Oral Anticoagulants vs. Aspirin for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation: The Verdict is in

There is an increased risk of stroke and other cardiovascular events in patients with atrial fibrillation (AF). Three meta-analyses of randomized clinical trials (RCTs) comparing oral anticoagulants (OAC) with aspirin (ASA) arrived at different conclusions regarding the relative efficacy of these agents to prevent ischemic stroke in AF patients. This article summarizes a recently published individual patient meta-analysis of all published RCTs comparing OAC and ASA in AF. In total, 4052 patients randomized to OAC or ASA were similar regarding important prognostic factors. Patients receiving OAC had a significantly lower risk of any stroke (hazard ratio [HR] 0.54 [95% CI 0.43-0.71]), ischemic stroke (HR 0.48 [0.37-0.63]), or cardiovascular events (HR 0.71 [0.59-0.85]). Patients receiving OAC were more likely to experience major bleeding (HR 1.71 [1.21-2.41]). The benefit of OAC was most prominent in patients at a high risk of stroke and other cardiovascular events, such as patients with hypertension, diabetes, or previous cerebrovascular events. Overall, OAC improves outcomes for cardiovascular events in AF patients but modestly increases the absolute risk of major bleeding. Since high-risk AF patients appear to benefit most from OAC, determining stroke risk in AF patients is very important.     

Left atrial appendage closure: A therapy uniquely suited for specific populations of patients with atrial fibrillation

Atrial fibrillation (AF) is the most common clinically relevant arrhythmia and confers a fivefold increased risk for stroke. Cardioembolic stroke secondary to AF is a devastating event, but is largely preventable with appropriate oral anticoagulation (OAC). The PROTECT and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage closure (LAAC) device in combination with short‐term warfarin therapy is noninferior to long‐term warfarin with respect to a composite endpoint of stroke, cardiovascular death, and systemic embolism. Importantly, the WATCHMAN confers a significant reduction in life‐threatening bleeding compared to OAC. Although direct‐acting oral anticoagulant (DOAC) are superior to warfarin in eligible patients, several important AF populations exist in whom left atrial appendage (LAA) closure may be preferable to DOAC. Populations warranting strong consideration of LAAC include patients with contraindications to DOAC, end‐stage renal disease, prior intracranial hemorrhage, recurrent gastrointestinal bleeding, and patients undergoing transcatheter aortic valve replacement or left atrial electrical isolation. Device‐related thrombosis is an important complication of LAAC, and DOAC may be preferential to warfarin for prevention and treatment of this complication remains unexplored. Prospective clinical trials comparing DOAC to LAAC in these unique populations are either ongoing or needed.     

Perkutaner Vorhofohrverschluss

Atrial fibrillation (AF) is the most common form of cardiac arrhythmia affecting up to 10–15?% of the population aged over 80 years. Oral anticoagulation (OAC) is necessary in the majority of AF patients for prevention of left atrial thrombus formation and thromboembolism of cardiac origin which are responsible for approximately 20–30?% of strokes. Thus, a considerable risk reduction can be achieved; however, OAC is associated with an increased bleeding risk. Many AF patients are not treated by OAC due to a history of bleeding complications or an increased bleeding risk. As over 90?% of thrombi in non-valvular AF develop in the left atrial appendage (LAA) percutaneous occlusion of the LAA is an alternative concept for the prevention of cardiovascular thromboembolism in AF patients. Currently, the most widely used occlusion devices are the WATCHMAN device and the Amplatzer Cardiac Plug. Available data records indicate that closure of the LAA is as equally effective as OAC. Moreover, with increasing experience percutaneous occlusion of the LAA can be performed with low complication rates. Therefore, according to the current guidelines of the European Society of Cardiology (ESC) this intervention is recommended as an alternative therapy, especially in patients with a high stroke risk and contraindications for OAC.     

