Abstract 20326: Impact of Gender on Clinical Outcomes in Non-Valvular Atrial Fibrillation: Contemporary Perspective From the GARFIELD Registry

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
John Camm ◽  
Samuel Z Goldhaber ◽  
Giuseppe Ambrosio ◽  
Petr Jansky ◽  
Wael Al Mahmeed ◽  
...  

Purpose: To evaluate the influence of gender on baseline characteristics and 1-year clinical outcomes in patients with non-valvular atrial fibrillation (AF). Methods: In the ongoing, international registry GARFIELD, a total of 12,458 prospective patients were enrolled at 739 randomly selected sites in 30 countries between March 2010 and January 2013. Results: Compared with men, women with AF were more likely to be older and have a history of hypertension or venous thromboembolism, but less likely to have a history of vascular disease. Use of antithrombotic therapy was similar in the two groups. At 1-year follow-up, the hazard ratio for women versus men, adjusted for age group, use of vitamin K antagonist, Factor Xa inhibitor, direct thrombin inhibitor, and antiplatelet, congestive cardiac failure, hypertension, diabetes, stroke/transient ischaemic attack, and vascular disease, was 0.815 (95% confidence interval, 0.695-0.957) for the incidence of all-cause mortality, 1.414 (1.053-1.899) for the incidence of stroke/systemic embolism (SE), and 1.024 (0.714-1.470) for the incidence of major bleeding. Conclusion: These findings suggest that women with non-valvular AF have a lower mortality rate despite a higher stroke/SE rate compared with men.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Kirchhof ◽  
M Unverdorben ◽  
Y Koretsune ◽  
C C Wang ◽  
Y H Kim ◽  
...  

Abstract Background Patients with atrial fibrillation (AF) who survive an intracranial haemorrhage (ICH) are at high risk of stroke, death, and recurrent haemorrhage. Effectiveness and safety of the nonvitamin K antagonist oral anticoagulant (NOAC) edoxaban in this patient population has not been reported. Purpose This snapshot analysis from the global ETNA-AF program compared 1-year outcomes in AF patients with and without history of ICH treated with edoxaban from Europe, Japan, and Korea/Taiwan. Methods Global ETNA-AF (EU: NCT02944019, Japan: UMINehz745.116117011, Korea/Taiwan: NCT02951039) is a multinational, multicentre, prospective, noninterventional program of AF patients receiving edoxaban in regular clinical care. Demographics, baseline characteristics, and outcomes at 1-year follow-up were reported for 19416 patients with and without a history of ICH. Results Of the 19416 patients, 297 had a history of ICH. At 1-year follow-up, incidences of International Society on Thrombosis and Haemostasis (ISTH) major bleeding (including ICH) and clinically relevant nonmajor bleeding (CRNMB) were generally low. The rate of ischaemic stroke was higher in patients with a history of ICH than in those without prior ICH. Europe (N=7672) Korea/Taiwan (N=1701) Japan (N=10043) History of ICH, n (%) Yes No Yes No Yes No 36 (0.5) 636 (99.5) 27 (1.6) 1674 (98.4) 234 (2.3) 9809 (97.7) Age, median (IQR) 75 (69, 78) 74 (68, 80) 70 (66, 76) 72 (66, 77) 76 (71, 82) 75 (68, 81) Gender, male % 72.2 57.4 70.4 59.9 60.7 59.3 Weight, median (IQR) kg 80.0 (75.0, 88.0) 80.0 (70.0, 92.0) 68.0 (54.0, 77.0) 65.0 (58.0, 73.0) 57.0 (50.0, 65.0) 59.0 (51.0, 68.0) CHA2DS2-VASc, mean (SD) 4.2 (1.44) 3.1 (1.38) 3.9 (1.63) 3.0 (1.43) 4.0 (1.56) 3.4 (1.64) HAS-BLED, mean (SD) 4.3 (1.23) 2.6 (1.12) 3.9 (1.55) 2.4 (10.7) 3.7 (1.07) 2.3 (1.12) CrCl [mL/min], median (IQR) 70.5 (58.8, 85.1) 70.4 (53.8, 90.1) 63.7 (45.8, 84.2) 61.6 (48.4, 78.1) 58.5 (46.0, 73.2) 60.2 (46.1, 77.0) Edoxaban 60/30 mg, % 83.3 / 16.7 77.1 / 22.9 55.6 / 44.4 50.2 / 49.8 21.8 / 78.2 27.8 / 72.2 1-year outcome, n (%/year)   Major bleeding (ISTH) 2 (5.94) 66 (0.92) 0 (0) 13 (0.82) 3 (1.92) 66 (0.96)   Intracranial haemorrhage 1 (2.91) 19 (0.26) 0 (0) 5 (0.32) 1 (0.64) 18 (0.26)   Major GI* bleeding 0 (0.00) 20 (0.28) 0 (0) 2 (0.13) 2 (1.28) 30 (0.43)   CRNMB 0 (0.00) 102 (1.43) 0 (0) 11 (0.70) 6 (3.82) 219 (3.20)   Ischaemic stroke 1 (2.93) 41 (0.57) 1 (4.04) 11 (0.70) 4 (2.57) 78 (1.13) *Gastrointestinal. Conclusion Our data underpin the need for effective stroke prevention. In AF patients with a history of ICH, data suggest that edoxaban can be safely and effectively administered in patients with and without prior ICH in regular clinical care. Acknowledgement/Funding Daiichi Sankyo


