 (0.9; 5.1) 26 (32.9) 49 (42.2) 1.49 (0.8; 2.7) 33 (3.9) 30 (2.7) 0.66 (0.4; 1.1) Conclusions The proportion of patients with recurrent VTE events after first acute symptomatic VTE provoked by transient risk factors was not negligible during the first year of follow-up during in both women and men. These results may have implications on the decision whether to consider extended anticoagulant therapy in selected patients with provoked events. Acknowledgement/Funding This study was funded by Daiichi Sankyo.


2019 ◽  
Vol 119 (12) ◽  
pp. 2053-2063 ◽  
Author(s):  
Trond Isaksen ◽  
Line H. Evensen ◽  
Sigrid K. Brækkan ◽  
John-Bjarne Hansen

Abstract Background Limited knowledge exists on the association between intake of long-chained n-3 polyunsaturated fatty acids (n-3 PUFAs) and risk of recurrence and all-cause mortality in patients with venous thromboembolism (VTE). Objectives This article investigates whether intake of marine n-3 PUFAs was associated with risk of recurrence and mortality in patients with incident VTE. Methods A total of 595 patients with incident VTE and available data on n-3 PUFA intake were derived from the Tromsø Study surveys 4 (1994–1995) and 6 (2007–2008). Weekly intake of n-3 PUFAs was categorized as low, medium, and high based on tertiles. Recurrent VTEs and all-cause mortality were registered up to December 31, 2016. Hazard ratios (HRs) were calculated using Cox regression models with the low intake category as reference. Results There were 98 recurrent VTEs and 227 deaths during follow-up. Overall, we found no association between intake of n-3 PUFAs and risk of recurrent VTE. However, inverse associations were found for high intakes in patients with unprovoked VTE (HR 0.45, 95% confidence interval [CI]: 0.20–1.01), cancer-free patients (HR 0.51, 95% CI: 0.27–0.95), and deep vein thrombosis (DVT) patients (HR 0.49, 95% CI: 0.24–0.97). The inverse associations were more evident when follow-up was restricted to the time after discontinuation of anticoagulant therapy. No association was observed between intake of n-3 PUFAs and mortality after incident VTE. Conclusion A high dietary intake of marine n-3 PUFAs was associated with lower risk of recurrent VTE after unprovoked index events, DVT, and in cancer-free patients.


Author(s):  
Nick P. de Boer ◽  
Stefan Böhringer ◽  
Radboud W. Koot ◽  
Martijn J. A. Malessy ◽  
Andel G. L. van der Mey ◽  
...  

Abstract Purpose The aim of this study is to compute and validate a statistical predictive model for the risk of recurrence, defined as regrowth of tumor necessitating salvage treatment, after translabyrinthine removal of vestibular schwannomas to individualize postoperative surveillance. Methods The multivariable predictive model for risk of recurrence was based on retrospectively collected patient data between 1995 and 2017 at a tertiary referral center. To assess for internal validity of the prediction model tenfold cross-validation was performed. A ‘low’ calculated risk of recurrence in this study was set at < 1%, based on clinical criteria and expert opinion. Results A total of 596 patients with 33 recurrences (5.5%) were included for analysis. The final prediction model consisted of the predictors ‘age at time of surgery’, ‘preoperative tumor growth’ and ‘first postoperative MRI outcome’. The area under the receiver operating curve of the prediction model was 89%, with a C-index of 0.686 (95% CI 0.614–0.796) after cross-validation. The predicted probability for risk of recurrence was low (< 1%) in 373 patients (63%). The earliest recurrence in these low-risk patients was detected at 46 months after surgery. Conclusion This study presents a well-performing prediction model for the risk of recurrence after translabyrinthine surgery for vestibular schwannoma. The prediction model can be used to tailor the postoperative surveillance to the estimated risk of recurrence of individual patients. It seems that especially in patients with an estimated low risk of recurrence, the interval between the first and second postoperative MRI can be safely prolonged.


Blood ◽  
2018 ◽  
Vol 131 (19) ◽  
pp. 2151-2160 ◽  
Author(s):  
Clive Kearon ◽  
Sameer Parpia ◽  
Frederick A. Spencer ◽  
Trevor Baglin ◽  
Scott M. Stevens ◽  
...  

Key Points The same type of APA on 2 occasions or >1 type of APA on the same or different occasions is associated with recurrent VTE. APA and D-dimer levels seem to be independently associated with recurrence after a first unprovoked VTE.


2017 ◽  
Vol 117 (10) ◽  
pp. 1930-1936 ◽  
Author(s):  
Andreas Limacher ◽  
Marie Méan ◽  
Hans-Jürg Beer ◽  
Joseph Osterwalder ◽  
Beat Frauchiger ◽  
...  