Antithrombotic Therapy for Atrial Fibrillation and Coronary Disease Demystified

Atrial fibrillation (AF) is a progressive chronic disease characterized by exacerbations and periods of remission. It is estimated that up to 20% to 30% of those with AF also have coronary artery disease (CAD), and 5% to 15% will require percutaneous coronary intervention (PCI). In patients with concomitant AF and CAD, management remains challenging and requires a careful and balanced assessment of the risk of bleeding against the anticipated impact on ischemic outcomes (AF-related stroke and systemic embolism, as well as ischemic coronary events). Oral anticoagulation (OAC) is indicated for the prevention of AF-related stroke and systemic embolism, whereas antiplatelet therapy is indicated for the prevention of coronary events. Each offers a relative efficacy benefit (dual antiplatelet therapy [DAPT] is more effective than OAC alone in reducing cardiovascular death, myocardial infarction, stent thrombosis, and ischemic coronary events in a population with acute coronary syndromes [ACS]), but with a relative compromise (DAPT is significantly inferior to OAC for the prevention of stroke/systemic embolism in an AF population at increased risk of stroke). The purpose of this review is to explore the current evidence and rationale for antithrombotic treatment strategies in patients with both AF and CAD. Specifically, there is a focus on how to best tailor the therapeutic choices (OAC and antiplatelet therapy) to individual patients based on their underlying coronary presentation.     

Dual Antiplatelet Therapy in the Anticoagulated Patient Undergoing Percutaneous Coronary Intervention Risks,Benefits, and Unanswered Questions

A commonly encountered scenario is the patient with atrial fibrillation (AF) on oral anticoagulation (OAC) who either develops an acute coronary syndrome or has to undergo percutaneous coronary intervention with stent placement. In such patients, separate indications suggest combining OAC and dual antiplatelet therapy (DAPT). This approach, however, increases the risk of bleeding as well as thromboembolic risk if bleeding does not occur. For optimal clinical results, the risks and benefits of all possible treatment options should be determined based on the best available data. This review provides an overview of the most recent data regarding the optimal treatment of AF patients with an indication for combined treatment with OAC and DAPT.     

An overview of current and emerging devices for percutaneous left atrial appendage closure

Atrial fibrillation (AF) is common and is a prominent risk factor for ischemic stroke. Oral anticoagulant (OAC) therapy has been the main strategy for stroke prevention in AF patients; however, OAC therapy carries a bleeding risk and is not tolerated by all patients. Left atrial appendage (LAA) closure offers a non-pharmacological alternative for stroke prevention in patients with non-valvular AF. In this update, an overview of current and emerging LAA occluders is given – with special attention to the key design features of every single device and, if available, preclinical or clinical data.     

Oral anticoagulation during atrial fibrillation ablation: Facts and controversies

On the background of population ageing atrial fibrillation (AF) has reached epidemic dimensions in developed countries. This condition is associated with major cardiovascular morbidity and mortality mainly due to its thrombo-embolic and heart failure related complications. Left atrial (LA) catheter ablation has emerged as a suitable alternative to antiarrhythmic drugs for sinus rhythm maintenance at least for paroxysmal atrial fibrillation in the settings of no/mild LA dilatation. Chronic oral anticoagulation (OAC) is helpful to prevent AF thromboembolic complications in high-risk patients. OAC is also protective around ablation procedures in patients with or without an indication for long-term OAC therapy, emphasizing a slight increase in periprocedural risk of stroke. Due to the potential catastrophic hemorrhagic complications during trans-septal LA instrumentation, traditional approach on LA ablations involved warfarin discontinuation with periprocedural heparin bridging. Recent observational data suggests that radiofrequency (RF) catheter ablation of AF under therapeutic OAC (mainly vitamin K antagonists [VKA]) may reduce the periprocedural risk of complications, mainly thromboembolic events (possibly including silent strokes). Uninterrupted OAC has been acknowledged as an alternative to heparin bridging by the recently published consensus and guidelines update on AF ablation. Currently the recommended therapeutic level of OAC during ablation is low (such as an INR of 2–2.5). In the general AF settings new OAC (NOAC) have shown non-inferiority compared to VKA for stroke prevention, with better safety. Rapidly acting NOAC seems a tempting alternative to VKA at least for the patients taken off OAC before the ablation, possibly avoiding any post-procedural heparin bridging. However, limited experience with periprocedural use of NOAC (mainly dabigatran) suggests an increased risk of bleeding or thromboembolic complications compared with VKA.     

