Non-vitamin K Oral Anticoagulants In Patients Research Articles

Safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: a prospective cohort study with historical control comparison

Abstract Introduction In adults with congenital heart disease (ACHD), atrial arrhythmias (AA) confer an increased risk of thromboembolic events. Data regarding treatment with non-vitamin K oral anticoagulants (NOACs) of patients with ACHD and AA are limited. Methods A prospective, multicenter, observational study of ACHD patients with AA (atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia) treated with apixaban from 2019 to 2022 was performed (PROTECT-AR, NCT03854149). Comparisons were made with a historical vitamin-K antagonist (VKA) treatment cohort from 2002 to 2014. The primary efficacy endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. Results The apixaban-treated cohort consisted of 215 patients (median follow-up 28 months) and the historical VKA-treated ­cohort consisted of 229 patients with ACHD and AA (median follow-up 48 months). The burden of age and comorbidities was higher in the apixaban versus the VKA treatment group (Table). Comparing the apixaban with the VKA treatment group yielded no significant differences in the annualized rate of stroke or thromboembolism (1.2% vs. 1.4%, respectively; p=0.24) and major bleeding (1.2% vs. 4.4%, respectively; p=0.08) (Figure). Conclusion In ACHD patients with AA treated with apixaban as part of routine care, the risk of major thromboembolic and bleeding events was low. This risk was comparable with historical cohort data on VKA. Prospective studies directly comparing NOAC and VKA-treated patients are needed.

Thromboprophylaxis in Patients With Fontan Circulation

BackgroundThe optimal strategy for thromboprophylaxis in patients with a Fontan circulation is unknown. ObjectivesThe aim of this study was to compare the efficacy and safety of aspirin, warfarin, and nonvitamin K oral anticoagulants (NOACs) in a network meta-analysis. MethodsRelevant studies published by February 2022 were included. The primary efficacy outcome was thromboembolic events; major bleeding was a secondary safety outcome. Frequentist network meta-analyses were conducted to estimate the incidence rate ratios (IRRs) of both outcomes. Ranking of treatments was performed based on probability (P) score. ResultsA total of 21 studies were included (26,546 patient-years). When compared with no thromboprophylaxis, NOAC (IRR: 0.11; 95% CI: 0.03-0.40), warfarin (IRR: 0.23; 95% CI: 0.14-0.37), and aspirin (IRR: 0.24; 95% CI: 0.15-0.39) were all associated with significantly lower rates of thromboembolic events. However, the network meta-analysis revealed no significant differences in the rates of major bleeding (NOAC: IRR: 1.45 [95% CI: 0.28-7.43]; warfarin: IRR: 1.38 [95% CI: 0.41-4.69]; and aspirin: IRR: 0.72 [95% CI: 0.20-2.58]). Rankings, which simultaneously analyze competing interventions, suggested that NOACs have the highest P score to prevent thromboembolic events (P score 0.921), followed by warfarin (P score 0.582), aspirin (P score 0.498), and no thromboprophylaxis (P score 0.001). Aspirin tended to have the most favorable overall profile. ConclusionsAspirin, warfarin, and NOAC are associated with lower risk of thromboembolic events. Recognizing the limited number of patients and heterogeneity of studies using NOACs, the results support the safety and efficacy of NOACs in patients with a Fontan circulation.

Oral anticoagulant treatment in patients with atrial fibrillation early after valvular intervention: a nationwide cohort study

