Quality Of Anticoagulation Research Articles

Management of therapeutic unfractionated heparin in COVID‐19 patients: A retrospective cohort study

BackgroundPatients hospitalized with severe acute respiratory syndrome coronavirus 2 infection are at risk for thrombotic complications necessitating use of therapeutic unfractionated heparin (UFH). Full‐dose anticoagulation limits requirements for organ support interventions in moderately ill patients with coronavirus disease 2019 (COVID‐19). Given this benefit, it is important to evaluate response to therapeutic anticoagulation in this population. ObjectivesThe aim of this study was to assess therapeutic UFH infusions and associated bleeding risk in patients with COVID‐19. Patients/MethodsThis retrospective cohort study includes patients at Brigham and Women’s Hospital, Boston, Massachusetts, receiving weight‐based nursing‐nomogram titrated UFH infusion during a 10‐week surge in COVID‐19 hospitalizations. Of 358 patients on therapeutic UFH during this interval, 97 (27.1%) had confirmed COVID‐19. Patient characteristics, laboratory values, and information regarding UFH infusion and bleeding events were obtained from the electronic medical record. ResultsPatients who were COVID‐19 positive had fewer therapeutic activatrd partial thromboplastin times (aPTTs) compared to COVID‐19–negative patients (median rate, 40.0% vs 53.1%; P < .0005). Both major and clinically relevant nonmajor bleeding were increased in COVID‐19–positive patients, with major bleeding observed in 10.3% (95% confidence interval [CI], 5.7%‐17.9%) of patients who were COVID‐19 positive and 3.1% (95% CI, 1.6%‐5.9%) of patients who were COVID‐19 negative (P< .005). In logistic regression, bleeding events were associated with receiving UFH for longer than 7 days, but not platelet count, coagulation, or inflammatory measurements. ConclusionsOur data indicate a higher incidence of bleeding complications in patients with COVID‐19 receiving weight‐based nursing‐nomogram titrated UFH infusions despite a higher prevalence of subtherapeutic aPTTs in this population. These data underscore the need for prospective studies aimed at improving the quality and safety of therapeutic anticoagulation in patients with COVID‐19.

Comparison of temporary interruption with continuation of direct oral anticoagulants for low bleeding risk procedures

IntroductionLimited data is available on the rates of bleeding and thromboembolic events for patients undergoing low bleeding risk procedures while taking direct oral anticoagulants (DOAC). MethodsAdults taking DOAC in the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) database who underwent a low bleeding risk procedure between May 2015 and Sep 2019 were included. Thirty-day bleeding (of any severity), thromboembolic events, and death were compared between DOAC temporarily interrupted and continued uninterrupted groups. Adverse event rates were compared using an inverse probability weighting propensity score. ResultsThere were 820 patients who underwent 1412 low risk procedures. DOAC therapy was temporarily interrupted in 371 (45.2%) patients (601 [42.6%] procedures) and continued uninterrupted in 449 (54.8%) patients (811 [57.4%] procedures). DOAC patients with temporary interruptions were more likely to have diabetes, prior stroke or TIA, prior bleeding, higher CHA2DS2-VASc, and higher modified HAS-BLED scores. DOAC interruption was common for gastrointestinal endoscopy, electrophysiology device implantation, and cardiac catheterization while it was less common for cardioversion, dermatologic procedures, and subcutaneous injection. After propensity score adjustment, bleeding risk was lower in the DOAC temporary interruption group (OR 0.62, 95% CI 0.41–0.95) as compared to the group with continuous DOAC use. Rates of thromboembolic events and death did not differ significantly between the two groups. ConclusionsDOAC-treated patients undergoing low bleeding risk procedures may experience lower rates of bleeding when DOAC is temporarily interrupted. Prospective studies focused on low bleeding risk procedures are needed to identify the safety DOAC management strategy.

Implementation and Evaluation of Virtual Anticoagulation Clinic Care to Provide Incessant Care During COVID-19 Times in an Indian Tertiary Care Teaching Hospital.