Anticoagulation With or Without Antiplatelet Therapy Following Transcatheter Aortic Valve Replacement for Patients With Atrial Fibrillation: A Meta-Analysis

BackgroundAlthough current guidelines recommend oral anticoagulants (OAC) with or without antiplatelet therapy (APT) following transcatheter aortic valve replacement (TVAR) in patients with an indication for long-term anticoagulation therapy, the optimal antithrombotic strategy remains unknown in these population. Herein, we conducted a meta-analysis comparing the outcome of OAC alone versus OAC with APT following TAVR in patients with atrial fibrillation (AF).MethodsMEDLINE and EMBASE were searched through May 2020 to identify clinical trials that investigated OAC alone versus OAC with APT following TAVR in patients with AF. From each study, we extracted the hazard ratios (HRs) or risk ratios of major or life threatening bleeding, stroke, all-cause mortality and cardiovascular mortality.Results1 randomized controlled trial and 3 observational studies were identified, which enrolled a total of 2032 patients with AF who underwent TAVR assigned to the OAC group (n = 722) or OAC with APT group (n = 1310). Pooled analyses demonstrated the rate of major or life threatening bleeding was significantly lower in the OAC group compared to the OAC with APT group (HR [95% Confidence Interval [CI] = 0.54 [0.38–0.77], P = .0006]). However, the rate of stroke was similar in both groups (HR [95% CI] = 1.22 [0.80–1.87], P = .36). All-cause and cardiovascular mortalities were also similar in both groups.ConclusionsWe observed that OAC with APT following TAVR in patients with AF increased the risk of bleeding compared to OAC alone without decreasing the risk of stroke.     

Association of anticoagulant-related bleeding events with cancer detection in atrial fibrillation: A systematic review and meta-analysis

BackgroundA bleeding episode may herald cancer in the general population. Oral anticoagulants (OACs), the mainstay treatment for atrial fibrillation (AF), are known to increase the risk of bleeding, and may thus promote an earlier diagnosis of cancer. Data regarding the association of bleeding episodes with cancer in patients with AF on OACs are scarce.MethodsIn this systematic review and meta-analysis, we searched electronic databases (Medline, Scopus, and Central) and gray literature sources for studies of patients with nonvalvular AF under any OAC, from inception until 14 October 2020. The primary outcome was the association of bleeding occurrences with the detection of cancer. A subgroup analysis was performed according to OAC type [NOAC (non-vitamin K oral anticoagulant) versus VKA (vitamin K antagonist)].ResultsOverall, 4 studies were included, accounting for a total of 144,362 patients with AF receiving OAC. During follow-up, 816 (0.57%) cases of cancer were confirmed. The presence of a bleeding event, either major or minor, was associated with a higher risk for cancer detection (odds ratio [OR] 8.79, 95% confidence interval [CI] 4.98-15.51, and I² 85%). Heterogeneity was explained after studies were stratified by the type of OAC (NOACs: OR 6.12, 95% CI 4.47-8.37, I² 0%, VKAs: OR 15.16, 95% CI 12.61-18.23, and I² 0%).ConclusionThe detection of a bleeding event could be an alerting sign of cancer in patients with AF on OACs, particularly in patients receiving VKAs.Registration number (DOI)available in https://doi.org/10.17605/OSF.IO/3948R, DOI: 10.17605/OSF.IO/3948R.     

