SAMe-TT2R2 to Predict Clinical Outcomes and Time in Therapeutic Range in Patients on Vitamin K Antagonists: A Systematic Review and Meta-Analysis.

BACKGROUND: The SAMe-TT2R2 score identifies patients on vitamin K antagonists (VKAs) who are more likely to have poor time in therapeutic range (TTR); however, the association between SAMe-TT2R2 and clinical outcomes remains controversial. OBJECTIVES: The objective is to assess the association of SAMe-TT2R2 score with clinical outcomes and poor TTR in patients on VKAs. METHODS: We searched using the term "SAMe-TT2R2." Original articles reporting clinical outcomes and SAMe-TT2R2 scores before October 2021 were included. Odds ratios (ORs) of clinical outcomes, diagnostic accuracy parameters of poor TTR (<60%-70%), and mean TTR were extracted. Meta-analysis was performed using random-effects models. RESULTS: Ten studies were included (N = 22 894); 4 showed pooled changes in TTR of -3.61% (95% CI:-4.88% to -2.35%) and -3.98% (95% CI: -6.08% to -1.87%) at SAMe-TT2R2 scores ≥2 and ≥3, respectively, compared with lower scores. The diagnostic accuracy parameters for poor TTR were too heterogeneous to conclude. SAMe-TT2R2 ≥3 significantly correlated with all adverse events (OR = 1.43 [95% CI: 1.29-1.54; P < 0.001]), composite thromboembolism (OR = 1.53 [95% CI: 1.19-1.97; P = 0.001]), and composite bleeding (OR = 1.33 [95% CI: 1.12-1.59; P = 0.001] regardless of the indication, while an SAMe-TT2R2 ≥2 significantly correlated with mortality (OR = 1.32 [95% CI: 1.02-1.70; P = 0.033]). We found no relationship between an SAMe-TT2R2 ≥3 and mortality or between a score ≥2 and clinical outcomes. CONCLUSIONS AND RELEVANCE: Patients on VKAs with SAMe-TT2R2 ≥3 experienced more adverse events, bleeding, and thromboembolism compared with patients who had an SAMe-TT2R2 <3. However, the score had limited and inconclusive predictability for poor TTR in the study.

Efficacy and safety outcomes of patients with atrial fibrillation compared between warfarin and non-vitamin K antagonist oral anticoagulants based on SAMe-TT2R2 score.

OBJECTIVES: This study aimed to investigate the efficacy and safety outcomes of patients with atrial fibrillation (AF) compared between those taking warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) based on SAMe-TT2R2 score. METHODS: AF patients using warfarin or NOACs were enrolled from Thailand's COOL-AF registry. A low SAMe-TT2R2 score was defined as a score of 0-2. The efficacy outcomes were all-cause death, ischemic stroke (IS), transient ischemic attack (TIA), and/or systemic embolization (SE). The safety outcome was major bleeding (MB). The secondary outcome was a combination of cardiovascular (CV) death, IS/TIA/SE, or MB. Cox proportional hazards model was used to compare the event rate between the AF patients taking warfarin and NOACs according to SAMe-TT2R2 score. RESULTS: A total of 2568 AF patients taking oral anticoagulants were enrolled. Warfarin and NOACs were used in 2340 (91.1%) and 228 (8.9%) patients, respectively. Among overall patients, 305 patients taking warfarin (13.0%) and 21 patients taking NOACs (9.2%) had the efficacy outcome, while 155 patients taking warfarin (6.6%) and 11 patients taking NOACs (4.8%) had the safety outcome. After adjustment for confounders, overall patients taking warfarin had significantly more secondary outcome than those taking NOACs (11.4% vs. 7.5%, respectively; adjusted hazard ratio: 1.74, 95% confidence interval: 1.01-2.99; p = 0.045) regardless of SAMe-TT2R2 score. CONCLUSIONS: AF patients taking warfarin had a significantly higher CV death or IS/TIA/SE or MB compared to those taking NOACs regardless of SAMe-TT2R2 score. The results of this study do not support the use of SAMe-TT2R2 score to guide OAC selection.