Background: COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-II) has become a global pandemic disrupting public health services. Telemedicine has emerged as an important tool to deliver care during these situations. Patients receiving Vitamin K antagonists (VKA) require structured monitoring which has posed a challenge during this pandemic. We aimed to evaluate the impact of Virtual anticoagulation clinic (VAC), a Telehealth model on the quality of anticoagulation, adverse events, and patient satisfaction vis-a-vis standard Anticoagulation clinic (ACC) care.Materials and methods: A bidirectional cohort study was conducted in the Department of Cardiology, JSS Hospital, Mysore. Two hundred and twenty-eight patients in the VAC and 274 patients in the ACC fulfilling inclusion criteria were the subjects of the study. Telehealth tools like WhatsApp and telephone were used. Time in therapeutic range (TTR), Percentage of International normalized ratio in range (PINRR), and adverse events were analyzed and compared between the VAC group and the ACC group, between pre-COVID and COVID ACC groups, and between the VAC group and the same pre-COVID cohort. Patient satisfaction was assessed by a questionnaire at the end of 8 months. Descriptive statistics were used for the patient characteristics and inferential statistics for the comparisons between pre-VAC and VAC care.Results: The mean TTR was 75.4 ± 8.9% and 71.2 ± 13.4% in the VAC group and ACC group, respectively (p < 0.001). The mean PINRR was 66.7 ± 9.4% and 62.4 ± 10.9% in the VAC group and ACC group respectively, (p < 0.001). There was no significant difference in TTR between the VAC group and the same pre-COVID cohort. The TTR differential between the pre-COVID and COVID ACC groups was significant. In either group, no major adverse events were seen. The most common tools used for data exchange were WhatsApp (83%) and SMS (17%). Seventy-four percent of patients were extremely satisfied with the overall VAC care.Conclusions: Virtual anticoagulation clinic, a telehealth model can be used as an alternative option to deliver uninterrupted anticoagulation care during pandemic times.

Quality of Anticoagulation with Phenprocoumon and Warfarin in Left Ventricular Assist Device Patients: A Multicenter Study

<h3>Purpose</h3> Anticoagulation with coumarin derivatives in left ventricular assist device (LVAD) patients is essential to prevent hemocompatibility related adverse events (HRAEs), but is challenging due to inter- and intra-individual variability of dose response and small therapeutic window. The aim of this study was to describe differences in quality of anticoagulation, HRAEs, and outcomes in users of phenprocoumon and warfarin. <h3>Methods</h3> This retrospective, multicenter study included 179 patients (Age: 57.4±11.8 yrs, female: 23.5%, BMI: 28.6±5.9kg/m², HM3/HVAD: 50.8%/49.2%) implanted at the Medical University of Vienna (n=102 phenprocoumon) and University of Chicago (n=77 warfarin), between 2014 and 2018. Primary outcome was INR TTR during one-year after first follow-up visit (FFUV), secondary outcomes included all-cause mortality, freedom from- and the evaluation of independent risk factors for the occurrence of HRAEs. <h3>Results</h3> During follow-up, phenprocoumon vs. warfarin users had a significantly higher TTR (64.9±16.1% vs. 37.7±21.8%, p<0.001). One-year survival (86.3% vs. 89.6%, p=0.65) and freedom from HRAE (59.8% vs. 54.5%, p=0.54) were comparable to both drugs/centers, but first HRAEs occurred earlier with warfarin (126 vs. 46 days post FFUV, p=0.002). In a multivariate cox proportional hazard model, female gender [hazard ratio (HR) 2.15, 95% CI 1.12-4.11; p=0.021], no beta blockers at FFUV (HR 2.16, 95% CI 1.03-4.52; p=0.042), GI bleeding pre-implant (HR 3.41, 95% CI 1.32-9.45; p=0.018) and time between INR tests (HR 0.85, 95% CI 0.74-0.99; p=0.03) were associated with a significantly higher risk of HRAEs, but drug/device type were not independent risk factors. <h3>Conclusion</h3> Despite similar working mechanism of phenprocoumon and warfarin, differences in pharmacokinetics may affect anticoagulation quality. Gender, time between INR tests, absence of beta blockers and GI bleeding pre-implant are independent risk factors for HRAEs during LVAD support.

Epidemiological characteristics, management, and outcomes of atrial fibrillation in TUNISIA: Results from the National Tunisian Registry of Atrial Fibrillation (NATURE-AF).