Management der interventionellen Therapie von Patienten mit akutem Koronarsyndrom und Vorhofflimmern

Atrial fibrillation (AF) is a common arrhythmia following acute myocardial infarction and the overall percentage observed in previous studies ranges between 10 and 12%. Acute coronary syndrome (ACS) and AF are associated with a higher in-hospital and long-term mortality. Predisposing factors are higher bleeding complications, higher incidence of stroke, heart failure and cardiogenic shock. Access site complications can be significantly reduced using the transradial approach for PCI which improves the clinical outcome of these patients. Stroke is an important complication in patients hospitalized with ACS. The incidence of acute stroke in patients with ACS and AF varies between 0.5 and 1.3%. The increasing use of drug-eluting stents (DES) to minimize in-stent restenosis necessitates long-term dual antiplatelet therapy with aspirin plus a thienopyridine (at present most frequently clopidogrel) to reduce the risk of early and late stent thrombosis. Combined aspirin-clopidogrel therapy, however, is less effective in preventing stroke compared with oral anticoagulation (OAC) alone—and OAC alone is insufficient to prevent stent thrombosis. In patients with ACS and AF a triple therapy consisting of aspirin, clopidogrel and OAC (INR 2.0–2.5) is recommended according to the risk stratification (CHA₂DS₂-VASc score), the bleeding risk (HAS-BLED score), and the implanted stent (DES vs BMS). Triple therapy is associated with a higher bleeding risk and should be administered as briefly as necessary. Using beta-blockers, ACE inhibitors, direct current cardioversion or intravenous administration of amiodarone may reduce the incidence of AF and restore sinus rhythm which can reduce the duration of triple therapy.     

Atrial fibrillation patient preferences for oral anticoagulation and stroke knowledge: Results of a conjoint analysis

Background

Guidelines recommend that patients with atrial fibrillation (AF) are involved in oral anticoagulant (OAC) treatment decisions. Understanding which OAC attributes AF patients value most could help optimize treatment.

Objective

To assess the relationship between patient's stroke knowledge and their preferences for specific OAC attributes.

Methods

A cross‐sectional online survey was conducted in patients with nonvalvular AF taking an OAC for stroke prevention in the United States, Canada, Germany, France, and Japan. Patients were asked about their stroke knowledge, perception of the seriousness of AF and concern about stroke, and to rank 7 OAC attributes in order of importance. A conjoint analysis was performed to determine the inherent value of 4 attributes.

Results

In total, 937 patients (mean age [standard deviation] 54.3 [16.6] years; 37.1% female) participated. Of these, 19.5%, 27.9%, and 29.8% had good, moderate, and low stroke knowledge, respectively; 22.8% had no stroke knowledge. Overall, 39.4% of patients (47.5% with good stroke knowledge) perceived AF as very/extremely serious. The OAC attribute ranked as most important was stroke prevention followed by major bleeding risk, other side effects, dosing frequency, antidote availability, dietary restrictions, and use with/without food. In the conjoint analysis, stroke risk reduction was the most valued property, followed by reduction in major bleeding risk, less frequent administration, and administration with/without food. Preferences did not differ with level of stroke knowledge, perception of seriousness of AF, concern of stroke, or medication burden.

Conclusions

Most AF patients consider efficacy and safety to be the most important OAC attributes, whereas dosing frequency was deemed as less important.     

Discontinuing anticoagulation following successful atrial fibrillation ablation in patients with prior strokes

Purpose

This study was conducted to examine the outcomes in patients with prior stroke/transient ischemic attack (CVA/TIA) after atrial fibrillation (AF) ablation and the feasibility of discontinuing oral anticoagulation (OAC).

Methods

This study examined long-term outcomes following AF ablations in 108 patients with a history of prior thromboembolic CVA/TIA. Because of risks of OAC, we frequently discontinue OAC in these patients after successful ablation. These patients understand the risks/benefits of discontinuing OAC and remain on OAC for a longer time following successful AF ablation, compared to our patients without prior CVA/TIA.

