SAMe-TT2R2 Score Research Articles

Use of the SAMe-TT2R2 score to predict anticoagulation control in atrial fibrillation and venous thromboembolism patients receiving vitamin K antagonists: A review

Identifying patients who are likely to achieve and maintain a therapeutic international normalized ratio when prescribed a vitamin K antagonist for stroke prevention in atrial fibrillation (AF) and venous thromboembolism (VTE) is challenging. The SAMe-TT2R2 score was developed on the basis of common clinical factors that can highlight patients who may be unable to achieve and maintain good anticoagulation control and for whom a "trial of warfarin" would be inadvisable. This review summarizes the main published prospective and retrospective studies that have validated the SAMe-TT2R2 score in patients with AF and VTE treated with a vitamin K antagonist and how the SAMe-TT2R2 score could aid clinical decision making; 19 studies were included. Taken together, validation studies suggest that the SAMe-TT2R2 score is able to predict good or poor anticoagulation control in patients with AF and VTE, although data on patients with VTE are limited (3 studies). The available evidence suggests that the SAMe-TT2R2 score may be a useful tool to aid clinical decision making for oral anticoagulants in patients with AF and VTE.

Quality of oral anticoagulation with vitamin K antagonists in 'real-world' patients with atrial fibrillation: a report from the prospective multicentre FANTASIIA registry.

The efficacy and safety of oral anticoagulation (OAC) using the vitamin K antagonists (VKA) are closely associated with the quality of anticoagulation, reflected by time in therapeutic range (TTR). The SAMe-TT2R2 is a risk score developed to predict the quality of anticoagulation control among VKA users. To analyse the quality of anticoagulation and its clinical determinants based on different methods in a prospective cohort of atrial fibrillation patients on VKA treatment participating in the multicentre Spanish observational registry FANTASIIA. Estimated TTR was calculated from Rosendaal, direct method, international normalized ratio variability, and NICE criteria. Time in therapeutic range values were compared for those patients with a SAMe-TT2R2 score 0-2 and >2. One thousand four hundred and seventy patients were analysed (56.4% male, mean age 74.1 ± 9.5 years). Mean TTR was 61.5 ± 25.1 with Rosendaal and 64.7 ± 24.2 with direct method. There was a high correlation between both methods (ρ = 0.805). The prevalence of poor anticoagulation control was 55%. Diabetes mellitus [odds ratio (OR) 1.38; P = 0.008], peripheral artery disease (PAD, OR 1.62; P = 0.048), and HAS-BLED (OR 1.13; P = 0.022) were independently associated with TTR < 70%. SAMe-TT2R2 score 0-2 had a higher mean TTR than patients with SAMe-TT2R2 >2 (P = 0.044), with a specificity of > 90% for predicting TTR < 70%. Patients with TTR < 70% had higher risk of events (21.7 vs. 16.8%; P = 0.021). In a multicentre prospective registry, 55% of AF patients had poor anticoagulation control with diabetes mellitus, PAD, and HAS-BLED being independently associated with TTR < 70%. A high SAMe-TT2R2 scores had a high specificity for predicting a TTR < 70% as an indicator of poor quality anticoagulation.

GW28-e0841 A Study of Predictive Capability of SAMe-TT2R2 Score in Elderly Patients with Atrial Fibrillation on Warfarin Anticoagulation

GW28-e0841 A Study of Predictive Capability of SAMe-TT2R2 Score in Elderly Patients with Atrial Fibrillation on Warfarin Anticoagulation

P2701Predicting the time in therapeutic range in patients with atrial fibrillation: validation of the SAMe-TT2R2 score in a Hispanic cohort

P2701Predicting the time in therapeutic range in patients with atrial fibrillation: validation of the SAMe-TT2R2 score in a Hispanic cohort

5743Clinical determinants of time in therapeutic range and the role of SAMe-TT2R2 score in atrial fibrillation patients receiving oral anticoagulation: data from FANTASIIA registry

5743Clinical determinants of time in therapeutic range and the role of SAMe-TT2R2 score in atrial fibrillation patients receiving oral anticoagulation: data from FANTASIIA registry

Influence of renal function on anticoagulation control in patients with non-valvular atrial fibrillation taking vitamin K antagonists.

