Oral Anticoagulants In Atrial Fibrillation Patients Research Articles

Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial.

The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y12 inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y12 inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y12 inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y12 inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y12 inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.

Screening over 100 000 patients in 39 general practices in the Netherlands for anticoagulation underprescription in atrial fibrillation: a descriptive, cross-sectional study

ObjectivesTo investigate the underprescription of oral anticoagulation (OAC) in individual atrial fibrillation (AF) patients in primary care.SettingScreening of patient records in 39 participating general practitioners (GPs) across the Netherlands.ParticipantsWe screened...

Differential efficacy and safety of oral anticoagulation in atrial fibrillation patients with or without comorbid vascular disease: insights from the GARFIELD-AF registry

Abstract Background Many patients with atrial fibrillation (AF) have comorbid vascular disease. The effects of oral anticoagulation (OAC) in AF patients with vascular disease, however, have not been widely studied. Purpose To investigate the impact of OAC in AF patients with (Vasc) or without (nVasc) concomitant vascular disease. Methods GARFIELD-AF is the largest multinational, prospective AF registry. The study comprised 51,574 GARFIELD-AF patients with newly diagnosed AF, 13,365 Vasc and 38,209 nVasc patients. All patients who reported coronary artery disease, aortic or peripheral artery disease, acute coronary syndromes, myocardial infarction, stenting, or coronary artery bypass graft were classified as having vascular disease. Adjusted hazard ratios were obtained via Cox proportional-hazards models to quantify the association of vascular disease with selected endpoints. Comparative effectiveness analyses were restricted to patients enrolled from April 2013-September 2016 (when NOACs became widely available) and who were eligible for anticoagulation (CHA2DS2-VASc ≥2 excl. gender). To evaluate the safety and efficacy of different anticoagulation strategies in Vasc and nVasc patients, propensity score using an overlap weighting scheme was applied. Weights were applied to Cox proportional-hazards models to estimate the effects of OAC vs No OAC and NOAC vs VKA. Results Vasc patients were older (median (Q1; Q3): 72.0 (65.0; 79.0) vs 70.0 (62.0; 78.0) and more often male (62.0 vs 53.6%). Vasc patients had a higher rate of comorbidities including heart failure, hypertension, and diabetes. Vasc patients received less OAC (62.8 vs 68.3%). NOACs were less common compared with nVasc patients (23.8% vs 28.7%) but a similar proportion of VKAs was observed in both (39.0% vs 39.6%). Antiplatelet monotherapy was more common in Vasc (31%) than nVasc (18%) patients. At 2-years, Vasc was associated with a higher risk of all-cause (HR [95% CI]: 1.30 [1.16–1.47]) and cardiovascular mortality (1.59 [1.28–1.97]). OACs significantly lowered the risk of all-cause mortality and stroke in nVasc patients (0.72 [0.63–0.82] and 0.64 [0.49–0.84], respectively), but not in nVasc patients. OACs led to a numerical increase in major bleeding in Vasc patients (1.32 [0.90–1.93]) and a significant increase in major bleeding in nVasc patients (1.40 [1.03–1.90]) (Figure 1). Compared with VKAs, NOACs did not significantly improve the risk of outcomes in nVasc patients. In Vasc patients however, NOACs significantly lowered the risk of all-cause mortality (0.74 [0.61–0.90]) and major bleeding (0.45 [0.29–0.70]) compared with VKAs (Figure 2). Conclusion AF patients with vascular disease have worse long-term outcomes than those without. They receive less often OAC, specifically NOAC, and more antiplatelet agents. The beneficial effects of NOAC over VKA are much more pronounced in patients with than in those without vascular disease. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by the Thrombosis Research Institute (London, UK).