BackgroundContemporary registries on atrial fibrillation (AF) are scare in North African countries.HypothesisIn the context of the epidemiological transition, prevalence of valvular AF in Tunisia has decreased and the quality of management is still suboptimal.MethodsNATURE‐AF is a prospective Tunisian registry, involving consecutive patients with AF from March 1, 2017 to May 31, 2017, with a one‐year follow‐up period. All the patients with an Electrocardiogram‐documented AF, confirmed in the year prior to enrolment were eligible. The epidemiological characteristics and outcomes were described.ResultsA total of 915 patients were included in this study, with a mean age of 64.3 ± 22 years and a male/female sex ratio of 0.93. Valvular AF was identified in 22.4% of the patients. The mean CHA2DS2VASC score in nonvalvular AF was 2.4 ± 1.6. Monotherapy with antiplatelet agents was prescribed for 13.8% of the patients. However, 21.7% of the subjects did not receive any antithrombotic agent. Oral anticoagulants were prescribed for half of the patients with a low embolic risk score. In 341 patients, the mean time in therapeutic range was 48.87 ± 28.69%. Amiodarone was the most common antiarrhythmic agent used (52.6%). During a 12‐month follow‐up period, 15 patients (1.64%) had thromboembolism, 53 patients (5.8%) had major hemorrhage, and 52 patients (5.7%) died.ConclusionsNATURE‐AF has provided systematic collection of contemporary data regarding the epidemiological and clinical characteristics as well as the management of AF by cardiologists in Tunisia. Valvular AF is still prevalent and the quality of anticoagulation was suboptimal.

The Risk of Falling and Consequences of Falling in Patients with Atrial Fibrillation Receiving Different Types of Anticoagulant.

Our objective was to investigate the predictors of falls requiring a visit to the emergency department in patients with nonvalvular atrial fibrillation (AF) receiving different types of anticoagulants and to investigate the clinical consequences of falling in the same population. A total of 1217 patients with nonvalvular AF from two institutions were retrospectively evaluated. Each patient underwent a physical examination, and clinical histories and medication profiles were taken from each patient at baseline. The median age of our cohort was 71 years; 52.3% were males, and 86.1% of patients were receiving anticoagulation at study baseline. The 5-year freedom-from-falling rate was 81.6%. The use and type of anticoagulation was not significantly associated with the risk of falling (P = 0.222), whereas higher Morse Fall Scale (MFS), CHA2DS2-VASC (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65-74 years, sex category), and HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly [> 65 years], drugs/alcohol concomitantly) scores were significantly associated with a higher hazard of the first fall in univariate analyses. In the multivariate Cox regression model, MFS, older age, osteoporosis, higher levels of high-density lipoprotein cholesterol, higher diastolic blood pressure, and use of amiodarone, diuretics, or short- and medium-acting benzodiazepines were mutually independent predictors of the first fall. Of 163 patients, 93 (57%) had a bone fracture during the fall. Type of anticoagulation significantly affected survival after the first fall (P < 0.001): patients inadequately anticoagulated with warfarin had worse survival rates, and patients receiving apixaban and dabigatran had the best survival rates after the first fall. Older patients who had comorbidities and were taking amiodarone, diuretics, or short- or medium-acting benzodiazepines had the highest risk of falls. The type and quality of anticoagulation did not seem to affect the risk of falling but did significantly affect survival after the first fall.

Evaluation of Warfarin Anticoagulation at University of Gondar Comprehensive Specialized Hospital, North-West Ethiopia.

PurposeTo assess the quality of warfarin anticoagulation and its clinical outcomes on patients treated with warfarin at the University of Gondar comprehensive specialized hospital, North-west Ethiopia.MethodsWe reviewed medical records of patients treated with warfarin between June 1, 2016, and May 30, 2018, at the University of Gondar comprehensive specialized hospital. The quality of anticoagulation was evaluated using the percentage of time spent in the therapeutic range. Data were entered into Statistical Product and Service Solutions (SPSS), version 20. Descriptive statistics were used to describe the socio-demographic and clinical characteristics of study participants. Multivariable logistic regression analysis was performed to identify independent predictors of quality of anticoagulation. Statistical significance was declared when the p-value was less than 0.05 at 95% confidence interval (CI).ResultsFrom a total of 202 patients’ charts reviewed, women accounted for 134 (67.3%). The mean participants’ age was 44.33 years (±17.05years SD). The median time spent in the therapeutic range was 37.91 with an IQR of (0.00–65.86). More than two-third (143, (70.8%)) of participants had poor anticoagulation quality (time spent in the therapeutic range is less than 65%). Twenty-seven patients (13.4%) experienced adverse medication events of bleeding and thromboembolic events. Logistic regression analysis showed that potential medication interaction [p= 0.003 95% CI Adjusted odds ratio (AOR): 0.32 (0.152–0.689)] and presence of co-morbidity [p= 0.037 95% CI AOR: 0.70 (1.046–4.105)] were significantly associated with quality of anticoagulation.ConclusionThe quality of warfarin anticoagulation at the University of Gondar comprehensive specialized hospital was poor. A strong effort is needed to improve the quality of anticoagulation. Patients who had other co-morbidity conditions and potentially interacting medication need special attention.

