Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial

BackgroundIn patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown.MethodsIn the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2–3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding.ResultsMedian (IQR) follow-up was 1.88 (1.01–3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk–adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68; P=0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61; P=0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90; P=0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08; P=0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85; P=0.02) in the pooled rivaroxaban groups.ConclusionsIn patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA.Clinical Trial registry name and registration number:Oral Anticoagulation in Hemodialysis, NCT03799822

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Relation of Renal Dysfunction to Quality of Anticoagulation Control in Patients with Atrial Fibrillation: The FANTASIIA Registry

Thrombosis and Haemostasis ◽

10.1160/th17-06-0416 ◽

2018 ◽

Vol 118 (02) ◽

pp. 279-287 ◽

Cited By ~ 7

Author(s):

María Esteve-Pastor ◽

José Rivera-Caravaca ◽

Inmaculada Roldán-Rabadán ◽

Vanessa Roldán ◽

Javier Muñiz ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Cardiovascular Mortality ◽

Real World ◽

Cardiovascular Events ◽

Vitamin K Antagonists ◽

Major Adverse Cardiovascular Events ◽

Anticoagulation Control

Background One-third of atrial fibrillation (AF) patients have chronic kidney disease (CKD), a condition that itself increases thromboembolic and major bleeding risks, especially in patients with severe CKD. Bleeding would be accentuated by suboptimal anticoagulation control with vitamin K antagonists (VKA). Purpose This article aimed to investigate the incidence of cardiovascular events, mortality and quality of anticoagulation in relation to CKD in a ‘real-world’ prospective cohort of AF patients included in the FANTASIIA registry. Methods We analysed consecutive AF patients who were prospectively recruited with a year of follow-up. The quality of anticoagulation was estimated by time in therapeutic range (TTR). The annual incidence of events was analysed. Results We studied 1,936 patients (male: 55.7%, mean: 73.8 ± 9.4 years): 445 (22.9%) had normal function, 698 (36.1%) had mild CKD, 713 (36.8%) had moderate CKD and 80 (4.2%) had severe CKD. Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (severe CKD) had lower TTR (53.3 ± 25.6% vs. 61.8 ± 25.1%, p = 0.007) and higher proportion of poor TTR (67.2 vs. 51.8%; p = 0.014) than patients with eGFR ≥30 mL/min/1.73 m2. Severe CKD was significantly associated with cardiovascular mortality (hazard ratio [HR]: 9.33; p = 0.002), major bleeding (HR: 2.94; p = 0.036) and major adverse cardiovascular events (MACE) (HR: 4.93; p = 0.004). Importantly, 375 patients (21.1%) showed a deteriorating eGFR of ≥10 mL/min during the follow-up, with significantly higher mortality and cardiovascular events. Conclusion In a prospective and real-world AF registry, approximately 67% of patients with severe CKD had poor anticoagulation control while taking VKA. The presence of severe CKD was an independent factor for cardiovascular mortality, MACE and major bleeding. Worsening eGFR of only ≥10 mL/min during follow-up was significantly associated with mortality and major bleeding.

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Cessation of oral anticoagulation in relation to mortality and the risk of thrombotic events in patients with atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th13-07-0556 ◽

2013 ◽

Vol 110 (12) ◽

pp. 1189-1198 ◽

Cited By ~ 155

Author(s):

Pilar Gallego ◽

Vanessa Roldan ◽

Francisco Marín ◽

Marta Romera ◽

Mariano Valdés ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Cardiovascular Events ◽