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Harbaoui ◽  
G Souteyrand ◽  
T Lefevre ◽  
H Liebgott ◽  
P Y Courand ◽  
...  

Abstract Background Both the valvular aortic calcifications (VAC) and the thoracic aorta calcifications (TAC) have a prognostic impact in patients with aortic stenosis. Their respective prognostic values in patients with and without low gradient aortic stenosis (LGAS) remain unknown after TAVI. Objectives To assess the prognostic significance of VAC and TAC in patients with and without LGAS regarding cardiovascular mortality after 3 years follow-up. Methods The CAPRI-LGAS is an ancillary study of the C4CAPRI trial (NCT02935491) including 1282 consecutive TAVI patients. Calcifications were measured on pre-TAVI CT. The primary outcome was defined as cardiovascular mortality 3 years after TAVI. Results Among the 1282 patients, 397 (31%) had a LGAS. Compared to the other patients, LGAS patients were more prone to be men, younger, with atrial fibrillation, and lower left ventricular ejection fraction (LVEF), p<0.05 for all. No statistically significant difference was noticed for pulmonary systolic pressures, history of diabetes, chronic respiratory disease, renal insufficiency or peripheral vascular disease. VAC was lower in LGAS compared to non-LGAS patients (1.05 cm3±0.7 vs 0.75 cm3±0.5), p<0.001, the contrary was noticed for TAC, (3.1 cm3±3 vs 3.7 cm3±3.7), p=0.011. After 3 years follow-up, 227 (17.7%) patients died from cardiovascular causes; respectively 85 (21.4%) and 142 (16.1%) patients with and without LGAS, p=0.02. In univariate analysis, in LGAS patients each increase of 1cm3 TAC was associated with cardiovascular mortality while VAC was not, respectively Hazard Ratio (HR) 1.07 and confidence interval (CI) (1.023–1.119) p=0.003, and HR 0.822 CI (0.523–1.292), p=0.39. In patients without LGAS both TAC and VAC were associated with mortality, respectively HR 1.054 CI (1.006–1.104), p=0.028 and HR 1.363 CI (1.092–1.701), p=0.006. Multivariate analysis was adjusted for TAC, VAC, age, gender, atrial fibrillation, and LVEF. In LGAS patients TAC but not VAC was still a predictor of cardiovascular mortality, respectively HR 1.092 CI (1.031–1.158), p=0.003, and HR 0.743 CI (0.464–1.191), p=0.21. In patients without LGAS TAC was no more associated with cardiovascular mortality while VAC was, respectively HR 1.306 CI (1.024–1.666), p=0.031, and HR 1.038 CI (0.985–1.094), p=0.161. When further adjusting on pulmonary systolic pressures, history of diabetes, chronic respiratory disease, renal insufficiency and peripheral vascular disease, the results remained similar ie in LGAS patients, TAC HR 1.090 CI (1.022–1.162), p=0.009 while in patients without LGAS VAC HR 1.377 CI (1.049–1.809), p=0.021. Conclusions The present study shows that VAC and TAC involve different prognostic information in patients with and without LGAS after TAVI. While VAC may be a marker of early and periprocedural mortality and aortic regurgitation in non-LGAS patients, TAC may continue to be harmful and increase afterload in patients with LGAS whom LVEF is often impaired.