Effect of SAMe-TT2R2 score and genetic polymorphism on the quality of anticoagulation control in Qatari patients treated with warfarin.

There is no strong evidence on pharmacogenetics role on the quality of INR control after the initiation phase and on the maintenance of stable INR on the long term as measured by the time in therapeutic range (TTR). The benefit of a score such as SAMe-TT2R2 is that it can preemptively guide clinicians on whether to start the patient on warfarin or direct oral anticoagulant. To determine the association between genetic variants in CYP2C9, VKORC1, and CYP4F2 and TTR. To validate SAMe-TT2R2 score predictive ability on the quality of anticoagulation in Qatari patients. This is an observational nested case-control study that was conducted on a cohort of Qatari patients treated with warfarin with previously identified genotype for the CYP2C9, VKORC1, and CYP2F4. The sample size of this cohort was 148 patients. Mean TTR was 62.7 ± 21%. TTR was not significantly different among carriers of the CYP2C9*2 &*3, VKORC1(-1639G>A) or CYP4F2*3 compared to their non-carriers alleles. None of the factors in the SAMe-TT2R2 score had a significant effect on the TTR except for the female gender where TTR was significantly lower in females (n = 89) compared to males (n = 59) (59.6 ± 21% vs. 67.2 ± 20%, p = 0.03). Furthermore, patients with SAMe-TT2R2 score of zero had significantly better TTR compared to those with higher scores (76.5 ± 17% vs. 61.8 ± 21%, p = 0.04). Logistic regression analysis showed that high SAMe-TT2R2 score was the only statistically significant predicting factor of poor INR control (odds ratio (OR) 5.7, 95% confidence interval (CI) 1.1-28.3, p = 0.034). Genetic variants have no contribution to the quality of INR control. SAMe-TT2R2 score was predictive for the poor quality of anticoagulation in a cohort of Qatari patients.

Evaluation of SAMe-TT2R2 Score on Predicting Success With Extended-Interval Warfarin Monitoring.

BACKGROUND: In patients with stable international normalized ratios, 12-week extended-interval warfarin monitoring can be considered; however, predictors of success with this strategy are unknown. The previously validated SAMe-TT2R2 score (considering sex, age, medical history, treatment, tobacco, and race) predicts anticoagulation control during standard follow-up (every 4 weeks), with lower scores associated with greater time in therapeutic range. OBJECTIVE: To evaluate the ability of the SAMe-TT2R2 score in predicting success with extended-interval warfarin follow-up in patients with previously stable warfarin doses. METHODS: In this post hoc analysis of a single-arm feasibility study, baseline SAMe-TT2R2 scores were calculated for patients with ≥1 extended-interval follow-up visit. The primary analysis assessed achieved weeks of extended-interval follow-up according to baseline SAMe-TT2R2 scores. RESULTS: A total of 47 patients receiving chronic anticoagulation completed a median of 36 weeks of extended-interval follow-up. The median baseline SAMe-TT2R2 score was 1 (range 0-5). Lower SAMe-TT2R2 scores appeared to be associated with greater duration of extended-interval follow-up achieved, though the differences between scores were not statistically significant. No individual variable of the SAMe-TT2R2 score was associated with achieved weeks of extended-interval follow-up. Analysis of additional patient factors found that longer duration (≥24 weeks) of prior stable treatment was significantly associated with greater weeks of extended-interval follow-up completed ( P = 0.04). Conclusion and Relevance: This pilot study provides limited evidence that the SAMe-TT2R2 score predicts success with extended-interval warfarin follow-up but requires confirmation in a larger study. Further research is also necessary to establish additional predictors of successful extended-interval warfarin follow-up.

[Randomized Comparison of Two Approaches to Initial Warfarin Dosing: Time in Therapeutic Range of International Normalized Ratio During Hospitalization].

