Anticoagulant Prescription Research Articles

Temporal trends in anticoagulation use and clinical outcomes among medicare beneficiaries with non-valvular atrial fibrillation

PurposeOral anticoagulants effectively prevent stroke/systemic embolism among patients with non-valvular atrial fibrillation but remain under-prescribed. This study evaluated temporal trends in oral anticoagulant use, the incidence of stroke/systemic embolism and major bleeding, and economic outcomes among elderly patients with non-valvular atrial fibrillation and CHA2DS2–VASc scores ≥ 2.MethodsRetrospective analyses were conducted on Medicare claims data from January 1, 2012 through December 31, 2017. Non-valvular atrial fibrillation patients aged ≥ 65 years with CHA2DS2–VASc scores ≥ 2 were stratified by calendar year (2013–2016) of care to create calendar-year cohorts. Patient characteristics were evaluated across all cohorts during the baseline period (12 months before diagnosis). Treatment patterns and clinical and economic outcomes were evaluated during the follow-up period (from diagnosis through 12 months).ResultsBaseline patient characteristics remained generally similar between 2013 and 2016. Although lack of oral anticoagulant prescriptions among eligible patients remained relatively high, utilization did increase progressively (53–58%). Among treated patients, there was a progressive decrease in warfarin use (79–52%) and a progressive increase in overall direct oral anticoagulant use (21–48%). There were progressive decreases in the incidence of stroke/systemic embolism 1.9–1.4 events per 100 person years) and major bleeding (4.6–3.3 events per 100 person years) as well as all-cause costs between 2013 and 2016.ConclusionsThe proportions of patients with non-valvular atrial fibrillation who were not prescribed an oral anticoagulant decreased but remained high. We observed an increase in direct oral anticoagulant use that coincided with decreased incidence of clinical outcomes as well as decreasing total healthcare costs.

Direct Oral Anticoagulants Affect Activated Clotting Time During and Bleeding Events After Percutaneous Coronary Intervention

Inappropriately high activated clotting time (ACT) during percutaneous coronary intervention (PCI) is associated with an increased risk of bleeding events. However, whether the prescription of direct oral anticoagulants (DOACs) affects ACT kinetics during heparin use and adverse clinical events in patients who underwent PCI remains unclear. We aimed to evaluate the relations between ACT changes during and adverse clinical events after PCI in patients who were prescribed DOAC. This observational study included 246 patients who underwent PCI at the 2 cardiovascular centers who were not receiving warfarin and whose ACT was recorded immediately before and 30minutes after injection of unfractionated heparin. Patients were divided into 2 groups according to DOAC prescription at the time of the index PCI: DOAC users (n=31) and nonusers (n=215). Any bleeding and systemic thromboembolic events were investigated until 30days after PCI. The average age of this population was 70.5years, and 66.3% were male. Average ACT was significantly higher in DOAC users than nonusers both before and 30minutes after unfractionated heparin induction (157.2±30.1 vs 131.8±25.1seconds, p<0.001; 371.1±122.2 vs 308.3±82.2seconds, p<0.001; respectively). The incidence of systemic thromboembolism after PCI was low and comparable between the 2 groups (0% vs 3.7%, p=0.60). However, the rate of any bleeding event was significantly higher in DOAC users than in nonusers (16.1% vs 4.7%, p=0.028). Patients receiving DOAC have higher ACT during PCI and higher incidence of bleeding events than those not receiving DOAC.

Insertable Cardiac Monitoring Results in Higher Rates of Atrial Fibrillation Diagnosis and Oral Anticoagulation Prescription after Ischaemic Stroke.

After an ischaemic stroke, atrial fibrillation (AF) detection allows for improved secondary prevention strategies. This study aimed to compare AF detection and oral anticoagulant (OAC) initiation in patients with an insertable cardiac monitor (ICM) versus external cardiac monitor (ECM) after ischaemic stroke. Medicare Fee-for-Service (FFS) insurance claims and Abbott Labs device registration data were used to identify patients hospitalized with an ischaemic stroke in 2017-2019 who received an ICM or ECM within three months. Patients with continuous Medicare FFS insurance and prescription drug enrolment in the prior year were included. Patients with prior AF, atrial flutter, cardiac devices, or OAC were excluded. ICM and ECM patients were propensity score matched 1:4 on demographics, comorbidities, and stroke hospitalization characteristics. The outcomes of interest were AF detection and OAC initiation evaluated with Kaplan-Meier and Cox proportional hazard regression analyses. A total of 5,702 Medicare beneficiaries (ICM, n=444; ECM, n=5,258) met inclusion criteria. The matched cohort consisted of 2,210 Medicare beneficiaries (ICM, n=442; ECM, n=1,768) with 53% female, mean age 75 years, and mean CHA₂DS₂-VASc score 4.6 (1.6). ICM use was associated with a higher probability of AF detection (hazard ratio (HR) 2.88, 95% confidence interval (CI) [2.31, 3.59]) and OAC initiation (HR 2.91, CI [2.28, 3.72]) compared to patients monitored only with ECM. Patients with an ischaemic stroke monitored with an ICM were almost 3 times more likely to be diagnosed with AF and to be prescribed OAC compared to patients who received ECM only.

