Effects of apixaban compared with warfarin as gain in event-free time – a novel assessment of the results of the ARISTOTLE trial

Background A novel approach to determine the effect of a treatment is to calculate the delay of event, which estimates the gain of event-free time. The aim of this study was to estimate gains in event-free time for stroke or systemic embolism, death, bleeding events, and the composite of these events, in patients with atrial fibrillation randomized to either warfarin or apixaban in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial (ARISTOTLE). Design The ARISTOTLE study was a randomized double-blind trial comparing apixaban with warfarin. Methods Laplace regression was used to estimate the delay in time to the outcomes between the apixaban and the warfarin group in 6, 12, 18 and 22 months of follow-up. Results The gain in event-free time for apixaban versus warfarin was 181 (95% confidence interval 76 to 287) days for stroke or systemic embolism and 55 (–4 to 114) days for death after 22 months of follow-up. The corresponding gains in event-free times for major and intracranial bleeding were 206 (130 to 281) and 392 (249 to 535) days, respectively. The overall gain for the composite of all these events was a gain of 116 (60 to 171) days. Conclusions In patients with atrial fibrillation, 22 months of treatment with apixaban, as compared with warfarin, provided gains of approximately 6 months in event-free time for stroke or systemic embolism, 7 months for major bleeding and 13 months for intracranial bleeding.

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A single institution’s experience with using dabigatran, rivaroxaban and warfarin for prevention of thromboembolism in atrial fibrillation

Proceedings of Singapore Healthcare ◽

10.1177/2010105817719913 ◽

2017 ◽

Vol 27 (1) ◽

pp. 20-25 ◽

Cited By ~ 2

Author(s):

Li Xin Chan ◽

Yee May Wong ◽

Pow-Li Chia ◽

Zhen Liang Kek

Keyword(s):

Atrial Fibrillation ◽

Adverse Events ◽

Oral Anticoagulants ◽

Tertiary Hospital ◽

Minor Bleeding ◽

Systemic Embolism ◽

Bleeding Events ◽

Warfarin Group ◽

One Year

Background: Although non-vitamin K antagonist oral anticoagulants (NOACs) are approved for stroke prevention in atrial fibrillation (AF) patients, their use in the local clinical setting has not been well studied. This study aims to evaluate the clinical outcomes of dabigatran, rivaroxaban and warfarin in a tertiary hospital in Singapore. Methods: This is a retrospective cohort study with one-year follow-up. A total of 383 patients recruited between June 2011 and December 2014 were studied. Incidents of stroke, systemic embolism and clinically relevant bleeding events were compared between dabigatran, rivaroxaban and warfarin. Results: Stroke rates were 5.47% per year with warfarin, 7.27% per year with dabigatran (HR=1.32; 95% CI 0.48−3.64; p=0.591) and 2.76% per year with rivaroxaban (HR=0.49; 95% CI 0.14−1.69; p=0.261). The warfarin group had significantly higher incidence of minor bleeding (62.4% vs 3.64% for dabigatran vs 13.79% for rivaroxaban; p<0.001), major bleeding (3.91% for warfarin, 0.91% for dabigatran, 0% for rivaroxaban; p=0.028) and other adverse events (51.18% for warfarin, 3.64% for dabigatran, 8.28% for rivaroxaban; p<0.001). Incidence of dyspepsia was higher in both NOAC groups compared to warfarin (0% for warfarin, 7.27% for dabigatran, 5.52% for rivaroxaban; p=0.003). Conclusion: Stroke and venous thromboembolism rates after one year were comparable among dabigatran, rivaroxaban and warfarin. Warfarin was associated with more bleeding and adverse events while both NOACs were associated with higher rates of dyspepsia. Further study is needed to assess the clinical benefit of NOACs in the Singaporean population.

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Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish Nationwide Cohort

European Heart Journal - Cardiovascular Pharmacotherapy ◽

10.1093/ehjcvp/pvz070 ◽

2019 ◽

Author(s):

Peter Brønnum Nielsen ◽

Torben Bjerregaard Larsen ◽

Flemming Skjøth ◽

Mette Søgaard ◽

Gregory Y H Lip

Keyword(s):