AIM: To perform a randomized, open-label comparison of average time in therapeutic range (TTR) of international normalized ratio (INR) using two approaches to initial warfarin dosing during hospitalization: the standard method and the one using individual patient characteristics (clinical algorithm - the studied approach). MATERIALS AND METHODS: We randomly assigned 60 patients with different indications for vitamin K antagonist therapy to the studied approach (n=31, intervention group) or to the standard method (n=29, control group). А target INR range for all patients was 2.0 to 3.0. RESULTS: The average TTR and portions of INR values within target range during the whole time of drug dosing turned out to be small. TTR was 22.4% with standard method and 21.4% with clinical algorithm, which was well below desired 60%. CONCLUSION: The opportunities for achieving target INR in inpatient settings, regardless of warfarin dosing regimen, are limited.

Evaluation of SAMe-TT2R2 risk score for predicting the quality of anticoagulation control in a real-world cohort of patients with non-valvular atrial fibrillation on vitamin-K antagonists.

AIMS: Clinicians need to get better at identifying patients who would have poor quality of anticoagulation control with vitamin-K antagonists (VKAs). We assessed the predictive ability of SAMe-TT2R2 score, recently conceived for the prior purpose, and examined its relationship with major bleeding, thromboembolic (TE) complications, and death. METHODS AND RESULTS: Retrospectively, 911 consecutive patients with non-valvular atrial fibrillation (NVAF) started on VKAs within 8 months were studied. The percentage of international normalized ratios in therapeutic range (PINRR) at different levels was used as a metric of anticoagulation quality. We also tested the SAMe-TT2R2 predictability for major bleeding, TE complications, and death throughout 10 ± 3 months. The PINRR decreased from 62% at zero point to 53% at ≥4 points of SAMe-TT2R2. 82.1% of patients who achieved PINRR ≥ 70% had 0 or 1 point of SAMe-TT2R2. SAMe-TT2R2 performed significantly better at PINRR 70% than at 65 and 60% (c-statistic = 0.60 vs. c-statistic = 0.56). The calibration of SAMe-TT2R2 was excellent (Hosmer-Lemeshow test P-values ≥ 0.6). SAMe-TT2R2 showed significant association with the composite outcome of major bleeding, TE complications, and death [n = 98; hazard ratio (HR) = 1.32; 95% confidence interval (CI) 1.08-1.60]; the c-statistic was 0.57 (95% CI: 0.51-0.62) and P = 0.03. As individual outcomes, SAMe-TT2R2 was significantly associated with death (n = 60; HR = 1.3; 95% CI: 1.03-1.69), but not with either major bleeding (n = 30; HR = 1.2; 95% CI: 0.85-1.76) or TE complications (n = 15; HR = 1.01; 95% CI: 0.58-1.77). CONCLUSION: Among NVAF patients, SAMe-TT2R2 could represent a useful clinical tool to identify patients who would have poor quality of anticoagulation control with VKAs. SAMe-TT2R2 successfully predicts the composite outcome of major bleeding, TE complications, and death.

The Role of the Pharmacist in a Patient's Care for Individuals Undergoing Anticoagulant Therapy: A Case Report.

Achieving clinical effectiveness with vitamin K antagonists (VKAs) requires a Time in Therapeutic Range (TTR) above 65%. TTR is influenced by genetics (CYP2C9, VKORC1, CYP4F2), treatment adherence, and knowledge. The SAMe-TT2R2 algorithm is used to assess VKA treatment suitability. In this case report, SAMe-TT2R2 and pharmacogenetic analysis were used to improve oral anticoagulant management in a patient with poor control of INR. An 84-year-old, obese male with atrial fibrillation, undergoing acenocoumarol therapy, had a suboptimal TTR. An assessment with the SAMe-TT2R2 algorithm indicated a favorable profile for VKA use. An educational intervention on vitamin K-rich foods was conducted, and his physician was informed about the interaction between omeprazole and acenocoumarol, recommending its replacement with pantoprazole. This intervention was accepted by the physician and, three months post-intervention, the patient's TTR improved to 100%. Poor adherence and limited knowledge contributed to treatment failures in patients with a good VKA profile. Pharmaceutical interventions significantly improved TTR management. Patients with favorable genetic and clinical profiles could achieve adequate control of their anticoagulant medication through these interventions. Predictive tools may help select patients who can effectively and safely use VKAs through pharmaceutical interventions.