Use of anticoagulants in patients with traumatic brain injury and intracranial hematomas with the novel coronavirus infection as a concomitant pathology

Anticoagulant therapy is an integral part in the treatment and prevention of diseases and symptoms associated with pathological thrombosis in the human body. Anticoagulant therapy is traditionally not used in traumatic brain injury and hemorrhagic strokes with the formation of intracranial hematomas, intracerebral hematomas, and contusion hemorrhagic foci. However, in such diseases as the novel coronavirus infection, anticoagulant therapy is life-saving, since there is a high risk of developing various thromboses. The article considers the indications for the prescription of anticoagulants in the combination of these pathologies. The article discusses the possibility of using anticoagulants in patients with the novel coronavirus infection and intracranial hematomas, when there are two life-threatening diseases, in which anticoagulants are vital in one case and contraindicated in the other one. It is necessary to understand the complex mechanisms of hemostasis and weigh the risks and benefits in each case.

Trends in oral anticoagulant use - A 10-year retrospective analysis from a general medicine department of a tertiary care hospital in south India.

The prescribing practice of newer oral anticoagulants (NOACs) has not been adequately studied in the Indian scenario. We aimed to describe the prescribing practices of oral anticoagulants, the patient profile and medical comorbidities among patients admitted in a general medicine unit. In this retrospective study of the 2742 patients prescribed vitamin- K antagonists (VKAs), during the study period, 150 cases were randomly taken for analysis to match the 105 NOACs cases. Their demographic details, clinical characteristics and treatment details were analyzed. More than 95% of anticoagulants prescribed were VKAs. The prescription of anticoagulants was more common in men (median age 63 years) for prescription of NOACs and 52 years for VKAs. Dabigatran (60.9%) and warfarin (81.3%) were the most prescribed drugs in their respective classes. The most common indication was for cardiovascular diseases with atrial fibrillation (32%). Diabetes and hypertension were the most common comorbidities in patients prescribed oral anticoagulants with a larger proportion of patients with heart failure being prescribed VKAs ( P < 0.01). Patients in the NOACs group had a higher HAS-BLED high-risk score (33.3% vs. 17.3%; P = 0.002). Logistic regression analysis revealed that patients with co-morbidities of congestive heart failure were more likely to be prescribed VKAs while diabetics were more likely to receive NOACs. VKAs were the most prescribed anticoagulants; congestive heart failure, diabetes, and hypertension were the commonest comorbidities; and atrial fibrillation was the commonest indication. Patients with a high HAS-BLED score were prescribed NOACs more often.

Associations of Tissue and Soluble LOX-1 with Human Abdominal Aortic Aneurysm.

Background Indication for prophylactic surgical abdominal aortic aneurysm (AAA) repair depends on the maximal aortic diameter. The lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor for uptake of oxidized low-density lipoprotein cholesterol and is implicated in atherosclerosis. A soluble form of LOX-1 (sLOX-1) has been discussed as a novel biomarker in coronary artery disease and stroke. Herein, we assessed the regulation of aortic LOX-1 as well as the diagnostic and risk stratification potential of sLOX-1 in patients with AAA. Methods and Results Serum sLOX-1 was assessed in a case-control study in AAA (n=104) and peripheral artery disease (n=104). sLOX-1 was not statistically different between AAA and peripheral artery disease but was higher in AAA (β=1.28, P=0.04) after adjusting for age, atherosclerosis, type 2 diabetes, prescription of statins, β-blockers, ACE inhibitors, and therapeutic anticoagulation. sLOX-1 was not associated with the aortic diameter, AAA volume, or the thickness of the intraluminal thrombus. Aortic LOX-1 mRNA expression tended to be higher in AAA when compared with disease, and expression was positively associated with cleaved caspase-3, smooth muscle actin, collagen, and macrophage content. Conclusions In AAA, sLOX-1 was differently affected by age, cardiometabolic diseases, and corresponding medical therapies. Comparison with nonatherosclerotic disease would be beneficial to further elucidate the diagnostic potential of sLOX-1, although it was not useful for risk stratification. Aneurysmal LOX-1 mRNA expression was increased and positively associated with smooth muscle cells and collagen content, suggesting that LOX-1 is eventually not deleterious in human AAA and could counteract AAA rupture.