Abstract Background Treatment with non-vitamin K oral anticoagulants (NOAC) is the first option for primary prevention of ischaemic stroke in patients with atrial fibrillation (AF). However, there is still an evidence gap regarding efficacy and safety of NOAC in patients with AF and severe valvular heart disease undergoing valvular intervention. Purpose The aim was to evaluate the efficacy and safety of NOAC or no oral anticoagulant (OAC) treatment versus warfarin during the first 3 months after valvular intervention. Methods We used data from the National Quality Register SWEDEHEART and included all patients with AF discharged after surgical valvular intervention with bioprosthesis or valvuloplasty, or transcatheter aortic valve implantation (TAVI) between 2010 and 2016. Outcomes, including the composite of cardiovascular (CV) events (CV death, ischaemic stroke or systemic embolism), major bleeding, and relevant comorbidities and OAC treatment at discharge were collected from the National Patient Register, the Swedish Prescribed Drug Register, and the National Cause of Death Register. The association between exposure (warfarin, NOAC or no OAC) and occurrence of composite CV events and major bleeding was explored using a time-dependent adjusted Cox regression analysis. Results In total, 4730 patients with AF and valvular intervention were included. The cohort had a mean age of 75 years, 35.9% were women and mean CHA2DS2-VASc score was 3.3 (Table 1). The proportion of patients treated with warfarin was higher in patients undergoing surgical valve intervention whereas NOAC was more commonly prescribed to patients treated with TAVI. Rates of composite CV events and major bleeding was similar between patients treated with NOAC versus warfarin. No OAC treatment versus warfarin was associated with higher rate of composite CV event, but with no difference with regard to major bleeding (Table 1). Conclusion A large proportion of patients with AF undergoing valvular intervention was not treated with OAC despite having a high CHA2DS2-VASc score. Also, patients on no OAC versus warfarin had a higher risk of i CV events in the early phase after valvular intervention. The efficacy and safety of NOAC was similar compared to warfarin during the first 3 months after intervention. Treatment with OAC in patients with AF, irrespective of NOAC or warfarin, was associated with improved clinical outcome early after valve intervention. Funding Acknowledgement Type of funding sources: None.

Abstract 12301: Anticoagulation for Left Ventricular Thrombus: An Updated Meta-Analysis of Stroke or Systemic Embolization Outcomes

Introduction: Thromboembolic events including stroke or systemic embolization (SSE) are the most dreaded complications in patients who develop left ventricular (LV) thrombus. Vitamin K antagonists (VKAs) and non-vitamin K oral anticoagulants (NOACs) have been used in the management of LV thrombus however the efficacy of these treatment strategies have been rarely studied in head-to-head trials. Our aim was to study the differences in embolization outcomes in patients with LV thrombus on either NOACs or VKAs. Methods: A comprehensive search of electronic databases was conducted for studies comparing VKAs and NOACs in patients with LV thrombus. Event level data were extracted from studies for each arm and used to calculate the risk ratio (RR) with 95% confidence intervals (CI) which were pooled for the effect of original treatment allocation on the outcome of SSE. Random effects model was used to calculate the risk ratio. Results: We found a total of 12 studies from which 2281 patients were identified with LV thrombus and were treated with anticoagulation. 596 (26.13%) received NOACs and 1685 (73.87%) received VKAs. Events of SSE occurred in 92 (15.44%) patients on NOACs and 307 (18.22%) patients on VKAs. Overall, patients treated with NOACs had similar rate of SSE events as compared to patients treated with VKAs using random effects model (RR: 1.02 [95% 0.64-1.65], p=0.08, I 2 =39%). Conclusions: This meta-analysis suggests that the use of NOACs is associated similar rate of SSE events in patients with LV thrombus as compared to the use of VKAs. Additional prospective studies are required to determine the most effective anticoagulant strategy for patients with LV thrombus.

Non-vitamin K oral anticoagulants in hypertrophic cardiomyopathy patients undergoing catheter ablation of atrial fibrillation.

