Poor Time In Therapeutic Range Research Articles

SAMe-TT2R2 Score to Predict Time in Therapeutic Range of Vitamin K Antagonists in Asian and Non-Asian patients: A Systematic Review and Meta-analysis.

Sex, age, medical history, treatment, tobacco use, and race (SAMe-TT2R2) score helps detect patients at risk of suboptimal anticoagulation control. A score above two suggests poor control; however, non-Caucasian status being assigned two points might hinder the recognition of poor control in patients of other races. To evaluate the SAMe-TT2R2 score's ability to predict poor anticoagulation control [defined as time in therapeutic range (TTR) < 60-70%] in Asian and non-Asian populations on vitamin K antagonists (VKAs). We searched PubMed, Cochrane Library, Scopus, SpringerLink, and Web of Science using the keyword "SAMe-TT2R2." Articles published before April 2022 were screened. We gathered mean TTR and diagnostic accuracy data for different SAMe-TT2R2 thresholds and conducted meta-analyses using random-effects models. A total of 30 studies were included (N = 36,690). The overall mean TTR differences were -4.88 and -6.41 for the cutoffs of ≥ 3 and ≥ 4, respectively. For non-Asian patients, the mean TTR differences were -3.86, -5.12, and -8.09 for the cutoffs ≥ 2, ≥ 3, and ≥ 4, respectively. For Asian patients, the mean TTR differences were -3.99 and -4.07 for the cut-offs ≥ 3 and ≥ 4, respectively. The highest positive likelihood ratio (LR+) for the Asian subgroup was 1.17 [95% confidence interval (CI): 1.06-1.28; I2 = 0%, p heterogeneity = 0.500] at cutoff ≥4 and for the non-Asian subgroup, at cut-off ≥ 3, the LR+ was 1.24 (95% CI 1.14-1.34; I2 = 0% p heterogeneity = 0.455). The lowest LR- was found at a lower cutoff for both races (at cutoff ≥ 3 and ≥ 2 for Asian and non-Asian subgroups, respectively). The pooled results of other accuracy parameters were modest at all cutoffs, except for the sensitivity at cutoff ≥ 3 in the Asian subgroup (83.05%). Our study results suggest that a higher SAMe-TT2R2 score resulted in a greater reduction of TTR among Asian and all races. The accuracy parameters showed the highest sensitivity for poor TTR at the SAMe-TT2R2 cutoff of ≥ 3 for Asian patients. However, the ability to identify patients likely to have poor TTR was limited. Further research is needed to enhance the risk assessment for poor anticoagulation control with VKAs. The protocol of this systematic review was registered in the International Prospective Register of Scientific Reviews: PROSPERO, registration number CRD42021291865.

Chinese stroke patients with atrial fibrillation used Robert's age-adjusted warfarin loading protocol obtained good INR results within therapeutic range

To assess whether Roberts’ age-adjusted warfarin loading protocol is effective in Chinese patients and whether the SAMeTT2R2 score can predict international normalized ratio (INR) control. Roberts’ protocol for warfarin titration was applied to patients with non-valvular atrial fibrillation (NVAF) complicated with ischemic stroke at the Department of Neurology between 2014 and 2019. Clinical and sociodemographic variables were recorded. A minimum of 1-year follow-up was used to calculate the time in therapeutic range (TTR) of the INR. A total of 94 acute ischemic stroke patients with NVAF were included in the study. Seventy-seven (81.9%) of the patients had attained stable INR (2.0–3.0) at the fifth dose, and 90.0% of the patients had achieved stable INR on the ninth day. Seventeen (18.1%) of the patients had an INR > 4 during dose-adjustment period. Patients with INR > 4 had significantly lower body weight (53.8 vs. 63.1 kg, P = 0.014), lower rate of achievement of stable INR (35.3% vs. 92.2%, P = 0.000), and lower rate of TTR ≥ 65% (23.5% vs. 70.1%, P = 0.001), but with no significant increase in bleeding risk. A total of 89 patients underwent long-term INR follow-up, of which 58 (65.2%) patients achieved TTR ≥ 65%. Patients with poor TTR had significantly lower body weight (56.3 vs. 63.7 kg, P = 0.020) and lower rate of stable INR achievement (64.5% vs. 89.7%, P = 0.002). All 94 patients had SAMeTT2R2 score ≥ 2. There was no linear association between SAMeTT2R2 score and the rate of TTR ≥ 65% (Ptrend = 0.095). Chinese ischemic stroke patients with NVAF on warfarin can safely and quickly achieve therapeutic INR using Roberts’ age-adjusted protocol and can obtain a good TTR. Lower body weight may be a predictor of poor TTR and INR > 4. Patients who have not attained stable INR after adjusting the dose five times are at high risk for poor TTR. SAMeTT2R2 score may not predict TTR in Chinese ischemic stroke patients with NVAF.