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.

Sex-based difference in anticoagulated patients with mechanical prosthetic heart valves and long-term mortality risk.

Vitamin K antagonists (VKAs) reduce thromboembolism in patients with mechanical prosthetic heart valves (MPHV). It is unclear whether a sex-based difference in MPHV patients regarding valve site, anticoagulation quality, and mortality risk does exist. We analysed 2111 MPHV patients from the nationwide PLECTRUM study promoted by the Italian Federation of Anticoagulation Clinics (FCSA). We analysed the site of MPHV, anticoagulation quality, as assessed by the time in therapeutic range (TiTR), and mortality risk in women and men. The mean age of the patients was 56.8±12.3years. Women were older with a lower prevalence of ischemic heart disease and smoking habit and a higher prevalence of atrial fibrillation at baseline. Aortic MPHV was more frequent in men (74.7% vs 43.3%, P<.001), whereas mitral (41.1% vs 17.6%, P<.001) and mitro-aortic (15.6% vs 7.7%, P<.001) MPVH in women. The association between female sex and mitral/mitro-aortic site remained at multivariable logistic regression analysis (Odds Ratio 3.623, 95% Confidence Interval [CI] 2.947-4.455, P<.001). Regarding anticoagulation quality, women showed lower mean TiTR (63.0±19.4 vs 57.5±19.2, P<.001), and a higher proportion of TiTR<60% (54.9% vs 43.3%, P<.001). During a mean follow-up of 123months (21665 pt-years), 152 deaths occurred (0.7%/year); 83 in the aortic (0.63%/year) and 69 in the mitral/mitro-aortic (0.81%/year) group. At multivariable Cox proportional hazard regression analysis, female sex was not associated with mortality (HR 0.953, 95%CI 0.678 1.340, P=.783). Female sex is independently associated with mitral/mitro-aortic MPHV. Despite a lower TiTR in women, mortality risk did not differ between the two groups.

Long-term oral anticoagulation for atrial fibrillation in low and middle income countries

With increasing life-expectancy and changing demographics, non-valvular atrial fibrillation (AF) is currently the most common indication for long-term oral anticoagulation (OAC) in low and middle income countries (LMICs). Due to a decreasing trend in the prevalence of rheumatic heart disease (RHD), valve disease as a primary cause of AF now constitutes a small fraction of all people with AF. Moreover, emerging data also indicate that, patients with significant valve disease and AF may have a risk of stroke similar to, if not lower than, those with non-valvular AF. Previous trials of anticoagulation for AF excluded people from LMICs partly because valvular AF constituted a large proportion of those with AF, and it was thought to confer a prohibitively high risk of stroke. Trialists should therefore be less reluctant to include patients with AF from LMICs in general, and those with valve disease in particular, in future trials of anticoagulation. The quality of vitamin K antagonist based oral anticoagulation remains poor in LMICs to a large extent because of poor monitoring. The widespread use of the direct oral anticoagulants (DOAC) presents a practical approach to improve anticoagulation quality. Randomised trials of DOACs in valvular AF are particularlycriticalto bridge the knowledge gap in this area.Discussions regarding oral anticoagulation (OAC) use in low and middle income countries (LMICs) have historicallybeendominated by severallong-held beliefs. The first is that the quality of vitamin K antagonist (VKA) based anticoagulation is poor in these countries. The veracity of this assumption is supported by a large number of studies documenting both lower prescription of OACs, and a lower proportion of international normalised ratio (INR) values in the therapeutic range.1The second is that a large proportion of patients receiving OAC in LMICs have atrial fibrillation (AF) related to valvular heart disease, and rheumatic mitral stenosis in particular. This assumption, perhaps valid several decades ago, is no longer supported by the data. Finally, patients with valvular heart disease and AF (specifically those with moderate or severe valve lesions), are thought to be at prohibitively high thromboembolic risk. 2 However, recent evidence suggests that this risk may have been overestimated.34Nevertheless, the aforementioned assumptions continue to contribute to the underrepresentation of patients from LMICs in clinical trials of oral anticoagulation. Knowledge of the characteristics of contemporary patients in LMICs who are eligible for long-term OAC, estimates of their stroke risk, and a better understanding of the drivers of poor anticoagulation quality, may help guide research and clinical practice. In this review, we seek to provide an evidence-based perspective on OAC use in patients with AF living in LMICs and China.

