SAMe-TT2R2 Score Research Articles

Erratum to Palareti et al. "The SAME-TT2R2 score predicts the quality of anticoagulation control in patients with acute VTE. A real-life inception cohort study" (Thromb Haemost 2016; 115: 1101-1108).

[This corrects the article DOI: 10.1160/TH15-10-0830.].

The SAME-TT2R2 score predicts the quality of anticoagulation control in patients with acute VTE

The SAMe-TT2R2 score has recently been proposed to predict the quality of vitamin K antagonist (VKA) anticoagulation control in patients with atrial fibrillation. We aimed at investigating whether the score is effective also in patients with venous thromboembolism (VTE). Patients included in the START-Register because started VKA therapy for a recent VTE episode and with > 3 months follow-up were analyzed. The score was calculated using the baseline patient's characteristics present in the electronic database of the registry, where all INR results were also available and analysed to calculate the time in therapeutic range (TTR). A total of 1308 patients (53.4 % female, median age 68 years) were analysed. During 998 patient-years follow-up, the median TTR was 63 %. The maximum score in the patients was 4, with 70 % of them having 0-1. INR controls within range (2.0-3.0) were significantly less prevalent in patients with score ≥ 2 vs 0-1 score (58.5 ± 20 % vs 61.5 ± 19 %, respectively, p = 0.046). Patients with score ≥ 2 vs 0-1 had a highly significant lower TTR during the first 3 months of therapy (53 ± 26 % and 61 ± 26 %, respectively; p=0.0001), difference mainly due to more time spent below 2.0 INR (38 ± 28 % vs 31.3 ± 26.7 %, respectively; p=0.0001). In conclusion, the study proved, for the first time, that the SAMe-TT2R2 score is useful to predict among VTE patients those who will have good (score 0-1) or less good (score ≥ 2) VKA anticoagulation control. The score can help decision-making in everyday clinical practice, especially when choosing between VKA and non-vitamin K antagonists direct anticoagulants.

Usefulness of the SAME-TT2R2 score to predict anticoagulation control on VKA in patients with atrial fibrillation and obstructive sleep apnea

BackgroundOral anticoagulation is crucial for the prevention of stroke and thromboembolism in atrial fibrillation (AF). One of the comorbidities potentially affecting thromboembolic risk and anticoagulation effectiveness is obstructive sleep apnea (OSA). The objective of this study was to establish if presence of OSA is associated with poor expected benefit from vitamin K antagonist (VKA) therapy as assessed using the SAMe-TT2R2 score. MethodsWe studied AF patients planned for invasive electrophysiological procedures. All patients had a whole night polygraphy performed for the diagnosis of OSA, and their SAMe-TT2R2 score was calculated. ResultsWe studied 211 AF patients (mean age=57.1±10.2years, 62.6% males). OSA with apnea–hypopnea index (AHI) ≥15/h was found in 48 (22.7%) patients. Mean SAMe-TT2R2 score in non-OSA patients was 1.4±0.9, compared to mild OSA patients, 1.5±0.9; moderate OSA patients, 1.9±1.1; and severe OSA patients, 2.8±0.6. A significantly higher percentage of patients with SAMe-TT2R2≥2, indicating poor predicted INR control on VKAs, was found with increasing AHI category (37% vs. 41% vs. 57% vs. 100%, respectively). Patients with poor predicted anticoagulation control (SAMe-TT2R2≥2) had a higher prevalence of OSA. There was a lower proportion of patients with TTR>70% among patients with moderate/severe OSA compared to no/mild OSA (13.6% vs. 29.6%, p=0.03). ConclusionSAMe-TT2R2 scores in patients with OSA are substantially higher than in those without sleep-disordered breathing. The mean SAMe-TT2R2 score, as well as the percentage of patients with SAMe-TT2R2 score≥2, suggests poor predicted anticoagulation control on VKA rises along with the AHI. There was a lower proportion of patients with TTR>70% among patients with moderate/severe OSA, compared to no/mild OSA.

