Anticoagulation Control Research Articles

Evaluation of inter-patient variability in the pharmacodynamic indices of warfarin

ABSTRACT Objectives Warfarin exhibits huge inter-individual variability in therapeutic response. We assessed the extent and the factors affecting inter-individual variability in the anticoagulation control using pre-validated pharmacodynamic indices. Methods Patients receiving warfarin for at least 6 months were recruited. CHA₂DS₂-VASc, HASBLED, SAMe-TT2R2 scores, warfarin sensitive index (WSI), log-INR variability, and warfarin composite measure (WCM) were assessed. National Institute for Health and Care Excellence (NICE) guideline was adhered for assessing the anticoagulation control using time in therapeutic range (TTR) (TTR < 65%-poor; and TTR ≥ 65%-good). Odds ratio [95% confidence interval] was the effect estimate measure. Results Eighty-seven (39.5%) of the patients were poorly anticoagulated. Those with lower HASBLED [OR: 0.3; 0.1, 0.6] and SAMe-TT2R2 scores [OR: 0.2; 0.04, 0.7] and higher CHA₂DS₂-VASc score [OR: 1.8; 1.1, 1.3] predicted good anticoagulation control. Thirty-five (15.9%) patients had high INR variability. Lower TTR, shorter duration of therapy, and higher WSI were observed in patients with high INR variability, and presence of drugs with potential interaction significantly predicted high INR variability. Conclusion Significant numbers of our patients on warfarin had poor anticoagulation control and high INR variability. We have identified duration of therapy, CHA₂DS₂-VASc score, and WSI as reliable predictors for anticoagulation control and INR variability.

46 ESOPHAGECTOMY FOR ESOPHAGEAL CANCER TO THE PATIENT ACCOMPANIED WITH PROTEIN C DEFICIENCY

Abstract Protein C deficiency is a rare genetic disease that predisposes to thrombotic disease, which is characterized by tendency to form thrombus due to hypercoagulation. The incidence of protein C deficiency with clinical symptoms has been reported to be estimated at 1 in 20,000. Only a few cases of surgery for gastrointestinal cancer with protein C deficiency have been reported, however, there have been no reports regarding the perioperative management in detail for those patients. Methods We present. We assess perioperative management for the case of esophagectomy for an esophageal cancer accompanied with protein C deficiency. Results A 63-year-old male with protein C deficiency underwent thoracoscopic esophagectomy and digestive reconstruction using gastric tube for thoracic esophageal cancer whose clinical stage was T1bN0M0. On postoperative day 3, his gastric tube was removed due to gastric tube necrosis. Digestive reconstruction using free jejunal graft has been attempted after 140 days from first surgery, however, thrombus formation in the jejunal artery and vein caused the reconstruction to failure. Ten days after this surgery, digestive reconstruction using colon was performed with anticoagulation control by administrating intraoperative heparin. The patient went fine without thrombus formation afterward. Conclusion During digestive reconstruction in patients with conditions predisposing to thrombus formation as typified by protein C deficiency, the perioperative management should be done with careful attention to prevent thrombus formation. In particular, because there is likely to develop necrosis of reconstructed organ due to thrombus formation, the appropriate anticoagulation control such as intraoperative heparin administration is recommended in patients with protein C deficiency.

Does fasting during Ramadan influence the therapeutic effect of warfarin?

