scholarly journals Association between thromboembolic and bleeding risk with adverse outcomes in contemporary European atrial fibrillation patients: final analysis from the ESC-EHRA EORP AF general long-term registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
G Boriani ◽  
M Proietti ◽  
C Laroche ◽  
L Fauchier ◽  
F Marin ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The ESC-EHRA EORP AF General Long-Term Registry provides a contemporary snapshot of European atrial fibrillation (AF) patients’ characteristics and management. Aims: We present data about the final 2-years follow-up observation of AF patients enrolled in the ESC-EHRA EORP AF General Long-Term Registry. Methods A contemporary evaluation of residual risk of adverse outcomes in a cohort of largely anticoagulated AF patients according to the baseline thromboembolic and bleeding risk, defined according to CHA2DS2-VASc and HAS-BLED scores. We determined cardiovascular (CV) events, CV death and all-cause death as outcomes. Results Among the original 11069 patients enrolled, 8409 (76.0%) patients had available follow-up status at the end of the 2-years follow-up. Patients age, female sex and most comorbidities were progressively more prevalent across the spectrum of thromboembolic and bleeding risk. Data on adverse outcomes were available for 10087 (91.1%), over the 2-year observation period. Outcome rates were progressively higher across CHA2DS2-VASc and HAS-BLED scores (all p < 0.0001). A fully adjusted Cox multivariable regression analysis, adjusted for clinical covariates selected by a univariate procedure and not included in the scores, showed that increasing baseline CHA2DS2-VASc score was associated with an higher risk for CV events (hazard ratio [HR]: 1.25, 95% confidence interval [CI]: 1.21-1.30), CV death (HR: 1.31, 95%CI: 1.25-1.38) and all-cause death (HR: 1.30, 95%CI: 1.25-1.36). Similarly, increasing baseline HAS-BLED score was associated with an increased risk for all 3 outcomes (HR: 1.21, 95%CI: 1.13-1.28; HR: 1.24, 95%CI: 1.14-1.34; HR: 1.22, 95%CI: 1.14-1.31, respectively). An association with a progressively higher risk was found for all outcomes across the spectrum of thromboembolic and bleeding risk [Figure]. Both CHA2DS2-VASc and HAS-BLED scores showed a modest to good predictive ability for cardiovascular (CV) events, CV death and all-cause death, in terms of c-index and 95% CI[0.66 (0.64-0.68) and 0.62 (0.61-0.64), 0.70 (0.68-0.72) and 0.65 (0.63-0.67), 0.69 (0.68-0.71) and 0.64 (0.63-0.66) for CHA2DS2-VASc and HAS-BLED for each outcome respectively. Conclusions In this large contemporary European-wide cohort of AF patients, both baseline thromboembolic and bleeding risks were associated to an increased risk of major clinical outcomes. Both scores are reflective of high risk clinical states, and are predictive of major adverse outcomes even in a large cohort of largely anticoagulated patients with a lower residual risk of adverse outcomes. Abstract Figure.

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


2015 ◽  
Vol 113 (01) ◽  
pp. 185-192 ◽  
Author(s):  
Chun-Cheng Wang ◽  
Cheng-Li Lin ◽  
Guei-Jane Wang ◽  
Chiz-Tzung Chang ◽  
Fung-Chang Sung ◽  
...  