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

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. The objective is to assess the association of SAMe-TT2R2 score with clinical outcomes and poor TTR in patients on VKAs. 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. 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. 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.

Anticoagulation Control and Major Adverse Clinical Events in Patients with Operated Valvular Heart Disease with and without Atrial Fibrillation Receiving Vitamin K Antagonists.

Good quality anticoagulation among patients with operated valvular heart disease is needed to reduce ischaemic and thromboembolic complications. There is limited evidence regarding factors that affect anticoagulation control in patients implanted with mechanical or tissue prosthetic valve(s). To examine the quality of and factors that affect anticoagulation control, major adverse clinical events and all-cause death in operated valvular heart disease patients with and without atrial fibrillation who are receiving a vitamin K antagonist. Quality of anticoagulation were retrospectively assessed among 456 operated valvular heart disease patients [164 (36%) with AF and 290 (64%) without AF] via time in therapeutic range (TTR) (Rosendaal method) and percentage of INRs in range (PINRR) over a median of 6.2 (3.3-8.5) years. VHD was defined by the presence of a mechanical or tissue prosthetic valve at the mitral, aortic, or both sites. Mean age 51 (14.7), 64.5% men. Most (96.1%) had a mechanical prosthesis and 64% had aortic valve replacement. Overall, mean TTR was 58.5% (14.6) and PINRR was 50.1% (13.8). Operated valvular heart disease patients with AF had significantly lower mean TTR and PINRR (TTR: 55.7% (14.2) vs. 60.1% (14.6); p = 0.002, respectively, PINRR: 47.4% (13.5) vs. 51.6% (13.7); p = 0.002, respectively), and a lower proportion of TTR ≥ 70%, despite a similar number of INR tests compared to those without AF. Predictors of TTR < 70% were female sex, AF and anaemia/bleeding history. Significantly higher proportions of operated valvular heart disease patients with AF died (20.7% vs. 5.8%; p < 0.001), but ≥1 MACE rates were similar between the two groups. Operated valvular heart disease patients with AF at baseline have poorer anticoagulation control compared to those without AF. The presence of concomitant AF, anaemia/bleeding history and female sex independently predicted poor TTR. Stringent INR monitoring is needed to improve anticoagulation control and prevent major adverse clinical events in patients with operated valvular heart disease.

Implementation of point-of-care INR testing to improve effectiveness of anticoagulation clinic

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Oral Vitamin K antagonist (VKA) is still widely used for anticoagulation. Anticoagulation clinics are set up to monitor patients’ INR and adjust their VKA doses accordingly. Anticoagulation clinic in our centre introduced point-of-care (POC) INR testing in June 2021 to improve the effectiveness of the clinic. Purpose This audit was done to evaluate the effectiveness of anticoagulation since the introduction of the POC INR test into the clinic workflow. Methods This was a retrospective, cross-sectional, cohort audit study. The study period was from 1st June 2021 to 31st July 2022. List of patients who attended the clinic from 1st – 31st January 2022 was taken from the clinic log and their electronic medical records were reviewed for the study period. Only patients who have been established on VKA for at least 3 months were included in the audit. The data collected included their basic demographics, indication for VKA, any complications / death during the study period and if their VKA had been stopped and why and serial INRs from the POC INR test during the study period. The time in therapeutic range (TTR) is calculated by Rosendaal method and all the results analysed on Microsoft Excel. The audit standard for safe and effective anticoagulation was a TTR ≥ 70%. Results were compared to an audit done previously for the centre’s anticoagulation clinic done in 2020. Results 207 patients were included in this audit. Male patients accounted for 53.6% of the study population. Their ages ranged from 22 years to 102 years with a median age of 67 years. Majority of the patients were on VKA as stroke prevention for their atrial fibrillation (AF) (79.7%), followed by metallic valve replacement (13%). The median TTR for patients with AF had improved from 40.8% in 2020 to 51.05% in 2020-21 study period and this difference is significant (p = 0.017). Patients getting effective anticoagulation also improved from 23.26% in 2020 to 26.79% during this audit period. 13% of the study population developed complications on VKA in which 2.9% of patients developed gastrointestinal bleed and 1% developed intracranial haemorrhage. There were 4 fatalities, none were from gastrointestinal bleeding, intracranial haemorrhage or stroke. 10% of patients had their VKA changed to a novel oral anticoagulant (NOAC) as they were identified to have poor TTR during clinic review. Conclusions The introduction of POC INR test has proven to make significant improvement in patient’s median TTR for patients with AF. However, more efforts need to be made to further improve effectiveness of anticoagulation in our patients such as converting them to a NOAC if eligible or more thorough counselling and more frequent INR checks.