Patients with hypertrophic cardiomyopathy (HCM) and atrial fibrillation (AF) require chronic anticoagulation due to high thromboembolic risk. Evidence supporting the use of non-vitamin K oral anticoagulants (NOACs) in patients with HCM remains sparse, and there are no data regarding the use of NOACs in patients with HCM undergoing catheter ablation of AF. Observational nonrandomized study in four European centers. We aimed to investigate the safety and efficacy of NOACs compared with vitamin K antagonists (VKAs) in patients with HCM undergoing catheter ablation for AF. A total of 137 patients with HCM (mean age: 55.0 ± 13.4, 29.1% female) underwent 230 catheter ablations for AF (1.7 ± 1.0 per patient). A total of 55 patients (39.4%) underwent 70 procedures (30.4%) on NOAC, while the remaining were on VKA. Warfarin (97.6%) and rivaroxaban (56.4%) were the most frequently used agents in the respective groups. No procedure-related deaths were reported. We observed no significant difference in the rate of thromboembolism (VKA: 0.6%; NOAC: 0%; p = 1.0) or minor bleeding (VKA: 0.6%; NOAC: 1.4%; p = .54). There was a nonsignificant trend towards a lower incidence of major bleeding (VKA: 6.9%; NOAC: 1.4%; p = .09). These preliminary data suggest that NOACs are at least as safe and effective as VKAs in patients with HCM undergoing catheter ablation for AF.

Percutaneous left atrial appendage closure versus non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk.

A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for non-vitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED ≥3). All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p<0.001) and lower CHADS-VASc (4.3% vs 4.7%, p=0.005) scores. After 1:1 PSM, 192 patients were enrolled in the final analysis (LAAO n=96; NOACs n=96). At two-year follow-up, no significant differences in thromboembolic (7.3% vs 6.3%, p=0.966) and ISTH major bleeding event rates (6.7% vs 4.8% p=0.503) were found between the two unmatched groups. All-cause death was significantly higher in the LAAO group (18.7% vs 10.6%; p=0.049). After PSM, all-cause death, thromboembolic and ISTH major bleeding event rates were similar between the groups. Significant independent predictors of all-cause death were dialysis (HR 5.65, 95% CI: 2.16-14.85, p<0.001) and age (HR 1.08, 95% CI: 1.05-1.13, p<0.001). In NVAF patients at HBR, LAAO and NOACs performed similarly in terms of thromboembolic and major bleeding events up to two-year follow-up. Our findings warrant further investigation in randomised trials and therefore can be considered as hypothesis-generating.

Ne-vitamin K oralni antikoagulansi (NOAK) kod bolesnika sa moždanim udarom i atrijalnom fibrilacijom

Patients with atrial fibrillation who had a previous transient ischemic attack or ischemic stroke had a significantly high risk of stroke recurrence and the introduction of oral anticoagulants should be mandatory. However, the long-term use of oral anticoagulants increases the risk of developing all types of intracranial hemorrhages. The advantages of non-vitamin K oral anticoagulants (NOACs) compared to warfarin are that they have a significantly lower risk for hemorrhagic stroke. They are preferred in elderly patients, those with small vessel disease, or those with previous intracerebral hemorrhage. The time of NOACs introduction after an ischemic stroke depends on its severity and the rule "1-3-6-12" days should be applied. The reintroduction of NOACs in patients with atrial fibrillation and previous intracerebral hemorrhage depends on its etiology and should be after about 4-8 weeks if the cardioembolic risk is high and the risk for intracranial hemorrhage small.

P4743Inappropriate dosing of non-vitamin K oral anticoagulants (NOACs) in atrial fibrillation patients in Europe