SummaryWhether atrial fibrillation (AF) is associated with an increased risk of venous thromboembolism (VTE) remains controversial. From Longitudinal Health Insurance Database 2000 (LHID2000), we identified 11,458 patients newly diagnosed with AF. The comparison group comprised 45,637 patients without AF. Both cohorts were followed up to measure the incidence of deep-vein thrombosis (DVT) and pulmonary embolism (PE). Univariable and multivariable competing-risks regression model and Kaplan-Meier analyses with the use of Aelon-Johansen estimator were used to measure the differences of cumulative incidences of DVT and PE, respectively. The overall incidence rates (per 1,000 person-years) of DVT and PE between the AF group and non-AF groups were 2.69 vs 1.12 (crude hazard ratio [HR] = 1.92; 95 % confidence interval [CI] = 1.54-2.39), 1.55 vs 0.46 (crude HR = 2.68; 95 % CI = 1.97-3.64), respectively. The baseline demographics indicated that the members of the AF group demonstrated a significantly older age and higher proportions of comorbidities than non-AF group. After adjusting for age, sex, and comorbidities, the risks of DVT and PE remained significantly elevated in the AF group compared with the non-AF group (adjusted HR = 1.74; 95 %CI = 1.36-2.24, adjusted HR = 2.18; 95 %CI = 1.51-3.15, respectively). The Kaplan-Meier curve with the use of Aelon-Johansen estimator indicated that the cumulative incidences of DVT and PE were both more significantly elevated in the AF group than in the non-AF group after a long-term follow-up period (p<0.01). In conclusion, the presence of AF is associated with increased risk of VTE after a long-term follow-up period.


Author(s):  
Kyle P Hornsby ◽  
Kensey Gosch ◽  
Amy L Miller ◽  
Jonathan P Piccini ◽  
Renato D Lopes ◽  
...  

Background: Little data are available regarding differences in prognosis and health status between new-onset and prior atrial fibrillation (AF) among patients with acute myocardial infarction (AMI). Methods: The TRIUMPH study enrolled 4340 AMI patients who received longitudinal follow-up including SF-12 health status assessments through 1 year post-AMI. We compared 1-year mortality, rehospitalization, and functional status according to AF type (none, prior, new) after adjusting for differences in baseline characteristics. Results: A total of 212 AMI patients (4.9%) had prior AF and 254 (5.9%) had new-onset AF. Compared with no AF, new AF was associated with older age, male sex, first MI, worse baseline physical function, home atrioventricular nodal blocker use, and worse ventricular function (c-index 0.77). Rates of 1-year mortality were 6.2%, 14.5%, and 13.0%, and 1-year rehospitalization rates were 29.1%, 44.2%, and 36.8% for no, prior, and new AF, respectively. After multivariable adjustment, neither prior nor new AF was associated with increased 1-year mortality, and only prior AF was associated with increased risk of 1-year rehospitalization (Figure). After adjusting for baseline SF-12 physical function scores, patients with prior AF had lower 1-year scores than those with no AF (40.6 vs. 43.7, p <0.003), whereas patients with new AF had similar scores (42.9 vs. 43.7, p=0.36). Conclusion: New-onset AF during AMI is associated with a number of comorbidities but, unlike prior AF, is not associated with adverse outcomes. These results raise the question of whether AF is itself a cause of or simply a marker of comorbidities leading to downstream adverse outcomes after AMI.


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Marrco Vitolo ◽  
Vincenzo Livio Malavasi ◽  
Marco Proietti ◽  
Igor Diemberger ◽  
Laurent Fauchier ◽  
...  