Direct oral anticoagulants versus warfarin in patients with non-valvular atrial fibrillation and CKD G3-G5D.

The use of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD) including dialysis is growing. Several studies have shown favorable results of DOAC compared with warfarin regarding bleeding risk but no difference in stroke protection. However, these studies had poor time in therapeutic range (TTR), in the warfarin comparison group. This was a Swedish national cohort study investigating the risk of ischemic stroke and major bleeding on DOAC compared with warfarin in patients with NVAF, glomerular filtration rate category 3-5D (G3-G5D), kidney transplant recipients excluded, between 2009 and 2018. Data extracted from high-quality national healthcare registries including the Swedish Renal Registry, AuriculA (the Swedish national quality register for AF and anticoagulation) and The Stroke Register. At enrolment, of 2453 patients 59% were treated with warfarin (mean TTR 67%) and 41% with DOAC. Overall, 693 (28.3%) had G3, 1113 (45.4%) G4, 222 (9.1%) G5 and 425 (17.3%) G5D. DOAC compared with warfarin showed lower hazard of major bleeding [hazard ratio 0.71 (95% confidence interval 0.53-0.96)] but no difference in ischemic stroke risk. Mortality was increased during DOAC treatment [1.24 (1.01-1.53)], presumably not a causal association since fewer fatal bleedings occurred on DOAC. DOAC treatment, compared with warfarin, is associated with almost 30% lower risk of bleeding in patients with NVAF and CKD G3-G5D. The stroke risk is comparable between the treatments. This is the first study comparing DOAC and well-managed warfarin (TTR 67%) in advanced CKD. Ongoing and planned randomized controlled trials need to confirm the possible benefit of DOAC.

Characteristics and management of patients with stroke and major hemorrhagic episodes with atrial fibrillation under vitamin K antagonist therapy. EVENTHO study

Introduction and objectiveIn Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes. Materials and methodsEVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units. The study included patients ≥18 years with AF who suffered major hemorrhagic episodes (67.8%) or stroke/SE (32.1%) during 2016 whileon VKA treatment [acenocoumarol (98.2%) or warfarin (1.8%)]. Time in therapeutic range (TTR) was calculated according to the Rosendaal method based on the international normalized ratio (INR) values of the previous 6 months. ResultsThe study included 585 patients (median age [range] 82.3 [43.6–96.2] years; 51.1% men; mean [95% confidence interval, CI] CHA2DS2-VASc: 4.3 [4.2–4.4] and HAS-BLED: 2.2 [2.1–2.3]). Poor anticoagulation and VKA maintenance were higher in patients with major hemorrhagic episode (p<0.0001). The most common situations after hospital discharge were: functional dependence, neurological sequelae and death. ConclusionsIn the sample studied, half of the AF patients who suffered stroke/SE or major hemorrhagic episode had inadequate TTR and, despite this, after hospital discharge, they restarted treatment with VKA. These results highlight the need to evaluate safer and effective therapeutic alternatives in AF patients with poor TTR control after suffering a stroke/SE or major hemorrhagic episode.

Rosendaal linear interpolation method appraising of time in therapeutic range in patients with 12-week follow-up interval after mechanical heart valve replacement.

