Anticoagulation Control Research Articles

Consequences of the Poor Anticoagulation Control of Patients with Non-Valvular Atrial Fibrillation Treated with Vitamin K Antagonists.

Background: The prevention of thromboembolisms through anticoagulation and heart rate control is crucial in managing non-valvular atrial fibrillation (NVAF). This study aimed to analyze the consequences of poor anticoagulation control with vitamin K antagonists (VKAs) in Spanish patients with NVAF, focusing on thrombotic events, bleeding, mortality, healthcare resources (HRU), and costs. Methods: This observational, retrospective study used electronic medical records (BIG-PAC® database) of NVAF patients who started VKA treatment between 1 January 2016 and 31 December 2018. Patients were followed up for two years and classified by poor or adequate anticoagulation control. Demographic and clinical characteristics, treatments, incidence of cardiovascular events, mortality rates, HRU, and costs were analyzed. Results: Patients with poor control (n = 2136) had a 75% greater probability of suffering a cardiovascular event compared to patients with adequate control (n = 2351) (HR, 1.75 [95%CI: 1.43-2.14; p < 0.001]). Cardiovascular events, major bleeding, minor bleeding, systemic thromboembolism, and ischemic strokes were reduced by 32.1%, 46.2%, 29.6%, 22.2%, and 16.1%, respectively. It was estimated that adequate anticoagulant control saved EUR 455/patient with NAVF due to reduced hospitalization for cardiovascular events. Conclusions: For VKA-treated NVAF patients, poor anticoagulation control was associated with a higher number of cardiovascular events, greater consumption of HRU, and higher management costs than for patients with adequate control.

Impact of Antibacterials on the Quality of Anticoagulation Control in Patients Initiating Warfarin Therapy.

Warfarin interacts with antibacterials to prolong the prothrombin time international normalized ratio (PT-INR) and increase the risk of bleeding. Patients initiating warfarin therapy often undergo precise dosage adjustments; however, the clinical implications of these interactions with antibacterials remain unclear. This study aimed to clarify the effect of antibacterials on PT-INR during the warfarin induction phase. This was a retrospective, observational study. Patients who were newly treated with warfarin after cardiovascular surgery were included. The primary endpoint was the comparison of the maximum PT-INR and time in therapeutic range (TTR) after warfarin initiation between the antibacterial-treated (ABx) and non-treated (non-ABx) groups. The maximum PT-INR was significantly higher in the ABx group (which included β-lactams, glycopeptides, quinolones, tetracyclines, and aminoglycosides) than in the non-ABx group (median [interquartile range] 2.37 [2.03-2.71] vs. 2.08 [1.93-2.33]; P = 0.005); however, the TTR did not differ significantly (65% [44-76] vs. 71% [43-85]; P = 0.150). The odds ratio for maximum PT-INR >2.6 with antimicrobial therapy was 2.51 (95% confidence interval 1.21-5.21). Antibacterial therapy was a risk factor for a maximum PT-INR >2.6. However, there was no association with the TTR, which is a marker of good outcomes. This was due to the strict warfarin dosing regimen according to the algorithm, which immediately and appropriately adjusted for PT-INR overexpansion. Antibacterials have been suggested to increase PT-INR during the induction phase of warfarin. However, with strict dose adjustments, the clinical impact on the PT-INR and TTR is likely limited.

Association between warfarin and direct oral anticoagulants users and risk of mortality: cohort studies in England and Hong Kong