Abstract Background Prescription of Non-vitamin K oral anticoagulants (NOACs) has increased since the first therapies were launched in Europe in 2011, and they are becoming the standard of care in prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). There are concerns about inappropriate NOAC dosing in clinical practice. Purpose This paper examines the extent of inappropriate dose prescription among NOAC patients in Germany, Italy, Spain and United Kingdom. Inappropriate dosing refers to patients who do not meet the criteria for dose reduction (under-dose) or patients who should be on the reduced dose as they meet the criteria for dose reduction (overdose). Methods Ipsos' Stroke Prevention in Atrial Fibrillation Therapy Monitor was fielded for 6 weeks between January 2017 to February 2017 and 6 weeks between January 2018 to March 2018, with 450 treating doctors in 2017 and 509 in 2018 providing data from 5,692 (2017: n=2,497, 2018: n=3,195) patients with non-valvular atrial fibrillation in Europe. We analysed the results for the 3,477 patients with a NOAC prescription that had sufficient data to decide on the appropriate dose. Results Overall, 23.4% of patients (n=813) were receiving an inappropriate dose of dabigatran, rivaroxaban, apixaban or edoxaban. Receiving an under-dose was more common than an overdose (19.2% vs 4.2%). Ipsos data indicate 32.8% of NOAC patients in EU4 (n=1,139) were prescribed a reduced dose, and Italy had a higher proportion of patients who received a reduced dosed; Italy: 41.0% (n=345), Germany: 30.2% (n=402), Spain: 30.6% (n=216) and UK: 29.4% (n=176). Among these patients, a considerable proportion did not meet the criteria for dose reduction in EU4 (58.6%). This suggests that reduced dose is frequently prescribed to patients when not indicated. Conclusion Overall, the majority of patients were prescribed a correct dose according to the product label. However, we see evidence that nearly half of patients receiving a reduced dose were not indicated for a dose reduction. Further research is needed to identify reasons prompting the over-use of reduced dose.

Changes in Oral Anticoagulation Therapy over One Year in 51,000 Atrial Fibrillation Patients at Risk for Stroke: A Practice-Derived Study.

This study assessed changes in anticoagulation therapy over time in patients with atrial fibrillation (AF). Analyses were performed on a claims-based dataset of 4 million health-insured individuals. The study population consisted of patients newly initiating a non-vitamin-K oral anticoagulants (NOACs) or vitamin K antagonist (VKA) for AF between 2013 and 2016. The study outcomes consisted of the proportion of patients who had (1) discontinued OAC treatment, (2) switched from VKA to NOAC, (3) switched from NOAC to VKA or (4) switched from one NOAC to another. Predictors of discontinuation or switching of OAC treatment were determined by Cox proportional hazards regression models with time-independent and time-dependent covariates. The study population comprised 51,606 AF patients initiating VKA (n = 21,468, 41.6%), apixaban (n = 8,832, 17.1%), dabigatran (n = 3,973, 7.7%) or rivaroxaban (n = 17,333, 33.6%). After 1 year, 29.9% of VKA and 29.5% of NOAC patients had discontinued OAC treatment without switching to another anticoagulant. A total of 10.7% of VKA patients switched to NOACs within 1 year, whereas 4.9% NOAC patients had switched to VKA. Of AF patients who were initiated on a NOAC, 5.2% switched to another NOAC. Treatment changes among NOAC starters were strongly associated with occurrence of stroke, myocardial infarction and gastrointestinal bleeding after treatment initiation. For VKA starters switching to a NOAC, stroke and bleeding events were associated with an increased likelihood of switching. Overall discontinuation rates of VKA and NOACs are comparable over the first year of therapy, while switching from VKA to NOAC was more common than from NOAC to VKA. The majority of treatment changes were associated with clinical events.

Acute Lower Gastrointestinal Bleeding in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice: Characteristics and Clinical Outcome.

BackgroundAcute lower gastrointestinal bleeding (ALGIB) can occur in patients on anticoagulant therapy (either warfarin or non-vitamin K oral anticoagulants (NOACs)). Use of NOACs has been increasing compared to warfarin in recent years. We analyzed patients with ALGIB on anticoagulation therapy and compared characteristics, management and clinical outcome in patients treated with NOACs versus warfarin.MethodsAll patients with ALGIB on anticoagulation therapy treated in two (affiliated) centers during a 7-year period were evaluated. Characteristics and clinical outcome were compared between patients on warfarin and patients on NOACs.ResultsOut of the 587 patients identified with ALGIB during the study period, 43 (7.3%) were on NOACs and 68 (11.6%) on warfarin. Mean age was 75.9 ± 9.5 and 77.1 ± 7.9 years respectively. Site of bleeding was located in the small bowel in 2/43 of NOAC patients and 6/68 of warfarin group. Vascular ectasias (8/43 vs. 6/68, P = 0.010) and polyps/neoplasia (13/43 vs. 6/68, P = 0.025) were more commonly causes of bleeding in patients on NOACs. While endoscopic hemostasis was more commonly needed in patients on NOACs (17/43 vs. 14/68, P = 0.049), they required less hospitalization days (4.5 ± 3.6 vs. 6.1 ± 4.2, P = 0.032). Blood transfusions and need for other interventions (embolization and/or surgery) as well as recurrence of bleeding and mortality were not statistically different.ConclusionsAlthough NOAC patients with ALGIB exhibit some differences on certain clinical characteristics when compared to warfarin patients, they share a similar clinical outcome.