Factors associated with oral anticoagulant prescription status among patients with a new diagnosis of atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained arrhythmia in adults and increases stroke risk. Treatment with oral anticoagulants (OACs) may reduce this risk however many patients do not receive OAC therapy. This study aimed to use electronic health record data to identify newly diagnosed AF patients at high risk for stroke and not anticoagulated as well as factors associated with OAC prescription. Timely prescription of OACs among patients with newly diagnosed AF is poor. We performed a retrospective study of patients with a new diagnosis of AF. We assessed stroke risk with the CHA2 DS2 -VASc score. The primary outcome was prescription of an OAC within 6 months following diagnosis. We used logistic regression to see how the odds of being prescribed an OAC differs for 17 independent variables. We identified 18 404 patients with a new diagnosis of AF. Among patients at high risk for stroke, 41.3% received an OAC prescription within 6 months. Male sex, Caucasian compared to African American race, stroke, obesity, congestive heart failure, vascular disorder, current antiplatelet, beta blocker, or calcium channel blocker prescription, and increasing CHA2 DS2 -VASc score were positively associated with receiving an OAC. Whereas anemia, renal dysfunction, liver dysfunction, antiarrhythmic drug use and increasing HAS-BLED score were negatively associated. Most newly diagnosed AF patients at high stroke risk do not receive an OAC prescription in the first 6 months following diagnosis. Our analysis suggests that patient sex, race, comorbidities, and additional prescriptions are associated with rates of OAC prescribing.

Management of anticoagulation in atrial fibrillation patients in Italy: insight from the &lt;i&gt;Atrial Fibrillation-Survey on Anticoagulated Patients Register&lt;/i&gt; (AF-START)

The survey on anticoagulated patients register (START-Register) is an independent, prospective, inception-cohort observational study aimed at providing information on patients on vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) in Italy. In this study, we describe the cohort of atrial fibrillation (AF) patients in the START-Register and report outcomes and changes in anticoagulant prescription from 2011 to 2021. The study included 11,078 AF patients, enrolled in 47 Italian centers distributed all over the Country; the median age was 77 years (range 18-99 years); 6029 (54.3%) were men; 5135 (46.4%) were on VKAs, and 5943 (53.6%) were on DOACs. Warfarin was the most prescribed VKA (98.4%), and apixaban was the most prescribed DOAC (31.6%). Among DOAC users, 4022 (67.7%) patients were naive to anticoagulation, and 2562 (43.1%) patients were treated with a reduced dose. DOAC patients were significantly older than VKA patients (median age 79 years vs 76 years respectively, P&lt;0.001), but no gender difference was detected. The mean CHA2DS2VASc score was higher in DOAC users than in VKA users (3.7 vs 3.6; P=0.03). The mean HAS-BLED score was not different between the two groups. During follow-up, 542 bleeding events were recorded [2.44 per 100 patient-years (pt-yrs)]; 240 were major (1.08 per 100 pt-yrs), and 301 were clinically relevant non-major bleedings (1.34 per 100 pt-yrs). 146 thrombotic events were recorded during follow-up (0.66 per 100 pt-yrs). The total mortality rate was 3.5 per 100 pt-yrs; the mortality rate was 4.54 per 100 pt-yrs among patients on VKAs and 2.31 per 100 pt-yrs among patients on DOACs. During the last 10 years, in Italy, AF patient management has changed with the large spread of DOACs all over the Country. DOAC patients are frequently treated with reduced doses and show a lower mortality rate in comparison to patients on VKAs.

Risk of venous thromboembolism or hemorrhage among individuals with chronic kidney disease on prophylactic anticoagulant after hip or knee arthroplasty.