Long term supervision as a crucial ingredient of all anticoagulant therapy

The proposal to put into place strategies tomonitor atrial fibrillation (AF) patients who have been prescribed long-term treatment with novel anticoagulants (NOACs) [1] goes a long way towards addressing the challenge of striking the right balance between bleeding risk and embolic risk in the absence of a tool to monitor the anticoagulant efficacy of an antithrombotic agent. The challenge is even greater in patients who experience marked fluctuations in renal function either as a result of comorbidity or as a result of coprescription of nephrotoxic drugs, hence the need for dedicated follow-up of patients on NOACs along the lines mentioned by the authors [1]. Above all else, however, anticoagulant management clinics are strongly indicated, regardless of choice of antithrombotic agent, so as to improve medication adherence and persistence [1,2,3]. Accordingly, although it has been proposed that the decision to allocate a patient either to vitamin K antagonist treatment or to NOAC therapy could be made simply on the basis of a risk score such as the SAMe-TT2R2 score [4] it should be remembered that the SAMe-TT2R2 score was originally intended to optimize antithrombotic drug adherence [5], which should remain a crucial component of all long term anticoagulant therapy, regardless of choice of antithrombotic therapy.

Effect of Active Smoking on Comparative Efficacy of Antithrombotic Therapy in Patients With Atrial Fibrillation: The Loire Valley Atrial Fibrillation Project

Active smoking is associated with elevated thrombotic risk. Smoking status has recently been incorporated into the SAMe-TT2R2 (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]) score that can help predict poor international normalized ratio control in patients with atrial fibrillation (AF) treated with vitamin K antagonists (VKAs). The clinical benefit of antiplatelet therapy (APT) has been seen primarily in smokers. We hypothesized that active smoking may differently influence the risks of stroke and bleeding in patients with AF treated with VKAs or with APT. We examined the clinical course of 7,809 consecutive patients with AF seen between 2000 and 2010. Outcomes in patients who were active smokers were compared with those in other patients. Among 7,809 patients with AF, 1,034 (13%) were active smokers. APT was prescribed on an individual basis for 2,761 patients (35%) and VKAs for 4,534 (57%). After a follow-up of 929 ± 1,082 days (median = 463 days, interquartile range = 1,564 days), smoking was not independently associated with a higher risk of stroke/thromboembolic event in patients with AF (hazard ratio [HR], 0.95; 95% CI, 0.78-1.22; P = .66). On multivariate analysis, smoking was independently associated with a worse prognosis for the risk of severe bleeding (HR, 1.23; 95% CI, 1.01-1.49; P = .04) and for the risk of major Bleeding Academic Research Consortium bleeding (HR, 1.40; 95% CI, 1.02-1.90; P = .03). Smoking was independently associated with a higher risk of bleeding in patients treated with VKAs (HR, 1.32; 95% CI, 1.04-1.67; P = .02), whereas the risk was nonsignificant in patients treated with APT (HR, 1.28; 95% CI, 0.94-1.74; P = .11). In AF, there was a higher risk of severe bleeding in smokers, mainly in those treated with VKAs.

International Normalized Ratio Variability: A Measure of Anticoagulation Quality or a Powerful Mortality Predictor

As atrial fibrillation (AF) carries twice the mortality hazard when compared with a similar population without diagnosed AF, the importance of risk stratifying is obvious. Several variables are related to outcome: age, comorbidities, and use of several medications, particularly oral anticoagulants. The CHA2DS2VASc score is an extremely useful tool to predict thromboembolic events and also mortality. The international normalized ratio (INR) variability is a treatment efficacy variable also associated with morbidity in patients receiving warfarin. The objective of the study is to compare the prognostic value of the CHA2DS2VASc versus the INR variability or its combination to predict mortality. In this observational study, we analyzed 589 patients from our Atrial Fibrillation Cohort, all on warfarin for more than 1 year and had more than 5 INRs performed in the last 2 years. The CHA2DS2VASc, HAS-BLED, and SAMe-TT2R2 scores were calculated as well as the INR variability using the time-in-therapeutic-range (TTR), the percentage of INRs (%INRs) within range, and the standard deviation of the INRs (SDINRs). Kaplan-Meier survival curves were plotted via different cutoff points. The mean TTR was 53 ± 23%; 34.6% of the patients had a TTR above 64%. The mean %INRs in range was 50.2 ± 20.2; 17.3% of the population had %INRs in range above 70%. The mean SDINRs was .84 ± .54, and 38.4% had SDINRs below .79. Of 598, 139 (22%) discontinued warfarin treatment. Death was responsible for almost 50% of treatment discontinuation. Of 598, 68 patients died during the study period (11.5 %); the most frequent causes of death were heart failure (30%), bleeding (17%), and ischemic stroke (15%). Patient survival had a correlation with TTR, %INRs in range, SDINRs, left ventricular ejection fraction, CHA2DS2VASc, and the combination of CHA2DS2VASc + SDINRs (cutoff >1 and >.79, respectively). INR variability is an extremely useful tool to assess anticoagulation quality. Calculation of both CHA2DS2VASc and INR variability appears to be extremely useful to predict mortality in patients with AF receiving warfarin. The SDINRs emerges as a strong mortality predictor compared to the other INR variability indexes.