Changes in renal function and occurrence of contrast-induced nephropathy after percutaneous coronary interventions in patients with atrial fibrillation treated with non-vitamin K oral anticoagulants or warfarin.

IntroductionPatients with atrial fibrillation (AF) receiving non-vitamin K oral anticoagulants (NOAC) have a slower decline in renal function than those taking warfarin. Moreover, a warfarin-related nephropathy has been described.AimWe assessed variation of estimated glomerular filtration rate (eGFR) and occurrence of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) in patients with AF taking warfarin compared with NOAC.Material and methodsWe retrospectively enrolled consecutive patients taking oral anticoagulation for AF undergoing PCI. The primary endpoint was variation in eGFR and serum creatinine levels within 48–72 h after PCI. The secondary endpoint was occurrence of CIN, defined as a ≥ 25% relative increase, or a ≥ 0.5 mg/dl absolute increase, in serum creatinine levels within 48–72 h.ResultsWe enrolled 420 patients (mean age: 75.0 ±5.5 years, 272 (64.7%) male), 124 (29.5%) treated with NOAC and 296 (70.5%) with warfarin. NOAC patients showed a reduced decline in renal function (eGFR change: –2.8 ±7.9 ml/min/1.73 m2 vs. –4.5 ±6.5 ml/min/1.73 m2, respectively, p = 0.02) and a smaller increase in serum creatinine levels (0.026 ±0.112 vs. 0.055 ±0.132, p = 0.032) after PCI compared with warfarin. In the multivariate linear regression model independent predictors of eGFR changes were diabetes, baseline eGFR ≤ 60 ml/min/1.73 m2 and warfarin use. Occurrence of CIN did not differ between NOAC and warfarin patients (13 (10.5%) vs. 46 (15.5%), p = 0.22).ConclusionsPatients with AF taking NOAC have a reduced decline in renal function after PCI compared with warfarin. The NOAC may be a reasonable option for patients with a high risk of developing CIN.

Management of Oral Anticoagulant-associated Intracerebral Hemorrhage

Introduction: Oral anticoagulant-associated intracerebral hemorrhages (OAC-ICHs) account for nearly 20% of all ICH and are associated with high mortality. The number of patients with an indication for oral anticoagulant therapy (OAT) is increasing with the aging population; therefore, despite the improved safety profile of non-vitamin K oral anticoagulants (NOACs), the number of patients with OAC-ICH will increase. OAT was simplified with the introduction of NOACs, which are easy to handle and show a favorable risk-benefit profile. The rate of ICH is lower than for vitamin K antagonists (VKA) and routine coagulation testing is not required. Nevertheless, OAC-ICH does occur and is still a devastating disease, thus representing the most feared complication in OAT, irrespective of treatment with VKA or NOAC. Purpose: The aim of this article is to address the clinical problem of bleeding management in patients with ICH due to OAC and will consider anticoagulation with NOAC and VKA. Recommendations: Restoring coagulation as soon as possible is the main goal and, therefore, knowledge of the actual coagulation status is essential. In VKA-associated ICH, the international normalized ratio (INR) should be lowered to below 1.3. However, laboratory measurement of anticoagulant activity in NOAC patients is more complex, rendering OAC-ICH treatment more complicated. The best assays are specialized and not widely available, whereas more accessible tests such as prothrombin time and activated partial thromboplastin time have important limitations. For VKA-ICH, prothrombin complex concentrate (PCC) should be administered to reverse the INR. For dabigatran-related ICH, 5 g idarucizumab should be administered. For factor Xa inhibitors, PCC is recommended in the absence of andexanet alfa as soon as an OAC-related ICH evolves. Resuming OAC after ICH should be considered, depending on risk factors and a risk-benefit evaluation.