The changes in the therapeutic effect of warfarin during Ramadan fasting are controversial. Hence, we carried out the present study to assess if there are any alterations in the anticoagulation response to warfarin and identify the associated risk factors. Patients receiving warfarin for at least 1year were included in the present study. Their demographic details, warfarin doses, prothrombin time-international normalized ratio (PT-INR) values and concomitant diseases/drugs were retrieved. The dates of Ramadan periods for the calendar years were obtained, and these periods were considered as Ramadan periods. One month before the start dates of Ramadan was considered as pre-Ramadan, and 1month later than the last dates was considered as post-Ramadan periods. Warfarin sensitivity index (WSI), PT-INR category and time spent in therapeutic range (TTR) were assessed. National Institute of Clinical Health Excellence (NICE) criteria for anticoagulation status were adhered to where TTR (%) <65 was considered as poor anticoagulation. One hundred and eighty-three patients were recruited. No significant differences were observed in warfarin doses between the study participants between pre-Ramadan, Ramadan and post-Ramadan periods. Significantly more numbers of PT-INR tests were carried out during Ramadan compared with pre- and post-Ramadan periods. A higher WSI was akin to PT-INR, and lower intra-individual variability was observed in middle-aged and older adults in the post-Ramadan period. Significantly fewer patients had their PT-INR in the therapeutic range and more in the subtherapeutic range during Ramadan periods. Greater proportion of patients had PT-INR in the supratherapeutic range during post-Ramadan periods, particularly the elderly. Although 38.3% had poor anticoagulation status overall, 92.4% met the NICE criteria for poor anticoagulation during the 3months (pre-Ramadan, Ramadan and post-Ramadan periods). Ramadan fasting influences the therapeutic effect of warfarin in terms of lowered TTR (%), reduced proportion of patients achieving therapeutic PT-INR and increased risk of poor anticoagulation control. Greater caution is required during the post-Ramadan period, particularly in the elderly category as they are more prone for over-anticoagulation and consequently the risk of bleeding.

Incidence and risk factors for thromboembolism and major bleeding in patients with mechanical heart valves: a tertiary hospital-based study in Botswana.

Mechanical heart valve (MHV) prostheses increase the risk of thromboembolic complications. While warfarin anticoagulation reduces this risk, its use increases the risk of bleeding. We sought to estimate the rate of thromboembolic and bleeding complications among patients with MHVs at a tertiary hospital in Botswana. Factors associated with bleeding and thromboembolic complications are also described. This retrospective cohort study involved a cohort of patients with MHV at Princess Marina Hospital who were operated on before September 2017. The study documented bleeding and thromboembolic events since the valve replacement, patients' demographic information, co-existing medical conditions, drug history and details of valve replacement. Using the recent international normalised ratio (INR) results, each patient's time in therapeutic range (TTR) was calculated to assess the level of anticoagulation control. The study enrolled 142 patients with a mean (SD) age of 42 (12) years and a median (IQR) duration since valve replacement of four years (1.8-10.0). The median (IQR) TTR was 29.8% (14.1-51.0) and only 14.8% of the patients had an optimal anticoagulation control. The rates of major bleeding and thromboembolic complications were 1.5 per 100 person-years and 2.80 per 100 person-years, respectively. A longer duration of warfarin use was associated with an increased risk of both bleeding (p = 0.008) and thromboembolic complications (p = 0.01). Bleeding and thromboembolic complications were common in MHV prosthesis patients in this study. Long duration of anticoagulation, albeit sub-optimal control, was a risk factor for bleeding and thromboembolic complications in these patients. Therefore, long-term efforts are necessary to address these complications and possibly improve the quality of life of these patients.

Anticoagulant efficacy of different pharmacological presentations of vitamin K antagonists

Vitamin K antagonist medications (VKA) are essential for the prevention of thromboembolic events, but their effectiveness is influenced by multiple factors, such as the type of medication chosen. To evaluate the efficacy in anticoagulant control of the bioequivalent and non-bioequivalent drugs of acenocoumarol compared to the reference drug. To evaluate the efficacy of warfarin bioequivalents available in Chile. To contrast the overall anticoagulant control efficacy between acenocoumarol and warfarin. The results of 69333 outpatient oral anticoagulation controls were analyzed. Patient were separated in groups according to the drug that they used. Subsequently, the proportions of controls outside the range for each of acenocoumarol and warfarin bioequivalent drugs were compared. Acenocoumarol non-bioequivalent drugs were also compared with the reference drug. Acenocoumarol was compared with warfarin. Acenocoumarol bioequivalent drugs and the reference drug had a similar proportion of controls outside the range (Odds ratios (OR) 0.812; 0.969; 0.974 and 0.963). Non-bioequivalent drugs had a higher proportion than the reference drug (OR 1.561 and 2.037). Both warfarin brands have a similar proportion of controls outside of the range (OR 1.050). Acenocoumarol compared to warfarin had a significant higher proportion of controls outside the range (OR 1.191). The pharmacological presentation of vitamin K antagonists could influence anticoagulant control. Therefore, it is not prudent to switch these presentations frequently.