Atrial Fibrillation ◽

Stroke Prevention ◽

Treatment Options ◽

Clinical Effectiveness ◽

Systemic Embolism ◽

Antithrombotic Treatment ◽

Bleeding Events ◽

Once Daily ◽

Randomized Controlled

Abstract Aims Edoxaban treatment for stroke prevention in atrial fibrillation (AF) has mainly been investigated in randomized controlled trials, and data reflecting clinical practice are limited. We ascertained the clinical effectiveness and safety of edoxaban 30 and 60 mg once daily among Danish patients with AF. Methods and results This was an observational study based on Danish nationwide registries collecting information for administrative purposes. From June 2016 through November 2018, we identified 3405 patients initiating edoxaban. After exclusions, 2285 AF patients were followed for the effectiveness outcome of thromboembolism (ischaemic stroke and/or systemic embolism) and bleeding outcomes (composite of major bleeding, gastrointestinal bleeding, and intracranial haemorrhage), as well as bleeding requiring hospitalization. Population mean age was 75 years and 43% were female; 643 patients received the 30 mg edoxaban dosage regimen and 1642 initiated 60 mg edoxaban. During follow-up, we observed 41 thromboembolic events and 89 bleeding events of which 40 events required hospitalization. Among patients with 30 mg edoxaban, the rate (per 100 person-years) of thromboembolism was 2.07 vs. 1.62 for 60 mg edoxaban. Rates of bleeding were similar for the two dosages at ∼3.85. Bleeding requiring hospitalization occurred at a rate of 1.74 for 30 mg edoxaban and 1.69 with 60 mg edoxaban. Conclusion In this nationwide cohort of Caucasian AF patients treated with edoxaban for stroke prevention, the clinical effectiveness and safety were in line with data from the ENGAGE AF-TIMI 48 trial. Studies investigating comparative effectiveness and safety for edoxaban in comparison with other choices of antithrombotic treatment options are needed.

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Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in Chinese patients with atrial fibrillation

Vascular ◽

10.1177/1708538113490423 ◽

2013 ◽

Vol 22 (4) ◽

pp. 252-258 ◽

Cited By ~ 11

Author(s):

Lizheng Mao ◽

Chengyan Li ◽

Tao Li ◽

Kunxiong Yuan

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Safety Concern ◽

Hazard Ratio ◽

Chinese Patients ◽

Systemic Embolism ◽

Double Blind ◽

Warfarin Group ◽

Double Blind Clinical Trial ◽

To Receive

This study assessed the effects and safety of rivaroxaban versus warfarin in Chinese patients with atrial fibrillation. In this double-blind clinical trial, a total of 353 consecutive patients with atrial fibrillation who were at risk of stroke or systemic embolism were enrolled to receive either rivaroxaban or warfarin. The primary effect endpoint occurred in five patients in the rivaroxaban group (2.29% per year) and in seven patients in the warfarin group (2.91% per year) (hazard ratio with warfarin, 0.76, 95% CI, 0.64–0.91; p = 0.03). Major and non-major clinically relevant bleeding occurred in 38 patients (14.3% per year) in the rivaroxaban group and in 36 patients (13.7% per year) in the warfarin group (hazard ratio rivaroxaban versus warfarin, 1.07; 95% CI, 0.93–1.14; p = 0.39). Adverse events were similar between these two arms ( p > 0.05). In conclusion, oral administration of rivaroxaban reduced the risk of stroke or systemic embolism without significantly increasing the safety concern.

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Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study

European Heart Journal - Cardiovascular Pharmacotherapy ◽

10.1093/ehjcvp/pvaa079 ◽

2020 ◽

Cited By ~ 1

Author(s):

Joris R de Groot ◽

Thomas W Weiss ◽

Peter Kelly ◽

Pedro Monteiro ◽

Jean Claude Deharo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Stroke Prevention ◽

Clinical Care ◽

Oral Anticoagulants ◽

Routine Care ◽

European Medicines Agency ◽

Systemic Embolism ◽

Bleeding Events

Abstract Aims Non-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care. Methods and results ETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban’s post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate: 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg. Conclusion The rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.

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Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry

Clinical Research in Cardiology ◽

10.1007/s00392-021-01874-3 ◽

2021 ◽

Author(s):

Shinwan Kany ◽

Johannes Brachmann ◽

Thorsten Lewalter ◽

Ibrahim Akin ◽

Horst Sievert ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial Appendage ◽

Systemic Embolism ◽

Long Term Outcomes ◽

Increased Risk ◽

History Of ◽

One Year ◽

The One

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

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Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

European Heart Journal ◽

10.1093/ehjci/ehaa946.0673 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

Y Hamatani ◽

M Iguchi ◽

Y Aono ◽

K Ishigami ◽

S Ikeda ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Chronic Kidney Disease ◽

Kidney Disease ◽

Clinical Outcomes ◽

Prognostic Marker ◽

Oral Anticoagulants ◽

Systemic Embolism ◽

The Mean

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 <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<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

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Apixaban versus Warfarin in Patients with Left Ventricular (LV) Thrombus, a prospective randomized trial

European Heart Journal ◽

10.1093/ehjci/ehaa946.1545 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

R Alcalai ◽

R Rashad ◽

A Butnaru ◽

G Moravsky ◽

D Leibowitz

Keyword(s):

Major Bleeding ◽

Thrombus Formation ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Left Ventricular ◽