Non-Vitamin K Oral Anticoagulants Associated Bleeding and Its Antidotes.

Oral anticoagulant-associated intracerebral hemorrhage (OAC-ICH) accounts for nearly 20% of all ICH. The number of patients with an indication for oral anticoagulant therapy (OAT) increases with increasing age. OAT became less complicate with the introduction of non-vitamin K oral anticoagulants (NOAC) OAT because of easier handling, favorable risk-benefit profile, reduced rates of ICH compared to vitamin K antagonists and no need for routine coagulation testing. Consequently, despite a better safety profile of NOAC the number of patients with OAC-ICH will increase. The mortality and complication rates of OAC-ICH are high and therefore they are the most feared complication of OAT. Immediate normalization of coagulation is the main goal and therefore knowledge of pharmacodynamics and coagulation status is essential. Laboratory measurements of anticoagulant activity in NOAC patients is challenging as specific tests are not widely available. More accessible tests such as the prothrombin time and activated partial thromboplastin time have important limitations. In dabigatran-associated ICH 5 g Idarucizumab should be administered. In rivaroxaban and apixaban-associated ICHs administration of andexanet alpha should be considered. Prothrombin complex concentrate may be considered if andexanet alpha is not available or in case of an ICH associated with edoxaban.

Antithrombotic Therapy After TAVR.

Transvascular Aortic Valve Replacement (TAVR) has emerged as a treatment option in patients with severe aortic stenosis who are inoperable and has recently been evaluated in patients with intermediate surgical risk. The number of procedures is increasing worldwide in parallel with the demographic changes in industrial countries. The risk for cerebral embolism is of main concern and represents a major determinant for prognosis and quality of live after TAVR. The empiric antithrombotic therapy consists of Dual Antiplatelet Therapy (DAPT); However the risk-benefit of this approach is lacking evidence from randomized, placebo-controlled trials regarding choice and duration of antithrombotic treatment. Although anticoagulation is generally not recommended in patients with aortic bioprosthesis without atrial fibrillation, there is current uncertainty whether combination of antiplatelet and anticoagulant therapy or anticoagulation alone might represent a more favorable antithrombotic regimen compared to the current empiric standard of DAPT. In addition, so far undetected atrial fibrillation is highly prevalent in the elderly population undergoing TAVR. In particular, the favorable safety profile of Non-Vitamin K Oral Anticoagulants (NOAC) offers an attractive option. A number of trials are currently underway to investigate the benefit of NOAC in patients with and without atrial fibrillation undergoing TAVR. The present article reviews the available evidence concerning stroke risk in TAVR patients and the current and future role of antithrombotic therapy during and after the procedure.

Prescription Patterns of Non-Vitamin K Oral Anticoagulants Across Indications and Factors Associated with Their Increased Prescribing in Atrial Fibrillation Between 2012-2015: A Study from the Norwegian Prescription Database.