BackgroundThe objective of this study was to evaluate the quality of anticoagulation by the time in therapeutic range (TTR) for patients with 12-week INR follow-up interval.Materials and methodsFrom January 2018 to December 2020, a selective group of patients who underwent mechanical valve replacement and followed up at our anticoagulation clinic for adjustment of warfarin dose were enrolled. The incidences of complications of anticoagulation therapy were reported by linearized rates. TTR was calculated by the Rosendaal linear interpolation method.ResultsTwo hundred and seventy-four patients were eligible for this study. The mean age of these patients was 52.8 ± 12.7 years, and 65.7% (180 cases) of them were females. The mean duration of warfarin therapy was 16.7 ± 28.1 months. A total of 1309 INR values were collected, representing 66789 patient days. In this study, the mean TTR was 63.7% ± 18.6%, weekly doses of warfarin were 20.6 ± 6.0 mg/weekly, and the mean monitoring interval for the patient was 53.6 ± 27.1 days. There were 153 cases in good TTR group (TTR ≥ 60%) and 121 cases in poor TTR group (TTR < 60%). The calculated mean TTR in both groups was 42.6% ± 22.1% and 74.8% ± 10.4%, respectively. Compared with the TTR ≥ 60% group, the TTR < 60% group exhibited a more prevalence of female gender (p = 0.001), atrial fibrillation (p < 0.001), NYHA ≥ III (p < 0.001), and lower preoperative left ventricular ejection fraction (LVEF, p = 0.032). In multivariate analysis, female gender (p = 0.023) and atrial fibrillation (p = 0.011) were associated with TTR < 60%. The incidence of major bleeding and thromboembolic events was 2.7% and 1.1% patient-years, respectively. There was one death which resulted from cerebral hemorrhage. The incidence of death was 0.5% patient-years. The difference in anticoagulation-related complications between the TTR < 60% group and the TTR ≥ 60% group was not statistically significant.ConclusionFor patients with stable international normalized ratio monitoring results who are follow-up at anticoagulation clinics, a 12-week monitoring interval has an acceptable quality of anticoagulation. The female gender and atrial fibrillation were associated with TTR < 60%.

Oral anticoagulants, time in therapeutic range and renal function over time in real-life patients with atrial fibrillation and chronic kidney disease

AimsTo describe the use of warfarin and direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and chronic kidney disease (CKD), to evaluate changes in renal function over time...

Characteristics and management of patients with stroke and major hemorrhagic episodes with atrial fibrillation under vitamin K antagonist therapy. EVENTHO study

Introduction and objectiveIn Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes. Materials and methodsEVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units. The study included patients ≥18 years with AF who suffered major hemorrhagic episodes (67.8%) or stroke/SE (32.1%) during 2016 whileon VKA treatment [acenocoumarol (98.2%) or warfarin (1.8%)]. Time in therapeutic range (TTR) was calculated according to the Rosendaal method based on the international normalized ratio (INR) values of the previous 6 months. ResultsThe study included 585 patients (median age [range] 82.3 [43.6–96.2] years; 51.1% men; mean [95% confidence interval, CI] CHA2DS2-VASc: 4.3 [4.2–4.4] and HAS-BLED: 2.2 [2.1–2.3]). Poor anticoagulation and VKA maintenance were higher in patients with major hemorrhagic episode (p<0.0001). The most common situations after hospital discharge were: functional dependence, neurological sequelae and death. ConclusionsIn the sample studied, half of the AF patients who suffered stroke/SE or major hemorrhagic episode had inadequate TTR and, despite this, after hospital discharge, they restarted treatment with VKA. These results highlight the need to evaluate safer and effective therapeutic alternatives in AF patients with poor TTR control after suffering a stroke/SE or major hemorrhagic episode.

TIME IN THERAPEUTIC RANGE (TTR) IN ATRIAL FIBRILLATION WITH WARFARIN THERAPY IN SEMARANG, INDONESIA

Background: Atrial fibrillation is one of the factors forming thromboembolism. The thromboembolism can be prevented with warfarin. A side effect of warfarin is increasing the occurrence of bleeding, these therapy requires an evaluation of its usage. These evaluations can be seen in the Time in Therapeutic Range (TTR) patients. TTR is the duration in which the International Normalized Ratio (INR) patients in referral value are 2.0-3.0. TTR &gt; 70% can prevent bleeding on FA patients with warfarin therapy.Aim: To determine TTR in patients receiving warfarin with atrial fibrillation.Methods: This study was descriptive with a cross-sectional design for six months at Dr. Kariadi Hospital Semarang. TTR was calculated using Rosendaal's Methods after collecting three INRs and patients' demographics.Results: Total subject was 111 patients with an average age of 52,63 and the TTR average is 53,75. TTR in this study was divided into two groups, that groups were poor TTR (TTR &lt; 70%) with 82 patients (73.88%) and good TTR (≥70%) with 29 patients (26.12%).Conclusions: The average TTR in FA patients with warfarin therapy was 53,75%.