Chronic kidney disease (CKD) has been related to poor anticoagulation control and an increased risk of bleeding. This study aims to evaluate the association between impaired renal function (eGFR <60mL/min/1.73m2 ) and anticoagulation control in patients with non-valvular atrial fibrillation (AF) on vitamin K antagonists (VKA) therapy. We also assessed whether the predictive value of the SAMe-TT2 R2 score prevailed for subgroups both with and without CKD. This is an ancillary analysis of 1381 patients from the PAULA study, which was a cross-sectional, retrospective and nationwide multicenter study. A total of 370 patients had eGFR <60mL/min/1.73m2 . Anticoagulation control levels progressively worsened across each stage of CKD. Multiple linear regression analysis showed CKD as an independent predictor of time in therapeutic range (TTR). In the subgroup of patients with preserved renal function, female sex, diet affecting INR, polypharmacy and amiodarone were associated with poorer TTR. The SAMe-TT2 R2 score had a significant but modest predictive value for TTR<65% (AUC, area under the curve 0.558, P=.002). In the subgroup of patients with CKD, the SAMe-TT2 R2 (>2 points) showed no significant predictive capacity for TTR (AUC 0.528, P=.354). The average TTR was similar for both sexes (P=.255), but with a higher percentage of males subjects with TTR ≥65% (P=.013). Chronic kidney disease is associated with poor anticoagulation control in patients with non-valvular AF taking VKA. The SAMe-TT2 R2 score was not predictive of poor TTR in the subgroup with CKD, although a modest predictive value for poor TTR was found in those without CKD.

Anticoagulation Control in Warfarin-Treated Patients Undergoing Cardioversion of Atrial Fibrillation (from the Edoxaban Versus Enoxaparin–Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation Trial)

In the Edoxaban Versus Enoxaparin-Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation (ENSURE-AF) study (NCT 02072434), edoxaban was compared with enoxaparin-warfarin in 2,199 patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF). In this multicenter prospective randomized open blinded end-point trial, we analyzed patients randomized to enoxaparin-warfarin. We determined time to achieve therapeutic range (TtTR); time in therapeutic range (TiTR); their clinical determinants; relation to sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) score; and impact on primary end points (composite of stroke, systemic embolic event[SEE], myocardial infarction [MI], and cardiovascular death [CVD] and composite of major + clinically relevant nonmajor bleeding). Among 1,104 patients randomized to enoxaparin-warfarin, 27% were naïve to oral anticoagulants. Mean age was 64.2 ± 11 years and mean congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female (CHA2DS2-VASc) score was 2.6. Mean TtTR was 7.7 days (median 7 days) and mean TiTR after reaching an international normalized ratio of 2.0 to 3.0 was 71%. In 695 patients who had an INR <2.0 before the first dose and who reached an INR ≥2.0, 436 had a SAMe-TT2R2 score ≤2 and 259 had a score >2. On multivariate regression, an independent predictor of extended TtTR was creatinine clearance (p = 0.02). TtTR was marginally related to stroke/SEE/MI/CVD (p = 0.06; odds ratio 0.23, 95% confidence interval 0.02 to 1.17) but not to any bleeding. Independent predictors of TiTR were previous vitamin K antagonist experience (p<0.01) and low hypertension, abnormal renal or liver function, stroke, bleeding, labile INRs, age >65, concomitant drugs or alcohol (HAS-BLED) score (p = 0.02). TiTR was related to any bleeding (p = 0.02; odds ratio 0.39, 95% confidence interval 0.16 to 0.88), but not stroke/SEE/MI/CVD. In this cohort of warfarin users with a high TiTR no difference was seen between TtTR and TiTR in relation to SAMe-TT2R2 score. In conclusion, even in this short-term study, TiTR was significantly related to bleeding events.