A multicenter prospective validation study on disseminated intravascular coagulation in trauma‐induced coagulopathy

BackgroundTrauma‐induced coagulopathy (TIC) may progress to disseminated intravascular coagulation (DIC) due to dysregulated inflammatory and coagulofibrinolytic responses to trauma. ObjectivesWe explored how DIC and TIC elicit the same coagulofibrinolytic changes which lead to massive transfusion. MethodsSeverely injured trauma patients with an injury severity score ≥ 16 were prospectively included. Platelet counts, global markers of coagulation and fibrinolysis and specific markers of thrombin and plasmin generation, anticoagulation, endothelial injury, and inhibition of fibrinolysis were measured at presentation to the emergency department (0 hour) and 3 hour after arrival. The patients were subdivided into those with and without DIC and those with and without TIC using the 0‐hour data. Time courses of specific markers and the frequency of massive transfusion were evaluated. The association of various variables with DIC development was also confirmed. ResultsTwo hundred and seventy‐six patients were eligible for the analyses. The severity of injury (odds ratio; 1.038, P = .022) and thrombin generation (odds ratio; 1.014, P = .024) were associated with the development of DIC. Both DIC and TIC patients showed increased thrombin generation, insufficient anticoagulation controls, endothelial injury and increased fibrinolysis followed by elevated plasminogen activator inhibitor‐1 levels at 0 and 3 hours. The frequency of massive transfusion was higher in both DIC (33.6% vs 7.9%, P < .001) and TIC (50.0% vs 13.3%, P < .001) patients than in those without DIC or TIC, respectively. ConclusionsDisseminated intravascular coagulation and TIC evoked the same coagulofibrinolytic responses in severely injured trauma patients immediately after trauma and needed massive transfusion.

Oral anticoagulation and bleeding risk in patients with non-valvular atrial fibrillation of the Central Military Hospital

Atrial fibrillation is the most frequent arrhythmia and can cause stroke. The objective of this study was to determine the type of oral anticoagulant received and the risk of bleeding in patients with non-valvular atrial fibrillation of the Central Military Hospital. The descriptive, retrospective cross-sectional study, included adult patients with a diagnosis of non-valvular atrial fibrillation from the Central Military Hospital from January 2015 to August 2018. Demographic variables, diagnosis of valvular and non-valvular atrial fibrillation, type of oral anticoagulation received, stroke scale (CHA2DS2-VASc), hemorrhage (HAS-BLED) scale, control of anticoagulation with the INR and adherence to anticoagulant treatment were determined. Two hundred and twenty patients with atrial fibrillation were included, 60% presented non-valvular atrial fibrillation, mean age of 71±4.6 years and 57.8% were men. Seventy nine percent of the patients received oral anticoagulation, of which 80% received anti-vitamin K anticoagulant. The average point on the CHA2DS2-VASc scale was 3.5 point and on the HAS-BLED scale the average point obtained was of 1.9 while the most common risk factors for bleeding were AHT and age over 65 years. In this study, it was found that the majority of patients with FANV was anticoagulated, had a high adherence to treatment, and good control of ancoagulation. The most widely used oral anticoagulant was anti vitamin K, intermediate risk for bleeding and risk factors for bleeding, the most common was arterial hypertension and age>65 years

Anticoagulation Control of Warfarin in Pharmacist-Led Clinics Versus Physician-Led Clinics: A Prospective Observational Study.