The SAMe-TT2R2 Score Predicts Poor Anticoagulation Control in AF Patients: A Prospective ‘Real-world’ Inception Cohort Study

ObjectivesInternational guidelines recommend that an average individual time in therapeutic range should be >65% to 70% for optimal efficacy and safety outcomes while taking a vitamin K antagonist. The Sex, Age (<60 years); Medical history (at least 2 of the following: hypertension, diabetes, coronary artery disease/myocardial infarction, peripheral arterial disease, congestive heart failure, previous stroke, pulmonary disease, hepatic or renal disease); Treatment (interacting drugs, eg, amiodarone for rhythm control) [all 1 point]; and the current Tobacco use (2 points) and Race (non-Caucasian; 2 points) (SAMe-TT2R2) score would help decision making by identifying those patients with newly diagnosed atrial fibrillation who could do well on vitamin K antagonists. The study objective was to validate the predictive value of the SAMe-TT2R2 score for discriminating those who would achieve a high time in the therapeutic range (≥65%) in a prospective “real-world” cohort of patients with atrial fibrillation initiating oral anticoagulation therapy with vitamin K antagonists. MethodsWe studied an inception cohort of consecutive patients with nonvalvular atrial fibrillation who initiated oral anticoagulation in our outpatient anticoagulation clinic. The baseline SAMe-TT2R2 score was calculated. At 6 months, we calculated the time in therapeutic range using a linear method. ResultsWe included 459 patients, of whom 222 (47%) were male. Their median age was 76 years (interquartile range, 70-82 years), median Cardiac failure or dysfunction, Hypertension, Age over 75 years [Doubled], Diabetes, Stroke [Doubled] – Vascular disease, Age between 65-74 and Sex category [Female] (CHA2DS2-VASc) score was 4 (3-5), and median Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HAS-BLED) score was 3 (2-3). The median SAME-TT2R2 score was 2 (1-2). At 6 months, the mean ± standard deviation time in therapeutic range was 64% ± 17% overall, and 248 patients (54%) had a time in therapeutic range value >65%. Patients with a SAME-TT2R2 score 0 to 1 had a mean time in therapeutic range of 67% ± 18%, whereas patients with a SAME-TT2R2 score ≥2 had a mean time in therapeutic range of 61% ± 16% (P < .001). The odds ratio for having a low time in therapeutic range value was 2.10 (95% confidence interval, 1.44-3.06; P < .001) for those patients with a SAME-TT2R2 score ≥2. ConclusionsIn a prospective “real-world” inception cohort of patients with atrial fibrillation initiating oral anticoagulation with acenocoumarol, we have validated the clinical value of the SAME-TT2R2 score for the identification of patients who would have poor-quality anticoagulation. Thus, rather than imposing a “trial of vitamin K antagonists” for such patients (and exposing such patients to thromboembolic risks), we can a priori identify those patients who can (not cannot) do well on a vitamin K antagonists. Such patients would benefit from additional strategies for improving anticoagulation control with vitamin K antagonists or alternative oral anticoagulant drugs.

Lack of Association of Clinical Factors (SAMe-TT2R2) with CYP2C9/VKORC1 Genotype and Anticoagulation Control Quality.