2018 ◽  
Vol 23 (6) ◽  
pp. 494-501 ◽  
Author(s):  
Ainhoa Gomez-Lumbreras ◽  
Jordi Cortes ◽  
Maria Giner-Soriano ◽  
M. Angeles Quijada-Manuitt ◽  
Rosa Morros

Background: Apixaban is a direct oral anticoagulant, which inhibits factor Xa. It has demonstrated clinical efficacy in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation and a better safety profile compared to warfarin. Objectives: (1) To describe the characteristics of patients with nonvalvular atrial fibrillation beginning treatment with apixaban, (2) to analyze concomitant prescriptions of medications that could potentially interact with apixaban, (3) to evaluate the level of appropriate usage according to the recommended dosage, and (4) to estimate the level of apixaban persistence among naive and non-naive patients. Methods: Cohort study using data from primary care (System for Research in Primary Care database, users of the Institut Català de la Salut; Catalonia, Spain) from August 2013 to December 2015. Results: Mean age for apixaban-treated patients was 71.8 years (standard deviation = 11.1) and 55.6% were male. In all, 3.2% of patients receiving apixaban were taking drugs described as potentially related to either pharmacokinetic or pharmacodynamic interactions. According to the summary of product characteristics, 81.1% of patients with a recommended dose of 2.5 mg twice daily and 51.8% with a recommended dose of 5 mg twice daily actually took this dose. After 1 year of follow-up, 62.6% of the apixaban users showed good adherence. Conclusion: The prescribed dose of apixaban did not fully follow the recommended dose, particularly in patients who were treatment naive. Patients with a prior history of anticoagulant treatment were more likely to remain persistent to treatment with apixaban.


Author(s):  
Jawad H Butt ◽  
Emil L Fosbøl ◽  
Peter Verhamme ◽  
Thomas A Gerds ◽  
Kasper Iversen ◽  
...  

Abstract Background Treatment with dabigatran, an oral direct thrombin inhibitor, reduces the virulence of Staphylococcus aureus in in vitro and in vivo models. However, it remains to be determined whether dabigatran reduces the risk of S. aureus infections in humans. We investigated the incidence rate of S. aureus bacteremia (SAB) in patients with atrial fibrillation treated with the direct thrombin inhibitor dabigatran compared with patients treated with the factor Xa-inhibitors rivaroxaban, apixaban, and edoxaban. Methods In this observational cohort study, 112 537 patients with atrial fibrillation who initiated treatment with direct oral anticoagulants (August 2011–December 2017) were identified from Danish nationwide registries. The incidence rates of SAB in patients treated with dabigatran versus patients treated with the factor Xa-inhibitors were examined by multivariable Cox regression accounting for time-dynamic changes in exposure status during follow-up. Results A total of 112 537 patients were included. During a median follow-up of 2.0 years, 186 patients in the dabigatran group and 356 patients in the factor Xa-inhibitor group were admitted with SAB. The crude incidence rate of SAB was lower in the dabigatran group compared with the factor Xa-inhibitor group (22.8 [95% confidence interval [CI], 19.7–26.3] and 33.8 [95% CI, 30.5–37.6] events per 10 000 person-years, respectively). In adjusted analyses, dabigatran was associated with a significantly lower incidence rate of SAB compared with factor Xa-inhibitors (incidence rate ratio, .76; 95% CI, .63–.93). Conclusions Treatment with dabigatran was associated with a significantly lower incidence rate of SAB compared with treatment with factor Xa-inhibitors.