Results

Patient age was 66.2?±?9.0 years with an average CHADS₂ score?=?3.0?±?0.9 and CHA₂DS₂-VASc score?=?4.1?±?1.4. Following 1.24 ablations, 71 (65.7 %) patients were AF free 2.8?±?1.6 (median 2.3)?years after their last ablation. OAC was discontinued in 55/71 (77.5 %) patients an average of 7.3 months following the final ablation. These 55 patients had 2.2?±?1.3 (median 1.8)?years of follow-up off of OAC. Kaplan–Meier analysis suggests little AF recurrence >1 year following initial or final ablations, suggesting that 1 year post successful ablation may be the appropriate time to consider discontinuing OAC. Thirty-seven patients had AF postablation, and 32/37 (86.5 %) remained on OAC. One patient with a mechanical valve had a stroke despite OAC. Bleeding occurred in 8.3 % of patients on OAC and 0 % of patients off OAC (P?=?0.027).

Conclusions

Patients with prior CVA/TIAs, who undergo successful AF ablation, have a low incidence of subsequent thromboembolic events. Most patients who appear AF free postablation may be able to discontinue OAC after successful ablation with a low thromboembolic risk and with a reduced bleeding risk.     

Thromboembolic risk and effect of oral anticoagulation according to atrial fibrillation patterns: A systematic review and meta‐analysis

Oral anticoagulation (OAC ) is recommended in both paroxysmal atrial fibrillation (pxAF ) and nonparoxysmal AF (non‐pxAF ), but disagreement exists in classes of recommendation. Data on incidence/rate of stroke in pxAF are conflicting, and OAC is often underused in this population. The objectives of the meta‐analysis were to investigate different impact on outcomes of pxAF and non‐pxAF , with and without OAC . Two reviewers searched for prospective studies on risk of stroke and systemic embolism (SE ) in pxAF and non‐pxAF , with and without OAC . Quality of evidence was assessed according to GRADE approach. Stroke combined with SE was the main outcome. Meta‐regression was performed to evaluate OAC effect on stroke and SE incidence rate. We identified 18 studies. For a total of 239 528 patient‐years of follow‐up. The incidence rate of stroke/SE was 1.6% (95% confidence interval [CI ]: 1.3%‐2.0%) in pxAF and 2.3% (95% CI : 2.0%‐2.7%) in non‐pxAF . Paroxysmal AF was associated with a lower risk of overall thromboembolic (TE ) events (risk ratio: 0.72, 95% CI : 0.65‐0.80, P < 0.00001) compared with non‐pxAF . In both groups, the annual rate of TE events decreased as proportion of patients treated with OAC increased. Non‐pxAF showed a reduction from 3.7% to 1.7% and pxAF from 2.5% to 1.2%. Major bleeding rates did not differ among groups. Stroke/SE risk is significantly lower, although clinically meaningful, in pxAF . OAC consistently reduces TE event rates across any AF pattern. As a whole, these data provide the evidence to warrant OAC irrespective of the AF pattern in most (virtually all) patients.     

One-year clinical events and management of patients with atrial fibrillation hospitalized in cardiology centers: Data from the BLITZ-AF study

BackgroundThe management of atrial fibrillation (AF) has changed with the introduction of direct anticoagulants (DOACs) and new techniques such as catheter ablation. An update collection of data from “real world” AF patients followed by cardiologists is useful to obtain information on both management, outcomes and guideline adherence in clinical practice.MethodsFollow-up information on survival, embolic and bleeding events and hospital readmission, persistence of oral anticoagulant (OAC) therapy was collected in 84 centers participating to the BLITZ-AF study.ResultsPatients were followed for a median of 366 days (IQR: 356–378) and vital status was available for 2159 patients. Mortality was 9.2%. Heart failure was the most common cardiovascular cause of death (70%) followed by arrhythmias (6.7%), acute coronary syndrome (5.0%) and ischemic stroke (2.5%). During follow-up 18.1% of the patients were readmitted, mainly (81.3%) for cardiovascular causes. Patients on OAC were 83.4%, 9.1% were on antiplatelets and 7.5% did not receive antithrombotic therapy. The use of DOACs increased from 42.1% to 46.4% during the follow-up, OAC discontinuation occurred in 9.1%. AF recurrences occurred in 23.4% of the patients discharged in sinus rhythm. Rate control strategy was adopted in 55.9% and beta-blockers were the most used drugs (81.9%). Amiodarone (22%) and flecainide (9.7%) were the most frequent used antiahrrythmic drugs.ConclusionsThe follow-up of the BLITZ-AF study provide an up to date picture of the clinical course of patients with AF, who appear frequently affected by heart failure and severe comorbidities which might have led to the high mortality rate.     