Warfarin: time in therapeutic range, a single centre study on patients using warfarin for stroke prevention in non-valvular atrial fibrillation and prosthetic heart valves

Background: Two common indications for oral anticoagulants are patients with non-valvular atrial fibrillation (AF) or prosthetic heart valves (PHV). The degree of anticoagulation is monitored by evaluating the international normalised ratio (INR); however, the quality of anticoagulation, determined by the time in therapeutic range (TTR), is less often evaluated. TTR has significant clinical implications in patient outcomes. Objectives: We sought to identify the indications for anticoagulation and determine its quality via the TTR at a single centre, community-based and district level hospital in the setting of usual care. We documented the prevalence of thrombo-embolic and haemorrhagic adverse events and we also collected data on factors that may contribute to a poor TTR or increased risk of adverse events. Methods: We conducted a retrospective, descriptive and observational study with chart audits evaluating the anticoagulation indication and control for the preceding 1 year for each patient. Descriptive statistics included mean and standard deviation for quantitative data and frequencies for categorical data. Chi-square tests were used to analyse comparisons of categorical data and the student’s t-test for continuous variables. Two-tailed p-values less than 0.05 were considered significant. Results: TTR was poor for patients with AF and PHV (44.5% and 13.7% respectively). We identified older age, less frequent testing and high target ranges as significant factors associated with poorer outcomes. We demonstrated a high prevalence of adverse events (25.4%). Conclusion: Patients in this setting demonstrated poor quality of anticoagulation and had a high prevalence of adverse events.

Physician-Pharmacist Collaborative Clinic Model to Improve Anticoagulation Quality in Atrial Fibrillation Patients Receiving Warfarin: An Analysis of Time in Therapeutic Range and a Nomogram Development.

Background: Poor time in therapeutic range (TTR) control is associated with an increased risk of stroke and bleeding in atrial fibrillation (AF) patients receiving warfarin. This study aimed to determine whether the physician–pharmacist collaborative clinic (PPCC) model could improve the anticoagulation quality as well as to create a nomogram for predicting anticoagulation quality in AF patients. Methods: This retrospective observational study enrolled AF patients who either initially received warfarin or returned to warfarin after withdrawal between January 1, 2016 and January 1, 2021, at our institution. The primary outcome was dynamic changes in TTRs (a TTR of ≥60% considered high anticoagulation quality). The secondary outcomes were thromboembolic and bleeding events during follow-up. We compared the dynamic changes in TTRs between the general clinic (GC) and PPCC groups in both the original and propensity score matching (PSM) cohorts. In addition, we explored the potential predictors of high anticoagulation quality and subsequently formulated a nomogram to predict anticoagulation quality. Results: A total of 265 patients with AF were included, comprising 57 patients in the PPCC group and 208 patients in the GC group. During a median follow-up period of 203 days, the PPCC group had a shorter time (76 vs. 199 days, p < 0.001) and more patients achieved a TTR ≥60% (73.7 vs. 47.1%, p = 0.002 by log-rank test) than the GC group. The results from the PSM cohort confirmed this finding. No significant differences in the incidences of thromboembolic events (5.3 vs. 5.3%, p = 1.000) and bleeding events (4.3 vs. 3.5%, p = 1.000) were observed between the two groups. Four variables were explored as predictors related to high anticoagulation quality: treatment within a PPCC, history of bleeding, history of bleeding, and the presence of more than four comorbidities. The nomogram revealed a moderate predictive ability (c-index: 0.718, 95% confidence interval (95%CI): 0.669–0.767) and a moderately fitted calibration curve. Conclusion: The PPCC model contributed to improved anticoagulation quality in AF patients receiving warfarin. The nomogram might be an effective tool to predict anticoagulation quality and could aid physicians and pharmacists in the selection of patients who will likely benefit from sustained and active intervention.

Gut Microbiota and the Quality of Oral Anticoagulation in Vitamin K Antagonists Users: A Review of Potential Implications.

The efficacy and safety of vitamin K antagonists (VKAs) as oral anticoagulants (OACs) depend on the quality of anticoagulation control, as reflected by the mean time in therapeutic range (TTR). Several factors may be involved in poor TTR such as comorbidities, high inter-individual variability, interacting drugs, and non-adherence. Recent studies suggest that gut microbiota (GM) plays an important role in the pathogenesis of cardiovascular diseases, but the effect of the GM on anticoagulation control with VKAs is unknown. In the present review article, we propose different mechanisms by which the GM could have an impact on the quality of anticoagulation control in patients taking VKA therapy. We suggest that the potential effects of GM may be mediated first, by an indirect effect of metabolites produced by GM in the availability of VKAs drugs; second, by an effect of vitamin K-producing bacteria; and finally, by the structural modification of the molecules of VKAs. Future research will help confirm these hypotheses and may suggest profiles of bacterial signatures or microbial metabolites, to be used as biomarkers to predict the quality of anticoagulation. This could lead to the design of intervention strategies modulating gut microbiota, for example, by using probiotics.

Anticoagulation Control, Outcomes, and Associated Factors in Patients with Atrial Fibrillation Receiving Warfarin at Tertiary Care Hospital in Ethiopia.