Author(s):  
Shinwan Kany ◽  
Johannes Brachmann ◽  
Thorsten Lewalter ◽  
Ibrahim Akin ◽  
Horst Sievert ◽  
...  

Abstract Background Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. Methods Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). Results A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02–2.72, p = 0.041). Conclusion Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality. Graphic abstract


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Alraddadi ◽  
A Alsagheir ◽  
S Gao ◽  
K An ◽  
H Hronyecz ◽  
...  

Abstract Background Managing endocarditis in intravenous drug use (IVDU) patients is challenging: unless patients successfully quit IVDU, the risk of re-infection is high. Clinicians often raise concerns with ethical and resource allocation principles when considering valve replacement surgery in this patient population. To help inform practice, we sought to determine the long-term outcomes of IVDU patients with endocarditis who underwent valve surgery in our center. Method After research ethics board approval, infective endocarditis cases managed surgically at our General Hospital between 2009 and 2018 were identified through the Cardiac Care Network. We reviewed patients' charts and included those with a history of IVDU in this study. We abstracted data on baseline characteristics, peri-operative course, short- and long-term outcomes. We report results using descriptive statistics. Results We identified 124 IVDU patients with surgically managed endocarditis. Mean age was 37 years (SD 11), 61% were females and 8% had redo surgery. During admission, 45% (n=56) of the patients had an embolic event: 63% pulmonary, 30% cerebral, 18% peripheral and 11% mesenteric. Causative organisms included Methicillin-Sensitive Staphylococcus Aureus (51%, n=63), Methicillin-Resistant Staphylococcus Aureus (15%, n=19), Streptococcus Viridans (2%, n=2), and others (31%, n=38). Emergency cardiac surgery was performed for 42% of patients (n=52). Most patients (84%) had single valve intervention: 53% tricuspid, 18% aortic and 13% mitral. Double valve interventions occurred in 15% (n=18). Overall, bioprosthetic replacement was most commonly chosen (79%, n=98). In-hospital mortality was 7% (n=8). Median length of stay in hospital was 13 days (IQR 8,21) and ICU 2 days (IQR 1,6). Mortality at longest available follow-up was 24% (n=30), with a median follow-up of 129 days (IQR 15,416). Valve reintervention rate was 11% (n=13) and readmission rate was 14% (n=17) at a median of 275 days (IQR 54,502). Conclusion Despite their critical condition, IVDU patients with endocarditis have good intra-hospital outcomes. Challenges occur after hospital discharge with loss of follow-up and high short-term mortality. IVDU relapse likely accounts for some of these issues. In-hospital and community comprehensive addiction management may improve these patients' outcomes beyond the surgical procedure. Annual rate 2009–2018 Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Stepien ◽  
P Furczynska ◽  
M Zalewska ◽  
K Nowak ◽  
A Wlodarczyk ◽  
...  