Oral anticoagulation across diabetic subtypes in patients with newly diagnosed atrial fibrillation: A report from the GARFIELD-AF registry

Aims

This study aims to describe both management and prognosis of patients with diabetes mellitus (DM) and newly diagnosed atrial fibrillation (AF), overall as well as by antidiabetic treatment, and to assess the influence of oral anticoagulation (OAC) on outcomes by DM status.

Methods

The study population comprised 52 010 newly diagnosed patients with AF, 11 542 DM and 40 468 non-DM, enrolled in the GARFIELD-AF registry. Follow-up was truncated at 2 years after enrolment. Comparative effectiveness of OAC versus no OAC was assessed by DM status using a propensity score overlap weighting scheme and weights were applied to Cox models.

Results

Patients with DM [39.3% oral antidiabetic drug (OAD), 13.4% insulin ± OAD, 47.2% on no antidiabetic drug] had higher risk profile, OAC use, and rates of clinical outcomes compared with patients without DM. OAC use was associated in patients without DM and patients with DM with lower risk of all-cause mortality [hazard ratio 0.75 (0.69-0.83), 0.74 (0.64-0.86), respectively] and stroke/systemic embolism (SE) [0.69 (0.58-0.83), 0.70 (0.53-0.93), respectively]. The risk of major bleeding with OAC was similarly increased in patients without DM and those with DM [1.40 (1.14-1.71), 1.37 (0.99-1.89), respectively]. Patients with insulin-requiring DM had a higher risk of all-cause mortality and stroke/SE [1.91 (1.63-2.24)], [1.57 (1.06-2.35), respectively] compared with patients without DM, and experienced significant risk reductions of all-cause mortality and stroke/SE with OAC [0.73 (0.53-0.99); 0.50 (0.26-0.97), respectively].

Conclusions

In both patients with DM and patients without DM with AF, OAC was associated with lower risk of all-cause mortality and stroke/SE. Patients with insulin-requiring DM derived significant benefit from OAC.     

Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation

ObjectivesThe study sought to determine the patterns of antithrombotic therapy and association with clinical outcomes in patients with atrial fibrillation (AF) and CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) score ≥2 following transcatheter aortic valve replacement (TAVR).BackgroundThe impact of antithrombotic regimens on clinical outcomes in patients with AF and severe aortic stenosis treated with TAVR is unknown.MethodsIn the randomized PARTNER II (Placement of Aortic Transcatheter Valve II) trial and associated registries, 1,621 patients with prior AF and CHA₂DS₂-VASc score ≥2 comprised the study cohort. Outcomes were analyzed according to antithrombotic therapy.ResultsDuring the 5-year enrollment period, 933 (57.6%) patients were discharged on oral anticoagulant therapy (OAC). Uninterrupted antiplatelet therapy (APT) for at least 6 months or until an endpoint event was used in 544 of 933 (58.3%) of patients on OAC and 77.5% of patients not on OAC. At 2 years, patients on OAC had a similar rate of stroke (6.6% vs. 5.6%; p = 0.53) and the composite outcome of death or stroke (29.7% vs. 31.8%; p = 0.33), compared with no OAC. OAC with APT was associated with a reduced rate of stroke (5.4% vs. 11.1%; p = 0.03) and death or stroke (29.7% vs. 40.1%; p = 0.01), compared with no OAC or APT. Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.ConclusionsAmong patients with prior AF undergoing TAVR, antiplatelet with or without anticoagulant therapy was associated with a reduced risk of stroke at 2 years, implicating multifactorial stroke mechanisms in this population.     