Background and PurposeAdvantages of new oral anticoagulations may be greater in atrial fibrillation (AF) patients of poor anticoagulation control with warfarin. The SAMe-TT2R2 scoring system, based on clinical variables, was recently developed to aid in identifying these patients. In this study, we investigated the association of this clinical composite score with genetic factors related warfarin dosing and the quality of anticoagulation control.MethodsClinical and genetic data were collected from 380 consecutive Korean patients with AF (CHA2DS2-VASc score, 3.5±1.8) who were followed for an average of 4 years. We evaluated factors associated with time in therapeutic range (TTR, INR 2-3), including the CYP2C9 and VKORC1 genotypes and the SAMe-TT2R2 score (Sex female, Age <60 years, Medical history [>two co-morbidities], Treatment [interacting drugs, e.g., amiodarone], Tobacco use within 2 years [doubled], and Race non-white [doubled]).ResultsThe average SAMe-TT2R2 score was 3.4±0.9, range 2-7; and 153 patients (40.2%) had SAMe-TT2R2 scores ≥4. Time in specific INR ranges varied depending on the VKORC1 genotype but not with the CYP2C9 genotype or the SAMe-TT2R2 score. TTR was higher in patients with the VKORC1 1173C>T than in VKORC1 TT (61.7±16% vs. 56.7±17.4%, P=0.031). Multivariate testing showed that VKORC1 genotype but not the SAMe-TT2R2 score was significantly associated with labile INRs. There was no correlation between the SAMe-TT2R2 scores and pharmacogenetic data.ConclusionsA genetic factor, but none of the common clinical and demographic factors, as combined in the SAMe-TT2R2 score, was associated with the quality of anticoagulation control in Korean patients with AF.

Validation of the SAMe-TT2R2 score in a nationwide population of nonvalvular atrial fibrillation patients on vitamin K antagonists

The SAMe-TT2R2 score has been proposed to identify patients with non valvular atrial fibrillation (AF) who maintain a high average time in therapeutic range (TTR) on vitamin K antagonists treatment (VKA). This score has been validated in several studies, either monocentric or including very selected populations in a specialised setting. Our objective was to validate this score in a nationwide cohort of AF patients. From November 2013 to March 2014 we included in this study the first 10 patients with AF on VKA consecutively seen in 120 outpatient cardiology clinics in Spain. The SAMe-TT2R2 score was calculated for each patient and TTR in the preceding six months was estimated by Rosendaal method. A total of 1,056 patients were recruited (mean age 73.6 ± 9.8 years, 42% female). Mean value of TTR was 63.8 ± 25.9% (median 66.8%, interquartile range 45.6%-85.4%). We found a progressive decline in mean TTR from a score of 0 (67.5% ± 24.6%) to ≥ 4 (52.7 ± 28.7%, p < 0.01). The score was able to discriminate which patients had a good anticoagulation control (TTR ≥ 65%) with a C-statistic of 0.57 (95 %CI 0.53-0.60, p < 0.0005). A SAMe-TT2R2 score of 0-1 was associated with a good anticoagulation control with a sensitivity, specificity, positive and negative predictive values of 64%, 48%, 58% and 54%, respectively; and the odds ratio of having a TTR< 65% if the score was ≥ 2 was 1.64 (95% confidence interval 1.33-1.95, p < 0.001). In conclusion, in this nationwide population with AF on VKA, the SAMe-TT2R2 score had a significant, although moderate, ability to identify patients with a good anticoagulation control.

Results from the Registry of Atrial Fibrillation (AFABE): Gap between Undiagnosed and Registered Atrial Fibrillation in Adults--Ineffectiveness of Oral Anticoagulation Treatment with VKA.

Objective. This study aimed to examine the effectiveness of the use of oral anticoagulation (OAC) medication, recommended by national guidelines for stroke prevention but reportedly underused in AF patients with moderate to high stroke risk. Method. A multicentre and cross-sectional study of undiagnosed AF among out-of-hospital patients over 60 years old was carried out, visiting 3,638 patients at primary health centres or at home for AF diagnosis using the IDC-10 classification. The main outcome measures were CHA2DS2VASC, HAS-BLED scores, cardiovascular comorbidity, pharmacological information, TTR, and SAMe-TT2R2 scores. Results. The main findings were undiagnosed AF in 26.44% of cases; 31.04% registered with AF but not using OAC despite 95.6% having a CHA2DS2VASC ≥ 2 score; a risk of bleeding in important subgroups using OAC without indication (37.50% CHA2DS2VASC < 2 score); the use of OAC with TTR < 60% (33.1%), of whom 47.6% had a HAS-BLED score ≥3. Thus, 35.4% of the expected AF prevalence achieved an optimal time in the therapeutic range. Conclusions. The expected AF prevalence was 10.9% (n 5267), but the registered prevalence was 7.5% (n 3638). Only 35.04% (CI = 95%, 33.7–36.3) of AF patients treated with vitamin K antagonists (VKAs) achieve the goal of TTR > 60%.