Integrating genotypes in the SAMe-TT2R2 score for the prediction of anticoagulation control in Chinese patients with atrial fibrillation on warfarin

IntroductionThe SAMe-TT2R2 score has been proposed to predict whether patients with atrial fibrillation (AF) would be well anti-coagulated with warfarin or not. However, it might over-estimate the number of patients under suboptimal warfarin treatment in non-Caucasians. This study was designed to modify the SAMe-TT2R2 score with genotypes and validate it in Chinese AF patients treated with warfarin. Material and methodsConsented Chinese-Han patients (n=510) with AF under the treatment of warfarin for at least 3months were randomly divided into a derivation (n=310) and a validation cohort (n=200). For each patient, CYP2C9*3 and VKORC1 −1639 A/G genotyping was performed, and the time in therapeutic range (TTR) was calculated over this period. ResultsThe modified SAMe-TT2R2 score was established by adding “warfarin genotype bins” to replace “the non-white race” variable. In the validation cohort, the discrimination performance of the modified score for good anticoagulation control (TTR≥70%) was significantly improved (c- index increased from 0.60 to 0.67). Significantly increased risks of major bleedings (HR: 4.91; 95% CI: 1.03–23.37; adjusted p=0.04) and all bleedings (HR: 1.93; 95% CI: 1.14–3.25; adjusted p=0.01) were found in patients with modified scores ≥2, as compared with patients with modified scores of 0–1. ConclusionsThe modified SAMe-TT2R2 score could improve the ability for the identification of good anticoagulation control, and the prediction of major bleeding events in Chinese patients with AF treated by warfarin.

SAMe-TT2R2 predicts quality of anticoagulation in patients with acute venous thromboembolism: The MAQI2 experience.

A high SAMe-TT2R2 score predicted poor warfarin control and adverse events among atrial fibrillation patients. However, the SAMe-TT2R2 score has not been well validated in venous thromboembolism (VTE) patients. A cohort of 1943 warfarin-treated patients with acute VTE was analyzed to correlate the SAMe-TT2R2 score with time in therapeutic range (TTR) and clinical adverse events. A TTR <60% was more frequent among patients with a high (>2) versus low (0-1) SAMe-TT2R2 score (63.4% vs 52.3%, p<0.0001). A high SAMe-TT2R2 score (>2) correlated with increased overall adverse events (7.9 vs 4.5 overall adverse events/100 patient years, p=0.002), driven primarily by increased recurrent VTE rates (4.2 vs 1.5 recurrent VTE/100 patient years, p=0.0003). The SAMe-TT2R2 score had a modest predictive ability for international normalized ratio (INR) quality and adverse clinical events among warfarin-treated VTE patients. The utility of the SAMe-TT2R2 score to guide clinical decision-making remains to be investigated.

SAMe-TT2R2 Score in the Outpatient Anticoagulation Clinic to Predict Time in Therapeutic Range and Adverse Events.

BackgroundThe SAMe-TT2R2 score was developed to predict which patients on oral anticoagulation with vitamin K antagonists (VKAs) will reach an adequate time in therapeutic range (TTR) (> 65%-70%). Studies have reported a relationship between this score and the occurrence of adverse events.ObjectiveTo describe the TTR according to the score, in addition to relating the score obtained with the occurrence of adverse events in patients with nonvalvular atrial fibrillation (AF) on oral anticoagulation with VKAs.MethodsRetrospective cohort study including patients with nonvalvular AF attending an outpatient anticoagulation clinic of a tertiary hospital. Visits to the outpatient clinic and emergency, as well as hospital admissions to the institution, during 2014 were evaluated. The TTR was calculated through the Rosendaal´s method.ResultsWe analyzed 263 patients (median TTR, 62.5%). The low-risk group (score 0-1) had a better median TTR as compared with the high-risk group (score ≥ 2): 69.2% vs. 56.3%, p = 0.002. Similarly, the percentage of patients with TTR ≥ 60%, 65% or 70% was higher in the low-risk group (p < 0.001, p = 0.001 and p = 0.003, respectively). The high-risk group had a higher percentage of adverse events (11.2% vs. 7.2%), although not significant (p = 0.369).ConclusionsThe SAMe-TT2R2 score proved to be effective to predict patients with a better TTR, but was not associated with adverse events.