Anticoagulation Quality of Warfarin and the Role of Physician-Pharmacist Collaborative Clinics in the Treatment of Patients Receiving Warfarin: A Retrospective, Observational, Single-Center Study.

Background: The management of patients receiving warfarin is complicated. This study evaluated the anticoagulation quality of warfarin, explored potential predictors associated with poor anticoagulation quality, and elucidated the role of clinical pharmacists in the management of warfarin treatment. Methods: We retrospectively collected data on patients who either initially received warfarin or returned to warfarin after withdrawal between January 1, 2015 and January 1, 2020. The primary outcome was time in therapeutic range (TTR), and a TTR of ≥60% was considered as good anticoagulation quality. The secondary outcomes included thromboembolic and bleeding events during the follow-up. We assessed the TTR of each participant and investigated the potential predictors of poor anticoagulation quality (TTR < 60%) using logistic regression analysis. Additionally, we compared the warfarin anticoagulant quality and the incidence of clinical adverse events between atrial fibrillation patients in physician–pharmacist collaborative clinics (PPCCs) and general clinics. Results: Totally, 378 patients were included. The mean TTR of patients was 42.6 ± 29.8%, with only 32% of patients having achieved good anticoagulation quality. During a mean follow-up period of 192 ± 92 days, we found no significant differences in the incidences of thromboembolic events (5.0% vs. 5.1%, p = 0.967) and bleeding events (1.7% vs. 4.7%, p = 0.241) between patients with good and those with poor anticoagulation quality. The presence of PPCCs (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.25–0.90, p = 0.022) was an independent protective factor of poor anticoagulation quality, while the presence of more than four comorbidities (OR: 1.98, 95% CI: 1.22–3.24, p = 0.006) and an average interval of international normalized ratio monitoring of >30 days (OR: 1.74, 95% CI: 1.10–2.76, p = 0.019) were independent risk factors of poor anticoagulation quality. Compared with atrial fibrillation patients in general clinics, patients in PPCCs were found to have a significantly increased mean TTR level (48.4% ± 25.7% vs. 38.0% ± 27.6%, p = 0.014). Conclusion: The anticoagulation quality of warfarin was relatively low at our institution. The presence of more than four comorbidities and an average interval of international normalized ratio monitoring of >30 days independently contributed to poor anticoagulation quality. Meanwhile, the use of PPCC model improved the anticoagulation quality of warfarin.

Identificação da qualidade da anticoagulação em pacientes que utilizam varfarina e fatores associados

Identificação da qualidade da anticoagulação em pacientes que utilizam varfarina e fatores associados

Developing and Validating a Clinical Warfarin Dose-Initiation Model for Black-African Patients in South Africa and Uganda.

Warfarin remains the oral anticoagulant of choice in sub-Saharan Africa. However, dosing is challenging due to a highly variable clinical response for a given dose. This study aimed to develop and validate a clinical warfarin dose-initiation model in sub-Saharan Black-African patients. For the development cohort, we used data from 364 patients who were recruited from 8 outpatient clinics and hospital departments in Uganda and South Africa (June 2018-July 2019). Validation was undertaken using the International Warfarin Pharmacogenetics Consortium (IWPC) dataset (690 black patients). Four predictors (age, weight, target International Normalized Ratio range, and HIV status) were included in the final model, which achieved mean absolute errors (MAEs; mean of absolute differences between true dose and dose predicted by the model) of 11.6 (95% confidence interval (CI) 10.4-12.8) and 12.5 (95% CI 11.6-13.4) mg/week in the development and validation cohorts, respectively. Two other clinical models, IWPC and Gage, respectively, obtained MAEs of 12.5 (95% CI 11.3-13.7) and 12.7 (95% CI 11.5-13.8) mg/week in the development cohort, and 12.1 (95% CI 11.2-13.0) and 12.2 (95% CI 11.4-13.1) mg/week in the validation cohort. Compared with fixed dose-initiation, our model decreased the percentage of patients at high risk of suboptimal anticoagulation by 7.5% (1.5-13.7%) and 11.9% (7.1-16.8%) in the development and validation cohorts, respectively. The clinical utility of this model will be tested in a prospective study. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? ☑ Warfarin dosing remains challenging due to a highly variable clinical response for a given dose. WHAT QUESTION DID THIS STUDY ADDRESS? ☑ Can a clinical dose-initiation model be developed and validated for sub-Saharan Black-African patients? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? ☑ We have developed the first warfarin dose-initiation clinical model for Black-African patients in Uganda and South Africa. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? ☑ We will be implementing and validating this model in a prospective cohort to inform future large-scale implementation. More optimized dosing should improve the quality of warfarin anticoagulation in these two developing countries.