Vitamin K Antagonists ◽

Bleeding Risk ◽

Vascular Events ◽

Coronary Syndrome ◽

Independent Risk Factors

SummaryBleeding risk (often perceived, rather than actual) is a common reason for cessation of oral anticoagulation with Vitamin K antagonists (VKA). We investigate clinical outcomes in a consecutive population of VKA naïve atrial fibrillation (AF) patients, who initiated VKA therapy in our clinic. We included consecutive VKA-naíve patients with non valvular AF, initiated on VKA therapy in our anticoagulation outpatient clinic in 2009. During follow-up, adverse events [thrombotic/vascular events (stroke, acute coronary syndrome, acute heart failure and cardiac death), major bleeding and death], and VKA cessation were recorded. At the end of the follow-up, we determined time within therapeutic range (TTR), using a linear approximation (Rosendaal method). We studied 529 patients (49% male, median age 76), median follow-up 835 days (IQR 719−954). During this period 114 patients stopped VKA treatment. 63 patients suffered a thrombotic/cardiovascular event (5.17%/year, 27 thrombotic/ischaemic strokes), 51 major bleeding (4.19%/year) and 48 died (3.94%/year). Median TTR was 54% (34a57). On multivariate analysis (adjusted by CHA2DS2-VASc score), VKA cessation was associated with death [Hazard Ratio (HR) 3.43; p<0.001], stroke [4.21; p=0.001] and thrombotic/cardiovascular events [2.72; p<0.001]. Independent risk factors for major bleeding were age [1.08; p<0.001], previous stroke [1.85; p=0.049], and TTR [0.97; p=0.001], but not VKA cessation. In conclusion, in AF patients AF, VKA cessation is independently associated with mortality stroke and cardiovascular events. Specifically, VKA cessation independently increased the risk of stroke, even after adjusting for CHA2DS2-VASc score. TTR was an independent risk factor for major bleeding following initiation of VKA therapy.Note: The editorial process for this paper was fully handled by Prof Christian Weber, Editor in Chief.

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Abstract 14344: Prognostic Factors of Atrial Fibrillation Patients With Coronary Artery Disease: The Fushimi Af Registry

Circulation ◽

10.1161/circ.142.suppl_3.14344 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Nobutoyo Masunaga ◽

Hisashi Ogawa ◽

Yuya Aono ◽

Syuhei Ikeda ◽

KOSUKE DOI ◽

...

Keyword(s):

Diabetes Mellitus ◽

Heart Failure ◽

Atrial Fibrillation ◽

Prognostic Factors ◽

Major Bleeding ◽

Cardiac Death ◽

Cardiovascular Events ◽

Factors Associated ◽

Artery Disease

Background: Atrial fibrillation (AF) patients are likely to have concomitant coronary artery disease (CAD). A new strategy of antithrombotic therapy in AF patients with stable CAD was demonstrated in recent randomized clinical trials. Now that antithrombotic therapy for AF patients with CAD has reached a major turning point, it is important to know the prognostic factors in those patients. Purpose: In this study, we investigated clinical characteristics, cardiovascular events and prognostic factors in AF patients with CAD. Methods: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. Follow up data including prescription status were available in 4,441 patients from March 2011 to November 2019. Of 4,441 patients, 645 patients had a history of CAD at enrollment. Results: The mean age was 76.4±8.6 and 65.9% were male. Averages of CHA 2 DS 2 -VASc score and HAS-BLED score were 4.41 and 2.35, respectively. Oral anticoagulant (OAC) was prescribed in 52.9% of those patients and antiplatelet drug (APD) was prescribed in 70.4%. The combination of OAC and APD was prescribed in 36.0%. During follow-up period (median 1,495 days), cardiac death occurred in 51 patients, composite of cardiac death, myocardial infarction (MI) and stroke in 136, and major bleeding in 77 (1.8, 5.1 and 2.9 per 100 person-years, respectively). In multivariate analysis, factors associated with composite of cardiac death, MI and stroke in AF patients with CAD were low body weight (<=50kg) (hazard ratio [95% confidence interval]; 1.62 [1.07-2.47]), previous stroke (1.69 [1.13-2.52]), heart failure (1.47 [1.02-2.11]), hypertension (0.60 [0.41-0.87]) and diabetes mellitus (1.62 [1.13-2.32]). Furthermore, factors associated with major bleeding in AF patients with CAD were anemia (male: hemoglobin<12 g/dl, female: hemoglobin<11 g/dl) (1.82 [1.09-3.04]) and thrombocytopenia (<150,000 /μL) (3.02 [1.29-7.03]). Conclusion: In Japanese AF patients with CAD, low body weight, previous stroke, heart failure, hypertension and diabetes mellitus were associated with cardiovascular events, and anemia and thrombocytopenia were associated with major bleeding.