Abstract Background The evidence of the association between warfarin and risk of mortality compared with direct oral anticoagulants (DOACs) has been mixed in current literature. Purpose To investigate the association between all-cause mortality and warfarin, compared with DOACs. Methods Population-based cohort studies were conducted using the data from the Hong Kong Clinical Data Analysis and Reporting System (CDARS) and United Kingdom Clinical Practice Research Datalink (CPRD) Aurum. People with atrial fibrillation aged ≥18 years who initiated warfarin or a DOAC during the study period (1st Jan 2014 - 31st Dec 2019) were identified. Follow-up started from the first date of oral anticoagulant prescription and ended at earliest of the date of death, the day before drug switching (between warfarin and DOACs), transferring out of the practice (CPRD Aurum only), last data collection date for the practice (CPRD Aurum only) or the end of study period. We estimated propensity score (PS) based on the list of potential confounders including demographics, co-morbidities, co-medications and polypharmacy. Cox proportional hazards regression model with PS-weighting was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Results Among 227,190 new oral anticoagulant users, 54,367 (23.93%) died. The median follow-up was 2.96 and 2.45 years in CPRD and CDARS, respectively. Compared with DOAC use, a lower hazard of all-cause mortality was found in warfarin use (PS-weighted hazard ratio [HR]=0.94, 95% confidence interval [CI]=0.89-0.99) in CPRD; while a higher hazard was observed in warfarin users (PS-weighted HR=1.31, 95% CI=1.24-1.39) in CDARS, versus DOAC users. Consistent results were seen in both databases when stratified warfarin users by Time in Therapeutic Range (TTR). We observed a lower hazard of all-cause mortality in warfarin users with TTR≥65% (PS-weighted HR=0.90, 95% CI=0.85-0.94 in CPRD; 0.87, 0.79-0.96 in CDARS) and increased hazard in warfarin users with TTR&amp;lt;65% (PS-weighted HR=1.37, 95% CI=1.25-1.49 in CPRD; 1.57, 1.48-1.66 in CDARS), versus DOAC users. Conclusions The hazard of all-cause mortality associated with warfarin compared with DOACs were found to be conflicting across databases. However, both databases consistently showed that an increased hazard of all-cause mortality was only found in warfarin users with TTR&amp;lt;65% but not in those with TTR≥65%, suggesting that the differences in hazard of all-cause mortality associated with warfarin compared with DOAC, in part may depend on anticoagulation control in warfarin users. We recommend that warfarin users with poor INR control warrant closer clinical attention and could be considered for a switch to DOACs.

Anticoagulation control challenges in patients with rheumatic heart disease and mechanical heart valves operated at a cardiac surgery center in a low-income country

Abstract Background Rheumatic heart disease (RHD) prevalence is very high in many low-income countries and valve replacement surgery can sometimes be the only available therapeutic strategy for the affected patients. Mechanical valves require lifelong anticoagulation and this can be very challenging in many poor countries where several barriers to effective anticoagulation monitoring and management are faced. Methods This is a retrospective study on 145 patients with RHD who underwent valve replacement surgery at a cardiac surgery center (CSC) in a low-income country between 2001 and 2022. The study aimed to evaluate the effectiveness of anticoagulation treatment to prevent thromboembolic events in patients with RHD with mechanical valves. The patients’ information such as social and demographic data, clinical features, surgical data and international normalized ratio (INR) records were collected and analyzed. Descriptive statistics were applied to the data and expressed as mean with standard deviation or simple frequencies and percentages. Results The mean age of the operated patients was 25.9 years (± 12.6) and 60% of them were female. Most of the patients (54%) were able to monitor their anticoagulation at the center and 8.2% of them monitored it in other hospitals. Three percent (3%) of the patients use a portable device to monitor their INR. These devices are provided by the CSC to help patients that live in distant provinces and are unable to go to the capital regularly. The device is held by one patient that is a focal point and helps monitor the INR of the other patients living in the same province. The INR results are communicated to the CSC by telephone text message. Seven percent (7%) of the operated patients haven’t monitored their INR for more than one year and 24.8% of them were lost to follow-up. Sixty-four percent (64%) of the patients who monitor their INR at the center have an optimal control of their anticoagulation therapy. Most of the patients that were lost to follow-up (N=20) and most of the patients that haven’t checked their INR for more than one year (N=7) are patients who had aortic valve replacements. At least 20% of the patients that live in capital of the country and close to the CSC don’t monitor their anticoagulation regularly. Conclusion The surgical outcomes in RHD patients who undergo mitral valve repair are usually satisfactory. However, valve replacement is often the only feasible alternative and anticoagulation monitoring and management in these patients can become a serious problem especially to those coming from areas with limited resources. Illiteracy and poverty play a major role as barriers to effective monitoring of anticoagulation therapy. Efforts must be made to increase access to facilities where INR can be monitored. Our experience showed us that providing portable devices for INR monitoring to the patients living in remote areas can be a favorable short-term solution.