Chronic kidney disease (CKD) confers a high risk of thrombosis and bleeding. However, little evidence exists regarding the optimal choice of postoperative thromboprophylaxis in these patients. We conducted a population-based, retrospective cohort study among adults ≥66 years old with CKD undergoing hip or knee arthroplasty who had filled an outpatient prophylactic anticoagulant prescription between 2010 and 2020 in Ontario, Canada. The primary outcomes of venous thrombosis (VTE) and hemorrhage were identified by validated algorithms using relevant diagnoses and billing codes. Overlap-weighted cause-specific Cox proportional hazard models were used to examine the association of direct oral anticoagulants (DOAC) on the 90-day risk of VTE and hemorrhage compared with low-molecular-weight heparin (LMWH). A total of 27 645 patients were prescribed DOAC (N = 22 943) or LMWH (N = 4702) after arthroplasty. Rivaroxaban was the predominant DOAC (94.5%), while LMWH mainly included enoxaparin (67%) and dalteparin (31.5%). DOAC users had higher eGFRs, fewer co-morbidities, and surgery in more recent years compared to LMWH users. After weighing, DOAC (compared with LMWH) was associated with a lower risk of VTE (DOAC: 1.5% vs. LMWH: 2.1%, weighted hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.59-0.94) and a higher risk of hemorrhage (DOAC: 1.3% vs. LMWH: 1.0%, weighted HR 1.44, 95% CI 1.04-1.99). Additional analyses including a more stringent VTE defining algorithm, different eGFR cut-offs, and limiting to rivaroxaban and enoxaparin showed consistent findings. Among elderly adults with CKD, DOAC was associated with a lower VTE risk and a higher hemorrhage risk compared to LMWH following hip or knee arthroplasty.

Risk of Venous Thromboembolism With Gout Flares.

Previous studies demonstrated that the risk of venous thromboembolism (VTE) is increased in patients with gout, but not whether there was a temporal association between gout flare and VTE. This study was undertaken to evaluate potential temporal associations between gout flare and VTE. Data were obtained from electronic primary-care records from the UK's Clinical Practice Research Datalink, which links data from hospitalization and mortality registers. Using self-controlled case series analysis adjusted for season and age, we evaluated the temporal association between gout flare and VTE. The 90 days after primary-care consultation or hospitalization for gout flare was designated the exposed period. This was divided into three 30-day intervals. The baseline period was up to 2 years before the start of and up to 2 years after the end of the exposed period. The association between gout flare and VTE was measured using adjusted incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs). In total, 314 patients met the inclusion criteria (age ≥18 years, incident gout, no presence of VTE or use of a primary-care anticoagulant prescription before the start of the pre-exposure period). Among the 314 patients, VTE incidence was significantly higher in the exposed period than in the baseline period (adjusted IRR 1.83, 95% CI 1.30-2.59). The adjusted IRR of VTE during the first 30 days after gout flare was 2.31 (95% CI 1.39-3.82) relative to the baseline period. No increase in the adjusted IRRs was observed in days 31-60 (adjusted IRR 1.49, 95% CI 0.79-2.81) and days 61-90 (adjusted IRR 1.67, 95% CI 0.91-3.06) relative to baseline. Results were consistent across sensitivity analyses. Among patients with gout, there was a transient increase in the rate of VTE within 30 days after primary-care consultation or hospitalization for gout flare.

Anticoagulation prescription among atrial fibrillation patients managed with and without an anticoagulant initiation pathway: a cohort study.

The Canadian Association of Emergency Physicians atrial fibrillation (AF) checklist advises that emergency physicians initiate anticoagulation therapy for patients with AF or flutter who are CHADS65 positive. The aim was to compare anticoagulation initiation rates between patients treated with and without an anticoagulation assessment pathway (the SAFE pathway). This was a retrospective cohort study. All emergency department patients were discharged home with a diagnosis of AF between June 2018 and May 2020 at two Canadian emergency departments. The SAFE pathway is a hard copy form which allows emergency physicians to document contraindications to anticoagulation, the positive components of the CHADS65 score, and details how to prescribe anticoagulation. Trained researchers abstracted data on the use of the SAFE pathway by the presence or absence of the completed, scanned pathway in the electronic medical chart. The exposure of interest was use of this pathway. Patients were followed forward in time for 90 days by electronic medical record review to document stroke, transient ischemic attack, arterial embolism and major bleeding events. All events were independently adjudicated. Adjusted odds ratios were calculated to compare outcomes between those managed with and without the SAFE pathway. In total, 766 patients were included, of whom 264 were already taking anticoagulation, 166 were CHADS65 negative and 65 had a contraindication to anticoagulation, leaving 271 patients eligible for anticoagulation prescription. Among the 271 eligible patients, 137/166 managed with the SAFE pathway were initiated on anticoagulation and 24/105 managed without the SAFE pathway started anticoagulation (adjusted odds ratio 25.9; 13.1-51.2). There was no statistically significant difference in the 90-day rate of stroke or bleeding. Use of the SAFE pathway was associated with a higher rate of anticoagulation prescription.