Abstract 19565: SAMeTT2R2 Scores Predict Stroke Risk After Initiation of Vitamin K Antagonist Therapy for Atrial Fibrillation: a Real-world Practice Study

Introduction: Quality and duration of anticoagulation reflected by high proportion of Time in Therapeutic INR range (TTR) is associated with reduced thrombo-embolic and bleeding events in atrial fibrillation (AF). SAMeTT2R2, a novel score incorporating age, sex, ethnicity, smoking, co-morbidities, and interacting drugs, predicts inadequate anticoagulation control (TTR &lt;0.6) after commencing Vitamin K Antagonist (VKA) for AF, with scores ≥2 suggested as a cut-off to predict inadequate control. Aims: To determine whether SAMeTT2R2 score ≥2 at VKA inception is associated with an increased stroke risk in real-world practice. Methods: A cohort of VKA-naïve patients with incident non-valvular AF between 2001 - 2010 was formed from a large UK primary care database (Clinical Practice Research Datalink, CPRD) with linkage to hospital discharges, and death registry. SAMeTT2R2 score was calculated in a subset of 4468 in whom VKA treatment was initiated within 90 days of AF diagnosis, and scores 0-1, ≥2 were related to 3-year stroke incidence. Competing risk analysis accounting for death was performed to compare the risk of stroke between the two groups in an intention-to-treat analysis. Results: Of 4468 patients with incident AF commenced on VKA (mean age 70.7, 41.2% female), 3422 (76.6%) had a SAMeTT2R2 score of 0-1, and 1046 (23.4%) a score of ≥2. During 3-years 138 patients had a stroke and 58 of these occurred in the year following AF. Cumulative risk estimates for stroke in patients with scores ≥2 compared to 0-1 were significantly increased at 1, 2 and 3 years (log rank test, p&lt;0.01)(Figure). The proportion with TTR≥0.6 was 37.1% for scores ≥2 compared to 44.1% for scores 0-1 (p&lt;0.01). Conclusions: SAMeTT2R2 scores ≥2 predict increased stroke risk in the 3 years following incident AF in patients commenced on VKA treatment. These findings suggest that patients with high SAMeTT2R2 scores may require intensified anticoagulation control or use of oral non-VKA anticoagulants.

Relationship of the SAMe-TT2 R2 Score to Poor-Quality Anticoagulation, Stroke, Clinically Relevant Bleeding, and Mortality in Patients With Atrial Fibrillation

The efficacy and safety of anticoagulation with use of vitamin K antagonists (VKAs) is highly dependent on the quality of anticoagulation control as reflected by the average time in a therapeutic range of 2.0 to 3.0. A clinical dilemma is trying to predict which anticoagulation-naive patients with atrial fibrillation (AF) would do well on a VKA (with a time in therapeutic range > 70%) and which are less likely to do well on a VKA but could be managed with novel oral anticoagulants. The cohort comprised 8,120 patients, among whom 4,637 patients were receiving VKA. We investigated whether the SAMe-TT₂R₂ (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]) score could discriminate among patients with AF who were likely to have a labile international normalized ratio (INR) during follow-up as well as stroke/thromboembolism (TE), clinically relevant bleeding (defined as severe bleeding and as Bleeding Academic Research Consortium [BARC]-defined major bleeding), and death while being treated with a VKA. During a mean follow-up of 1,016 ± 1,108 days, there was a significant increase in risk of severe bleeding events (risk ratio [RR], 1.38; 95% CI, 1.12-2.68; P = .002) and a significant increase in risk of major BARC bleeding (RR, 1.77; 95% CI, 1.29-2.44; P = .0005) in patients with AF with a high SAMe-TT₂R₂ score (> 2). Increasing SAMe-TT₂R₂ score was associated with an increasing risk of labile INR (P = .004), stroke/TE (P = .007), severe bleeding (P < .0001), major BARC bleeding (P < .0001), and death (P = .002) at follow-up. Among the patients taking VKAs, the SAMe-TT₂R₂ score was predictive of labile INR (C statistic approximately 0.58) as well as of stroke/TE, severe bleeding, major BARC bleeding, and death (C statistic, 0.54-0.57 for events), reflecting the suboptimal time in therapeutic range in such patients. This was not the case for patients who were not taking VKAs. We demonstrate that the SAMe-TT₂R₂ score was predictive for an increasing risk of stroke/TE, severe bleeding, major BARC bleeding, and death, reflecting poor anticoagulation control (and labile INRs) among patients with AF given VKAs.