Impact of Educational Intervention on Anticoagulation Control Using SAMe-TT22R2 Score-Guided Strategy in Atrial Fibrillation

Impact of Educational Intervention on Anticoagulation Control Using SAMe-TT22R2 Score-Guided Strategy in Atrial Fibrillation

Clinical outcomes of patients with atrial fibrillation in relation to multimorbidity status changes over time and the impact of ABC pathway compliance: a nationwide cohort study.

Patients with atrial fibrillation (AF) commonly have associated comorbidities. The primary aim was to determine the effect of increasing numbers of comorbidity on clinical outcomes. The secondary aims were (1) the association of comorbidities with oral anticoagulants (OAC) discontinuation, and quality control, (2) the impact of holistic care based on the ABC pathway on clinical outcomes. The primary outcome was the composite of all-cause death, ischemic stroke/systemic embolism, major bleeding, and heart failure. A total of 3405 patients were enrolled; mean age 67.8 ± 11.3 years, 41.8% female. Compared to low comorbidity group [n = 897 (26.3%)], hazard ratios (HR) and 95% confidence intervals (CI) for the composite outcome in the high [n = 929 (27.3%)] and moderate comorbidity [n = 1579 (46.4%)] groups were 5.40 (4.20-6.94) and 2.54 (1.97-3.27), respectively. ABC pathway adherence was associated with reduction of the composite outcome overall (HR 0.63; 0.54-0.74). High comorbidity adversely impacted on OAC use, OAC discontinuation, and quality of warfarin control. If quality of anticoagulation control was included as part of the ABC pathway adherence, the reduction in composite outcome risk was greater (HR 0.46; 0.36-0.58). During 3-year follow-up, 33.9% changed from low- to the moderate-high comorbidity groups and 22.3% changed from moderate- to the high comorbidity group. In conclusion, comorbidity burden in AF patients is an important determinant of clinical outcomes, and changed over time. OAC use, OAC discontinuation, and quality of OAC control were impacted by comorbidity burden. ABC pathway adherence was associated with a reduced risk of adverse clinical outcomes.

Comparative effectiveness of warfarin management strategies: a systematic review and network meta-analysis

The management of warfarin therapy presents clinical challenges due to its narrow therapeutic index. We aimed to evaluate the comparative effectiveness of different management strategies in patients using warfarin. PubMed, Embase, Cochrane CENTRAL, CINAHL, and EBSCO Open Dissertation were searched from inception to 8 May 2024. Randomized controlled trials that compared the following interventions: patient self-management (PSM), patient self-testing (PST), anticoagulation management services (AMS), and usual care in patients prescribed warfarin for any indication were included. Risk ratios (RR) with 95% confidence interval (CI) were estimated using a random-effects model. Surface under the cumulative ranking curves (SUCRA) were used to rank different interventions. The certainty of evidence was assessed using the Confidence in Network Meta-Analysis (CINeMA) online platform. This study is registered with PROSPERO (CRD42023491978). Twenty-eight trials involving 8100 participants were included, with follow-up periods of 1-24 months. Mean warfarin dosages were 4.9-7.2mg/day. Only PSM showed a significant reduction of major TE risk compared with usual care (RR=0.41; 95% CI: 0.24, 0.71; I2=0.0%) with moderate certainty of evidence. The 97.6% SUCRA also supported the beneficial effects of PSM over other interventions. The combined direct and indirect evidence showed significantly higher TTR in PSM compared with usual care (MD=7.39; 95% CI: 2.39, 12.39), with very low certainty. However, direct evidence showed non-significant TTR improvement (MD=6.49; 95% CI:-3.09, 16.07, I2=96.1%). No differences across various strategies were observed in all-cause mortality, major bleeding, stroke, transient ischemic attack, and hospitalization. PSM reduces the risk of major TE events compared with usual care, tends to improve anticoagulation control, and should be considered where appropriate. Agency for Healthcare Research and Quality (grant ID 5R18HS027960).