A comparison of front-line oral anticoagulants for the treatment of non-valvular atrial fibrillation: effectiveness and safety of direct oral anticoagulants in the FANTASIIA registry

ABSTRACT Introduction For a long time, vitamin K antagonists (VKA) were the only oral anticoagulation therapy available to reduce adverse events in atrial fibrillation (AF) patients. Direct-acting oral anticoagulants (DOAC) are at least as effective and safe as VKA with few drug interactions, rapid onset, and short half-life. Four DOACs, dabigatran, apixaban, rivaroxaban, and edoxaban, have demonstrated efficacy and safety for treatment in AF patients. Areas Covered The purpose of this review article is to analyze the current evidence in clinical trials and in real-world populations and performed a new analysis with the estimated effect of those DOACs over the VKA population from the FANTASIIA registry. Expert Opinion In the absence of randomized, controlled head-to-head comparisons between DOACs, high-quality observational data can provide useful information on the comparative effectiveness of DOACs. Current clinical guidelines recommend the management of oral anticoagulation in AF patients with DOACs over VKA for stroke prevention; however, many guidelines generally do not suggest a specific DOAC choice in clinical practice. The revised evidence in this manuscript and our real experience reflects that apixaban and dabigatran show the best efficacy and safety profile.

Adherence to oral anticoagulation in a Belgium atrial fibrillation population measured by a medical event monitoring system

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): The AF-EduCare study is a project supported by the Fund for Scientific Research, Flanders (T002917N). The AF-EduApp study is supported by an BMS/Pfizer European Thrombosis Investigator Initiated Research Program (ERISTA) grant. Background Treatment with oral anticoagulation (OAC) is one of the main pillars in the management of atrial fibrillation (AF). Therapy adherence to both VKA and NOAC is important. Education and intake monitoring are recommended to improve therapy adherence. Purpose The main purpose of this project was to evaluate the effect of personalized follow-up strategies on therapy adherence to OAC in AF patients. Methods In a multicentre, Belgian randomized controlled trial, the AF-EduCare/AF-EduApp study, the effect of different personalized education strategies (i.e. in-person, online or app-based education) is evaluated on clinical outcome parameters of AF patients compared to standard care (SC). One of the outcome parameters is therapy adherence to OAC. During the first 3 months of the trial, patients’ adherence to NOAC or VKA was measured with the Electronic Medication Event Monitoring System (MEMS). The MEMS cap fits on a medication bottle and registers the date and time of every bottle opening. Regimen adherence was defined as the the number of days with the correct number of openings according to the specific OAC regimen divided by the total number of monitored days. As dabigatran has to be stored in the original package to protect it from moisture and VKAs have a variable scheme between patients, a proxy-medication (i.e. another oral drug that needed to be taken once or twice daily and on the same moment of the day as dabigatran or VKA) was chosen to measure medication adherence. Patients in the education groups received a MEMS cap with LCD screen providing direct feedback by showing the number of openings within 24h. A small sample of the SC group also received a MEMS cap as controls, but without LCD screen to minimally trigger these patients. Results A total of 593 AF patients underwent adherence monitoring, of which 514 (86.7%) in the intervention group and 79 (13.3%) in the SC group. The mean age was 70.1±7.7 years, mean time since AF diagnosis was 5.8±6.9 years, and mean CHA2DS2-VASc score was 3.2±1.5. Overall adherence was high: 94.8% of the patients had an adherence >80% and 80.9% had an adherence >90%. A small but significant difference in adherence was observed between the intervention groups and the standard care group (intervention group 97% (5-100); SC 96%(24-100); p=0.024; Figure1). Also between the four study groups a significant difference was seen (in-person 97% (93.5-99); online 98% (94-100); app-based 98% (92-99); p=0.049) driven by a significant difference between the online and SC group (p=0.009). Conclusion Overall adherence to OAC in all study groups and even in SC was high. The high adherence percentage in the SC group could be related to the Hawthorne effect of using the MEMS. Nevertheless, electronic monitoring and targeted education slightly improved therapy adherence further in the intervention groups.