Anticoagulation is the cornerstone in the prevention of stroke in atrial fibrillation. This study aimed at assessing the anticoagulation control and outcome and predictive factors in atrial fibrillation patients on warfarin therapy. A retrospective chart review was used to evaluate patients with atrial fibrillation who were on warfarin during two years follow up at the anticoagulation clinic of the hospital. The time in therapeutic range (TTR) was calculated using Rosendaal's method. Data were analyzed using SPSS software version 25. Univariable and multivariable analyses were computed to determine factors affecting TTR and bleeding events. We included 300 patients in this study. The mean percentage TTR was 42.03 ± 18.75. Only 38 (12.67%) patients achieved a TTR of above 65%. The average international normalized ratio (INR) testing frequency was 35 days (16.3-67.2 days). Taking 1 or 2 drugs along with warfarin was found to be better in achieving good TTR as compared to taking more than two drugs (p = .014). Having heart failure was associated with a 2.45 times odds of poor anticoagulation control (TTR< 65%) (p = .047). Male study participants were 2.53 times more likely of developing bleeding events than females (p = .009). Bleeding events were observed in 62 (20.67%) patients. Study participants, who didn't have Diabetic Mellitus and those not receiving aspirin were at lower odds developing bleeding events (AOR = .196; C.I. = .060-.638; p−.007 and AOR = .099; CI. = .024-.416; p−.02), respectively. In summary, the time spent in the therapeutic range was minimal in this population of patients with AF on warfarin managed at a hospital run anticoagulation clinic in Ethiopia. Moreover, the number of co-prescribed medications, and having heart failure were associated with poor TTR. Bleeding events were high and affected by male sex, having DM comorbidity, and using aspirin.

Spanish cohort profile, antithrombotic therapy and clinical outcomes at 1 year in the EORP atrial fibrillation long-term registry

Abstract Background Atrial fibrillation (AF) is associated with a high risk of stroke and mortality. Some years ago, the EURObservational Research Programme launched the General Long-Term Registry with the aim to evaluate contemporary management of AF patients in Europe, the current use of vitamin K antagonists (VKAs), direct-acting oral anticoagulants (DOACs) and other AF treatments, in relation to guideline recommendations. Purpose The present report aims to describe the characteristics of a large database on the management of AF in Spain, using the Spanish cohort included in the EORP-AF Long-Term Registry. Methods The EORP-AF Long-Term General Registry is a prospective, observational, large-scale multicentre registry sponsored and conducted by the ESC, enrolling AF patients in current cardiology practices in 250 centres from 27 participating ESC countries. Patients were enrolled consecutively when presenting with AF as primary or secondary diagnosis to inpatients and outpatient cardiology services from October 2013 to September 2016. The first Spanish patient in the EORP-AF Long-Term Registry was included in 2014. Initially, the aim was to carry out a follow-up up to 3 years but this was reduced to 2 years by the Executive Committee. To date, only data from the first year of follow-up is available for the Spanish cohort. Results A cohort of 729 AF Spanish patients was included (57.1% male, median age 75 [IQR 67–81] years, median CHA2DS2-VASc and HAS-BLED of 3 [IQR 2–5] and 2 [IQR 1–2], respectively). A relatively low proportion of patients (634, 87%) received oral anticoagulants (OACs), of which 389 (53.4%) were on VKAs and 245 (33.6%) were on DOACs (rate ratio = 1.59 [95% CI 1.35–1.87], p&amp;lt;0.001). Importantly, there were 98 (13.4%) patients taking concomitantly antiplatelet therapy and OACs; as well as 5.5% of patients were taking parenteral anticoagulation or antiplatelets alone. After 1 year, the proportion of patients on OACs increased from 87.0% to 88.1%. The proportion of DOACs users increased from 33.6% at baseline to 39.9%, partly due to switches from VKA to DOACs in relation to poor time in therapeutic range. At the same time, 34 (4.7%) patients withdrew OACs. During the first year of follow-up, 48 patients (6.6%) died, 7 (1.0%) suffered ischemic strokes and 6 (0.8%) transient ischemic attacks. Of note, there was a substantial rate of major bleeds (ISTH criteria) (57, 7.8%), of which 10 (1.4%) were intracranial haemorrhages. Conclusions Baseline data of the Spanish cohort are similar to that reported for the whole EORP cohort, including similar stroke and bleeding risks. OAC use slightly increased at 1-year, with low discontinuation rates which could be related with a low incidence of thromboembolic events. However, despite the ∼8% rate of major bleeding in overall, the use of a safer therapy such as DOACs is still low compared to VKAs, being the antiplatelets commonly used concomitantly with OACs Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unconditional grant by Boehringer-Ingelheim