Efficacy of remote consultation between hospital cardiologists and primary care in cardiovascular disease management: the "Cardiologia in linea" project in Trentino, Italy

Telemedicine enables patients to receive better care via the simplification of procedures while allowing for a significant reduction of in-office appointments and emergency room visits. The "Cardiologia in linea" project started with the objective of strengthening communications between cardiologists and primary care, particularly with general practitioners. Between January 2017 and October 2022, by means of a facilitated telephonic and digital contact between territorial professionals and the cardiologist, the project provided in most cases immediate answers to cardiology queries, which were logged. A total of 2066 telephonic or digital consultations have been recorded, originating from 316 general practitioners in the Trento province (Italy). The mean age of patients was 76.4 years, 53% were male. After consultation, an immediate response was provided in 1989 (96%) of cases. A total of 1112 (54%) cardiology visits were avoided. After the consultation, a cardiologic visit was suggested in 29 cases (1%), and the emergency system was activated in 20 cases (1%). Overall, most questions concerned direct oral anticoagulant prescriptions (537 cases, 31%) and anti-hypertensive treatment (241 cases, 14%). The "Cardiologia in linea" project demonstrated a low-cost improvement in the patient assistance workflow, in the communication between hospital cardiology and primary care, while reducing the number of emergency room accesses. The project successfully shows the feasibility of a real-time dialogue between the general practitioner and the hospital cardiologist.

Anticoagulation prescribing practices in high-risk, under-represented patients with malignancy and venous thromboembolism (VTE).

e18532 Background: Incidence of VTE in cancer patients is 9x higher than the general population with higher rates amongst Black patients. Current published guidelines indicate that low molecular weight heparin be utilized first line; however, studies have found that oral anticoagulants are easier to use, offer a lower bleeding risk, and improve quality of life. Historically, these studies have &lt; 10% minority populations and extensive exclusion criteria. Here we seek to determine anticoagulation (AC) prescribing patterns amongst a largely underserved, under-represented inner city population. Methods: Retrospective chart review was performed utilizing international classification of disease codes that consist of cancer, VTE and bleeding events. Patients recruited were age 18+ with cancer, hospitalized (inpatient, IP) or cared for at an outpatient appointment (outpatient, OP) at Temple University Hospital or Fox Chase Cancer Center between January 1, 2016 - December 1, 2021. Data extracted: demographics, cancer type, pertinent past medical history, weight, creatinine clearance (CrCl), type and dose of AC prescribed, adverse events, and subsequent VTE events. Following data extraction, manual chart review was performed to remove duplicates and verify accuracy of data. Results: 1060 patients were included (n = 529 OP, n = 531 IP). 45.2% minorities (n = 479/1060): 35.6% Black (n = 377/1060), 8.2% Hispanic (n = 87/1060), 1.1% Asian/Pacific Islander (n = 12/1060), 0.57% Native American/Eskimo (n = 6/1060). Average age was 65 years old. Average CrCl &lt; 30 was 3.2% (n = 14/529 OP, n = 20/531 IP) with 70.6% prescribed apixaban (n = 15/20 IP, n = 9/14 OP). 15.6% of patients weighed &lt; 60 kg and 40.3% of these patients were prescribed apixaban (n = 45/106 IP, n = 22/60 OP). 4.3% of patients weighed &gt; 120 kg and 32.6% of these patients were prescribed apixaban (n = 9/18 IP, 6/28 OP). AC prescribing practices did not vary amongst IP and OPs. Apixaban (39%, n = 410/1060) was prescribed more frequently than enoxaparin (34.8%, n = 369/1060), followed by rivaroxaban (18.9%, n = 201/1060); then, a mix of other anticoagulants, including warfarin, edoxaban, fondaparinux, and dabigatran. Serious bleeding events that caused physicians to discontinue AC were most often found amongst patients prescribed rivaroxaban in OPs (5.63%, n = 8/142) and enoxaparin in IPs (7.07%, n = 15/212). Conclusions: We present the largest data set presently known in an under-represented IP and OP cancer population to better provide guidance when selecting AC. Apixaban appeared to be most often prescribed with the least amount of serious adverse bleeding effects requiring cessation of AC. Many patients did not meet apixaban prescribing criteria, (weight &lt; 60 kg or &gt; 120 kg; CrCl &lt; 30) or had characteristics excluded from prior studies (ie, IVC filters, PORTs, PICCs) calling for further analysis regarding safety and adverse event profile.