Oral anticoagulation in atrial fibrillation patients at intermediate risk of stroke: a nationwide registry-based cohort (Atrial Fibrillation in Norway – AFNOR)

Abstract Background The effect of oral anticoagulants (OAC) on prevention of stroke must be carefully balanced against the potential risk of bleeding in patients with atrial fibrillation (AF). The net benefit of OAC in AF patients at intermediate risk of stroke remains unclear. Aim We aimed to determine whether the rates of ischemic and haemorrhagic stroke differ between users and non-users of OAC in a nationwide cohort of AF patients at intermediate risk of stroke. Method We investigated the association between initiation of OAC treatment and rates of ischemic and haemorrhagic stroke in a cohort of Norwegian patients with non-valvular AF aged ≥18 years with one non-sex CHA2DS2-VASc risk factor registered from 2011 to 2018, linking data from the Norwegian Population Registry, Patient Registry, Prescription Database and Cause of Death Registry. Individuals using OAC at baseline were excluded. Each individual had at least a three years look-back period for identification of their first non-sex CHA2DS2-VASc risk factor, after which they entered the study cohort and were followed until occurrence of stroke, death, emigration, higher CHA2DS2-VASc score or end of follow-up on December 31, 2018. Individuals were defined as exposed to OAC from the first redeemed prescription of OAC with a reimbursement code for AF and throughout follow-up. Rates of ischemic and haemorrhagic stroke were calculated as the number of stroke cases per 100 person-years, with 95% confidence intervals (CI). Results During 2011–2018, a total of 61,631 individuals with AF and intermediate risk of stroke were included (mean age 63,8±7,6 years (SD); 37% women), of whom 75% initiated OAC treatment. In total, 1709 ischemic strokes (405 cases in OAC users and 1304 in non-users) were registered during 214,738 person-years, and 378 haemorrhagic strokes (251 cases in OAC users and 127 in non-users) during 213,487 person-years. The rate of ischemic stroke was 0.39 (95% CI, 0.35–0.43) and 1.19 (95% CI, 1.12–1.25) per 100 person-years in OAC users and non-users, respectively. The haemorrhagic stroke rate was 0.24 (95% CI, 0.21–0-27) and 0.12 (95% CI, 0.10–0.14) per 100 person-years in OAC users and non-users, respectively. Both ischemic and haemorrhagic stroke rates were highest among those over 65 years of age (Figure 1). Conclusion In a nationwide cohort of Norwegian AF patients at intermediate risk of stroke, three out of four initiated treatment with OAC. Use of OAC was associated with a considerably lower rate of ischemic stroke compared to non-OAC use. Although haemorrhagic stroke rates were increased in the OAC-users vs. non-users, the hemorrhagic stroke rates were generally low. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Vestre Viken Health Trust Figure 1. Rates of ischemic and haemorrhagic stroke per 100 person-years in AF-patients at intermediate risk of stroke (CHA2DS2-VASc score 1 in men, score 2 in women) by OAC use during 2011 to 2018. Age corresponds to age at attainment of the first non-sex CHA2DS2-VASc risk factor.

Abstract 13201: Atrial Fibrillation Detection in Community Ischemic Stroke Patients is Improved With Implantable Cardiac Monitors

Introduction: Although implantable cardiac monitors (ICM) improve atrial fibrillation (AF) detection relative to Holters or other extended ambulatory cardiac monitors (EACMs) (e.g., 30-day event monitors or outpatient telemetry) in clinical trials, data are limited on their performance in the community setting. We investigated AF detection in ischemic stroke patients and subsequent initiation of oral anticoagulation (OAC) in a real-world setting. Methods: We identified patients with ischemic stroke (2010-2015) in IBM MarketScan, a national prospectively acquired data set in whom Holters, EACMs, or ICMs were ordered. We further selected patients with no prior history of AF or OAC and continuous database enrollment 6 mos pre- and 24 mos post monitoring. Propensity score matching (PSM) was used to adjust for baseline characteristics differences between monitoring types. Logrank test was used to compare the Kaplan-Meier (KM) curves for AF detection and OAC initiation in patients with AF. Results: A total of 6,287 patients were analyzed: 4,107 Holter (age 63±14 yrs, 46% female, 28% coronary artery disease [CAD], 71% hypertension [HTN]), 1,829 EACM (age 61±14 yrs, 49% female, 27% CAD, 73% HTN), and 351 implanted with ICM (age 63±13 yrs, 51% female, 38% CAD, 82% HTN). After 1:1 PSM, the Holter-ICM cohort comprised of 664 patients and the EACM-ICM cohort comprised of 676 patients. In the Holter-ICM pair, 2 yr AF diagnoses rate was 14.5% for Holter vs 38.3% for ICM (logrank p<0.01, Panel A). In the EACM-ICM pair, 2 yr AF diagnoses rate was 15.4% for EACM vs 38.2% for ICM (logrank p<0.01, Panel B). Initiation of OAC in AF patients by 2 yrs was 41.7% for Holters vs 49.6% for ICMs (logrank p=0.30, Panel C) and 61.5% for EACM vs 49.6% for ICM (logrank p=0.16, Panel D). Conclusion: In community patients with ischemic stroke with no history of AF or prior OAC, rates of OAC initiation are comparable between monitoring types when AF is detected, and ICM outperforms Holter and EACM for the detection of AF.