A Retrospective Cohort Study on The Anticoagulation Control of Patients Receiving Warfarin in Queen Elizabeth Hospital (QEH) Sabah

A Retrospective Cohort Study on The Anticoagulation Control of Patients Receiving Warfarin in Queen Elizabeth Hospital (QEH) Sabah

Comparison of anticoagulation control and outcomes between usual medical care and pharmacist-led anticoagulation service in ambulatory patients taking warfarin at tertiary hospital in Ethiopia: a quasi-experimental study

BackgroundWe aimed to compare anticoagulation control and outcomes between usual medical care (UMC) and pharmacist-led anticoagulation services (PLAS) in patients receiving warfarin at the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia.MethodsA quasi-experimental study was conducted, including 350 (66.7%) and 175 (33.3%) patients from the UMC and PLAS groups, respectively, from 525 patients. The time in therapeutic range (TTR) was determined using the Rosendaal method, with a TTR ≥ 65% set as the cut-off for optimal anticoagulation. The two-sample Wilcoxon rank-sum (Mann–Whitney U) test was used to compare continuous variables between groups. Categorical variables were compared between groups using Pearson’s chi-square test or Fisher’s exact test. Logistic regression and negative binomial regression analyses were conducted to identify the factors associated with suboptimal TTR and secondary outcomes, respectively, at the p values < 0.05, and 95% confidence interval (CI).ResultsCompared with the UMC group, the patients in the PLAC group showed a significantly higher median (IQR) TTR [60.89% (43.5–74.69%) vs. 53.65% (33.92–69.14%), p < 0.001]. A significantly higher optimal TTR (≥ 65%) was achieved in the PLAC group (41.7% vs. 31.7%) than in the UMC group (p = 0.002). The odds of having a poor TTR were reduced by 43% (AOR = 0.57, 95% CI = 0.36–0.88, p = 0.01) among patients in the PLAC group compared to those in the UMC group. There were no statistically significant differences in the secondary outcomes between the groups, except for all-cause emergency visits (p = 0.003). The incidence of bleeding events decreased by 3% (IRR = 0.97, 95% CI = 0.96–0.99, p < 0.001) for every increase in INR monitoring frequency. The incidence of thromboembolic events increased by a factor of 15.13 (IRR = 15.13, 95% CI = 1.47–155.52, p = 0.02) among patients with a high-risk CHA2DS2-VASc score compared with those with a moderate score.ConclusionPatients in the PLAC group had a significantly higher median TTR than those in the UMC group did. There were no statistically significant differences in the secondary outcomes between the groups, except for fewer all-cause emergency department visits in the PLAC group.

Anticoagulation control among patients on vitamin K antagonists in nine countries in Sub-Saharan Africa

Vitamin K antagonists (VKA) is the primary anticoagulant in most settings of Sub-Saharan Africa. Understanding the quality of anticoagulation services in the continent is vital in optimising the intended benefits. This study assessed the quality of anticoagulation and associated factors among VKA-treated patients in nine SSA countries. We conducted a retrospective cohort study of randomly selected patients on anticoagulation from 20 clinics in Botswana, the Democratic Republic of Congo, Ethiopia, Gambia, Ghana, Mozambique, Nigeria, Tanzania, and South Africa. Eligible participants were those on VKAs for at least three months and with at least four international normalised ratios (INR) results in 2019–2021. We report the proportion of INR values in the therapeutic range, time-in-therapeutic range (TTR) using the Rosendaal method, and the proportion of patients with TTR ≥ 65% (optimal anticoagulation). The mean age was 51.1(16.1) years, and 64.2% were women. The most common indications for VKA included venous thromboembolism (29.6%), prosthetic valves (26.7%) and atrial fibrillation/flutter (30.1%). We analysed 6743 INR tests from 1011 participants, and of these, 48.5% were sub-therapeutic, 34.1% therapeutic, and 17.4% were supratherapeutic relative to disease-specific reference ranges. TTR was calculated for 660 patients using 4927 INR measurements. The median (interquartile range [IQR]) TTR was 35.8(15.9,57.2) %. Optimal anticoagulation control was evident in 19.2% of participants, varying from 2.7% in Tanzania to 23.1% in Ethiopia. The proportion of patients with TTR ≥ 65% was 15,4% for prosthetic heart valves, 21.1% for venous thromboembolism and 23.7% for atrial fibrillation or flutter. Countries with universal health coverage had higher odds of optimal anticoagulation control (adjusted odds ratio (aOR) 1.79, 95% confidence interval [CI], 1.15– 2.81, p = 0.01). Patients on VKAs for different therapeutic indications in SSA had suboptimal TTR. Universal health coverage increased the odds of achieving TTR by 79%. The evidence calls for more intensive warfarin management strategies in SSA, including providing VKA services without out-of-pocket payments.