Clinical and pharmacological approaches to personalization of the prescription of oral anticoagulants: clinical cases

Anticoagulants play an important role in reducing complications and mortality associated with thromboembolic disease. For some time, vitamin K antagonists (VKAs) have been the main drugs used for long-term oral anticoagulant therapy, but because of the significant limitations of VKAs over the past decade, pharmacological research has led to the development of new direct acting oral anticoagulants (DOACs). Direct acting oral anticoagulants have a rapid onset of action with peak levels within 2–4 hours and a half-life of about 12 hours, which is much shorter than that of vitamin K antagonists, a more predictable anticoagulant effect, no need for dose selection, routine laboratory monitoring of pharmacodynamic effects, and a lower frequency of clinically significant drug-drug interactions compared with warfarin. But anticoagulants can still cause serious adverse drug reactions (ADRs) in the form of hemorrhagic complications in hospitalized patients, as confirmed in studies. Currently, clinicalpharmacological technologies of personalized medicine such as pharmacogenetic and pharmacokinetic studies are considered as promising approaches to improve the safety of modern pharmacotherapy, allowing the prediction and prevention of various ADRs. In addition, there are emerging studies showing the importance of genetic features of patients in relation to the metabolism of oral anticoagulants, as well as described clinical situations where different gene polymorphisms, could be responsible for changes in the pharmacokinetics of DOACs. This article reviews clinical cases in which pharmacogenetic testing and therapeutic drug monitoring are used to optimize the clinical efficacy and maximum safety of anticoagulant therapy with apixaban and rivaroxaban.

Implementing pharmacist-prescriber collaboration to improve evidence-based anticoagulant use: a randomized trial

BackgroundDirect oral anticoagulant medications are commonly used to treat or prevent thrombotic conditions, such as pulmonary embolism, deep vein thrombosis, and atrial fibrillation. However, up to 10–15% of patients receiving these medications get unsafe doses based on a patient’s kidney or liver function, potential interactions with other medications, and indication for taking the medication. Alert systems may be beneficial for improving evidence-based prescribing, but can be burdensome and are not currently able to provide monitoring after the initial prescription is written.Methods/designThis study will improve upon existing alert systems by testing novel medication alerts that encourage collaboration between prescribers (e.g., physicians, nurse practitioners, physician assistants) and expert pharmacists working in anticoagulation clinics. The study will also improve upon the existing alert system by incorporating dynamic long-term monitoring of patient needs and encouraging collaboration between prescribers and expert pharmacists working in anticoagulation clinics. Incorporating state-of-the-art user-centered design principles, prescribing healthcare providers will be randomized to different types of electronic health record medication alerts when a patient has an unsafe anticoagulant prescription. We will identify which alerts are most effective at encouraging evidence-based prescribing and will test moderators to tailor alert delivery to when it is most beneficial. The aims of the project are to (1) determine the effect of notifications targeting existing inappropriate DOAC prescriptions; (2) examine the effect of alerts on newly prescribed inappropriate DOACs; and (3) examine changes in the magnitude of effects over time for both the new prescription alerts and existing prescription notifications for inappropriate DOACs over the 18-month study period.DiscussionFindings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high-risk medications, including anticoagulants. If effectively implemented at the more than 3000 anticoagulation clinics that exist nationally, hundreds of thousands of patients taking direct oral anticoagulants stand to benefit from safer, evidence-based healthcare.Trials registrationNCT05351749.

Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2)

BackgroundDespite widely available risk stratification tools, safe and effective anticoagulants, and guideline recommendations, anticoagulation for stroke prevention in atrial fibrillation (AF) is under-prescribed in ambulatory patients. To assess the impact of alert-based computerized decision support (CDS) on anticoagulation prescription in ambulatory patients with AF and high-risk for stroke, we conducted this randomized controlled trial. MethodsPatients with AF and CHA2DS2−VASc score ≥ 2 who were not prescribed anticoagulation and had a clinic visit at Brigham and Women's Hospital were enrolled. Patients were randomly allocated, according to Attending Physician of record, to intervention (alert-based CDS) versus control (no notification). The primary efficacy outcome was the frequency of anticoagulant prescription. ResultsThe CDS tool assigned 395 and 403 patients to the alert and control groups, respectively. Alert patients were more likely to be prescribed anticoagulation within 48 h of the clinic visit (15.4 % vs. 7.7 %, p < 0.001) and at 90 days (17.2 % vs. 9.9 %, p < 0.01). Direct oral anticoagulants were the predominantly prescribed form of anticoagulation. No significant differences were observed in stroke, TIA, or systemic embolic events (0 % vs. 0.8 %, p = 0.09), symptomatic VTE (0.5 % vs. 1 %, p = 0.43), all-cause mortality (2 % vs. 0.7 %, p = 0.12), or major adverse cardiovascular events (2.8 % vs. 2.5 %, p = 0.79) at 90 days. ConclusionsAn alert-based CDS strategy increased a primary efficacy outcome of anticoagulation in clinic patients with AF and high-risk for stroke who were not receiving anticoagulation at the time of the office visit. The study was likely underpowered to assess an impact on clinical outcomes. Trial registrationClinicalTrials.gov Identifier- NCT02958943.

Choice of Oral Anticoagulant: Outcomes in Atrial Fibrillation Patients Post-Stroke Despite Direct Oral Anticoagulant Use

BackgroundFor patients with atrial fibrillation who have an ischemic stroke or transient ischemic attack (TIA) despite taking direct oral anticoagulants (DOACs), the optimal strategy for ongoing anticoagulation is unknown. MethodsUsing provincial administrative databases in Alberta, Canada, we compared anticoagulant use before/after the breakthrough stroke/TIA and assessed recurrence of stroke/TIA or bleeding, with consideration of medication adherence. Adherence was defined as the proportion of days covered (PDC) being ≥ 80%. ResultsAmong 985 patients, the median age was 80 years (interquartile range 13), with a mean CHADS2 score of 1.7± 1 prior to the index event. Patients were followed for a median of 643 days (interquartile range 836). Following the index stroke/TIA event, 623 patients (63%) filled a prescription for the same DOAC regimen, 83 (8%) filled a prescription for a different dose, 155 (16%) switched DOAC agents, 51 (5%) switched to warfarin, and 73 (7%) filled no oral anticoagulant prescription. Patients who kept the same regimen more commonly had TIA index events (59%); patients who changed dose or drug more often had stroke index events (55%-78%). During follow-up, 135 (14%) had stroke/TIA recurrence, and 46 (5%) had bleeding; rates of each did not differ between prescribing patterns. Post-index event, the proportion of patients with a proportion of days covered ≥ 80% improved from 55% to 80%. ConclusionsAlthough most maintained the same DOAC regimen after stroke/TIA, rates of recurrent stroke/TIA and bleeding were similar across prescribing patterns. Stroke/TIA severity may have influenced prescribing practices. DOAC prescription adherence improved poststroke/TIA and signals an opportunity for optimization in patients with atrial fibrillation.

Incident atrial fibrillation and adverse clinical outcomes during extended follow-up of participants recruited to the remote heart rhythm sampling using the AliveCor heart monitor to screen for atrial fibrillation: the REHEARSE-AF study.

Atrial fibrillation (AF) is an important risk factor for stroke, which is commonly asymptomatic, particularly in older patients, and often undetected until cardiovascular events occur. Development of novel technology has helped to improve detection of AF. However, the longer-term benefit of systematic electrocardiogram (ECG) screening on cardiovascular outcomes is unclear. In the original REHEARSE-AF study, patients were randomized to twice-weekly portable electrocardiogram (iECG) assessment or routine care. After discontinuing the trial portable iECG assessment, electronic health record data sources provided longer-term follow-up analysis. Cox regression was used to provide unadjusted and adjusted hazard ratios (HR) [95% confidence intervals (CI)] for clinical diagnosis, events, and anticoagulant prescriptions during the follow-up period. Over the median 4.2-year follow-up, although a greater number of patients were diagnosed with AF in the original iECG group (43 vs. 31), this was not significant (HR 1.37, 95% CI 0.86-2.19). No differences were seen in the number of strokes/systemic embolisms or deaths between the two groups (HR 0.92, 95% CI 0.54-1.54; HR 1.07, 95% CI 0.66-1.73). Findings were similar when restricted to those with CHADS-VASc ≥ 4. A 1-year period of home-based, twice-weekly screening for AF increased diagnoses of AF for the screening period but did not lead to increased diagnoses of AF or a reduction in cardiovascular-related events or all-cause death over a median of 4.2 years, even in those at highest risk of AF. These results suggest that benefits of regular ECG screening over a 1-year period are not maintained after cessation of the screening protocol.