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study

Abstract Aims Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention, are limited. We analysed the impact of LD and OAC treatment in determining stroke, major bleeding, all-cause death and secondary bleeding outcomes. Methods A retrospective observational population-based cohort study. The study cohort is derived from the administrative health databases of Lombardy region (>10 million inhabitants), Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. AF and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical (ATC) codes. Primary study outcomes were stroke, major bleeding and all-cause death. Results Among 393,507 AF patients, 16,168 (4.1%) had concomitant LD. LD AF patients were significantly less treated with OAC independent of associated clinical characteristics (OR: 0.96, 95% CI: 0.92–0.98). Concomitant LD was found associated with an increased risk in all the study outcomes (HR: 1.18, 95% CI: 1.11–1.25 for stroke; HR: 1.57, 95% CI: 1.47–1.66 for major bleeding; HR: 1.41, 95% CI: 1.39–1.44 for all-cause death. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70–0.92), major bleeding (HR: 0.86, 95% CI: 0.74–0.99) and all-cause death (HR: 0.85, 95% CI: 0.80–0.90), with similar results according to several clinically relevant subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375–0.472). Conclusions In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant benefit/risk ratio, even in high-risk patient subgroups. Funding Acknowledgement Type of funding source: None

The difference of burden of ectopic beats in different types of atrial fibrillation and the effect of atrial fibrillation type on stroke risk in a prospective cohort of patients with atrial fibrillation (CODE-AF registry)

The relationship between atrial fibrillation (AF) type and stroke risk is still controversial. We investigated the difference of burden of atrial ectopic beats in different types of AF and the effect of the AF type on stroke risk in patients with non-valvular AF. In the prospective, multicenter observational registry with more than about 10,000 AF patients, 8883 non-valvular AF patients (mean age, 67.0 years; 36% were women) with eligible follow-up visits participated. We compared the burden of ectopic beats and stroke risk between patients with paroxysmal AF (n = 5,808) and non-paroxysmal AF (n = 3,075). The patients with a non-paroxysmal type of AF were older, male-predominant and had a higher prevalence of comorbidities and had more anticoagulation and rhythm control treatment than those with paroxysmal AF. In terms of the difference in burden of ectopic beats, patients with non-paroxysmal AF had a higher proportion of atrial premature beats (APBs) (paroxysmal vs. non-paroxysmal, median 3% vs. 5%; p = 0.001) in 24 hours Holter monitoring. During a median follow-up period of 16.8 months (Interquartile range [IQR], 11.67–20.52), a total of 82 (0.92%) patients experienced ischemic stroke with incidence rates of 0.50 and 1.09 events per 100 person-year for paroxysmal and non-paroxysmal AF, respectively. The cumulative incidence of stroke events was significantly higher in non-paroxysmal AF than in paroxysmal AF (p < 0.001). The risk of ischemic stroke was higher in non-paroxysmal AF with an adjusted hazard ratio (HR) of 2.08 (95% confidence interval [CI], 1.33–3.25; p = 0.001) than in paroxysmal AF. The type of AF was associated with an increased risk of stroke, along with the difference of burden of ectopic beats (specially in APBs) in different types of AF. These results suggest that the type of AF should be considered in stroke prevention and decision-making for oral anticoagulation in AF patients.