Management of anticoagulation in rate controlled atrial fibrillation: A three-step approach

Atrial Fibrillation is the most common type of cardiac arrhythmia managed in clinical practice. This condition predisposes patients to a multitude of potential complications that can be managed or prevented by medical or surgical means. Such complications include stroke, hemorrhage, or heart failure, among others. Although surgical intervention may be a viable option in some cases, pharmacological rate-control is a less invasive and more robust method in preventing the genesis of these sequelae. However, current guidelines regarding pharmacologic control of atrial fibrillation sequelae may be difficult to interpret. Based upon clinical prediction rules derived from large-scale clinical trials, we provide a simple three-step sequential algorithm that clinicians may use as guidelines when managing patients with rate controlled atrial fibrillation. These protocols can help clinicians decide if anticoagulation medication is indicated (CHA2DS2-VASc score), select the appropriate agent for anticoagulation (SAMe-TT2R2 score), and anticipate a high risk of hemorrhage (HAS-BLED score).

Anticoagulant therapy and prognosis in patients with CHF and AF in the setting of real-life clinical practice

Prevalence of atrial fibrillation (AF) grows with the increase in CHF FC and reaches 45% in III-IV FC CHF. With an adequate anticoagulant (AC) therapy, the risk of thromboembolic complications does not significantly differ between patients with I-II FC and III-IV FC CHF. Of particular interest is studying administration of the anticoagulant treatment and correspondence between the SAMe-TT2R2 scale and actual TTR values in patients with CHF and AF in real-life clinical practice. Toanalyze the efficacy of anticoagulant therapy and prognosis in patients with CHF and AF in the setting of real-life clinical practice. The study included 272 patients with CHF and AF who were discharged from the hospital where they had been treated for decompensated CHF and who were followed up as outpatients for a year. Efficacy of the AC therapy was evaluated; parameters of CHA2DS2-VASc, HAS-BLED, and SAMe-TT2R2 scales were calculated at baseline. TTR was computed to determine the maintenance time. Patients with CHF had permanent (56.3%), persistent (38.6%), or paroxysmal (5.1%) AF. The mean CHA2DS2-VASc score was 3.83±1.16 and the mean HAS-BLED score was 1.3±0.83. SAMe-TT2R2 scores were 0 for 1.6% of patients; 1 for 36.9%, and 2< for 61.5%. At baseline, one third of patients with CHF and AF received antiplatelet therapy (APT) and every forth patient received no therapy. At one year, 69.0% of patients took AC on a constant basis (р.

The Sex, Age, Medical History, Treatment, Tobacco Use, Race Risk (SAMe TT2R2) Score Predicts Warfarin Control in a Singaporean Population