PCV81 Virtual Anticoagulation Clinic Care a Telehealth MODEL to Deliver Continuity of Anticoagulation Care during the COVID 19 Pandemic: Insights from Southern India

COVID -19 pandemic is a disaster which has affected the entire world. Nationwide lockdown during this pandemic rendered healthcare inaccessible to many. Patients taking oral anticoagulants need continuity of care. Hence, we aimed to study the impact of Virtual anticoagulation clinic initiative on the quality of anticoagulation and patient satisfaction during COVID-19.

Telemedicine-Based Specialized Care Improves the Outcome of Anticoagulated Individuals with Venous Thromboembolism-Results from the thrombEVAL Study.

Venous thromboembolism (VTE) is a life-threatening disease with risk of recurrence. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) is effective to prevent thromboembolic recurrence. We aimed to investigate the quality of OAC of VTE patients in regular medical care (RMC) compared to a telemedicine-based coagulation service (CS). The thrombEVAL study (NCT01809015) is a prospective, multi-center study to investigate OAC treatment (recruitment: January 2011–March 2013). Patients were evaluated using clinical visits, computer-assisted personal interviews, self-reported data and laboratory measurements according to standard operating procedures. Overall, 360 patients with VTE from RMC and 254 from CS were included. Time in therapeutic range (TTR) was higher in CS compared to RMC (76.9% (interquartile range [IQR] 63.2–87.1%) vs. 69.5% (52.3–85.6%), p < 0.001). Crude rate of thromboembolic events (rate ratio [RR] 11.33 (95% confidence interval [CI] 1.85–465.26), p = 0.0015), clinically relevant bleeding (RR 6.80 (2.52–25.76), p < 0.001), hospitalizations (RR 2.54 (1.94–3.39), p < 0.001) and mortality under OAC (RR 5.89 (2.40–18.75), p < 0.001) were consistently higher in RMC compared with CS. Patients in RMC had higher risk for primary outcome (clinically relevant bleedings, thromboembolic events and mortality, hazard ratio [HR] 5.39 (95%CI 2.81–10.33), p < 0.0001), mortality (HR 5.54 (2.22–13.84), p = 0.00025), thromboembolic events (HR 6.41 (1.51–27.24), p = 0.012), clinically relevant bleeding (HR 5.31 (1.89–14.89), p = 0.0015) and hospitalization (HR 1.84 (1.34–2.55), p = 0.0002). Benefits of CS care were still observed after adjusting for comorbidities and TTR. In conclusion, anticoagulation quality and outcome of VTE patients undergoing VKA treatment was significantly better in CS than in RMC. Patients treated in CS had lower rates of adverse events, hospitalizations and lower mortality. CS was prognostically relevant, beyond providing advantages of improved international ratio (INR) monitoring.

A nurse-led atrial fibrillation clinic: Impact on anticoagulation therapy and clinical outcomes.

Nurses play a central role in the management of atrial fibrillation (AF) patients. An unresolved question is whether a nurse-led clinic would improve clinical outcomes. Herein, we investigated the impact of a nurse-led clinic on anticoagulation therapy and clinical outcomes in a cohort of naïve AF patients. Prospective study including AF patients starting vitamin K antagonists (VKAs) into a nurse-led AF clinic. These patients were followed in this specific AF clinic. Additionally, AF patients already taking VKAs for 6months followed according to the routine clinical practice were included as comparison group. The quality of anticoagulation was assessed at 6months. Efficacy and safety endpoints were recorded during follow-up. We included 223 patients (Nurse-led clinic: 107; Usual care: 116). The mean time in therapeutic range and the proportion of INRs within the therapeutic range were similar in both groups. During 2.06 (IQR 1.01-2.94) years of follow-up, 64 (28.7%) patients changed to direct-acting oral anticoagulants. The proportion of switchers was higher in the nurse-led clinic (37.4%) than in the usual care group (20.7%) (P=.006) and these patients spent less time to switch (2.0 [IQR 0.7-2.9] vs 6.0 [IQR 3.7-11.2] years; P<.001). Importantly, the annual rate of ischaemic stroke/TIA was significantly lower in the nurse-led clinic (0.47%/year vs 3.88%/year, P=.016), without differences in safety endpoints. A nurse-led AF clinic may offer a "patient-centered" review and holistic follow-up, and it would be associated with a reduction of ischaemic stroke/TIA, without increasing bleeding complications. Further studies should confirm these results.