IMPACT OF THYROID DYSFUNCTION IN PATIENTS WITH ATRIAL FIBRILLATION

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice, affecting approximately 2% of the general population and increasing the risk of stroke, heart failure and mortality. AF is often associated with several clinical conditions, including thyroid dysfunction, which can alter metabolism, function and cardiac structure. Thyroid dysfunction can be classified as hypothyroidism (low production of thyroid hormones) or hyperthyroidism (excess production of thyroid hormones), both of which can cause or worsen AF. The mechanism by which thyroid dysfunction affects AF is complex and involves electrophysiological, hemodynamic, inflammatory and structural changes in the atria. Appropriate diagnosis and treatment of thyroid dysfunction can improve AF control and reduce thromboembolic and hemorrhagic complications. However, the prevalence, incidence, risk factors, prognosis and management of AF in patients with thyroid dysfunction are still controversial topics in the literature. Objective: to evaluate the impact of thyroid dysfunction in patients with AF, addressing the following aspects: epidemiology, pathophysiology, diagnosis, treatment and clinical outcomes. Methodology: This review was carried out in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) protocol. The PubMed, Scielo and Web of Science databases were searched, using the following descriptors: "atrial fibrillation", "thyroid dysfunction", "hypothyroidism", "hyperthyroidism" and "thyrotoxicosis". Articles published in the last 10 years, in Portuguese, English or Spanish, that addressed the proposed topic were included. Articles that were not original, did not have sufficient data or were not relevant to the research question were excluded. Results: 18 studies were selected. The diagnosis of AF in patients with thyroid dysfunction requires confirmation of the heart rhythm by electrocardiogram (ECG) and assessment of serum thyroid hormone levels (TSH, free T4 and free T3). Treatment of AF in patients with thyroid dysfunction aims to restore and maintain sinus rhythm, control ventricular rate, prevent thromboembolic events, and correct thyroid dysfunction. Therapeutic options include antiarrhythmic drugs, antithyroid drugs, anticoagulant drugs, electrical cardioversion, catheter ablation, and surgical thyroid treatment. The clinical outcomes of AF in patients with thyroid dysfunction are influenced by the type, severity and duration of thyroid dysfunction, as well as rhythm, frequency and anticoagulation control. AF in patients with thyroid dysfunction is associated with a higher risk of arrhythmia recurrence, heart failure, stroke and mortality. Conclusion: Thyroid dysfunction is a frequent and important clinical condition in patients with AF, as it can cause or worsen arrhythmia, as well as increase the risk of complications. Appropriate diagnosis and treatment of thyroid dysfunction can improve AF control and reduce adverse outcomes. However, there are still gaps in knowledge about the epidemiology, pathophysiology, prognosis and management of AF in patients with thyroid dysfunction, which require further studies of high quality and clinical relevance.

Atrial fibrillation considerations in the fourth trimester (postpartum period).

Postpartum atrial fibrillation is an uncommon but increasingly prevalent tachyarrhythmia that merits special management considerations with regards to the safety and efficacy of anticoagulation, rate and rhythm control as well as drug exposure to infants throughout breastfeeding. In this state-of-the-art review, we examine the demographics of postpartum atrial fibrillation with its associated risk factors, describe the safety of commonly used atrial fibrillation therapies, and discuss important considerations for women considering subsequent pregnancies.

Mechanical valve replacement for patients with rheumatic heart disease: the reality of INR control in Africa and beyond.

The majority of patients requiring heart valve replacement in low- to middle-income countries (LMICs) need it for rheumatic heart disease (RHD). While the young age of such patients largely prescribes replacement with mechanical prostheses, reliable anticoagulation management is often unattainable under the prevailing socioeconomic circumstances. Cases of patients with clotted valves presenting for emergency surgery as a consequence of poor adherence to anticoagulation control are frequent. The operative mortality rates of reoperations for thrombosed mechanical valves are several times higher than those for tissue valves, and long-term results are also disappointing. Under-anticoagulation prevails in these regions that has clearly been linked to poor international normalised ratio (INR) monitoring. In industrialised countries, safe anticoagulation is defined as >60%-70% of the time in the therapeutic range (TTR). In LMICs, the TTR has been found to be in the range of twenty to forty percent. In this study, we analysed >20,000 INR test results of 552 consecutive patients receiving a mechanical valve for RHD. Only 27% of these test results were in the therapeutic range, with the vast majority (61%) being sub-therapeutic. Interestingly, the post-operative frequency of INR tests of one every 3-4 weeks in year 1 had dropped to less than 1 per year by year 7. LMICs need to use clinical judgement and assess the probability of insufficient INR monitoring prior to uncritically applying Western guidelines predominantly based on chronological age. The process of identification of high-risk subgroups in terms of non-adherence to anticoagulation control should take into account both the adherence history of >50% of patients with RHD who were in chronic atrial fibrillation prior to surgery as well as geographic and socioeconomic circumstances.

