ASH Clinical News October 2015 | Page 37

CLINICAL NEWS Assessing the Updated Vienna Prediction Model for Unprovoked VTE: Does It Hold Up? The Vienna Prediction Model was established to identify patients with unprovoked venous thromboembolism (VTE) who have a low risk of recurrence, with the aim of avoiding unnecessary anticoagulant therapy. In validation tests, though, the model showed a “less than optimal calibration, underestimating the observed cumulative recurrence rates at 12 months,” according to Tobias Tritschler, MD, from the Department of General Internal Medicine at Bern University Hospital in Switzerland. “Given that one-third of the patients with unprovoked VTE have a low recurrence risk and may stop anticoagulation therapy after three months, a risk stratification tool to identify these patients is important,” Dr. Tritschler told ASH Clinical News. Recently, the original developers of the model published an updated version to address these concerns. Unlike the original version, the updated model allows for prediction of recurrence at several different time points after stopping anticoagulation (3 weeks and 3, 9, 15, and 24 months). However, in a study recently published in Blood, Dr. Tritschler and co-authors discovered that the updated model still leaves something to be desired. The original Vienna Prediction Model was devised through a prospective cohort study of 929 patients with a first unprovoked VTE, and assigned risk based on the following three parameters: • Sex • Location of VTE (pulmonary embolism [PE]/proximal deep vein thrombosis [DVT] vs. distal DVT) • Quantitative D-dimer level determined by ELISA between three weeks and 15 months after discontinuation of anticoagulation The updated version was developed in a prospective cohort of 553 patients with unprovoked VTE and uses the same clinical parameters as the original model to estimate recurrent VTE risk at up to 60 months of follow-up using nomograms or a Web-based calculator. ASHClinicalNews.org TABLE 3. Patient Baseline Characteristics Low-risk patients (n=39) All (N=156) Higher-risk patients (n=117) Age (years) Male sex 74.0 (69.0; 79.8) 73.0 (68.0; 77.0) 75.0 (69.0; 80.0) 0.27 92 (59) 4 (10) 88 (75) <0.01 The current multicenter study attempts 137 (88) 28 (72) 109 (93) PE and/or proximal DVT to validate the updated 1022 (607; 1755) 717 (410; 1016) 1,161 (694; 1,913) D-dimer (ng/ml) model included 156 27.5 (24.8; 30.5) 27.7 (24.9; 31.9) 27.5 (24.8; 30.4) BMI (kg/m2) patients ≥65 years old 23 (15) 8 (21) 15 (13) Prior VTE with acute symptomatic unprovoked VTE from Time since stopping anti5.7 (4.9; 6.9) 5.9 (5.0; 7.6) 5.6 (4.7; 6.6) coagulation (months) nine Swiss hospitals. Patients were excluded Duration of prior antico6.3 (5.3; 7.1) 6.0 (4.1; 6.9) 6.4 (5.5; 7.2) agulation (months) from the study if they were immobile, had major surgery, were taking oral estrogen therapy, or had active ≥1022 ng/mL had recurrent VTE, updated Vienna Prediction Model cancer during the previous three compared with 15% of patients was developed in patients with a months. All patients had completwith a D-dimer <1022 ng/mL broader age distribution. Ultied a three- to 12-month course of (p=0.83) mately, it is still too soon to make anticoagulation. any treatment recommendations Study participants had a Ultimately, the updated Vienna based on this risk prediction tool, median age of 74 years, 41 percent Prediction Model failed to corthe authors added. were female and 88 percent had rectly identify patients as low- or “The updated Vienna PredicPE or proximal DVT as the initial high-risk for recurrent VTE. “The tion Model does not allow the VTE event (TABLE 3). proportion of recurrent VTE did identification of elderly patients at not differ between low- versus low risk of VTE recurrence who To validate the updated model, higher-risk patients at 12 months may stop anticoagulation therapy Dr. Tritschler and colleagues (13% vs. 10%, respectively; after three months,” Dr. Tritschler determined the proportion of p=0.77) and 24 months (15% vs. said. “A risk stratification tool that patients classified as low-risk 17%, respectively; p=1.0),” the accurately identifies elderly paaccording to the updated Vienna authors reported. tients with unprovoked VTE who Prediction Model and compared Limitations of the study are at low risk of VTE recurrence the proportion of VTE recurrence include the relatively small sample is still needed.” between low- and higher-risk size, and that the study may have patients at 12 and 24 months. REFERENCE been underpowered to detect a In the updated model, they Tritschler T, Mean M, Limacher A, et al. Predicting difference in VTE recurrence. noted, patients with a predicted recurrence after unprovoked venous thromboembolism: The study also focused on older 12-month risk <6.2 percent are prospective validation of the updated Vienna Prediction patients with VTE, whereas the classified as “low risk.” Model. Blood. 2015 September 4. [Epub ahead of print] Overall, the proportion of VTE recurrence was 11 percent (17 of 156 patients) after 12 months and 17 percent (26 of 156) after 24 months. At 12 months: • 5% of men had recurrent VTE compared with 19% of women (p=0.02) • 11% of patients with both PE/ proximal DVT and distal DVT had recurrent VTE (p=1.0) • 13% of patients with a D-dimer ≥1022 ng/ml had recurrent VTE, compared with 9% of those with a D-dimer <1022 ng/mL (p=0.61) At 24 months: • 12% of men and 23% of women had recurrent VTE (p=0.08) • 17% of patients with PE/proximal DVT and 16% of patients with distal DVT had recurrent VTE (p=1.0) • 18% of patients with a D-dimer p Value n (%) or median (interquartile range) <0.01 <0.01 0.44 0.30 0.20 0.20 Iron Supplementation for Women