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Abstract P640: Incident Atrial Fibrillation and Cardiovascular Risk Increases in Patients With Increased Burden of Atrial Ectopy

Stroke ◽

10.1161/str.52.suppl_1.p640 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Michael N Sattin ◽

Zhe Li ◽

Marko Mrkobrada ◽

Erin I Spicer

Keyword(s):

Atrial Fibrillation ◽

Cardiovascular Events ◽

Univariate Analysis ◽

Composite Outcome ◽

Ecg Monitoring ◽

Reduced Ejection Fraction ◽

Final Sample ◽

Atrial Ectopy ◽

The Relationship

Introduction: Atrial fibrillation (AF) is a major risk factor for cerebral ischemia in North America. Atrial ectopy has been associated with incident AF and increased stroke risk on short-duration ECG monitoring. The objective of this study was to characterize the relationship between the burden of atrial ectopy with future AF, stroke, and cardiovascular events on prolonged ECG monitoring. Methods: A retrospective, observational study was conducted at a single centre enrolling patients >18 years old referred from TIA clinic. Data was collected from 7- and 14-day Holter monitor reports, patient charts, and cardiac investigations. The final sample included 1124 patients; a subgroup of 759 patients had echocardiograms. Univariate and multivariate logistic regression determined the odds ratio (OR) of developing the composite outcome (AF, TIA/stroke, ACS, death) or secondary outcomes (AF or TIA/stroke). Results: The population was high-risk with a mean CHA 2 DS 2 -VASc of 4.0 (±1.8); during 1-year of follow-up, the primary outcome occurred amongst 116 (10.3%) patients. Univariate analysis ORs are displayed in Table 1. There was a statistically significant relationship (p<0.001) between percentage of PACs and the composite outcome (OR 4.066), and AF (11.886) for patients with 2-5% PACs. PAC runs/day was significant if >5/day for AF (OR 5.989, p<0.01) and for the composite (OR 2.231, p<0.05). Long PAC runs (>30 beats) also had significant ORs for AF (2.849, p<0.01) and the composite (5.320, p<0.01). In the subgroup analysis, reduced ejection fraction had an OR of 2.172 (1.407-5.771) for the composite outcome, and atrial dilatation had an OR of 2.778 (1.390-5.551) for AF. Conclusions: Increased burden of atrial ectopy is associated with increased odds of developing AF and a composite of cardiovascular events. Patients with increased ectopy should be considered for further, future ECG monitoring and risk stratification with echocardiogram.

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Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽

10.1182/blood.v120.21.502.502 ◽

2012 ◽

Vol 120 (21) ◽

pp. 502-502

Author(s):

Vera Gelbricht ◽

Sebastian Werth ◽

Christina Koehler ◽

Ulrike Haensel ◽

Luise Tittl ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Cardiovascular Events ◽

Safety Data ◽

Real Life ◽

Bleeding Complications ◽

Efficacy And Safety ◽

Daily Care ◽

Short Period

Abstract Abstract 502 Background: In the RE-LY trial, dabigatran (DB) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF), which lead to approval in many countries. However, patients in RCT‘s present a selected population treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives: To evaluate the efficacy, safety and management issues of dabigatran anticoagulation in AF in daily care. Patients and methods: In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July31th 2012, 938 patients were registered. Of these, 201 received DB for AF (table 1). The population in our registry is older than in RELY (74.2 vs. 71.5 years) and has a higher CHADS2-Score (2.7 vs. 2.1). Interestingly, 110 mg BID was the preferred dosage in DB patients (55.7%) despite the fact that these patients had higher CHADS2-scores than patients receiving 150 mg BID (2.3 vs. 2.9). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications. Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 86.8 patient years. During FU, Three patients (1.5%) experienced major cardiovascular events (xyz) and another two patients (1.0%) minor cardiovascular events (syncope). Until now, no deaths occurred. Bleeding complications were frequent (14.9%) but major bleeding was rare (n=3; 1.5%) none of which was fatal. At 3 month, 93% of patients were still taking DB but switch to other anticoagulants increased between 3 and 6 month, mainly due to side effects or incompliance. Conclusion: In unselected patients in daily care, DB is effective and safe with low rates of cardiovascular or major bleeding events. However, within 6 month, about 20% of patients are switched to other anticoagulants. Long-term data will be reported. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