Warfarin reduces stroke risk in atrial fibrillation (AF) patients but requires ongoing monitoring. Time in therapeutic range (TTR) is used as a measure of warfarin control, with a TTR less than 60% associated with adverse patient outcomes. The Sex, Age, Medical history, Treatment, Tobacco use, Race (SAMe-TT2R2) score has been identified as a model able to predict warfarin control, but this has been tested in mainly Caucasian populations. Therefore, the aim of this study was to determine the ability of the SAMe-TT2R2 score to predict warfarin control in a Singaporean population consisting of Chinese, Malay, and Indian race. Retrospective data were collected from the National Heart Centre Singapore for AF patients receiving warfarin between January and June 2014. The TTR and the SAMe-TT2R2 score were calculated for each patient. The 1137 non-valvular AF patients had a mean TTR of 58.0 ± 34.3% and a median SAMe-TT2R2 score of 3. The categorized SAMe-TT2R2 scores (2 versus >2) showed a significant reduction in mean TTR for the entire population (63.2% versus 55.8%, P = .0004) and also when categorized according to race for Chinese (62.7% versus 56.9%, P = .0075) and Malay (68.4% versus 50.6%, P = .0131) populations. The SAMe-TT2R2 tool is effective in predicting warfarin control in a Singaporean population as patients with a score greater than 2 had poor control. The minimum score for non-Caucasian patients is 2; thus, in these patients, the presence of any additional risk factors identified in the SAMe-TT2R2 tool categorizes them as unlikely to achieve adequate warfarin control and possible candidates for alternative anticoagulants.

Determinants of Time in Therapeutic Range in Patients Receiving Oral Anticoagulants (A Substudy of IMPACT)

Implanted cardiac arrhythmia devices can detect atrial tachyarrhythmias (atrial high-rate episodes [AHREs]) that are considered to correlate with atrial fibrillation and risk of stroke. In the IMPACT trial, oral anticoagulation was initiated when AHREs were detected by implanted cardioverter-defibrillators and withdrawn when they abated, according to a protocol accounting both for AHRE duration as detected by remote device monitoring and stroke risk assessment. In this analysis, we ascertained determinants of time in therapeutic range (TTR) among protocol-determined vitamin K antagonist-treated patients during the trial. We enrolled 2,718 patients with at least 1 additional stroke risk factor (CHADS2 score ≥1) at 104 arrhythmia centers. The sex, age <60, medical history, treatments interacting with VKA, tobacco use (2 points) and race (2 points for non-Caucasian) (SAMe-TT2R2) score is a simple clinical-derived score designed to aid decision-making on whether a patient is likely to achieve good anticoagulation control on vitamin K antagonist (e.g., warfarin), which was calculated and related to TTR achieved using the Rosendaal method. We analyzed 229 patients (mean age 66.7years; mean CHADS2 score 2.85 [SD 1.1]) with mean TTR of 0.536 (SD 0.23) overall. Univariate analysis identified 5 variables associated with differences in mean TTR. Mean TTR was lower in those who were women (p= 0.031), of black race (p= 0.005) and in New York Heart Association class IV (p= 0.014), whereas hemoglobin >13.5g/dl (p= 0.010) and New York Heart Association class I (p= 0.037) were associated with higher mean TTR. There was a significant difference in mean TTR value between US and non-US sites (Canada and Germany) (mean TTR for US: 0.513 vs non-US: 0.686; p <0.0001). Mean TTR was significantly lower (Δ= 0.1382, 95% CI 0.0382 to 0.2382) for patients with SAMe-TT2R2 scores of 4 (p= 0.007) and higher (Δ= 0.0612, 95% CI 0.0005 to 0.1219) for patients with SAMe-TT2R2 scores of 1 (p= 0.048). Linear regression confirmed a significant association between lower SAMe-TT2R2 score and improved anticoagulation control (p= 0.0021) with a 1-unit decrease in SAMe-TT2R2 score associated with an increase in TTR of 0.0404 (95% CI 0.0149 to 0.0659). In conclusion, clinical, geographical, and demographic factors were associated with the quality of anticoagulation control as reflected by TTR. Although overall TTR in this population was poor, lower SAMe-TT2R2 scores were associated with better TTR.

Assessment of the mean time in the therapeutic INR range and the SAME-TT2R2 score in patients with atrial fibrillation and cognitive impairment.