PurposeWarfarin is an affordable drug used for numerous indications, and still a favorable choice for patients with a history of bleeding from direct oral anticoagulants or presence of valvular heart diseases. However, warfarin requires regular international normalized ratio (INR) monitoring for safety and efficacy. Warfarin’s efficacy and safety is correlated with actual time spent within the therapeutic INR. Time in therapeutic range (TTR) is an estimate that measures the percentage of actual time spent within the therapeutic INR. Our aim was to investigate differences in anticoagulation control of warfarin using TTR between pharmacists and other health-care providers.MethodsThis prospective observational study was conducted in an ambulatory-care setting of a tertiary hospital to compare anticoagulation management using TTR between clinics run by pharmacists versus other health-care providers.ResultsA total of 62 patients were enrolled: 33 in the pharmacist-led clinic and 29 in the physician-led clinic. TTR levels were statistically higher among patients in the pharmacist-led clinic than than the physician-led clinic (87.27%±3.82% and 52.48%±5.49%, respectively; p<0.001). For 27 patients followed retrospectively by physicians and prospectively by clinical pharmacists, TTR was statistically higher during clinical pharmacists’ care (91.70%±2.93% versus 61.39%±5.11%, respectively; p<0.001). During the study, approximately 82% of patients reached their target INR in the pharmacist-led clinic compared to 24% in the physician-led clinic.ConclusionThe findings of our study found that patients followed in the pharmacist-led clinic had higher TTR levels than those followed in the physician-led clinic.

Quality of oral anticoagulation control in Chinese patients with non-valvular atrial fibrillation: a prospective controlled study

Objective The sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) Score; the sex, age, medical history, treatment, tobacco use, genotype combination (SAMe-TT2G2) Score; and the so-called modified SAMe-TT2R2 scores have been proposed to predict the anticoagulation quality for patients with non-valvular atrial fibrillation (NVAF). The data from a prospective controlled study is used to validate the SAMe-TT2R2 and SAMe-TT2G2 scores in Chinese NVAF patients treated with warfarin and to evaluate the association of factors with time in therapeutic range (TTR) to predict the quality of oral anticoagulation control. Methods A total of 379 patients with NVAF under warfarin treatment for a three-month follow-up were included in this prospective, multicenter study. The quality of oral anticoagulation control was evaluated by the TTR. The TTR was dichotomized for binary logistic regression analysis, using a cutoff point for classification as an inadequate (TTR < 65.0%) control. Results The 379 NVAF patients had a mean TTR of 58.35 ± 26.33% and median SAMe-TT2R2 and SAMe-TT2G2 scores of 3 and 2, respectively. The discrimination performances of the SAMe-TT2R2 and SAMe-TT2G2 scores for inadequate anticoagulation control (TTR < 65.0%) were poor (c-index < 0.60). The gene frequency of CYP2C9*3 was 3.2% and that of VKORC1-1639 G > A was 89.3%. Genetic variation of CYP2C9*3 and VKORC1-1639 G > A did not affect TTR after initial treatment. The condition TTR < 65.0% was associated with an age below 60 without genotype-guided warfarin dose initiation and concomitant torasemide. Conclusions A warfarin-dosing algorithm used for initial treatment of patients older than 60 helps to achieve a better quality of oral anticoagulation control, whereas concomitant torasemide can produce a negative effect. These findings provide useful information for future investigations on the quality of oral anticoagulation control in Chinese anticoagulation clinical practice.

VTE in ICU Patients With COVID-19

VTE in ICU Patients With COVID-19

Comparative effects of telemedicine and face-to-face warfarin management: A systematic review and network meta-analysis