Abstract Aims Cardiac troponins (cTn) have been reported to be predictors for adverse outcomes in atrial fibrillation (AF), patients, but their actual use is still unclear. To assess the factors associated with cTn testing in routine clinical practice and to evaluate the association of elevated levels of cTn with adverse outcomes in a large contemporary cohort of European AF patients. Methods and results Patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry were stratified into three groups according to cTn levels as (i) cTn not tested, (ii) cTn in range (≤99th percentile), and (iii) cTn elevated (&gt;99th percentile). The composite outcome of any thromboembolism/any acute coronary syndrome (ACS)/cardiovascular (CV) death, defined as major adverse cardiovascular events (MACE) and all-cause death were the main endpoints. 10 445 (94.1%) AF patients were included in this analysis [median age 71 years, interquartile range (IQR): 63–77; males 59.7%]. cTn were tested in 2834 (27.1%). Overall, cTn was elevated in 904 (8.7%) and in-range in 1930 (18.5%) patients. Patients in whom cTn was tested tended to be younger (P &lt; 0.001) and more frequently presenting with first detected AF and atypical AF-related symptoms (i.e. chest pain, dyspnoea, or syncope) (P &lt; 0.001). On multivariable logistic regression analysis, female sex, in-hospital enrollment, first-detected AF, CV risk factors, history of coronary artery disease (CAD), and atypical AF symptoms were independently associated with cTn testing. After a median follow-up of 730 days (IQR: 692–749), 957 (9.7%) composite endpoints occurred while all-cause death was 9.5%. Kaplan–Meier analysis showed a higher cumulative risk for both outcomes in patients with elevated cTn levels (Figure) (Log Rank tests, P &lt; 0.001). On adjusted Cox regression analysis, elevated levels of cTn were independently associated with a higher risk for MACE [hazard ratio (HR): 1.74, 95% confidence interval (CI): 1.40–2.16] and all-cause death (HR 1.45, 95% CI: 1.21–1.74). Elevated levels of cTn were independently associated with a higher occurrence of MACE, all-cause death, any ACS, CV death and hospital readmission even after the exclusion of patients with history of CAD, diagnosis of ACS at discharge, those who underwent coronary revascularization during the admission and/or who were treated with oral anticoagulants plus antiplatelet therapy. Conclusions Elevated cTn levels were independently associated with an increased risk of all-cause mortality and adverse CV events, even after exclusion of CAD patients. Clinical factors that might enhance the need to rule out CAD were associated with cTn testing.


Cardiology ◽  
2021 ◽  
Author(s):  
Dorte Marie Stavnem ◽  
Rakin Hadad ◽  
Bjørn Strøier Larsen ◽  
Olav Wendelboe Nielsen ◽  
Mark Aplin Frederiksen ◽  
...  

Background: In patients with atrial fibrillation (AF), the long-term prognosis of long electrocardiographic pauses in the ventricular action is not well-studied. Methods: Consecutive Holter recordings in patients with AF (n=200) between 2009-2011 were evaluated, focusing on pauses of at least 2.5 s. Outcomes of interest were all-cause mortality and pacemaker implantation. Results: Forty-three patients (21.5%) had pauses with a mean of 3.2 s and SD of 0.9 s. After a median follow-up of 99 months (ranging 89-111), 47% (20/43) of the patients with, and 45% (70/157) without pauses were deceased. Pauses of ≥ 2.5 s did not constitute a risk of increased mortality: HR = 0.75; (95% CI: 0.34 - 1.66); p = 0.48. Neither did pauses of ≥ 3.0 s: HR = 0.43; (95% CI: 0.06 - 3.20); p = 0.41. Sixteen percent of patients with pauses underwent pacemaker implantation during follow-up. Only pauses in patients referred to Holter due to syncope and/or dizzy spells were associated with an increased risk of pacemaker treatment: HR = 4.7 (95% CI: 1.4-15.9), p = 0.014, adjusted for age, sex and rate-limiting medication. Conclusion: In patients with AF, prolonged electrocardiographic pauses of ≥ 2.5 s or ≥ 3.0 s are not a marker for increased mortality in this real-life clinical study.


2018 ◽  
Vol 27 (6) ◽  
pp. 633-644 ◽  
Author(s):  
Marco Proietti ◽  
Alessio Farcomeni ◽  
Giulio Francesco Romiti ◽  
Arianna Di Rocco ◽  
Filippo Placentino ◽  
...  