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Novel Oral Anticoagulant Use in Adults With Congenital Heart Disease: a Single-center Experience

10.21203/rs.3.rs-871696/v1 ◽

2021 ◽

Author(s):

Daniel Samarai ◽

Nazim Isma ◽

Sandra Lindstedt ◽

Joanna Hlebowicz

Keyword(s):

Atrial Fibrillation ◽

Congenital Heart Disease ◽

Heart Disease ◽

Major Bleeding ◽

Congenital Heart ◽

Vitamin K Antagonists ◽

Quality Register ◽

Increased Risk ◽

National Quality

Abstract IntroductionAdults with congenital heart disease (ACHD) are a group with an increased risk of thromboembolic complications and arrhythmias. Vitamin K antagonists (VKA) are the most commonly used thromboprophylaxis therapy in this population. Studies on the efficacy and safety of novel oral anticoagulants (NOAC) are scare, but emerging together with their increasing use.MethodsACHD patients taking NOAC treatment were identified in AuriculA, a Swedish national quality register for atrial fibrillation and anticoagulation. Data on duration of treatment and patient characteristics were provided by the Register. CHA2DS2-VASc and HAS-BLED scores for atrial fibrillation were calculated. CHD severity was determined according to guidelines. Thromboembolic and major bleeding events were provided by AuriculA. Results30 patients who had been taking NOAC treatment for a minimum of 3 months were included. Their median age was 55 years (SD 17 years) and 57% were male. Median follow-up was 17 months (IQR: 10-41). Apixaban was the most commonly used NOAC (47%). Median CHA2DS2-VASc score was 2 (IQR: 0-3) and HAS-BLED was 1 (IQR: 0-2). Complex CHD was prevalent in 27% of the patients. No thromboembolic events were recorded; however, one major bleeding, unspecified, was reported during the total cumulative patient follow-up time of 64 years. ConclusionThe results of our study, although limited in size, suggest NOAC to be a non-inferior alternative to VKA in a heterogenic study group with a balanced inclusion of CHD severity defects. Further and larger studies on VKA and NOAC in ACHD patients are warranted.

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Patterns of oral anticoagulation use with cardioversion in clinical practice

Heart ◽

10.1136/heartjnl-2019-316315 ◽

2020 ◽

pp. heartjnl-2019-316315

Author(s):

Kyle Geurink ◽

DaJuanicia Holmes ◽

Michael D Ezekowitz ◽

Karen Pieper ◽

Gregg Fonarow ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Major Bleeding ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Inclusion Criteria ◽

Related Hospitalisation ◽

Informed Treatment ◽

Ischaemic Attack

BackgroundCardioversion is common among patients with atrial fibrillation (AF). We hypothesised that novel oral anticoagulants (NOAC) used in clinical practice resulted in similar rates of stroke compared with vitamin K antagonists (VKA) for cardioversion.MethodsUsing the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II, patients with AF who had a cardioversion, follow-up data and an AF diagnosis within 6 months of enrolment were identified retrospectively. Clinical outcomes were compared for patients receiving a NOAC or VKA for 1 year following cardioversion.ResultsAmong 13 004 patients with AF, 2260 (17%) underwent cardioversion. 1613 met the inclusion criteria for this analysis. At the time of cardioversion, 283 (17.5%) were receiving a VKA and 1330 (82.5%) a NOAC. A transoesophageal echocardiogram (TOE) was performed in 403 (25%) cardioversions. The incidence of stroke/transient ischaemic attack (TIA) at 30 days was the same for patients having (3.04 per 100 patient-years) or not having (3.04 per 100 patient-years) a TOE (p=0.99). There were no differences in the incidence of death (HR 1.19, 95% CI 0.62 to 2.28, p=0.61), cardiovascular hospitalisation (HR 1.02, 95% CI 0.76 to 1.35, p=0.91), stroke/TIA (HR 1.18, 95% CI 0.30 to 4.74, p=0.81) or bleeding-related hospitalisation (HR 1.29, 95% CI 0.66 to 2.52, p=0.45) at 1 year for patients treated with either a NOAC or VKA.ConclusionsCardioversion was a low-risk procedure for patients treated with NOAC, and there were statistically similar rates of stroke/TIA 30 days after cardioversion as for patients treated with VKA. There were no statically significant differences in death, stroke/TIA or major bleeding at 1 year among patients treated with NOAC compared with VKA after cardioversion.