Evolución clínica de los pacientes con FA y diabetes mellitus en la pandemia de COVID-19. Registro REFADI

Introduction and objectivesTo analyze the evolution of patients with atrial fibrillation (AF) and diabetes in the mid-term follow-up during the COVID-19 pandemic and to describe its impact on this population. MethodsMulticenter and prospective registry that included patients with AF and diabetes attended in cardiology clinics. A multivariate analysis was performed to determine the variables associated with the occurrence of clinical events and mortality. Recruitment was performed in February-December 2019. ResultsThe evolution of 633 patients, 96,2% of those included in the REFADI registry with a median follow-up of 835 days was analyzed (mean age 73.8±8.5 years, 54.3% male, CHA2DS2-VASc 4,34±1,4, HAS-BLED 2,47±0,96) were analyzed. The proportion of anticoagulated patients remained constant (95.6% vs 94.5%; P=.24). There was a decrease in the prescription of vitamin K antagonists (from 31.4% to 19.7%; P <.01), and an increase in the use of direct anticoagulants (from 62.0% to 70.3%; P <.01). During the follow-up there was an increase in the prescription of SGLT2 inhibitors (from 20.0% to 25.5%; P <.01) and GLP1 agonists (from 4.2% to 9.1%; P <.01). During this period, 17.2% of patients died, the majority from cardiovascular causes, 6.4% from COVID-19, 2.8% from stroke, and 1.8% from hemorrhage. Older age, lower ejection fraction, lower hemoglobin levels, and especially lower direct anticoagulants prescription were associated with mortality. ConclusionsPatients with AF and diabetes have a high thromboembolic risk and a high risk of developing complications, especially of cardiovascular origin.

Hemostasis in children with COVID-19-RELATED illness

BACKGROUND:During the COVID-19 pandemic, the problem of coronavirus-associated coagulopathy was one of the most difficult and poorly studied. The detected hemostasis disorders in adults are extrapolated to children and adolescents without sufficient representation in the literature. Because of COVID-19 is generally told as a mild disease in children a detailed laboratory examination not required. As a result, thrombotic and hemorrhagic complications, as well as the childrens multisystem inflammatory syndrome (MIS-C) are unexpected. At the same time, the hemostasis assessment in children with COVID-19 is necessary for the coronavirus-associated coagulopathy timely diagnosis, adequate anticoagulant therapy prescribing, various convalescence thrombotic complications prevention, as well as determining the necessary period of dynamic monitoring of patients. AIM:To assess the hemostasis in children with COVID-19-related illness in the acute disease period and convalescence. MATERIALS AND METHODS:The results of the examination of 460 patients from 2 days to 18 years old hospitalized with confirmed SARS-CoV-2 infection and 110 outpatient children from 3 months to 17 years old at different periods of COVID-19 convalescence are presented. The study included platelet count measured using automated hematocytometers, the main coagulation laboratory parameters and D-dimer level. RESULTS:The observational study indicate that children hospitalized with acute COVID-19-related illness have adult like coagulation changes, which significantly depend on the disease severity, presents of pneumonia and in the intensive care need cases, and the most sensitive indicator was the D-dimer level. However, there were opposite changes: both hyper- and hypocoagulation, a high frequency of normal or elevated platelet counts, as well as the presence of coagulopathy in 1/5 of cases even with a mild COVID-19 and the absence in 1/4 of severe cases. During the convalescence, coagulation laboratory parameters were normal, with the exception of an increased D-dimer level in every sixth patient within 1 month after recovery. CONCLUSIONS:Hemostasis changes in children with COVID-19-related illness differ from the adults by opposite, duration and risk factors. The anticoagulant therapy selection and duration requires an individual approach with the hematologist assistance. Further studies are needed to clarify the causes and consequences of hemostasis changes in children with mild forms of novel coronavirus SARS-CoV-2 infection, to establish additional coronavirus-associated coagulopathy factors in children with moderate and severe COVID-19, to develop recommendations for anticoagulant therapy in childhood.