Aims Many clinical scores for risk stratification in patients with atrial fibrillation have been proposed, and some have been useful in predicting all-cause mortality. We aim to analyse the relationship between clinical risk score and all-cause death occurrence in atrial fibrillation patients. Methods We performed a systematic search in PubMed and Scopus from inception to 22 July 2017. We considered the following scores: ATRIA-Stroke, ATRIA-Bleeding, CHADS2, CHA2DS2-VASc, HAS-BLED, HATCH and ORBIT. Papers reporting data about scores and all-cause death rates were considered. Results Fifty studies and 71 scores groups were included in the analysis, with 669,217 patients. Data on ATRIA-Bleeding, CHADS2, CHA2DS2-VASc and HAS-BLED were available. All the scores were significantly associated with an increased risk for all-cause death. All the scores showed modest predictive ability at five years (c-indexes (95% confidence interval) CHADS2: 0.64 (0.63–0.65), CHA2DS2-VASc: 0.62 (0.61–0.64), HAS-BLED: 0.62 (0.58–0.66)). Network meta-regression found no significant differences in predictive ability. CHA2DS2-VASc score had consistently high negative predictive value (≥94%) at one, three and five years of follow-up; conversely it showed the highest probability of being the best performing score (63% at one year, 60% at three years, 68% at five years). Conclusion In atrial fibrillation patients, contemporary clinical risk scores are associated with an increased risk of all-cause death. Use of these scores for death prediction in atrial fibrillation patients could be considered as part of holistic clinical assessment. The CHA2DS2-VASc score had consistently high negative predictive value during follow-up and the highest probability of being the best performing clinical score.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
B Corica ◽  
G.F Romiti ◽  
V Raparelli ◽  
R Cangemi ◽  
S Basili ◽  
...  

Abstract Background Long-term anticoagulation in patients with atrial fibrillation (AF) imposes a careful balance between the thromboembolic and hemorrhagic risks. An association between cerebral microbleeds (CMBs) and an increased risk of intracranial hemorrhage (ICH) has already been described; however, conflicting evidence exist on the association with ischemic stroke (IS). Although CMBs are often observed in AF patients, the actual prevalence and the magnitude of the risk of adverse events in patients with CMBs is unclear. Purpose We aimed to estimate the pooled prevalence of CMBs in patients with AF through a systematic review and meta-analysis of the literature. Additionally, we evaluated the risk of ICH and IS according to the presence and burden of CMBs. Methods We perform a systematic search on PubMed and EMBASE from inception to 6th March 2021. We included all studies reporting the prevalence of CMBs, the incidence of ICH and/or IS in AF by presence of CMBs. Pooled prevalence and odds ratios (OR), along with their 95% Confidence Intervals (CI), were computed using random-effect models; we also calculated 95% Prediction Intervals (PI) for each outcome investigated. Additionally, we performed subgroup analyses according to the number and localization of CMBs. Results We retrieved 562 records from the literature search, and 17 studies were finally included. Pooled prevalence of CMBs in AF population was 28.3% (95% CI: 23.8%-33.4%; 95% PI: 12.2%-52.9%, Figure 1). Individuals with CMBs showed a higher risk of both ICH (OR: 3.04, 95% CI: 1.83–5.06) and IS (OR: 1.78, 95% CI: 1.26–2.49). Moreover, patients with more than 5 CMBs, as well as patients with both lobar and mixed CMBs, showed a higher risk of ICH. Conclusions CMBs were found in 28.3% of AF patients, with 95% PIs indicating a potentially higher prevalence. Moreover, CMBs were associated with an increased risk of both ICH and IS, with the effect potentially modulated by their number and localization. CMBs may represent an important and often overlooked risk factor for adverse outcomes in patients with AF. FUNDunding Acknowledgement Type of funding sources: None. Prevalence of CMBs in patients with AF


Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
M Vitolo ◽  
S Harrison ◽  
G.A Dan ◽  
A.P Maggioni ◽  
...  