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study.

Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention are limited. A retrospective observational population-based cohort study on the administrative health databases of Lombardy region Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. Atrial fibrillation and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical codes. Primary study outcomes were stroke, major bleeding, and all-cause death. Among 393 507 AF patients, 16 168 (4.1%) had concomitant LD. Liver disease AF patients were significantly less treated with OAC. Concomitant LD was associated with an increased risk in all the study outcomes [hazard ratio (HR): 1.18, 95% confidence interval (CI): 1.11-1.25 for stroke; HR: 1.57, 95% CI: 1.47-1.66 for major bleeding; HR: 1.41, 95% CI: 1.39-1.44 for all-cause death]. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70-0.92), major bleeding (HR: 0.86, 95% CI: 0.74-0.99), and all-cause death (HR: 0.77, 95% CI: 0.73-0.80), with similar results according to subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375-0.472). In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant favourablebenefit/risk ratio, even in high-risk patient subgroups.

Do computerized clinical decision support systems improve the prescribing of oral anticoagulants? A systematic review

BackgroundSerious adverse drug reactions have been associated with the underuse or the misuse of oral anticoagulant therapy. We systematically reviewed the impact of computerized clinical decision support systems (CDSS) on the prescribing of oral anticoagulants and we described CDSS features associated with success or failure. MethodsWe searched Medline, Embase, CENTRAL, CINHAL, and PsycINFO for studies that compared CDSS for the initiation or monitoring of oral anticoagulants with routine care. Two reviewers performed study selection, data collection, and risk-of-bias assessment. Disagreements were resolved with a third reviewer. Potentially important CDSS features, identified from previous literature, were evaluated. ResultsSixteen studies were included in our qualitative synthesis. Most trials were performed in primary care (n = 7) or hospitals (n = 6) and included atrial fibrillation (AF) patients (n = 9). Recommendations mainly focused on anticoagulation underuse (n = 11) and warfarin-drug interactions (n = 5). Most CDSS were integrated in electronic records or prescribing and provided support automatically at the time and location of decision-making. Significant improvements in practitioner performance were found in 9 out of 16 studies, while clinical outcomes were poorly reported. CDSS features seemed slightly more common in studies that demonstrated improvement. ConclusionsCDSS might positively impact the use of oral anticoagulants in AF patients at high risk of stroke. The scope of CDSS should now evolve to assist prescribers in selecting the most appropriate and tailored medication. Efforts should nevertheless be made to improve the relevance of notifications and to address implementation outcomes.

Effectiveness and Safety of Restarting Oral Anticoagulation in Patients with Atrial Fibrillation after an Intracranial Hemorrhage: Analysis of Medicare Part D Claims Data from 2010-2016.

In patients with atrial fibrillation (AF) who survive an anticoagulant-related intracranial hemorrhage (ICH), the benefits of restarting oral anticoagulation (OAC) remain unclear. In this study, we sought to determine the effectiveness and safety associated with resumption of OAC in atrial fibrillation patients who survive an ICH. Using 2010-2016 Medicare claims data, we identified patients with non-valvular AF who experienced an OAC-related ICH and survived at least 6weeks after the ICH (n=1502). The primary outcomes included the composite of ischemic stroke and transient ischemic attack (TIA), thromboembolism (TE), a composite of ischemic stroke/TIA and TE, recurrent ICH, and all-cause mortality. We constructed Cox proportional hazard models to evaluate the association between post-ICH OAC resumption, which was measured in a time-dependent manner, and the risk of primary outcomes, while controlling for a comprehensive list of covariates. Among patients who survived an ICH, 69% reinitiated OAC within 6weeks of the event, and among those who resumed OAC, 83% restarted warfarin. There was no significant difference in the risk of ischemic stroke/TIA (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.62-1.21), TE (HR 0.85, 95% CI 0.55-1.32), and ischemic stroke/TIA/TE (HR 0.81, 95% CI 0.61-1.07) between post-ICH OAC use and non-use. Post-ICH OAC use was associated with a lower risk of recurrent ICH (HR 0.62, 95% CI 0.41-0.95) and all-cause mortality (HR 0.48, 95% CI 0.37-0.62) compared with non-OAC use. In AF patients who survived an ICH, restarting OAC was not associated with a greater risk of recurrent ICH. Evidence from randomized controlled studies is needed to further clarify the clinical benefit of restarting OAC in this high-risk population. Further evaluation of which individuals benefit from restarting OAC is also needed to provide more clinical guidance.