Evaluation of the Relationship between Cognitive Impairment and Atria Score Systems in Patients with Atrial Fibrillation.

Background: Atrial fibrillation (AF) is the main arrhythmia associated with thromboembolic complications and cognitive impairment. In this study, we aimed to evaluate the relationship between cognitive impairment and different scoring systems developed for AF to improve the medical follow-up of cognitive impairment. Methods: Between January 2019 and December 2020, 124 patients between the age of 30 and 80 years, diagnosed with AF for at least 5 years and complaining about memory impairment during cardiological follow-up, were included in the study. The patients were divided into two groups based on their cognitive status as assessed by the Mini-Mental State Examination group 1 consisted of 52 patients with cognitive impairment and group 2 comprised 72 patients without cognitive impairment. Results: The ATRIA bleeding score had a positive moderate correlation (r = 0.454, P < 0.001), the ATRIA stroke score had a strong correlation (r = 0.738, P < 0.001), and the SAMe-TT2R2 score had a strong correlation (r = 0.688, P < 0.001) with cognitive impairment. However, CHADS2 and CHA2DS2VASc scores were not statistically correlated with cognitive impairment. According to the receiver operating characteristic (ROC) curve, the area under the curve (AUC) of the ATRIA bleeding score was 0.761 with a 95% confidence interval (CI) of 0.678-0.844 and P < 0.001; also, for the ATRIA stroke score, AUC was 0.930 with a 95% CI of 0.886-0.974 and P < 0.001. In addition, for the SAMe-TT2R2 score, AUC was 0.895 with a 95% CI of 0.838-0.952 and P < 0.001. In the pairwise comparison of AUC on ROC curves, the ATRIA stroke score and the SAMe-TT2R2 score were statistically similar (P = 0.324). ATRIA bleeding, ATRIA stroke, and SAMe-TT2R2 scores were greater than CHADS2 stroke score (P: 0.0004, P < 0.0001, and P < 0.0001, respectively), but CHA2DS2-VASc and CHADS2 stroke scores were statistically similar (P: 0.402). Conclusion: Both ATRIA stroke and SAMe-TT2R2 scoring systems can provide a better correlation than CHADS2 and CHA2DS2-VASc scores in patients with AF to evaluate their cognitive status. These two scores can be more useful to monitor the patients with AF for medical follow-up of cognitive status.

Revised HAS-BLED score for bleeding prediction in atrial fibrillation patients with oral anticoagulants.

Background: There were several limitations to the original HAS-BLED (oHAS-BLED) score in patients with atrial fibrillation (AF). This trial studied the revised HAS-BLED (rHAS-BLED) score for predicting bleeding events in anticoagulated AF patients. Methods: This study retrospectively recruited anticoagulated AF patients in the Central Chest Institute of Thailand between 2014 and 2021. The rHAS-BLED score was oHAS-BLED using the estimated glomerular filtration rate of <60 ml/min/1.73 m2 for abnormal renal function, SAMe-TT2R2 score of ≥3 for labile INR, and adding clinically relevant nonmajor bleeding (CRNMB) into bleeding history. The outcome was major bleeding (MB) and/or CRNMB at 1-year follow-up visit. The outcome between both groups was compared by using the chi-square test or Fisher's exact test. Receiver-operating characteristics curve was used to analyze the discrimination performances of both scores and the results were illustrated by using c-statistics. Results: A total of 256 anticoagulated AF patients were enrolled. The average age was 73.6 ± 10.1 years. The average oHAS-BLED and rHAS-BLED scores were 1.7 ± 0.9 and 2.6 ± 1.2, respectively. Twenty patients in rHAS-BLED ≥3 (15.9%) and 9 patients in rHAS-BLED <3 (6.9%) experienced MB and/or CRNMB. The rHAS-BLED score of ≥3 increased the bleeding risk with statistical significance (OR 2.54, 95% CI 1.11-5.81, p = .04). The discriminative performance of the rHAS-BLED score was illustrated with c-statistics of 0.61 (95% CI 0.50-0.71). Conclusions: The rHAS-BLED score could predict bleeding events in anticoagulated AF patients. However, a larger study is needed to confirm these results in the future.

Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry.