Modified application of SAMe-TT2R2 scoring system in Asian patients with atrial fibrillation for the selection of oral anticoagulants.

The SAMe-TT2R2 score is used for assessing anticoagulation control (AC) quality with warfarin. However, it is hard to apply SAMe-TT2R2 score in Asian patients with atrial fibrillation (AF), because it has not been proven in those populations. This study aimed to validate the SAMe-TT2R2 score in Asian patients with AF and suggest a modified SAMe- TT2R2 score for this population. We analyzed 710 Korean patients with AF who were using warfarin. The AC quality was assessed as the mean time in therapeutic range (TTR). Each component of SAMe-TT2R2 score was evaluated for the relationship with AC. Further clinical factors that predict AC were analyzed. Identified factors were re-assorted and constructed as SA2Me-TTR scoring system. Of the components of the SAMe-TT2R2 score, female, age, and rhythm control were associated with AC. Heart failure and renal insufficiency were newly identified factors associated with AC. The modified SA2Me-TTR score was reconstructed with the relevant risk factors (S, female gender, 1 point; A, age < 60 yr, 2 points; Me, medical history of heart failure, 1 point; T, treatment for rhythm control, 1 point; T, history of stroke or transient ischemic attack, 1 point; R, renal insufficiency, 1 point). The modified SA2Me-TTR score demonstrated an excellent relationship with the grading of AC. The modified SA2Me-TTR score ≤ 1 identified patients with good AC (hazard ratio 2.46, 95% CI 1.75-3.47). The modified SA2Me-TTR score was useful for guiding oral anticoagulants selection in Asian patients with AF.

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.

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin.

Patients with a mechanical heart valve (MHV) require oral anticoagulation. Poor anticoagulation control is thought to be associated with adverse outcomes, but data are limited. To assess the risks of clinical outcomes in patients with a MHV and poor anticoagulation control on warfarin. We conducted a retrospective study of consecutive patients undergoing MHV implantation at a tertiary care center (2010-2019). Primary outcome was a composite of ischemic stroke, systemic embolism, or prosthetic valve thrombosis. Major bleeding and death were key secondary outcomes. We constructed multivariable regression models to assess the association between time in therapeutic range (TTR) on warfarin beyond 90 days after surgery with outcomes. We included 671 patients with a MHV (80.6% in aortic, 14.6% in mitral position; mean age 61 years, 30.3% female). Median follow-up was 4.9 years, mean TTR was 62.5% (14.5% TTR <40%, 24.6% TTR 40-60%, and 61.0% TTR >60%). Overall rates of the primary outcome, major bleeding, and death were 0.73, 1.41, and 1.44 per 100 patient-years. Corresponding rates for patients with TTR <40% were 1.31, 2.77, and 3.22 per 100 patient-years. In adjusted analyses, every 10% decrement in TTR was associated with a 31% increase in hazard for the primary outcome (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.13-1.52), 34% increase in major bleeding (HR: 1.34, 95% CI: 1.17-1.52), and 32% increase in death (HR: 1.32, 95% CI: 1.11-1.57). In contemporary patients with a MHV, poor anticoagulation control on warfarin was associated with increased risks of thrombotic events, bleeding, and death.