SummaryExisting clinical scores do not perform well in predicting bleeding in elderly patients with acute venous thromboembolism (VTE). We sought to derive an easy-to-use clinical score to help physicians identify elderly patients with VTE who are at high-risk of bleeding during extended anticoagulation (>3 months). Our derivation sample included 743 patients aged ≥65 years with VTE who were enrolled in a prospective multicenter cohort study. All patients received extended anticoagulation with vitamin K antagonists. We derived our score using competing risk regression, with the time to a first major bleeding up to 36 months of extended anticoagulation as the outcome, and 17 candidate variables as predictors. We used bootstrapping methods for internal validation. Sixty-six (9%) patients suffered major bleeding. The clinical score is based on seven clinical factors (previous bleeding, active cancer, low physical activity, anemia, thrombocytopenia, antiplatelet drugs/NSAIDs, and poor INR control). Overall, 48% of patients were classified as low-risk, 37% as moderate-risk, and 15% as high-risk of bleeding. The rate of major bleeding was 1.4 events in low-risk, 5.0 events in moderate-risk, and 12.2 events per 100 patientyears in high-risk patients. The c-statistic was 0.78 at 3 months and 0.71 at 36 months of extended anticoagulation. Model calibration was excellent (p=0.93). Internal validation showed similar results. This simple clinical score accurately identified elderly patients with VTE who are at high risk of major bleeding and who may not benefit from extended anticoagulation. Further validation of the score is important before its implementation into practice. The study is registered to https://clinicaltrials.gov as NCT00973596.This work was carried out at the Department of General Internal Medicine in the Bern University Hospital, Switzerland.


2007 ◽  
Vol 98 (12) ◽  
pp. 1232-1236 ◽  
Author(s):  
Gregor Hron ◽  
Mirko Hirschl ◽  
Christine Bialonczyk ◽  
Erich Minar ◽  
Marietta Kollars ◽  
...  

SummaryIn patients with venous thromboembolism (VTE) a laboratory assay that globally measures the overall thrombophilic tendency is not available. We hypothesized that determination of ProC® Global, a plasma assay which tests the global function of the protein C pathway, could be used to stratify patients according to their risk of recurrent VTE. We prospectively followed 774 patients with first spontaneous VTE for a mean time of 52 months. ProC Global normalized ratio (NR) was measured in plasma by use of a commercially available assay based on activated partial thromboplastin time. Ninety-eight of the 774 patients had recurrent VTE. Patients with ProC Global NR ≥ 0.75 had a relative risk of recurrence of 0.59 (95% CI 0.40–0.87) as compared with those with lower ratio. After four years, cumulative probability of recurrence was 8.6% in patients with ProC Global NR ≥ 0.75 and 17.4% in patients with a lower ratio (p=0.006). Patients with a high ProC Global NR have a low risk of recurrent VTE. ProC Global NR can be used to stratify patients with a first unprovoked VTE according to their risk of recurrence.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 475-475 ◽  
Author(s):  
Martha L Louzada ◽  
Alejandro Lazo-Langner ◽  
Vi Dao ◽  
Jerry Zhang ◽  
Michael J. Kovacs ◽  
...  

Abstract Abstract 475 Background: Current guidelines suggest that all cancer patients with venous thromboembolism be treated with long-term low molecular weight heparin (LMWH). However, whether treatment strategies should vary according to patient and malignancy characteristics, in particular whether patients with low risk of VTE recurrence can be identified, remains unknown. Methods: We performed a single centre retrospective cohort study conducted at the Thrombosis Unit of the Ottawa Hospital. The charts of patients with cancer and VTE followed from 2002 to 2004 and from 2007 to 2008 were reviewed to assess the feasibility of derivation of a clinical prediction rule that stratifies VTE recurrence risk in patients with cancer—associated venous thrombosis through identification and evaluation of characteristics of malignancy and other clinical characteristics. We analysed only the patients who had a recurrent VTE within the first 6 months of anticoagulation. A univariate analysis determined the strength of association between each potential predictor and VTE recurrence. All potential predictor variables (p<0.25) were evaluated in a logistic regression model. Result: Of 543 patients 55 (10.1%) presented with a VTE recurrence during the first 6 months of anticoagulation. At VTE recurrence 19 (9.5%) patients were using VKA and 36 (10.5%) patients were using LMWH. The relative risk for VTE recurrence was not significantly different between patients who used VKA or LMWH [RR= 1. 13 (95%CI, 0.743 – 1.711; p= 0.565)]. A multivariate analysis suggested that gender, primary tumour site, tumour stage and history of prior VTE were significant variables to include in the clinical prediction rule. The final model included female gender, lung cancer and prior history of VTE as increasing risk and breast cancer and stage I disease as lowering risk. Patients with a score equal or less than 0 have low risk (4.5%) for VTE recurrence and this represented 48% of our patients. Patients with a score equal or above 1 have high risk (> 19%) for VTE recurrence (Tables 1 and 2). Conclusion: We were able to derive a simple and easy scoring system that stratifies patients with cancer-associated thrombosis into low or high risk of recurrent VTE. Future prospective validation of the model is warranted and may be very relevant to better tailor anticoagulation treatment in this heterogeneous population. Disclosure: No relevant conflicts of interest to declare.


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