Systemic Embolism ◽

Bleeding Events ◽

Open Label ◽

Warfarin Group ◽

Acute Mi

Abstract Background Patients with acute myocardial infarction (MI) have an elevated risk of stroke, mostly due to left ventricular (LV) thrombus formation, which typically occur within the first 2 weeks following an anterior MI. Currently the recommended management of LV thrombus after acute MI is anticoagulation with vitamin K antagonist. To date, there are no prospective data on the use of direct oral anticoagulants (DOACS) for stroke prevention in the setting of LV thrombus. Aim To assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI. Methods The study is a prospective, randomized, multi-center open label trial comparing apixaban (at a dose of 5 mg twice daily) with s.c enoxaparin 1mg/kg BID followed by dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months in patients with LV thrombus detected by echocardiography 3 to 14 days after acute MI. The primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation as assessed by 2D echocardiogram. Secondary outcomes were stroke or systemic embolism, major bleeding and death from any cause. Results 25 patients have been enrolled to date in 3 medical centers, 13 were randomized to apixaban and 12 to warfarin. Mean age was 59.8±10.7 and 19 (76%) were males with no difference between the study groups. Mean LV thrombus size at enrollment was 24X15 mm in the apixaban group and 19X14 in the warfarin group (p=NS). After 3 months of treatment thrombus completely resolved in all patients in the warfarin group and in 12 of 13 in the apixaban group. In one patient in the apixaban group who had a very large thrombus of 40x20mm size upon enrollment the thrombus size was reduced significantly to 20x12 after 3 months. No death, stroke or systemic embolism was documented in either group. There were two patients with major bleeding in the warfarin group, one had sub-arachnoid hemorrhage after 2 months and anticoagulation was stopped, and another had GI bleeding after 1 month and was switched to enoxaparin. One patient in the warfarin group refused to continue the treatment after 3 weeks. No major bleeding events were recorded in the apixaban group and all patients completed 3 months of treatment. Conclusions Our preliminary results indicate that apixaban is a safe and effective treatment for patients with LV thrombus post anterior wall MI. Funding Acknowledgement Type of funding source: None

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Anticoagulation Challenges in Hematogeriatrics: Effectiveness and Safety of Direct Oral Anticoagulants Vs Vitamin k Antagonist in Elderly with Atrial Fibrillation

Blood ◽

10.1182/blood-2019-125150 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1162-1162

Author(s):

Desirée Campoy ◽

Gonzalo Artaza ◽

César A Velasquez ◽

Tania Canals ◽

Erik A Johansson ◽

...

Keyword(s):

Atrial Fibrillation ◽

Elderly Patients ◽

Vitamin K ◽

Major Bleeding ◽

Frail Elderly ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Systemic Embolism ◽

Bleeding Events

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.

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Brief Intermittent Neuroleptic Prophylaxis for Selected Schizophrenic Out-patients

The British Journal of Psychiatry ◽

10.1192/s0007125000018237 ◽

1989 ◽

Vol 155 (05) ◽

pp. 702-706 ◽

Cited By ~ 3

Author(s):

H. A. McClelland ◽

G. Harrison ◽

S. D. Soni

Keyword(s):

Psychotic Symptoms ◽

Intermittent Treatment ◽

Double Blind ◽

Prodromal Symptoms ◽

Novel Approach ◽

Depot Neuroleptic ◽

One Year ◽

Depot Injections ◽

To Receive

“A study was conducted to investigate a novel approach to the prophylaxis of schizophrenic relapse. The treatment strategy comprised brief intermittent courses of neuroleptic agents begun as soon as non-psychotic symptoms believed to be early signs of relapse appeared. Fifty four stable, remitted outpatients meeting the American Psychiatric Association's DSM–III criteria for schizophrenia were randomised double blind to receive brief intermittent treatment with either active or placebo depot neuroleptic injections. Only three patients given placebo injections and two controls were admitted to hospital during one year of follow up. Eight (30%) of the patients given placebo injections and only 2 (7%) of the controls, however, had a recurrence of schizophrenic symptoms. Patients given placebo injections experienced fewer extrapyramidal side effects and showed a trend towards a reduction in tardive dyskinesia. Dysphoric and neurotic symptoms were identified before eight out of 11 relapses, and these symptoms were more frequent in patients given placebo depot injections. These results suggest a viable but not necessarily better alternative to continuous oral or depot treatment for less ill, chronic, stabilised schizophrenics based on the early treatment of putative prodromal symptoms of relapse.”

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Impact of atrial fibrillation pattern on left atrial appendage closure: insights from the prospective LAARGE registry

EP Europace ◽

10.1093/europace/euab116.123 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

S Kany ◽

J Brachmann ◽

T Lewalter ◽

I Akin ◽

H Sievert ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Systemic Embolism ◽

Long Term Outcomes ◽

Left Atrial Appendage Closure ◽

History Of ◽

One Year

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Stiftung für Herzinfarkforschung Background Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death compared with paroxysmal AF (PAF). This study investigates the procedural safety and long-term outcomes of left atrial appendage closure (LAAC) in patients with different forms of AF. Methods Comparison of procedural details and long-term outcomes in patients (pts) with PAF against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC in Germany (LAARGE). Results A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. NPAF consisted of 31.6% patients with persistent AF and 68.4% with longstanding persistent AF or permanent AF. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The PAF group had significantly less history of heart failure (19.0% vs 33.0%, p < 0.001) while the current median LVEF was similar (60% vs 60%, p = 0.26). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), but no difference in the HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was observed. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77) in both groups. In the three-month echo follow-up, device-related 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). Conclusion Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE of patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality and combined outcome of death, stroke and systemic embolism.

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