INTRODUCTION Most patients with atrial fibrillation (AF) are elderly and may have an increased risk of cognitive disorders. Low mean values of the therapeutic international normalized ratio (INR) range (TTR) (≤60%) are associated with increased risk of stroke, vascular events, and bleeding complications. OBJECTIVES The aim of the study was to evaluate the efficacy of long-term anticoagulant therapy in patients treated with vitamin K antagonists (VKAs), depending on their cognitive functions. In addition, we used the SAMe-TT2R2 risk score to predict the risk of ineffective anticoagulation. PATIENTS AND METHODS The analysis comprised 154 patients (68 men and 86 women; mean age, 76 ±10 years) with AF and indications for long-term therapy with VKA (CHA2DS2-VASc score ≥1, HAS-BLED score <3). Cognitive functions were evaluated using the Mini-Mental State Examination (MMSE) score. The efficacy of VKA therapy was determined by the TTR values from the preceding 6 months of treatment. We used the SAMe-TT2R2 score to identify patients who were likely to have poor INR control. RESULTS Depending on the number of MMSE points, patients treated with VKAs were divided into 2 groups: patients with normal cognitive functions (MMSE score ≥27; n = 62) and those with cognitive impairment (MMSE score <27; n = 42). Despite the fact that all patients had indications for anticoagulant therapy, 50 patients (32%) received no VKAs on admission. The mean TTR value exceeded 60% in 61% of patients with an MMSE score of 27 points or higher, whereas mean TTR value was 28% in patients with an MMSE score of less than 27 (P <0.0001). Patients with a SAMe-TT2R2 score of 0 to 1 had higher TTR values than those with a SAMe-TT2R2 score of 2 or higher (r = -0.24; P <0.05 ). The cognitive status was significantly more impaired in patients with persistent and permanent AF compared with patients with paroxysmal AF (MMSE score, 25.8 ±3.7 vs 28.6 ±2; P <0.0001). CONCLUSIONS Cognitive disorders in patients with AF significantly reduce the efficacy of VKA therapy. The decision to administer VKA treatment should be based not only on the CHA2DS2-VASc and HAS-BLED scores, but also on the SAMe-TT2R2 score and the evaluation of the patient's cognitive functions.

PM184 The Same-TT2R2 Score Does not Predict the Quality of Anticoagulation or Outcomes of Atrial Fibrillation in Middle Eastern Patients

No pharmacy program, however well-resourced, has sufficient time or resources to teach students all current, practice-relevant knowledge. And while the volume of potential pharmacy education curriculum content increases exponentially each year, available time for direct instruction continues to decline. Given these constraints, pharmacy curricula must focus on promoting deep learning of the most critical, fundamental, broadly applicable, and lasting knowledge. Yet, in terms of didactic knowledge, pharmacy education currently has no agreed upon, evidence-based criteria for determining which foundational concepts are most important to teach nor any research-based assessment tools to demonstrate how well students have learned those core concepts.This lack of consensus regarding core conceptual knowledge makes disparities in learning outcomes both more likely to occur and less likely to be detected or addressed. Over the past 30 years, several scientific disciplines undergirding pharmacy have developed research-based lists of core concepts and related concept inventories, demonstrating their transformative educational potential. Core concepts are big, fundamental ideas that experts agree are critical for all students in their discipline to learn, remember, understand, and apply. Concept inventories are research-based, psychometrically validated, multiple-choice tests designed to uncover learners' prior knowledge and potential misconceptions and determine their depth of understanding of disciplinary core concepts.This commentary proposes adapting and applying this evidence-based core concepts approach to enhance pharmacy education's overall effectiveness and efficiency and outlines an ongoing, multinational research initiative to identify and define essential pharmacy concepts to be taught, learned, and assessed.