Which drug should we use for stroke prevention in atrial fibrillation?

Oral anticoagulation (OAC) remains the mainstay for prevention of ischaemic stroke in atrial fibrillation. This article reviews the latest evidence and development of new oral anticoagulants for the prevention of ischaemic stroke, as well as bleeding risk assessment, mitigation and management. Decision-making for stroke prevention has evolved towards the initial identification of 'low-risk' patients who do not need any antithrombotic therapy. Subsequent to this step, patients with at least 1 stroke risk factor can be offered effective stroke prevention, which is OAC. There is increased morbidity and mortality amongst warfarin users, if time in therapeutic range is poor. New oral anticoagulants (such as dabigatran, rivaroxaban, apixaban and edoxaban) offer relative efficacy, safety and convenience compared to warfarin, in relation to stroke prevention in atrial fibrillation. Bleeding risk can be assessed by HAS-BLED score, whereas the new SAMe-TT2R2 score can predict the patient's suitability for vitamin K antagonists. The landscape for stroke prevention in atrial fibrillation has greatly changed. It is no longer a question of 'if we treat' but more of 'how to treat', as the presence of one or more stroke risk factors in atrial fibrillation confers a risk of fatal and devastating strokes. OAC use, whether as well controlled vitamin K antagonists or nonvitamin K antagonists oral anticoagulant, will reduce the burden of stroke in atrial fibrillation.

SAME-TT2R 2 score and vitamin K antagonist therapy

We read with interest a recent publication on ‘‘SAME-TT2R 2 score and vitamin K antagonist therapy’’ published in Internal and Emergency Medicine [1]. Over the past few months there have been several reports concerning the usefulness of SAME-TT2R 2 score in clinical practice. Poli et al. [1] note that ‘‘the SAME-TT2R2 score is able to identify the patients who are less likely to do well on VKA therapy’’. Some recent publications also show the usefulness of the score in predicting bleeding [2]. However, the important point is the complexity of the score, and its performance seems to be very complicated in day-to-day clinical practice [3]. Without good education and sufficient training, scoring cannot be successfully done [3]. Some authors have also reported concerns about the predictive value of the score itself. For instance, Skov et al. [4] note that the score does not ‘‘predict time in the therapeutic range of the international normalized ratio in patients attending a high-quality anticoagulation clinic’’. Thus, an adjustment of the score seems to be required [5], and an individualized approach in using SAME-TT2R 2 score is suggested [6]. More in-depth studies, as an international multi-center project, to find the proper score for clinical application are recommended. Conflict of interest None.

MY APPROACH to the use of NOACs for stroke prevention in patients with atrial fibrillation

Stroke prevention is central to the management of atrial fibrillation (AF). The approach is to initially identify patients at a low risk for stroke (CHA2DS2-VASc score of 0 [men] or 1 [women]), who do not need any antithrombotic therapy. Subsequent to this step, patients with Z additional stroke risk factors (thus, CHA2DS2-VASc score of Z2, as well as men with a score of 1) can be offered effective stroke prevention. Effective stroke prevention essentially means oral anticoagulation (OAC), whether given as a well-controlled, adjusteddose vitamin K antagonist (VKA; e.g., warfarin), or one of the non-VKA oral anticoagulants (NOACs; previously referred to as new, or novel, OACs) [1]. If VKAs are used, the challenge is to maintain patients within an international normalized ratio (INR) of 2.0–3.0. Guidelines recommend good-quality anticoagulation control, as reflected by an average individual time in therapeutic range (TTR) of Z70% [2,3]. The TTR correlates with the efficacy and safety of VKAs, whereby a high TTR is associated with low risks for thromboembolism and bleeding, but a low TTR (i.e., o60%) is associated with a high risk for thromboembolism or hemorrhage [3,4]. For newly diagnosed anticoagulation-naive patients with AF, use of the SAMe-TT2R2 score can help identify those patients (SAMe-TT2R2 score of 0–2) who are likely to do well with a VKA (with TTR Z 70%). On the other hand, patients with a

SAMe-TT2R2 Score, Time in Therapeutic Range, and Outcomes in Anticoagulated Patients with Atrial Fibrillation