Time in therapeutic range, quality of life and treatment satisfaction of patients on long-term warfarin for non-valvular atrial fibrillation: a cross-sectional study

BackgroundThe use of warfarin in patients with non-valvular atrial fibrillation (NVAF) can be challenging. In this study, we evaluate the time in therapeutic range (TTR), health-related quality of life (HRQoL) and treatment satisfaction of patients on long-term warfarin for NVAF. The HRQoL and treatment satisfaction were compared based on the TTR.MethodsA cross-sectional study was conducted among patients on warfarin for NVAF who attended the anticoagulant clinic of a tertiary cardiology referral center in Sarawak from 1st June 2018 to 31st May 2019. Patients’ TTR was calculated by using Rosendaal technique, while their HRQoL and treatment satisfaction were assessed by using Short Form 12 Health Survey version 2 (SF12v2) and Duke Anticoagulant Satisfaction Scale (DASS), respectively.ResultsA total of 300 patients were included, with mean TTR score of 47.0 ± 17.3%. The physical component summary (PCS) and mental component summary (MCS) score of SF-12v2 were 47.0 ± 9.0 and 53.5 ± 9.6, respectively. The total score for DASS was 55.2 ± 21.3, while the score for limitations (L), hassles and burdens (H&B) and positive psychological impacts (PPI) were 18.0 ± 10.0, 15.6 ± 9.1 and 21.6 ± 5.9, respectively. Seventy-three (24.3%) patients had good TTR (≥ 60%), with mean of 70.2 ± 8.7%; while 227 (75.5%) patients with poor TTR had significantly lower mean of 39.5 ± 11.9% (p = 0.006). There was no significant difference in the score of PCS (p = 0.150), MCS (p = 0.919) and each domain of SF-12v2 (p = 0.184–0.684) between good and poor TTR, except for social functioning (p = 0.019). The total DASS score was also not significantly different between group (p = 0.779). Similar non-significant difference was also reported in all the DASS sub dimensions (p = 0.502–0.699).ConclusionsMajority of the patients on long-term warfarin for NVAF in the current study have poor TTR. Their HRQoL and treatment satisfaction are independent of their TTR. Achieving a good TTR do not compromise the HRQoL and treatment satisfaction. Therefore, appropriate measures should be taken to optimise INR control, failing which direct oral anticoagulant therapy should be considered.

Use of SAMe-TT₂R₂ Score to Predict the Quality of Anticoagulation Control in Patients with Atrial Fibrillation Receiving Warfarin in Thailand

Objective: To predict the quality of anticoagulation control in patients with atrial fibrillation (AF) receiving warfarin in Thailand. Materials and Methods: The present study retrospectively recruited Thai AF patients receiving warfarin for three months or longer between June 2012 and December 2017 in Central Chest Institute of Thailand. The patients were classified into those with SAMe-TT₂R₂ of 2 or less, and 3 or more. The Chi-square test or Fisher’s exact test was used to compare the proportion of the patients with poor time in therapeutic range (TTR) between the two groups of SAMe-TT₂R₂ score. The discrimination performance of SAMe-TT₂R₂ score was demonstrated with c-statistics. Results: Ninety AF patients were enrolled. An average age was 69.89±10.04 years. Most patients were persistent AF. An average CHA₂DS₂-VASc, SAMe-TT₂R₂, and HAS-BLED score were 3.68±1.51, 3.26±0.88, and 1.98±0.85, respectively. The present study showed the increased proportion of AF patients with poor TTR with higher SAMe-TT₂R₂ score. The AF patients with SAMe-TT₂R₂ score of 3 or more had a larger proportion of patients with poor TTR than those with SAMe-TT₂R₂ score of 2 or less with statistical significance when TTR was below 70% (p=0.03) and 65% (p=0.04), respectively. The discrimination performance of SAMe-TT₂R₂ score was demonstrated with c-statistics of 0.60, 0.59, and 0.55 when TTR was below 70%, 65% and 60%, respectively. Conclusion: Thai AF patients receiving warfarin had a larger proportion of patients with poor TTR when the SAMe-TT₂R₂ score was higher. The score of 3 or more could predict poor quality of anticoagulation control in those patients. Keywords: Time in therapeutic range, Poor quality of anticoagulation control, Warfarin, SAMe-TT₂R₂, Labile INR

Poor Time in Therapeutic Range Control is Associated with Adverse Clinical Outcomes in Patients with Non-Valvular Atrial Fibrillation: A Report from the Nationwide COOL-AF Registry.