We studied prescription patterns for non-vitamin K oral anticoagulants (NOACs) in Norway between 2012 and 2015, and compared NOAC and warfarin patient characteristics such as age, gender and cardiovascular (CV) co-medications across reimbursed indications. Factors associated with NOAC prescribing in atrial fibrillation (AF) were also analysed. All Norwegian patients (N=156,124) who received at least one dispensed NOAC or warfarin prescription within the indications of AF, deep vein thrombosis and pulmonary embolism (DVT_PE) or prevention of venous thromboembolic events after a hip or knee surgery (VTE_surg) between 2012 and 2015 were included in the study. Descriptive statistics was applied to compare patient characteristics between NOACs and warfarin across indications and a logistic regression model was used to identify factors associated with NOAC prescribing in AF. NOACs and warfarin were most commonly prescribed in AF (83,729 patients in 2015), followed by DVT_PE (16,077 patients) and lastly in VTE_surg (4060 patients). In 2015, NOACs achieved a dominant (>50%) patient share over warfarin in AF and DVT_PE, and were prescribed in>80% of new oral anticoagulation (OAC) patients. Apixaban, despite its delayed market entry, emerged as the preferred NOAC in VTE_surg (46% share), whereas rivaroxaban captured a 43% patient share in DVT_PE. Warfarin patients were on average older and received more CV co-medication than NOAC patients in AF and DVT_PE. Age, gender and certain CV co-medications emerged as significant predictors of NOAC prescribing in AF. AF patients <70years old had higher odds of NOAC prescribing (OR 1.19-1.29, depending on age category), in contrast to patients >74years old (OR 0.51-0.77). Women had 32% higher odds of receiving a NOAC in AF. NOACs achieved a dominant market share over warfarin within 3years from receiving reimbursement in Norway. There were significant differences in patient characteristics between drugs and indications.

Gastrointestinal endoscopy in patients receiving novel direct oral anticoagulants: results from the prospective Dresden NOAC registry.

Patients receiving direct-acting, non-vitaminK oral anticoagulants (NOAC) frequently undergo gastrointestinal endoscopies (GIE) but little is known on the management and outcome of these interventions. With use of data from an ongoing, prospective, noninterventional registry of NOAC patients, the management and outcome of GIE were evaluated with use of standard event definitions. Patients undergoing GIE were categorized into two subgroups: (1) scheduled GIE (scheduled appointment, no acute bleeding) and (2) unscheduled GIE (unscheduled including management of acute gastrointestinal bleeding). The rates of major bleeding complications, cardiovascular complications, and all-cause death within 30days after the procedure were evaluated. Between October 1, 2011, and March 31, 2015, 492 patients underwent a total of 713 GIE (44.5% gastroscopies, 53.0% colonoscopies, 2.5% endoscopic retrograde cholangiopancreatography procedures), with 70.0% being scheduled procedures and 30.0% being unscheduled procedures. Endoscopies were performed within 24h after the last NOAC intake in 45 of 713 cases (6.3%), between 24 and 48h after the last intake in 336 cases (47.1%), and after NOAC therapy interruption for more than 48h in 213 cases (29.9%). Heparin bridging therapy was used in 180 of 713 procedures (25.3%) and predominantly (170/180; 94.4%) in cases of NOAC therapy interruption for longer than 72h. Until day 30 after the procedure, the event rates were 1.4% for cardiovascular events and 0.7% for major bleeding events. Continuation or short-term interruption of NOAC therapy seems to be a safe strategy for GIE. Heparin bridging therapy is predominantly used in cases of prolonged NOAC therapy interruption.

Periprocedural Management of Novel Oral Anticoagulants During Atrial Fibrillation Ablation: Controversies and Review of the Current Evidence

Oral anticoagulation (OAC) has been the cornerstone for the prevention of thromboembolic complications in patients with atrial fibrillation (AF) at significant risk of stroke. Catheter ablation is an established efficacious technique for the treatment of AF. Ameliorating the risk of stroke or transient ischaemic attack (TIA) in patients with AF undergoing ablation requires meticulous planning of pharmacotherapy. The advent of non-vitamin K oral anticoagulants (NOACs) has broadened the therapeutic scope, representing a viable alternative to traditional vitamin K antagonists (VKA) in non-valvular AF. Potential advantages of NOACs include greater pharmacokinetic predictability, at least comparable efficacy as compared to VKA and a superior haemorrhagic complication profile. However, robust evidence for the safety and efficacy of periprocedural NOAC use for AF ablation remains uncertain with a non-uniform clinical approach between and within institutions. The following review will summarise the current and emerging evidence on periprocedural management of NOACs in patients undergoing catheter ablation of AF. An overview of NOAC pharmacology will provide a foundation for the review of reversal agents in the context of catheter ablation of AF. The purpose of the review is to outline key studies and identify key areas for further critical research with the ultimate aim of developing evidence-based guidelines for optimal care.

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.