AIM: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. METHODS AND RESULTS: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. CONCLUSIONS: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007.

A new index to predict quality of anticoagulation control in patients on vitamin K antagonists: the DAFNE score.

Aim: To derive a new clinical score to improve the prediction of those at risk of poor International Normalized Ratio control among patients with atrial fibrillation taking vitamin K antagonists. Materials & methods: The score was calculated using PAULA database and validated in the FANTASIIA population. Results: The DAFNE score (cardiovascular Disease, concomitant treatment with Amiodarone, Food/dietary transgression and taking ≥7 pills daily, fEemale sex) score was related to a higher probability of poor International Normalized Ratio control. C-indexes were 0.611 and 0.576 (De Long test, p = 0.007) for the DAFNE and SAMe-TT2R2 scores, respectively. Conclusion: The DAFNE score is a new clinical score which may potentially help determine those patients with atrial fibrillation who are at high risk of poor anticoagulation control with vitamin K antagonists.

Evaluation of the Validity of SAMe-TT2R2 Score in a Cohort of Venous Thromboembolism Patients Treated With Warfarin.

Low SAMe-TT2R2 score of <2 was validated as a predictor of optimum anticoagulation control, reflected by mean time in therapeutic range (TTR) above 65% to 70%, among warfarin-treated atrial fibrillation patients. This study aimed to validate the ability of SAMe-TT2R2 score and its individual components in predicting anticoagulation control (mean TTR and clinical events) among a cohort of venous thromboembolism (VTE) patients in Qatar. A total of 295 patients were retrospectively evaluated. There was a trend toward statistical significance in mean TTR between low (<2) and high (≥ 2) SAMe-TT2R2 score groups (P = .05), a difference that was not sustained when a cutoff of 3 was used (ie, a score of 3 or more). Patients with poor INR control (TTR <70%) were numerically less likely to have SAMe-TT2R2 score of <2 compared with those with good INR control, though the difference was not statistically significant (16.7% vs 83.3%, respectively, P = .4). No thromboembolic events were reported, and no association was found between the score and risk of bleeding. Non-Caucasian origin was the only significant predictor of good anticoagulation in the studied cohort. In conclusion, SAMe-TT2R2 score could not predict quality of anticoagulation control in a cohort of VTE patients treated with warfarin in Qatar. Contribution of other clinical factors and whether a different scoring may yield better prediction of anticoagulation control remains to be tested.

SAMe-TT2R2 score for prediction of suboptimal time in therapeutic range in a Thai population with atrial fibrillation.

INTRODUCTION: International normalised ratio (INR) control is an important factor in patients with non-valvular atrial fibrillation (NVAF) being treated with warfarin. INR control was previously reported to be poorer among Asians compared to Westerners. We aimed to validate the SAMe-TT2R2 score for prediction of suboptimal INR control (defined as time in therapeutic range [TTR] < 65% in the Thai population) and to investigate TTR among Thai NVAF patients being treated with warfarin. METHODS: INR data from patients enrolled in a multicentre NVAF registry was analysed. Clinical and laboratory data was prospectively collected. TTR was calculated using the Rosendaal method. Baseline data was compared between patients with and without suboptimal INR control. Univariate and multivariate analyses were performed to identify variables independently associated with suboptimal INR control. RESULTS: A total of 1,669 patients from 22 centres located across Thailand were included. The average age was 69.1 ± 10.7 years, and 921 (55.2%) were male. The mean TTR was 50.5% ± 27.5%; 1,125 (67.4%) had TTR < 65%. Univariate analysis showed hypertension, diabetes mellitus, heart failure, renal disease and SAMe-TT2R2 score to be significantly different between patients with and without optimal TTR. The SAMe-TT2R2 score was the only factor that remained statistically significant in multivariate analysis. The C-statistic for the SAMe-TT2R2 score in the prediction of suboptimal TTR was 0.54. CONCLUSION: SAMe-TT2R2 score was the only independent predictor of suboptimal TTR in NVAF patients being treated with warfarin. However, due to the low C-statistic, the score may have limited discriminative power.