Long-term outcome and risk factors associated with events in patients with atrial fibrillation treated with oral anticoagulants: The ASSAF-K registry

BackgroundOral anticoagulant therapy for atrial fibrillation (AF) has changed dramatically. Direct oral anticoagulant (DOAC) therapy is administered by general practitioners and specialists. However, the beneficial long-term effects and safety of DOACs have not been well investigated in real-world clinical practice.MethodsThe ASSAF-K (a study of the safety and efficacy of OAC therapy in the treatment of AF in Kanagawa), a prospective, multi-center, observational study, was conducted to clarify patient characteristics, status of OAC treatment, long-term outcomes, and adverse events, including cerebrovascular disease, bleeding, and death.ResultsA total of 4014 patients were enrolled (hospital: 2500 cases; clinic: 1514 cases). The number of patients in the final dataset was 3367 (mean age, 72.6 ± 10.0 years; males, 66.3 %). CHA₂DS₂-VASc and HAS-BLED scores were 3.0 ± 1.6 and 2.2 ± 1.0, respectively. The risk factors of the primary composite outcome (all-cause death, serious bleeding events, cerebral hemorrhage, and stroke) were higher age, lower body mass index, lower diastolic blood pressure, lower creatine clearance, history of heart failure, history of stroke, and medication of anti-platelet agents. The event-free rates of the primary composite outcome with DOACs, warfarin, and without OACs were 92.7 %, 88.0 %, and 87.4 %, respectively. The event rate of DOACs was significantly lower than that of warfarin [HR 0.63 (95 % CI 0.48–0.81)], and similar results were observed after adjustment for AF stroke risk score [HR 0.70 (95 % CI 0.54–0.90)]. Serious bleeding events tended to occur less frequently with DOACs compared with warfarin [unadjusted HR 0.53 (95 % CI 0.31–0.91), adjusted HR 0.61 (95 % CI 0.33–1.11)].ConclusionsThis multi-center registry demonstrated the long-term outcome in patients with AF treated with and without OACs and suggests that DOAC therapy is safe and beneficial in hospitals and clinics.     

How many patients in atrial fibrillation admitted to an acute medical unit will benefit from oral anticoagulation?: Application of the results of the major randomized controlled trials to 141 consecutive,unselected, elderly patients using a decision support computer program

BackgroundAlthough several randomized, control trials (RTC) suggest that oral anticoagulation (OAC) benefits patients with atrial fibrillation (AF), this might not be true for hospitalized patients with co-morbid conditions. If the results of the RTCs are valid, then how many patients in AF admitted to an acute medical unit will benefit from OAC?MethodsAn RCT-based decision analysis model calculated the quality-adjusted life expectancy (QALE) gain from OAC for 141 unselected consecutive patients over 65 years of age with AF admitted to an acute medical unit.ResultsIf treated with aspirin, all 141 patients were predicted to gain QALE compared with placebo. If the quality of life adjustment (QoLA) on OAC was the same as placebo, then 104 patients were predicted to benefit from OAC compared with aspirin, while 63 patients were predicted to benefit at a QoLA of 0.99 (overall benefit 0.13±0.15 QALYs, range 0.01–0.88 QALYs). These 63 patients were more likely to have had a stroke, diabetes, hypertension, heart failure or heart attack, and less likely to have impaired renal function than those predicted not to benefit. The 78 patients predicted not to benefit from OAC included 11 younger patients without heart failure, hypertension, diabetes or cerebrovascular disease; the remaining 67 patients, however, were older, more likely to have heart failure and/or renal impairment and were at high risk of both stroke and bleeding.ConclusionAn RCT-based decision analysis model suggests that more than half the patients in AF admitted to a small rural hospital with acute medical conditions are unlikely to benefit from OAC, while all will benefit from aspirin.