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Real Life Efficacy and Safety of Rivaroxaban for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽

10.1182/blood.v120.21.1156.1156 ◽

2012 ◽

Vol 120 (21) ◽

pp. 1156-1156

Author(s):

Sebastian Werth ◽

Christina Koehler ◽

Vera Gelbricht ◽

Ulrike Haensel ◽

Luise Tittl ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Cardiovascular Events ◽

Safety Data ◽

Real Life ◽

Bleeding Complications ◽

Efficacy And Safety ◽

Daily Care ◽

Short Period

Abstract Abstract 1156 Background: In the ROCKET-AF trial, rivaroxaban (RX) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF) and is approved in many countries. However, patients in RCT‘s present a selected population which is treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives: To evaluate the efficacy, safety and management issues of rivaroxaban anticoagulation in AF in daily care. Patients and methods: In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July 31th 2012, 938 patients were registered. Of these, 504 patients received RX for atrial fibrillation (demographic data in table 1). Despite similar age (mean 75 years), our real world cohort has lower CHADS2-Scores compared to ROCKET-AF (2.4 vs. 3.5). The preferred dosage in most RX patients (68.8%) was 20mg, but these patients had lower CHADS2-scores than patients receiving 15 mg (2.2 vs. 2.8). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications. Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 112.2 patient years. Five patients (1.0%) experienced major cardiovascular events (3 ACS, 1 ischemic stroke, 1 TIA). Another five patients experienced minor cardiovascular events (syncope). Three patients (0.6%) died within the first month of treatment (one due to sudden cardiac death, possibly related to ventricular fibrillation, two of underlying disease). Bleeding complications were frequent (15.2%) but major bleeding was rare (n=1; 0.2%). At 3 month, 95% of patients were still taking RX. Conclusion: In unselected patients in daily care, RX is effective and safe with low rates of cardiovascular or major bleeding events and low rates of treatment discontinuation in the first 180 days of treatment. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

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Two-year outcomes of patients with atrial fibrillation treated with rivaroxaban: results from RIVER registry

European Heart Journal ◽

10.1093/eurheartj/ehab724.0578 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J Beyer-Westendorf ◽

A.J Camm ◽

S Virdone ◽

K.A.A Fox ◽

K.S Pieper ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Major Bleeding ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Real Life ◽

