IJCS | Volume 31, Nº5, September / October 2018

485 Pivatto Júnior et al. SAMe-TT 2 R 2 score forVTE patients? Int J Cardiovasc Sci. 2018;31(5)483-491 Original Article Liver disease was defined as the presence of chronic liver disease (e.g., cirrhosis) or biochemical evidence of significant hepatic derangement (e.g., bilirubin > 2x the upper limit of normal, in association with aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase > 3x the upper limit of normal). 12 Peripheral artery disease was defined as the presence of any of the following: claudication, carotid occlusion or > 50% stenosis, and previous or planned intervention on the abdominal aorta, limb arteries, or carotids. 13 Pulmonary disease was defined as long-term use of bronchodilators or steroids for lung disease. 13 Renal disease was defined as kidney damage for ≥ 3months, as defined by structural or functional abnormalities of the kidney, or glomerular filtration rate < 60 mL/min/1.73m 2 for ≥ 3 months. 14 Thromboembolismduringanticoagulationwasdefined as acute lower-limb DVT, PE, or thromboembolism at other sites, demonstrated by objective diagnostic techniques, such as compression ultrasonography, lung ventilation-perfusion scintigraphy, and computed tomography angiography. Only patients with clinical signs or symptoms of VTE underwent specific evaluation. Major bleeding was defined as fatal bleeding, and/ or symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome), and/or bleeding causing a drop in hemoglobin level ≥ 2 g/dL or leading to transfusion of ≥ 2 units of whole blood or red cells. 15 All decisions regarding the management of anticoagulation were based on the protocol published by Kim et al. 16 The Rosendaal linear interpolationmethod was used to calculate TTR. 17 Statistical analysis Data were analyzed using SPSS, version 21.0 (IBM, Armonk, NY, USA). Qualitative variables were expressed as absolute and relative frequencies, while quantitative variables were expressed as mean ± standard deviation for normally distributed data and as median (25-75 th percentile) for non-normally distributed data. The Shapiro-Wilk test was used to assess data distribution. Quantitative variables were compared between groups using non-paired Student t test for normally distributed data, and Mann-Whitney U test for non-normally distributed data. The chi-square test was used for categorical variables. Fisher exact test was used in cases of low frequency. Pearson’s (if normally distributed) or Spearman’s (if non-normally distributed) correlation test was used for TTR and the SAMe-TT 2 R 2 score. The area under the receiver operating characteristic (ROC) curve was calculated to assess the ability of the SAMe- TT 2 R 2 score to predict a TTR ≥ 65%. Adverse event-free survival curves according to the SAMe-TT 2 R 2 score were calculated by the Kaplan-Meier method and compared by the log-rank test. A p-value < 0.05 was considered statistically significant. Results During the screeningperiod, of 681 consecutivepatients who received care at the outpatient anticoagulation clinic, 111 (16.3%) were included in the analysis after applying the inclusion and exclusion criteria (Figure 1). The demographic characteristics of the sample are shown in Table 1. Mean patient age was 54.1 ± 15.7 years, and 71 (64.0%) were women. Twenty-five (22.5%) patients had cancer (16 current and 9 previous). Patients with current cancer were initially treated with heparin and then switched to VKA after being in the therapeutic range. Median follow-up was 2.3 (0.7-6.4) years. During this period, 34 (30.6%) patients discontinued anticoagulation following appropriate treatment, 5 (4.5%) due to adverse events (bleeding) and 1 (0.9%) due to switch to NOAC. Nineteen (17.1%) patients were lost to follow-up. The VKA of choice was warfarin, used in 109 (98.2%) patients. Only 2 (1.8%) patients used phenprocoumon. Anticoagulation monitoring consisted of 5,657 PT/INR measurements. Of these, 2,379 (42.1%) were within the PT/INR interval of 2.0-3.0, over a total treatment time of 438.8 patient-years. The median time between PT/ INR measurements was 25.7 (14.7-35.1) days. Mean TTR was 50.6 ± 21.9%. Patients were below this range for a median time of 31.3% (16.8-47.9) and above this range for a median time of 12.9% (6.2-20.9). Duration of VKA treatment was < 6 months in 7 (8.1%) cases, 6-12 months in 21 (24.4%) cases, and > 12 months in 58 (67.5%) cases, not including patients who died during the anticoagulant treatment or were lost to follow-up. Forty-four (39.6%) patients were still on VKA treatment at the end of follow-up. The median SAMe-TT 2 R 2 score was 2 (1-2), and 66 (59.5%) patients had a score ≥ 2. The most prevalent score component was female sex (64.0%), followed by age < 60 years (61.3%), medical history of > 2 comorbidities (14.4%), non-white race (10.8%), and tobacco use within the past 2 years (8.1%). No patient was using amiodarone.