Abstract Introduction Frailty is a major health determinant for cardiovascular disease. Thus far, data on frailty in patients with atrial fibrillation (AF) are limited. Aims To evaluate frailty in a large contemporary cohort of European AF patients, the relationship with oral anticoagulant (OAC) prescription and with risk of all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. A 38-items frailty index (FI) was derived from baseline characteristics according to the accumulation of deficits model proposed by Rockwood and Mitnitsky. All-cause mortality was the primary study outcome. Results Out of the 11096 AF enrolled patients, data for evaluating frailty were available for 6557 (59.1%) patients who have been included in this analysis (mean [SD] age 68.9 [11.5], 37.7% females). Baseline median [IQR] CHA2DS2-VASc and HAS-BLED were 3 [2–4] and 1 [1–2], respectively. At baseline, median [IQR] FI was 0.16 (0.12–0.23), with 1276 (19.5%) patients considered “not-frail” (FI&lt;0.10), 4033 (61.5%) considered “pre-frail” (FI 0.10–0.25) and 1248 (19.0%) considered “frail” (FI≥0.25). Age, female prevalence, CHA2DS2-VASc and HAS-BLED progressively increased across the FI classes (all p&lt;0.001). Use of OAC progressively increased among FI classes; after adjustments FI was not associated with OAC prescription (odds ratio [OR]: 1.09, 95% confidence interval [CI]: 0.98–1.19 for each 0.10 FI increase). Conversely, FI was directly associated with vitamin K antagonist (VKA) use (OR: 1.26, 95% CI: 1.18–1.34 for each 0.10 FI increase) and inversely associated with non-VKA OACs (NOACs) use (OR: 0.82, 95% CI: 0.77–0.88). FI was significantly correlated with CHA2DS2-VASc (Rho= 0.516, p&lt;0.001). Over a median [IQR] follow-up of 731 [704–749] days, there were 569 (8.7%) all-cause death events. Kaplan-Meier curves [Figure] showed an increasing cumulative risk for all-cause death according to FI categories. A Cox multivariable analysis, adjusted for age, sex, type of AF and use of OAC, found that increasing FI as a continuous variable was associated with an increased risk of all-cause death (hazard ratio [HR]: 1.56, 95% CI: 1.40–1.73 for each 0.10 FI increase). An association with all-cause death risk was found across the FI categories (HR: 1.71, 95% CI: 1.23–2.38 and HR: 2.88, 95% CI: 2.02–4.12, respectively for pre-frail and frail patients compared to non-frail ones). FI was also predictive of all-cause death (c-index: 0.660, 95% CI: 0.637–0.682; p&lt;0.001). Conclusions In a European contemporary cohort of AF patients the burden of frailty is significant, with almost 1 out of 5 patients found to be “frail”. Frailty influenced significantly the choice of OAC therapy and was associated with (and predictive of) all-cause death at follow-up. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP programme, several companies have supported it with unrestricted grants.


2020 ◽  
Vol 9 (9) ◽  
pp. 2713
Author(s):  
Rungroj Krittayaphong ◽  
Ply Chichareon ◽  
Chulalak Komoltri ◽  
Sakaorat Kornbongkotmas ◽  
Ahthit Yindeengam ◽  
...  

We aimed to determine if low body weight (LBW) status (<50 kg) is independently associated with increased risk of ischemic stroke and bleeding in Thai patients with non-valvular atrial fibrillation (NVAF). (1) Background: It has been unclear whether LBW influence clinical outcome of patients with NVAF. (2) Methods: This prospective multicenter cohort study included patients enrolled in the COOL-AF Registry. The following data were collected: demographic data, medical history, risk factors and comorbid conditions, laboratory and investigation data, and medications. Follow-up data were collected every 6 months. Clinical events during follow-up were confirmed by the adjudication committee. (3) Results: A total of 3367 patients were enrolled. The mean age was 67.2 ± 11.2 years. LBW was present in 338 patients (11.3%). Anticoagulant and antiplatelet was prescribed in 75.3% and 26.2% of patients, respectively. Ischemic stroke, major bleeding, intracerebral hemorrhage (ICH), and death occurred during follow-up in 2.9%, 4.4%, 1.4%, and 7.7% of patients, respectively, during 25.7 months follow-up. LBW was an independent predictor of ischemic stroke, major bleeding, ICH, and death, with a hazard ratio of 2.40, 1.79, 2.37, and 2.65, respectively. (4) Conclusions: LBW was independently associated with increased risk of adverse outcomes in Thai patients with NVAF. This should be carefully considered when balancing the risks and benefits of stroke prevention among patients with different body weights.


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