Net clinical benefit of oral anticoagulants in Asian patients with atrial fibrillation based on a CHA2DS2-VASc score

BackgroundThis study was conducted to assess the net clinical benefit (NCB) for oral anticoagulant (OAC) in atrial fibrillation (AF) patients according to the CHA2DS2-VASc score.MethodsPatients with AF were prospectively recruited in the COOL AF Thailand registry from 2014 to 2017. The incidence rate of thromboembolic (TE) events and major bleeding (MB) was calculated. Cox proportional hazards model was used to compare the TE and MB rate in patients with and without OACs in CHA2DS2-VASc score of 0–1 and ≥ 2, respectively. The survival analysis was performed based on CHA2DS2-VASc score. The NCB of OACs was defined as the TE rate prevented minus the MB rate increased multiplied by a weighting factor.ResultsA total of 3,402 AF patients were recruited. An average age of patients was 67.38 ± 11.27 years. Compared to non-anticoagulated patients, the Kaplan Meier curve showed anticoagulated patients with CHA2DS2-VASc score of 2 or more had the lower thromboembolic events with statistical significance (p = 0.043) and the higher MB events with statistical significance (p = 0.018). In overall AF patients, there were positive NCB in warfarin patients with CHA2DS2-VASc score of 3 or more while there were positive NCB in DOACs patients regardless of CHA2DS2-VASc score. Females with CHA2DS2-VASc score of 3 or more had a positive NCB regardless of OACs type. Good anticoagulation control (TTR ≥65%) improved an NCB in males with CHA2DS2-VASc score of 3 or more.ConclusionsAF patients with CHA2DS2-VASc score of 3 or more regardless warfarin or DOACs had a positive NCB. The NCB of OACs was more positive for DOACs compared to warfarin and for females compared to males.

Code ICH: A Call to Action.

Intracerebral hemorrhage is the most serious type of stroke, leading to high rates of severe disability and mortality. Hematoma expansion is an independent predictor of poor functional outcome and is a compelling target for intervention. For decades, randomized trials aimed at decreasing hematoma expansion through single interventions have failed to meet their primary outcomes of statistically significant improvement in neurological outcomes. A wide range of evidence suggests that ultra-early bundled care, with multiple simultaneous interventions in the acute phase, offers the best hope of limiting hematoma expansion and improving functional recovery. Patients with intracerebral hemorrhage who fail to receive early aggressive care have worse outcomes, suggesting that an important treatment opportunity exists. This consensus statement puts forth a call to action to establish a protocol for Code ICH, similar to current strategies used for the management of acute ischemic stroke, through which early intervention, bundled care, and time-based metrics have substantially improved neurological outcomes. Based on current evidence, we advocate for the widespread adoption of an early bundle of care for patients with intracerebral hemorrhage focused on time-based metrics for blood pressure control and emergency reversal of anticoagulation, with the goal of optimizing the benefit of these already widely used interventions. We hope Code ICH will endure as a structural platform for continued innovation, standardization of best practices, and ongoing quality improvement for years to come.

Appropriateness of anticoagulation level in older adult patients on Warfarin: A multicenter retrospective study

Warfarin is favored over newer direct oral anticoagulants (DOACs) for many older adults. However, its use necessitates rigorous monitoring due to the fine line between toxic and therapeutic doses. Few studies have evaluated the anticoagulation quality of warfarin among elderly patients in Saudi Arabia. This study aimed to assess and identify factors affecting the anticoagulation quality of warfarin using the time in the therapeutic range (TTR) among older adults attending two hospitals in Saudi Arabia. Additionally, we aimed to evaluate differences in the anticoagulation quality of warfarin when managed by pharmacists or physicians. This cross-sectional study was conducted at King Abdullah bin Abdulaziz University Hospital (KAAUH) and King Fahad Medical City (KFMC) in Riyadh, Saudi Arabia. After calculating the TTR of each patient, the anticoagulation control level was determined using these values: a) good control: >70 %; b) intermediate control: 50–70 %; c) poor control: <50 %. A total of 132 patients prescribed warfarin therapy for different indications were included. Most patients (45.5 %) had poor control with TTRs < 50 %, while 18.2 % had intermediate control, and 36.4 % had good control.Our exploratory findings suggest that having three or more comorbidities was a significant factor associated with a poor TTR [odds ratio (OR) = 3.36; (95 % confidence interval 1.28–8.81); P = 0.014]. Thus, the anticoagulation quality of warfarin among older adult patients was poor in two Saudi Arabian tertiary hospitals, and the number of comorbidities was a potentially poor TTR predictor.

Quality of anticoagulation control among patients receiving vitamin K antagonist in pharmacist-managed anticoagulation medication therapy adherence clinic

Quality of anticoagulation control among patients receiving vitamin K antagonist in pharmacist-managed anticoagulation medication therapy adherence clinic