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.

Evaluation of the Long-Term Impact on Quality After the End of Pharmacist-Driven Warfarin Therapy Management in Patients With Poor Quality of Anticoagulation Therapy.

BackgroundWarfarin is the most common oral anticoagulant drug, especially in low-income and emerging countries, because of the high cost of direct oral anticoagulant (DOACs), or when warfarin is the only proven therapy (mechanical prosthetic valve and kidney dysfunction). The quality of warfarin therapy is directly associated with dose management. Evidence shows that pharmaceutical care achieves a better quality of therapy with warfarin. However, there are no studies showing this intervention in a specific patient group with poor quality of anticoagulation in a long period after the end of the follow-up by a pharmacist. Thus, the aim of this study was to evaluate whether the quality of warfarin therapy driven by a pharmacist remains stable in the long term after the end of follow up with a pharmacist, in AF patients with poor quality of anticoagulation.MethodsThis is a prospective study, which evaluated about 2,620 patients and selected 262 patients with AF and poor quality of anticoagulation therapy with warfarin (TTR<50% - based on the last three values of international normalized ratio). Pharmacist-driven therapy management was performed up to 12 weeks. Data from patients were evaluated 1 year after the end of the follow-up with pharmacist.ResultsComparison between mean TTR after 12 weeks of pharmaceutical care (54.1%) and mean TTR one year after the end of the pharmaceutical care (56.5%; p=0.081) did not achieve statistical difference, demonstrating that the increment of quality due to intervention of 12 weeks was maintained for 1 year after intervention.ConclusionThe long-term impact of pharmaceutical care was beneficial for patients with AF and poor quality of warfarin anticoagulation. This design might be an important strategy to treat a subgroup of patients without proven effectiveness of warfarin.

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.

International Normalized Ratio Test Frequency in Left Ventricular Assist Device Patients Affects Anticoagulation Quality and Adverse Events.

Anticoagulation therapy in patients using left ventricular assist device (LVAD) is essential to reduce hemocompatibility related adverse events (HRAEs). Vitamin K-antagonist dosage must be adapted and monitored by INR point-of-care testing (POCT) in outpatients. The study aims to determine if the frequency of INR POCT in LVAD outpatients has an influence on the quality of anticoagulation therapy (ACQ), HRAEs, and outcomes. This retrospective study included n = 48 patients who received LVAD implantation (HMII, HM3, and HVAD) between 2013 and 2017. ACQ (% of INR tests in range, PTR), outcomes and HRAEs using Kaplan-Meier curves were compared in a daily (n = 36) and 3×/week (n = 12) INR POCT group. Further, based on the achieved PTR ranging from 0-60% (poor), 61-70% (acceptable), and 71-100% (well controlled), HRAEs and outcomes were compared. Daily and 3×/week groups were similar in perioperative risk factors and INR target (p = 0.28). Freedom from any HRAE (38.9% vs. 25.0%, p = 0.44), any readmission (72.2% vs. 75.0%, p = 0.97), and 1 year survival (91.7% vs. 91.7%, p = 0.98) were comparable in both groups. The PTR was significantly higher with the daily self-assessments (73.5% vs. 68.4%, p = 0.006). Well vs. poorly controlled INR POCT patients more often had (p = 0.01) a daily POCT frequency (92%) vs. poorly controlled (54%) and significantly higher freedom from neurologic events (96.0 vs. 69.2%, p = 0.024) as well as hemorrhagic strokes (100% vs. 76.9%, p = 0.011). Well-controlled anticoagulation of LVAD outpatients is associated with less neurologic events. The frequency of INR POCT could be one of the key factors in the reduction of HRAEs, so future prospective, large-scale studies should help to clarify the effects.