Relation of the SAMe-TT2R2 score to quality of anticoagulation control and thromboembolic events in atrial fibrillation patients: Observations from the SPORTIF trials

BackgroundOral anticoagulant therapy is central to the prevention thromboembolic events in atrial fibrillation (AF) patients. The SAMe-TT2R2 score is a simple clinical-derived score designed to aid decision-making on whether or not a patient is likely to achieve good anticoagulation control on vitamin K Antagonists (VKA, e.g. warfarin). Good anticoagulation control is associated with optimal VKA efficacy and safety. MethodsThe SAMe-TT2R2 score was studied in a large cohort of warfarin-treated non-valvular AF patients from the SPORTIF trials, and related to time in therapeutic range (TTR) as measure of anticoagulation control, and thromboembolism-related outcomes. ResultsAmong the 3665 patients originally assigned to the warfarin arm, a SAMe-TT2R2 score>2 was found in 19.5%. In these patients, a linear relationship was reported between SAMe-TT2R2 score and TTR (p<0.001). SAMe-TT2R2>2 was inversely associated with a higher proportion with TTR >65% (p=0.014) or TTR >70% (p=0.011).Patients with SAMe-TT2R2 score>2 had a significantly higher event rate of the composite thromboembolism-related outcome, vs. SAMe-TT2R2 0–2 (10.2% vs. 7.9%, p=0.045).On survival analysis, SAMe-TT2R2>2 was associated with a higher risk for the composite outcome (Log-Rank: 5.471, p=0.019). On Cox regression, a SAMe-TT2R2 score>2 was independently associated with the composite outcome (p=0.020). ConclusionsIn this large trial cohort of AF patients, the SAMe-TT2R2 score was able to identify patients more likely to obtain suboptimal anticoagulation control on VKA, with an increase in major thromboembolism-related adverse events consequent upon such poor anticoagulation control.

Evaluation of SAMe-TT2R2 score and other clinical factors influencing the quality of anticoagulation therapy in non-valvular atrial fibrillation: a nationwide study in Spain

Objective: To assess the major clinical factors affecting the quality of anticoagulation and evaluate the predictive value of the SAMe-TT2R2 score to identify patients who will achieve a high average time in therapeutic range (T.T.R.) with vitamin K antagonist (V.K.A.) treatment. Research design and methods: This observational, cross-sectional, retrospective and nationwide multicenter study included 1524 patients from the primary care setting with non-valvular atrial fibrillation receiving V.K.A. (≥12 months). We performed a bivariate analysis to identify factors individually associated with the T.T.R. and a multiple regression analysis to identify the independent predictive factors. For the validation of the SAMe-TT2R2 score, the receiver operating characteristic (R.O.C.) curve was calculated and the Hosmer–Lemeshow test was used to test calibration. Results: A total of 94.8% of patients received acenocumarol (4.8% warfarin). A progressive decrease in mean T.T.R. was found when the SAMe-TT2R2 score increased from 0 points (72.1 ± 17.1%) to 4 points (64.1 ± 23.2%), p < 0.001. Other risk scores (CHADS2 and CHA2DS2-VASc, HAS-BLED) were also associated with the mean T.T.R. We found a significant association between low T.T.R. and the following clinical factors: female sex, three or more comorbidities, amiodarone treatment, dietary habits, bleeding history and the intake of ≥7 tablets per day besides V.K.A. (p < 0.01). Regarding SAMe-TT2R2 score validation, the R.O.C. curve showed significant capability, although not high, of discriminating good anticoagulation control (T.T.R. ≥65%) with an area under the curve of 0.562 (95% C.I. 0.533–0.592, p < 0.001) which increased, remaining modest, to 0.594 (95% C.I. 0.564–0.624, p < 0.001) when the factors not included in SAMe-TT2R2 score were added. Conclusion: In this cohort, the SAMe-TT2R2 score had a significant, although modest, ability to assess the likelihood of good international normalized ration (I.N.R.) control, and its predictive value might slightly improve by adding other simple clinical factors. Further research is needed to refine the predictive scales.

Use of the SAMe-TT2R2 Score to Predict Good Anticoagulation Control with Warfarin in Chinese Patients with Atrial Fibrillation: Relationship to Ischemic Stroke Incidence.