BackgroundOral anticoagulation is highly effective in preventing stroke and mortality in nonvalvular atrial fibrillation patients. However, the efficacy and safety of vitamin K antagonists (the main oral anticoagulation drug used) strongly depends upon the quantity of anticoagulation control, as reflected by the average percentage of the time in therapeutic range of international normalized ratio 2.0-3.0. An easy, simple prediction of which atrial fibrillation patients are likely to do well on vitamin K antagonists (with good average time in therapeutic range) could guide decision-making between using vitamin K antagonists (eg, warfarin) and non-vitamin K antagonist oral anticoagulants. Methods and ResultsIn a consecutive cohort of nonvalvular atrial fibrillation patients attending our anticoagulation clinic, we tested the hypothesis that the new Sex, Race, Medical history, Tobacco use, Race (SAMe-TT2R2) score was a predictor for good average time in therapeutic range, and second, this would translate into adverse events in a “real world” cohort of patients with nonvalvular atrial fibrillation. The incidence of bleeding, adverse cardiovascular events (including stroke/thromboembolism), and mortality during the follow-up was higher with increasing SAMe-TT2R2 score. The SAMe-TT2R2 score was predictive for the composite of all adverse events (hazard ratio 1.32 [95% Confidence Interval 1.17-1.50]; P <.001), adverse cardiovascular events (1.52 [1.28-1.83]; P <.001), and all-cause mortality (1.41 [1.16-1.67]; P = .001). A trend was also observed for major bleeding events (1.23 [0.99-1.53]; P = .059). ConclusionIn a “real world” cohort of consecutive patients with nonvalvular atrial fibrillation, a high SAMe-TT2R2 score (reflecting poor anticoagulation control with poor time in therapeutic range) was associated with more bleeding, adverse cardiovascular events, and mortality during follow-up.

C0589: Relationship of the SAME-TT2R2 Score to Poor Quality Anticoagulation, Stroke, Clinically Relevant Bleeding and Mortality in Patients with Atrial Fibrillation

C0589: Relationship of the SAME-TT2R2 Score to Poor Quality Anticoagulation, Stroke, Clinically Relevant Bleeding and Mortality in Patients with Atrial Fibrillation

C0378: The Predictive Value of the SAME-TT2R2 Score for Anticoagulation Control and Adverse Outcomes in Anticoagulated Patients with Atrial Fibrillation

C0378: The Predictive Value of the SAME-TT2R2 Score for Anticoagulation Control and Adverse Outcomes in Anticoagulated Patients with Atrial Fibrillation

GENDER BASED DIFFERENCES IN BENEFIT FROM NOVEL ORAL ANTICOAGULANT DRUGS COMPARED TO WARFARIN IN ATRIAL FIBRILLATION: AN ANALYSIS OF PUBLISHED STUDIES

Women develop atrial fibrillation at an older age and have a higher risk of stroke than men. Female gender is an independent risk factor for not being in the therapeutic range of warfarin in the recently published SAMe-TT2R2 score. Even within the therapeutic range of warfarin, women remain at

A prospective validation of the SAME-TT2R2 score: how to identify atrial fibrillation patients who will have good anticoagulation control on warfarin

Stroke prevention, achieved with oral anticoagulation therapy (OAT), is central to the management of patients with atrial fibrillation (AF). Well-managed OAT, as reflected by a long time in therapeutic range (TTR), is associated with good clinical outcomes. The SAME-TT2R2 score has been proposed to identify patients who will maintain a high average TTR on vitamin K antagonists (VKA) treatment. The objective of the study was to validate this score in a cohort of AF patients followed by an anticoagulation clinic. We applied the SAME-TT2R2 score to 1,089 patients with AF on VKAs followed by two anticoagulation clinics. The median TTR overall for the whole cohort was 73.0%. There was a significant decline in mean (or median) TTR in relation to the SAME-TT2R2 score (p=0.042). When the SAME-TT2R2 scores were categorized we find a TTR 74.0% for score ≤2 and 68.0% for score >2 (p=0.006). The rate of major bleeding events and stroke/TIA was 1.78×100 patient-years (pt-yrs) and 1.26×100 pt-yrs, respectively. No relationship exists between the SAME-TT2R2 score and adverse events. We describe the first validation of the SAME-TT2R2 score in AF patients where, despite an overall good quality of anticoagulation, the SAME-TT2R2 score is able to identify the patients who are less likely to do well on VKA therapy if this is the chosen OAT.