ObjectiveTo determine the comparative effects of different types of telemedicine on anticoagulation control and adverse outcomes in patients taking warfarin. Data sourcesA systematic search was conducted in PubMed, the Cochrane library, EMBASE, CINAHL, OpenGrey, and DART-Europe from inception to September 2019. Study selectionRandomized controlled trials, quasi-experimental and cohort studies were included if they evaluated the effect of telemedicine in patients using warfarin for 3 months or more. MethodsTwo reviewers extracted and assessed the quality of studies by means of the Cochrane Effective Practice and Organization of Care Group. Network meta-analyses were performed using a random-effects model. Surface under the cumulative ranking curve (SUCRA) methods were used to rank different telemedicine types. ResultsOf the 14,673 articles retrieved, 12 studies involving 11,478 patients met the inclusion criteria. The 5 types of telemedicine categorized were 1) laboratory draw with individual telephonic follow-up by health care (HC) providers (Lab/Tel/HC); 2) laboratory draw with individual telephonic follow-up with periodic, routine routine face-to-face (F2F) visit (Lab/Tel+F2F/HC); 3) laboratory draw with individual and group follow-up via online access (Lab/Online/HC); 4) patient self-test (PST) with telephonic or Web-based follow-up by automated management system (PST/Tel-Online/Auto); and 5) PST with telephonic follow-up by HC provider (PST/Tel/HC). PST/Tel-Online/Auto appears to be superior to F2F for TTR (mean difference 8.78%; 95% CI 0.06%–17.50%) and Lab/Online/HC for in-range INR (odds ratio 2.59; 95% CI 1.04–6.46). The SUCRAs suggested that PST/Tel-Online/Auto was preferred for both TTR and INR, at 84.2% and 93.9%, respectively, whereas Lab/Tel/HC was preferred to prevent major bleeding (74.1%) or thromboembolic event (70.7%). ConclusionAccording to the current evidence of uncertain quality, the best effects on anticoagulation control and adverse outcomes were achieved from different types of telemedicine. Variations in the effects of telemedicine on diverse outcomes should be considered before implementing telemedicine interventions in patients taking warfarin.

Man with Penile Pain.

Case PresentationWe describe a case of spontaneous partial segmental thrombosis of the corpus cavernosum (PSTCC).DiscussionPSTCC is a rare condition in which thrombus formation occurs in the corpus cavernosum. This condition is managed in conjunction with a urologist, and management typically includes anticoagulation and pain control.

Carga y coste del mal control de la anticoagulación con antagonistas de la vitamina K en pacientes con fibrilación auricular no valvular en España

Introduction and objectivesThe aim of this analysis was to evaluate the burden and cost of complications due to poor anticoagulation control in patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA) in Spain. MethodsAn analytical model was used to estimate annual differences in ischemic stroke, major bleeding, deaths, costs, and potential years of life lost between patients with poor anticoagulation control (time in therapeutic range <65%) and adequate control (time in therapeutic range ≥ 65%) with a 1-year time horizon. Information on the target population (patients ≥ 65 years), event rates, and costs were obtained from national sources. Direct costs in euros (2018) were included from the perspective of the national health system (NHS) and direct and indirect costs from the societal perspective. A sensitivity analysis was performed with post-hoc data from the SPORTIF III/V trials. ResultsWe analyzed a hypothetical cohort of 594 855 patients, 48.3% with poor anticoagulation control, with an increase of 2321 ischemic strokes, 2236 major bleeding events and 14 463 deaths, and an annual incremental cost between €29 578 306 from the NHS perspective and €75 737 451 from the societal perspective. The annual impact of mortality was 170 502 potential years of life lost. The results of the sensitivity analysis showed that the annual cost would reach €97 787 873 from the societal perspective. ConclusionsPoor anticoagulation control with AVK has a strong impact on loss of health and on increased spending for the NHS.

The best practices of the Russian Federation in the organization of anticoagulant therapy in patients with high risk of thromboembolic events

Organization of anticoagulant therapy control plays a key role in ensuring the effectiveness and safety of anticoagulant use. Currently, several models of organization are successfully used in the Russian Federation, which cover more than 23000 patients at high risk for thromboembolic events. There are following common features of the models used: the maximum reduction in the time from the moment of international normalized ratio (INR) testing with a quick communication with a patient for the need to adjust the dose, the ability to sort patients depending on the degree of hypocoagulation and the risks of events with the creation of a personalized approach to treatment, the organization of a shared information space and maintaining a register of patients.