BackgroundThe efficacy and safety of warfarin therapy for stroke prevention in atrial fibrillation (AF) depends on the time in therapeutic range (TTR). We aimed to assess the predictive ability of SAMe-TT2R2 score in Chinese AF patients on warfarin, whose TTR is notoriously poor.Methods and ResultsThis is a single-centre retrospective study. Patients with non-valvular AF on warfarin diagnosed between 1997 and 2011 were stratified according to SAMe-TT2R2 score, and TTR was calculated using Rosendaal method. The predictive power of SAMe-TT2R2 scores for good TTR i.e. >70% was assessed. We included 1,428 Chinese patients (mean age 76.2±8.7 years, 47.5% male) with non-valvular AF on warfarin. The mean and median TTR were 38.2±24.4% and 38.8% (interquartile range: 17.9% and 56.2%) respectively. TTR decreased progressively with increasing SAMe-TT2R2 score (p = 0.016). When the cut-off value of SAMe-TT2R2 score was set to 2, the sensitivity and specificity to predict TTR<70% were 85.7% and 17.8%, respectively. The corresponding positive and negative predictive values were 10.1% and 92.0%. After a mean follow-up of 4.7±3.6 years, 338 patients developed an ischemic stroke (4.96%/year). Patients with TTR≥70% had a lower annual risk of ischemic stroke of 3.67%/year compared with than those with TTR<70% (5.13%/year)(p = 0.08). Patients with SAMe-TT2R2 score ≤2 had the lowest risk of annual risk of ischemic stroke (3.49%/year) compared with those with SAMe-TT2R2 score = 3 (4.56%/year), and those with SAMe-TT2R2 score ≥4 (6.41%/year)(p<0.001). There was also a non-significant trend towards more intracranial hemorrhage with increasing SAMe-TT2R2 score.ConclusionsThe SAMe-TT2R2 score correlates well with TTR in Chinese AF patients, with a score >2 having high sensitivity and negative predictive values for poor TTR. Ischemic stroke risk increased progressively with increasing SAMe-TT2R2 score, consistent with poorer TTRs at high SAMe-TT2R2 scores.

A tailored treatment strategy: a modern approach for stroke prevention in patients with atrial fibrillation.

The main priority in atrial fibrillation (AF) management is stroke prevention, following which decisions about rate or rhythm control are focused on the patient, being primarily for management of symptoms. Given that AF is commonly associated with various comorbidities, risk factors such as hypertension, heart failure, diabetes mellitus and sleep apnoea should be actively looked for and managed in a holistic approach to AF management. The objective of this review is to provide an overview of modern AF stroke prevention with a focus on tailored treatment strategies. Biomarkers and genetic factors have been proposed to help identify 'high-risk' patients to be targeted for oral anticoagulation, but ultimately their use must be balanced against that of more simple and practical considerations for everyday use. Current guidelines have directed focus on initial identification of 'truly low-risk' patients with AF, that is those patients with a CHA2 DS2 -VASc [congestive heart failure, hypertension, age ≥75 years (two points), diabetes mellitus, stroke (two points), vascular disease, age 65-74 years, sex category] score of 0 (male) or 1 (female), who do not need any antithrombotic therapy. Subsequently, patients with ≥1 stroke risk factors can be offered effective stroke prevention, that is oral anticoagulation. The SAMe-TT2 R2 [sex female, age <60 years, medical history (>2 comorbidities), treatment (interacting drugs), tobacco use (two points), race non-Caucasian (two points)] score can help physicians make informed decisions on those patients likely to do well on warfarin (SAMe-TT2 R2 score 0-2) or those who are likely to have a poor time in therapeutic range (SAMe-TT2 R2 score >2). A clinically focused tailored approach to assessment and stroke prevention in AF with the use of the CHA2 DS2 VASc, HAS-BLED [hypertension, abnormal renal/liver function (one or two points), stroke, bleeding history or predisposition, labile international normalized ratio, elderly (>65 years) drugs/alcohol concomitantly (one or two points)] and SAMeTT2 R2 scores to evaluate stroke risk, bleeding risk and likelihood of successful warfarin therapy, respectively, is discussed.