Nonvalvular Atrial Fibrillation ◽

Funding Sources ◽

European Society Of Cardiology

Abstract Introduction Non-vitamin-K oral anticoagulants (NOACs) were recommended in preference to oral vitamin K antagonists (VKAs) in the 2020 updated guidelines for stroke prevention in atrial fibrillation (AF), from the European Society of Cardiology (ESC). Rivaroxaban is a NOAC that is approved in many countries worldwide for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (AF). Purpose To explore the baseline characteristics, dosing and 2-year outcomes of patients with AF treated with rivaroxaban. Methods RIVaroxaban Evaluation in Real Life setting (RIVER) is a prospective international, multicenter registry of patients with newly diagnosed non-valvular AF treated with rivaroxaban for the prevention of thromboembolic stroke and at least one investigator-determined risk factor for stroke. Results A total of 5043 patients were enrolled into RIVER between January 2015 and June 2017. Mean (SD) age at diagnosis was 69.5 (11.0) years and 55.7% were males. Caucasian patients represented the largest proportion of patients in RIVER (80.3%), followed by Asians (5.5%) and hispanic/latino (3.7%). Almost all patients (98.5%) were prescribed a single daily dose of rivaroxaban, most commonly 20 mg (77.3%) and 15 mg (20.4%), while a 10 mg dose was prescribed in only 2.3% of patients. During the 2-year follow-up, the rates (95% CI) of all-cause mortality, stroke/SE, and major bleeding were 2.75 (2.43 to 3.12), 0.89 (0.72; 1.11), and 1.26 (1.05 to 1.52) per 100 person years, respectively (Figure 1). The most common cardiovascular cause of death was congestive heart failure (30.4%) and myocardial infarction (11.4%). Leading non-cardiovascular causes of death were malignancy (27.4%), respiratory failure (18.9%) and infections/sepsis (13.2%). Over 2 years, 710 (14.1%) of patients discontinued rivaroxaban. The corresponding proportions at 6 months and 1 year were 7.8% and 10.8%, respectively. Out of all the patients who discontinued, 62 (8.7%) restarted rivaroxaban during their follow-up (Table 1). Conclusion During 2 years of follow up in the international, prospective RIVER registry, rivaroxaban treatment for AF was associated with low rates of stroke or major bleeding. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted research grant from Bayer AG, Berlin, Germany, to TRI, London, UK. This work is supported by KANTOR CHARITABLE FOUNDATION for the Kantor-Kakkar Global Centre for Thrombosis Science.

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The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

TH Open ◽

10.1055/s-0040-1721499 ◽

2020 ◽

Vol 04 (04) ◽

pp. e417-e426

Author(s):

Carline J. van den Dries ◽

Sander van Doorn ◽

Patrick Souverein ◽

Romin Pajouheshnia ◽

Karel G.M. Moons ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Routine Care ◽

P Value ◽

Risk Of Mortality ◽

Mortality Effect

Abstract Background The benefit of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) on major bleeding was less prominent among atrial fibrillation (AF) patients with polypharmacy in post-hoc randomized controlled trials analyses. Whether this phenomenon also exists in routine care is unknown. The aim of the study is to investigate whether the number of concomitant drugs prescribed modifies safety and effectiveness of DOACs compared with VKAs in AF patients treated in general practice. Study Design Adult, nonvalvular AF patients with a first DOAC or VKA prescription between January 2010 and July 2018 were included, using data from the United Kingdom Clinical Practice Research Datalink. Primary outcome was major bleeding, secondary outcomes included types of major bleeding, nonmajor bleeding, ischemic stroke, and all-cause mortality. Effect modification was assessed using Cox proportional hazard regression, stratified for the number of concomitant drugs into three strata (0–5, 6–8, ≥9 drugs), and by including the continuous variable in an interaction term with the exposure (DOAC vs. VKA). Results A total of 63,600 patients with 146,059 person-years of follow-up were analyzed (39,840 person-years of DOAC follow-up). The median age was 76 years in both groups, the median number of concomitant drugs prescribed was 7. Overall, the hazard of major bleeding was similar between VKA-users and DOAC-users (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.87–1.11), though for apixaban a reduction in major bleeding was observed (HR 0.81; 95% CI 0.68–0.98). Risk of stroke was comparable, while risk of nonmajor bleeding was lower in DOAC users compared with VKA users (HR 0.92; 95% CI 0.88–0.97). We did not observe any evidence for an impact of polypharmacy on the relative risk of major bleeding between VKA and DOAC across our predefined three strata of concomitant drug use (p-value for interaction = 0.65). For mortality, however, risk of mortality was highest among DOAC users, increasing with polypharmacy and independent of the type of DOAC prescribed (p-value for interaction <0.01). Conclusion In this large observational, population-wide study of AF patients, risk of bleeding, and ischemic stroke were comparable between DOACs and VKAs, irrespective of the number of concomitant drugs prescribed. In AF patients with increasing polypharmacy, our data appeared to suggest an unexplained yet increased risk of mortality in DOAC-treated patients, compared with VKA recipients.

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