Background: Warfarin remains the most commonly used oral anticoagulant (OAC) in Thailand for stroke prevention among patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to investigate the relationship between time in therapeutic range (TTR) after warfarin initiation and clinical outcomes of NVAF. Methods: TTR was calculated by the Rosendaal method from international normalized ratio (INR) data acquired from a nationwide NVAF registry in Thailand. Patients were followed-up every six months. The association between TTR and clinical outcomes was analyzed. Results: There was a total of 2233 patients from 27 hospitals. The average age was 68.4 ± 10.6 years. The average TTR was 53.56 ± 26.37%. Rates of ischemic stroke/TIA, major bleeding, ICH, and death were 1.33, 2.48, 0.76, and 3.3 per 100 person-years, respectively. When patients with a TTR < 65% were compared with those with TTR ≥ 65%, the adjusted hazard ratios (aHR) for the increased risks of ischemic stroke/TIA, major bleeding, ICH, and death were 3.07, 1.90, 2.34, and 2.11, respectively. Conclusion: Poor TTR control is associated with adverse clinical outcomes in patients with NVAF who were on warfarin. Efforts to ensure good TTR (≥65%) after initiation of warfarin are mandatory to minimize the risk of adverse clinical outcomes.

P2753Anticoagulation control and all-cause death in patients with operated valvular heart disease with and without atrial fibrillation receiving vitamin K antagonists

Abstract Introduction Good quality of anticoagulation in patients with valvular heart disease (VHD) is needed to reduce ischaemic complications. There is limited evidence on factors affecting anticoagulation control in patients implanted with mechanical or tissue prosthetic valve(s). Objective To examine quality, factors affecting anticoagulation control and all-cause death in VHD patients with and without atrial fibrillation (AF) receiving a vitamin K antagonist (VKA) oral anticoagulant. The relationship between INR control with all-cause death and ≥1 adverse clinical events (ACE) [thromboembolism, bleeding, cardiovascular hospitalisation and all-cause death] were explored. Methods Anticoagulation control of 456 VHD patients [164 (36%) with AF and 290 (64%) without AF] referred to a hospital-based anticoagulation clinic were assessed retrospectively by time in therapeutic range (TTR) (Rosendaal) and percentage of INRs in range (PINRR) for a median of (IQR) 6.2 years (3.3–8.5). VHD was defined by the presence of mechanical or tissue prosthetic valve at either the mitral or aortic site or both. Results Mean (SD) age 51 (14.7), 64.5% male, mean (SD) CHA2DS2-VASc score 2.0 (1.4), 96.1% mechanical prosthesis and 64% aortic valve replacement. VHD patients with AF had lower mean TTR and PINRR, lower proportion of optimal TTR (i.e.≥70%) despite similar number of INR tests compared to VHD patients without AF [Table 1]. Predictors of poor TTR on multivariate logistic regression analysis were female sex, AF and anaemia/bleeding history. Significantly higher proportions of VHD patients with AF died [Table 1]. More deaths (13.1% vs. 4.1%; p=0.011) and ≥1 ACE (42.7% vs. 27.6%; p=0.006) were seen in VHD patients with TTR &lt;70% vs. TTR≥70%, respectively. Table 1 N (%) Total (N=456) AF (N=164) No AF (N=290) p-value Mean (SD) TTR 58.5 (14.6) 55.7 (14.2) 60.1 (14.6) 0.002 TTR ≥70% 98 (21.5) 23 (14.0) 75 (25.7) 0.004 Mean (SD) PINRR 50.1 (13.8) 47.4 (13.5) 51.6 (13.7) 0.002 Mean (SD) INR tests 96.2 (55.3) 100.7 (58.8) 93.7 (53.1) 0.19 All-cause death 51 (11.2) 34 (20.7) 17 (5.8) &lt;0.001 AF: Atrial fibrillation; IQR: interquartile range; PINRR: percentage of INRs in range; SD: standard deviation; TTR: Time in therapeutic range. Conclusion The quality of anticoagulation in VHD patients with AF was low. The presence of AF, anaemia/bleeding history and female sex independently predicted poor TTR. All-cause death was more common in VHD patients with AF and poor TTR. Closer INR monitoring is needed especially in VHD patients with AF to improve anticoagulation control and prevent adverse clinical outcomes. Acknowledgement/Funding Kementerian Pendidikan Malaysia and Universiti Teknologi MARA for PhD study but not directly for work under consideration