Prevalence and Associated Stroke Risk of Human Immunodeficiency Virus-Infected Patients With Atrial Fibrillation - A Nationwide Cohort Study.

Patients infected with human immunodeficiency virus (HIV) are at increased risk of cardiovascular diseases. However, little is known regarding the risk of ischemic stroke in HIV-infected individuals with atrial fibrillation (AF).Methods and Results:From the Korean National Health Insurance Service (NHIS) database from January 1, 2005 to December 31, 2016, we analyzed 962,116 patients with prevalent non-valvular AF aged ≥18 years. The overall HIV prevalence in AF patients was 0.17% (1,678 of 962,116). Oral anticoagulant (OAC)-naïve non-valvular AF (NVAF) patients with HIV had increased risks of ischemic stroke/systemic embolism (SE) [adjusted hazard ratio (HR) 1.37; 95% confidence interval (CI), 1.21-1.54], and major bleeding (adjusted HR 1.29; 95% CI, 1.15-1.46), compared with those without HIV. The incidence of ischemic stroke/SE in NVAF patients with HIV without any risk factors was similar to that of those without HIV at intermediate risk (i.e., male CHA2DS2-VASc score of 1) (2.04 vs. 2.18 events per 100 person-years). However, the use of OACs in AF patients with HIV was suboptimal, being only 8.9% at the time of AF diagnosis and 31.8% throughout the study period. The risks of ischemic stroke/SE and major bleeding were significantly higher in HIV-infected patients compared with non-HIV-infected patients with AF. Despite this, the actual use of OACs among AF patients with HIV was suboptimal.

Physicians' Perceptions of Their Patients' Attitude and Knowledge of Long-Term Oral Anticoagulant Therapy in Bulgaria.

Background and Objectives: Oral anticoagulation (OAC) is widely used in daily clinical practice worldwide for various indications. We aimed to explore the perception of Bulgarian clinicians about their patients’ attitude and knowledge of long-term OAC, prescribed for atrial fibrillation (AF) and/or known deep venous thrombosis (DVT)/pulmonary embolism (PE). Materials and Methods: We performed a cross-sectional study that involved 226 specialists: 187 (82.7%) cardiologists, 23 (10.2%) neurologists, and 16 (7.1%) vascular surgeons. They filled in a questionnaire, specially designed for our study, answering various questions regarding OAC treatment in their daily clinical practice. Results: The mean prescription rate of OACs in AF patients was 80.3% and in DVT/PE—88.6%. One hundred and eighty-seven (82.7%) of the participants stated they see their patients on OAC at least once per month. According to more than one-third of the inquired clinicians, the patients did not understand well enough the provided information concerning net clinical benefit of OAC treatment. About 68% of the clinicians declared that their patients would prefer a “mutual” approach, discussing with the physician the OAC options and taking together the final decision, whereas according to 43 (19.0%), the patients preferred the physician to take a decision for them. Patients’ OAC treatment had been interrupted at least once within the last year due to a physician’s decision by 178 (78.8%) of the participants and the most common reason was elective surgery. The most influential factors for a patient’s choice of OAC were the need of a specific diet to be kept, intake frequency, and possible adverse reactions. Conclusions: Our results suggest that a clinician’s continuous medical education, shared decision-making, and appropriate local strategies for improved awareness of AF/DVT/PE patients are key factors for improvement of OAC management.

Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

The choice of appropriate antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary interventions (PCI) should be approached prudently. Careful consideration is necessary, balancing the ischemic and bleeding risk. Traditionally, triple antithrombotic therapy comprising of aspirin, a P2Y12 inhibitor, and an oral anticoagulant is associated with high bleeding rates. Recent trials have evaluated the safety and effectiveness of dual antithrombotic therapy in AF patients undergoing PCI. These studies have shown a significant reduction in bleeding with no increase in ischemic events. Clopidogrel is the preferred P2Y12 agent in the dual antithrombotic regimens. The novel oral anticoagulants (NOAC) rivaroxaban and dabigatran have been evaluated as part of dual antithrombotic therapy and are preferred options for oral anticoagulation in AF patients undergoing PCI. Studies are in progress to evaluate the role of alternate NOACs in this clinical scenario. This review explores the contemporary management of antithrombotic therapy in AF patients undergoing PCI.

Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation: A systematic review and meta-analysis

BackgroundUse of oral anticoagulant (OAC) therapy in atrial fibrillation (AF) is associated with an inherited risk of bleeding. Benefits and risks of OAC restarting after a major bleeding are still uncertain. We aimed to assess effectiveness and safety of restarting OAC in AF patients after a major bleeding event. MethodsWe performed a systematic review and meta-analysis of all studies reporting data about AF patients that sustained a major bleeding, reporting data on restarting or not restarting OAC therapy. ResultsA total of seven studies were included, involving 5685 patients. No significant difference was found in “any stroke” occurrence between OAC restarters and non-restarters (odds ratio [OR]: 0.75, 95% confidence interval [CI]: 0.37–1.51), with a significant 46% relative risk reduction (RRR) (p < 0.00001) for “any thromboembolism” in OAC restarters, with consistent results when the index bleeding event was an intracranial or gastrointestinal bleeding. A significantly higher risk of recurrent major bleeding was seen (OR: 1.85, 95% CI: 1.48–2.30), but no difference in risk for recurrence of index event. OAC restarters had a 10.8% absolute risk reduction for all-cause death (OR: 0.38, 95% CI: 0.24–0.60); p < 0.00001). Net clinical benefit (NCB) analysis demonstrated that restarting OAC therapy after a major bleeding was significantly associated with a clinical advantage (NCB: 0.11, 95% CI: 0.09–0.14; p < 0.001). ConclusionsRestarting OAC therapy after a major bleeding event in AF was associated with a positive clinical benefit when compared to non-restarting OAC, with a significant reduction in any thromboembolism and all-cause mortality.

Stroke prevention in atrial fibrillation and 'real world' adherence to guidelines in the Balkan Region: The BALKAN-AF Survey.

Data on the management of atrial fibrillation (AF) in the Balkan Region are limited. The Serbian AF Association (SAFA) prospectively investigated contemporary ‘real-world’ AF management in clinical practice in Albania, Bosnia&Herzegovina, Bulgaria, Croatia, Montenegro, Romania and Serbia through a 14-week (December 2014-February 2015) prospective, multicentre survey of consecutive AF patients. We report the results pertinent to stroke prevention strategies. Of 2712 enrolled patients, 2663 (98.2%) with complete data were included in this analysis (mean age 69.1 ± 10.9 years, female 44.6%). Overall, 1960 patients (73.6%) received oral anticoagulants (OAC) and 762 (28.6%) received antiplatelet drugs. Of patients given OAC, 17.2% received non-vitamin K antagonist oral anticoagulants (NOACs). CHA2DS2-VASc score was not significantly associated with OAC use. Of the ‘truly low-risk’ patients (CHA2DS2-VASc = 0 [males], or 1 [females]) 56.5% received OAC. Time in Therapeutic Range (TTR) was available in only 18.7% of patients (mean TTR: 49.5% ± 22.3%). Age ≥ 80 years, prior myocardial infarction and paroxysmal AF were independent predictors of OAC non-use. Our survey shows a relatively high overall use of OAC in AF patients, but with low quality of vitamin K antagonist therapy and insufficient adherence to AF guidelines. Additional efforts are needed to improve AF-related thromboprophylaxis in clinical practice in the Balkan Region.

Suboptimal oral anticoagulant treatment among Chinese non-valvular atrial fibrillation patients: the Nanchang Atrial Fibrillation Project.