Assessing quality of life using WHOQOL-BREF: A cross-sectional insight among patients on warfarin in Malaysia

Background and aimThe effect of anticoagulation control on overall Health-Related Quality of Life (HRQoL) in patients taking warfarin in Malaysia has not been explored yet. Therefore, this study aimed to evaluate HRQoL among patients on warfarin in Malaysia. MethodsHRQoL among patients on warfarin was measured using WHOQOL-BREF (World Health Organization Quality of life Assessment: Brief Version). Descriptive and inferential statistical analysis was done using Statistical Package for the Social Sciences (SPSS) version 22. ResultsOut of 319 patients, more female patients were observed than the males (n = 221, 69.3%, and n = 98, 30.7% respectively). Mean scores for the physical (61.14 ± 15.96), psychological (68.58 ± 16.11), social (63.55 ± 27.06) and environmental domains (62.78 ± 17.58) were observed. Statistically, a significant association was found between the comorbidities other than CVDs with health satisfaction (p = 0.002), physical (p = 0.001), psychological (p < 0.001), social (p = 0.003) and environmental domains of the WHOQOL-BREF. A weak positive correlation between overall health satisfaction and the social domain (r = 0.153) and a moderate positive correlation between the physical and environmental domains (r = 0.628) of the WHOQOL-BREF were observed. ConclusionPatients had overall better perceived HRQoL scores in the psychological domain as compared with the rest of the domains of the WHOQOL-BREF. Age, gender, employment status, education level, the indication of use and duration of warfarin therapy associated with overall perceived HRQoL.

Relationship of adverse events to quality of anticoagulation control in atrial fibrillation patients with diabetes: real-world data from the FANTASIIA Registry

Background Atrial fibrillation (AF) patients with diabetes (DM) have high risk of cardiovascular events. Purpose To compare clinical characteristics, adverse outcomes and quality of anticoagulation in AF patients regarding DM status. Methods AF patients from FANTASIIA registry were included. Baseline characteristics and comorbidities were recorded. After 2-years follow-up, the association between adverse events and DM was evaluated. Results 1956 patients (mean age 73.8 ± 9.5 years, 56% male) were analyzed; 574 (29.3%) had DM. Diabetic patients had also high prevalence of hypertension (90.6% vs 76.1%; p < .001) or renal disease (21.4% vs 15.9%; p < .001). After median follow-up of 1077 days (IQR 766–1113 days), diabetic patients had high total mortality (16.9%/year vs 11.4%/year; p < .001), cardiovascular mortality (9.1%/year vs 3.9%/year; p < .001) and MACE (12.9%/year vs 6.8%/year; p < .001). DM patients had poor anticoagulation control (time in therapeutic range: 58.52 ± 24.37% vs 62.68 ± 25.31%; p = .002). DM with lower TTR showed higher cardiovascular death and MACE. Multivariate analysis showed an independent association between DM and cardiovascular mortality [HR 1.73 (IC95% 1.07–2.80); p = .024]. Conclusion AF Diabetic patients have higher comorbidities and poorer TTR than nondiabetic patients. Low TTR was associated with adverse events. The risk of cardiovascular outcomes was higher in DM patients, with independent association between DM and mortality risk.

Determinants of health-related quality of life among warfarin patients in Pakistan.

IntroductionThe effect of anticoagulation control on overall Health-Related Quality of Life (HRQoL) in patients taking warfarin in Pakistan has not been explored yet. Therefore, this study aimed to evaluate HRQoL among warfarin patients in Pakistan.MethodsThis cross-sectional study was conducted among patients on warfarin in Pakistan. By purposive sampling, data were collected using demographic data collection form and the World Health Organization Quality of Life: Brief Version (WHOQOL-BREF). The WHOQOL-BREF is comprised of four domains; physical, psychological, social relationships, and environment. Descriptive and inferential statistical analysis was done using SPSS version 22.ResultsOut of 295 warfarin patients, more females than males (<0.001) were observed (n = 184, 62.4%, and n = 111, 37.6% respectively). One hundred and eighteen (40.0%) patients were less than 30-years of age, whereas one hundred and seventy-seven (60.0%) patients were above 30-years of age. Mean scores for the physical (62.44±15.36), psychological (67.84±15.54), social (64.27±26.28) and environment domains (63.45±17.66) were observed.ConclusionPatients had overall lower to moderate but satisfactory HRQoL scores in all four domains. Age, gender, employment status, education level, the indication of use and duration of warfarin therapy was associated with one or more domains of HRQoL among warfarin patients. The findings of this study would serve as a primary database for future studies. This study highlights how non-clinical factors could impact HRQoL in studied patients.