The SAMe-TT2R2 Score Predicts Warfarin Control in an Australian Population with Atrial Fibrillation.

BACKGROUND: Warfarin requires regular monitoring with the time in therapeutic range (TTR), a common indicator of control and TTR > 70% is indicative of efficient anticoagulation. The SAMe-TT2R2 (sex, age, medical history, treatment, tobacco use, race) model has been utilised as a predictor of warfarin control, with a score ≥ 2 indicative of poor control. However, it has been suggested that race may be over-represented in this model. To date, no Australian studies have applied this model, possibly because race is not routinely recorded. Therefore, the aim of this study was to apply the SAMe-TT2R2 model in an Australian population on warfarin managed by both a warfarin care program (WCP) and general practitioner (GP). METHODS: Retrospective data was collected for patients receiving warfarin via a WCP in Queensland and whilst being managed by a GP. Patient data was used to calculate the SAMe-TT2R2 score and the TTR for each patient. Mean TTR was used for analysis and comparison with the categorised SAMe-TT2R2 score. RESULTS: Of the 3911 patients managed by a WCP, there was a significantly lower mean TTR for patients with a SAMe-TT2R2 score ≥ 2 compared to 0-1 (78.6 ± 10.7% vs. 80.9 ± 9.5%, p < 0.0001). Of these patients, 200 were analysed whilst managed by a GP and the categorised SAMe-TT2R2 score did not result in a statistically different mean TTR (69.3 ± 16.3% with 0-1 vs. 63.6 ± 15.0% with ≥2, p = 0.089), but a score ≥2 differentiated patients with a TTR less than 65%. CONCLUSIONS: The SAMe-TT2R2 model differentiated Australian patients with reduced warfarin control, despite the exclusion of race. In Australia, the SAMe-TT2R2 score could assist clinicians in identifying Australian patients who may obtain reduced warfarin control and benefit from additional interventions such as a dedicated WCP.

Use of simplified HAS-BLED score in patients with atrial fibrillation receiving warfarin.

BACKGROUND: Oral anticoagulant drugs are proven to prevent thromboembolism in patients with atrial fibrillation (AF). To date, HAS-BLED score is used to assess bleeding risk. This study was conducted to compare simplified HAS-BLED (sHAS-BLED) with conventional HAS-BLED (cHAS-BLED) scores. METHODS: This retrospective study recruited patients with AF receiving warfarin among July 2013 to December 2018 in Central Chest Institute of Thailand. The cHAS-BLED score used the time in therapeutic range less than 70% as labile INR, whereas sHAS-BLED score used SAMe-TT2R2 score of 3 or more as a substitute for labile INR. A paired Student's t test was used to compare sHAS-BLED and cHAS-BLED. The Pearson's correlation was used to assess the correlation of sHAS-BLED to cHAS-BLED scores. The Bland-Altman plot was used to confirm the agreement of individual sHAS-BLED to cHAS-BLED score. RESULTS: A total of 126 AF patients were enrolled. The average age, SAMe-TT2R2 score, and cHAS-BLED score were 70.52 ± 10.37 years, 3.53 ± 1.03, and 2.03 ± 0.95, respectively. The sHAS-BLED score was not statistically significantly different compared with cHAS-BLED score (P = .08). The sHAS-BLED and cHAS-BLED scores had a very strong correlation with a correlation coefficient of .86 (P < .01). The Bland-Altman plot was performed to confirm the agreement of individual sHAS-BLED to cHAS-BLED scores. CONCLUSIONS: The sHAS-BLED was not statistically significantly different compared with cHAS-BLED and can be used in clinical practice. However, larger clinical trial will be needed to prove whether sHAS-BLED can predict bleeding risk in the future.

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.

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

INTRODUCTION: The 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 METHODS: Consented 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. RESULTS: The 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. CONCLUSIONS: The 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.

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

BACKGROUND: Oral 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. METHODS: We 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. RESULTS: We studied 211 AF patients (mean age = 57.1 ± 10.2 years, 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). CONCLUSION: SAMe-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.

The SAME-TT2R2 score predicts the quality of anticoagulation control in patients with acute VTE. A real-life inception cohort study.

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.