Suboptimal oral anticoagulant treatment among Chinese non-valvular atrial fibrillation patients: the Nanchang Atrial Fibrillation Project.

0444: Risk stratification for thromboembolic events in patients with atrial fibrillation and biological valve prosthesis

Current ESC guidelines require anticoagulation with VKA in patients with “valvular atrial fibrillation (AF)”, which includes all types of prosthetic valve. We evaluated the value of the CHA 2 DS 2 -VASc score for thromboembolism risk assessment in AF patients with biological valve replacement. Among 8962 patients with AF seen between 2000 and 2010, 8053 (90%) had "non-valvular AF” and 909 (10%) had valvular AF. Patients with valvular AF had a biological prosthesis in 59% (n=549), among which 77% (n=426) had a single aortic prosthesis and 64% (n=309) received a VKA. Patients with aortic bioprosthesis were older and had a higher CHA 2 DS 2 -VASc score than those with a mitral prosthesis or a double valve replacement. During a follow up of 876±1048 days, 681 stroke/thromboembolic events were recorded. The occurrence of events were similar in patients with bioprosthesis compared to the patients without prosthesis: (hazard ratio HR 1.10, 95% CI 0.83-1.45, p=0.52). Patients with aortic bioprosthesis tended to have a higher risk of embolic events vs other AF patients with bioprosthesis (HR 1.73, 95% CI 0.87-3.45), p=0.12). In multivariate analysis, older age and higher CHA 2 DS 2- VASC score were the only predictors of embolic events whilst the presence of a bioprosthesis was not an independent predictor of events. The CHA 2 DS 2 -VASC score predicted the embolism risk in AF patients with a bioprosthesis (c-statistic 0.55 95% CI 0.47-0.63) but was less efficient than in “non-valvular” AF patient (c-statistic 0.66, 95% CI 0.64-0.67). This “real world” results support the use of oral anticoagulation in AF patients who have bioprosthetic heart valves. It also supports the use of CHA 2 DS 2 -VASc scoring for the risk evaluation of AF patients with bioprostheses, albeit with reduced reliability. Patients with aortic bioprosthesis had a non significant higher risk of embolic events. A higher CHA2DS2-VASc score in these patients is likely to explain these results.

Oral Anticoagulant Prescription in Patients With Atrial Fibrillation and a Low Risk of Thromboembolism: Insights From the NCDR PINNACLE Registry.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated 1 in 4 lifetime risk in those older than 40 years of age and a projected increase in prevalence to approximately 5.6 million affected individuals in the United States by the year 2050 (1,2). In patients with AF at higher risk for thromboembolism, anticoagulation with warfarin (a vitamin K antagonist) or the newer novel anticoagulants reduces morbidity and mortality (3–6). Because oral anticoagulant use carries a risk of bleeding, including potentially fatal intracranial hemorrhage, anticoagulant treatment is not recommended in AF patients at a particularly low risk for stroke. Specifically, previous AF guidelines recommend against the use of oral anticoagulation in patients under 60 years of age without heart disease or other known risk factors for thromboembolism (7), and more recently updated guidelines do not recommend oral anticoagulation in AF patients without any established risk factor for stroke (8). Although it is well known that appropriate oral anticoagulant prescription in AF patients at risk for stroke outside clinical trial settings falls short of guideline-based expectations (9–12), it is unknown whether young and healthy AF patients with the lowest stroke risk are being treated with oral anticoagulation that may increase bleeding risk without a commensurate reduction in stroke risk. To our knowledge, a real-world evaluation of guideline adhering practice patterns of anticoagulation prescription in AF patients with the lowest stroke risk has never been performed. We evaluated the prevalence of oral anticoagulant prescription by cardiovascular specialists in a cohort of outpatients using data from the National Cardiovascular Data Registry (NCDR)’s Practice Innovation and Clinical Excellence (PINNACLE) Registry®. Use of this prospective national registry of cardiovascular care in the United States provides a unique opportunity to examine patterns of oral anticoagulant treatment in routine practice among outpatients as well as clinical predictors of this practice.