Evaluation of the SAMe-TT2R2 score to predict the quality of anticoagulation control in patients with venous thromboembolism treated with vitamin K antagonists: Findings from the RIETE registry

BackgroundThe time in therapeutic range (TTR) of patients with venous thromboembolism (VTE) treated with vitamin K antagonists (VKA) is usually below recommended, leading to higher frequency of vascular events, bleeding and mortality. The SAMe-TT2R2 prediction score discriminates those patients with high or low probability of obtaining poor INR control and its use is recommended in patients with atrial fibrillation. Its usefulness has been evaluated in patients with VTE, with conflicting results. MethodWe included consecutive patients enrolled in Registro Informatizado Enfermedad TromboEmbolica (RIETE), a prospective multicenter VTE registry, treated with VKA for >90 days and a minimum of 3 INR determinations. We analyzed the relationship between the SAMe-TT2R2 score and TTR, determined by the Rosendaal method and by the percentage of INR determinations (after excluding the first month). A ROC curve was calculated considering a cut-off point of TTR ≥65% for good anticoagulation control. Results3893 patients were included and classified in high (1411 patients) or low (2482 patients) probability of obtaining poor INR control according to the total score obtained (0–1 points versus 2 points, respectively). TTR, calculated by direct method and Rosendaal method, was 51.2 (±23.4) and 55.4 (±25.9) in the high probability group; and 54.4 (±23.0) and 58.2 (±25.6) in the low probability group, respectively (p < 0.001 for both comparisons). The outcomes were similar between groups. The predictive capacity of the SAMe-TT2R2 score showed an area under the ROC curve of 0.54 (CI 95% 0.52–0.56) and 0.53 (CI 95% 0.51–0.55). ConclusionsIn patients with VTE treated with VKA, the SAMe-TT2R2 score discriminated those patients with high probability of obtaining poor INR control, but with a low predictive capacity. Further studies are required to assess the usefulness of the score in clinical decision-making.

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

Polypharmacy, Adverse Outcomes, and Treatment Effectiveness in Patients ≥75 With Atrial Fibrillation.

BackgroundPolypharmacy is highly prevalent in elderly people with chronic conditions, including atrial fibrillation (AF). The impact of polypharmacy on adverse outcomes and on treatment effectiveness in elderly patients with AF remains unaddressed.Methods and ResultsWe studied 338 810 AF patients ≥75 years of age enrolled in the MarketScan Medicare Supplemental database in 2007–2015. Polypharmacy was defined as ≥5 active prescriptions at AF diagnosis (defined by the presence of International Classification of Diseases, Ninth Revision, Clinical Modification [ICD‐9‐CM] codes) based on outpatient pharmacy claims. AF treatments (oral anticoagulation, rhythm and rate control) and cardiovascular end points (ischemic stroke, bleeding, heart failure) were defined based on inpatient, outpatient, and pharmacy claims. Multivariable Cox models were used to estimate associations of polypharmacy with cardiovascular end points and the interaction between polypharmacy and AF treatments in relation to cardiovascular end points. Prevalence of polypharmacy was 52%. Patients with polypharmacy had increased risk of major bleeding (hazard ratio [HR], 1.16; 95% CI, 1.12–1.20) and heart failure (HR, 1.33; 95% CI, 1.29–1.36) but not ischemic stroke (HR, 0.96; 95% CI, 0.92–1.00), compared with those not receiving polypharmacy. Polypharmacy status did not consistently modify the effectiveness of oral anticoagulants. Rhythm control (versus rate control) was more effective in preventing heart failure hospitalization in patients not receiving polypharmacy (HR, 0.87; 95% CI, 0.76–0.99) than among those with polypharmacy (HR, 0.98; 95% CI, 0.91–1.07; P=0.02 for interaction).ConclusionPolypharmacy is common among patients ≥75 with AF, is associated with adverse outcomes, and may modify the effectiveness of AF treatments. Optimizing management of polypharmacy in AF patients ≥75 may lead to improved outcomes.