Abstract Background Recently heart failure (HF) has been found to be a new dementia risk factor, nevertheless their relations in patients following HF decompensation remain unknown. Purpose We sought to investigate whether a screening diagnosis for dementia (SDD) in this high-risk population may predict unfavorable long-term clinical outcomes. Methods 142 patients following HF decompensation requiring hospitalization were enrolled. Within a median time of 55 months all patients were screened for dementia with ALFI-MMSE scale whereas their compliance was assessed with the Morisky Medication Adherence Scale. Any incidents of myocardial infarction, coronary revascularization, stroke or transient ischemic attack (TIA), revascularization, HF hospitalization and bleedings during follow-up were collected. Results SDD was established in 37 patients (26%) based on the result of an ALFI-MMSE score of &lt;17 points. By multivariate analysis the lower results of the ALFI-MMSE score were associated with a history of stroke/TIA (β=−0.29, P&lt;0.001), peripheral arterial disease (PAD) (β=−0.20, P=0.011) and lower glomerular filtration rate (β=0.24, P=0.009). During the follow-up, patients with SDD were more often rehospitalized following HF decompensation (48.7% vs 28.6%, P=0.014) than patients without SDD, despite a similar level of compliance (P=0.25). Irrespective of stroke/TIA history, SDD independently increased the risk of rehospitalization due to HF decompensation (HR 2.22, 95% CI 1.23–4.01, P=0.007). Conclusions As shown for the first time in literature patients following decompensated HF, a history of stroke/TIA, PAD and impaired renal function independently influenced SDD. In this high-risk population, SDD was not associated with patients' compliance but irrespective of the stroke/TIA history it increased the risk of recurrent HF hospitalization. The survival free of rehospitalization Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Doi ◽  
K Ishigami ◽  
Y Aono ◽  
S Ikeda ◽  
Y Hamatani ◽  
...  

Abstract Background We previously reported that valvular heart disease (VHD) was not at the significant risk of stroke/systemic embolism (SE), but was associated with an increased risk of hospitalization for heart failure (HF) in Japanese atrial fibrillation patients. However, the impact of combined VHD on clinical outcomes has been little known. Purpose The aim of this study is to investigate the prevalence of combined VHD and its clinical characteristics and impact on outcomes such as stroke/SE, all-cause death, cardiac death and hospitalization for HF. Method The Fushimi AF Registry is a community-based prospective survey of AF patients in one of the wards of our city which is a typical urban district of Japan. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. In the entire cohort, echocardiography data were available for 3,574 patients. 68 AF patients with prosthetic heart valves were excluded and we compared clinical characteristics and outcomes between 488 single VHD (103 Aortic valve disease (AVD), 315 mitral valve disease (MVD), 70 tricuspid valve disease (TVD)) and 158 combined VHD (46 AVD and MVD, 11 AVD and TVD, 66 MVD and TVD, 35 AVD and MVD and TVD). Result Compared with single VHD, patients with combined VHD were older (combined vs. single VHD: 78.5 vs. 76.0 years, respectively; p&lt;0.01), more likely to have persistent/permanent type AF (73.4% vs. 63.9%, p=0.02) and prescription of warfarin (63.1% vs. 53.8%, p=0.04). Combined VHD was less likely to have diabetes mellitus (13.9% vs. 23.6%, p=0.01) and dyslipidemia (26.6% vs. 40.4%, p&lt;0.01). Sex, body weight, hypertension, pre-existing HF were comparable between the two groups. During the median follow-up of 1,474 days, the incidence rate of stroke/SE was not significantly different between the two groups (1.58 vs. 1.89 per 100 person-years, respectively, log rank p=0.10). The incidence rate of all-cause death (7.35 vs. 5.33, p=0.65), cardiac death (1.20 vs. 0.99, p=0.91) and hospitalization for HF (5.55 vs. 4.43, p=0.53) were also not significantly different. We previously reported AVD had significant impacts on cardiac adverse outcomes in AF patients, and we further analyzed event rates between combined VHD including AVD (AVD and MVD/TVD) and without AVD (MVD and TVD). Combined VHD with AVD group had higher incidence rate of all-cause death (10.7 vs. 5.79, p=0.03) than that without AVD group. However, the incidence rate of stroke/SE (1.98 vs. 1.56, p=0.59), cardiac death (0.98 vs. 1.14, p=0.68), hospitalization for HF (8.03 vs. 5.38, p=0.17) were not significantly different between the two groups. Conclusion As compared with single VHD, the risk of stroke/SE, all-cause death, cardiac death and hospitalization for HF in combined VHD was not significantly different. Among patients with combined VHD, those having AVD had higher incidence rate of all-cause death than those without AVD. Figure 1 Funding Acknowledgement Type of funding source: None


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