scholarly journals Rivaroxaban in non valvular atrial fibrillation: subgroups analysis

2015 ◽  
Vol 82 (1) ◽  
Author(s):  
Cesare Greco
Keyword(s):  
Atrial Fibrillation ◽  
Randomized Study ◽  
Thrombosis Prophylaxis ◽  
Main Paper ◽  
Coronary Syndromes ◽  
Pharmacological Cardioversion ◽  
Clinical Conditions ◽  
Post Hoc ◽  
Moderate Renal Failure

After the ROCKET AF study main paper several subgroups analysis were recently published. These studies are useful to better evaluate the rivaroxaban efficacy and safety in different clinical conditions. Here the subgroup analysis of patients with moderate renal failure, heart failure and diabetes are presented. Post hoc data on patients who underwent an electrical or pharmacological cardioversion during ROKET AF follow up were available and here we analyze also the results of the first randomized study on electrical cardioversion in patients treated with new oral anticolagulants: the X-VeRT trial. A metanalysis of all the studies with rivaroxaban (one on stroke prevention in atrial fibrillation, two on acute coronary syndromes, four on deep venous thrombosis prophylaxis and two on pulmonary embolism treatment) with respect to the risk of myocardial infarction is examined.

Abstract 20107: Randomized Comparison of Personalized versus Standardized Substrate Modification During Catheter Ablation for Symptomatic Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Simon Kircher ◽  
Arash Arya ◽  
David Altmann ◽  
Sascha Rolf ◽  
Andreas Bollmann ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Low Voltage ◽  
Randomized Study ◽  
Standard Group ◽  
Linear Lesions ◽  
Substrate Modification ◽  
Arrhythmogenic Substrate ◽  
Group 2 ◽  
Group 1

Introduction: Pulmonary vein (PV) isolation forms the cornerstone of any ablation procedure for atrial fibrillation (AF). There is, however, no uniform strategy how to detect and target left atrial (LA) arrhythmogenic substrate outside the PV antra. Fibrosis that corresponds well to LA low-voltage areas (LVAs) seems to play a key role in AF arrhythmogenesis and might therefore be a suitable target for additional substrate modification (SM). Objective: The purpose of this prospective randomized study was to compare a novel technique for SM based on ablation of potentially arrhythmogenic LA LVAs with a standard approach consisting of empiric LA linear ablation. Methods: Patients (pts) with symptomatic paroxysmal or persistent AF were randomized to standard (group 1) or personalized (group 2) SM. Circumferential PV isolation was the primary step in both groups. In group 1, pre-defined linear lesions were applied at the LA roof and bottom, respectively, and at the mitral isthmus only in pts with persistent AF. In group 2, targets for SM (i.e. LVAs) were identified by detailed bipolar voltage mapping (BVM) during sinus rhythm irrespective of AF type. Peak-to-peak electrogram amplitudes were defined as “normal” (> 0.5 mV), as “low voltages” (0.2 to 0.5 mV), or as “scar” (< 0.2 mV). LVAs were targeted by tissue homogenization and / or strategic linear lesions. The primary endpoint was freedom from any atrial arrhythmia (i.e. AF, atrial flutter, or atrial tachycardia) > 30 seconds off antiarrhythmic drugs on serial 7-d-Holter ECG recordings after a follow-up period of 12 months. Results: In total, 124 ablation-naïve pts (mean age 63 ± 9 years, 62 % male, 49 % with persistent AF) were enrolled in this study. LVAs were present in 18 % of pts with paroxysmal and in 41 % of pts with persistent AF (p<0.05). At the end of the follow-up period, 25 out of 59 pts (42 %) in the conventional group were free from arrhythmia recurrence as compared to 40 out of 59 pts (68 %) in the BVM-guided group (unadjusted log rank p = 0.003). Conclusion: Personalized SM guided by endocardial BVM is associated with a higher success rate compared to a conventional approach applying empirical SM based on AF phenotype.

P3793Spironolactone in patients with permanent atrial fibrillation, possible heart failure protective potential

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Dabrowski ◽  
T Chwyczko ◽  
I Kowalik ◽  
E Smolis-Bak ◽  
A Borowiec ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Beta Blocker ◽  
Interstitial Fibrosis ◽  
Randomized Study ◽  
Treated Group ◽  
Control Treatment ◽  
Permanent Atrial Fibrillation ◽  
Minute Walk

Abstract Background Atrial fibrillation (AF) promotes electrical, neurohormonal and structural remodeling of atria and ventricles. Long lasting AF leads to atrial interstitial fibrosis, apoptosis, loss of myofibrils and finally to heart failure (HF). Purpose The aim of the study was impact of aldosterone antagonist, spironolactone, on exercise tolerance and neurohormonal activity in patients with permanent AF without symptoms of HF. Methods In prospective, randomized study patients with permanent AF at least for 1 year, no signs and symptoms of HF and stable clinical condition were included. Patients were randomized to: beta-blocker plus spironolactone (dose: 25 mg) treatment and rate-control treatment with only beta-blocker. Propranolol, metoprolol and bisoprolol were used, doses were adjusted to achieve resting heart rate 60–80/min. Ergospirometry (CPX) and 6-minute walk (6-MWT) tests were performed during separate days. Results Study group consisted of 49 patients, 69% men, mean age 62.1±9.6 without structural and chronic active diseases, mean time of arrhythmia was 5.5 years, Q1: 2, Q3: 8 years. Follow-up was 11.2 months. All patients were treated with beta-blockers, 27 patients were treated with 25 mg spironolactone. Surprisingly physical capacity in 6-minute walk test (6-MWT) in studied patients was not significantly reduced in comparison with values ranges for healthy volunteers. After 11.2 months follow-up significantly longer exercise time (433±113 vs. 367±162 sec, p<0.05) and lower maximal HR (159±25 vs. 165±22 beats/min, p<0.0550) were observed in spironolactone treated group. Other CPX variables did not differ significantly between groups after 11,2 months: VO2: 20.7±5.1 vs. 20.1±4.8 [ml/kg/min]; VO2 as % of normal value: 78.4±15.2 vs. 76.8±15.2; O2 pulse: 12±2.8 vs. 12.7±3.6 [ml/beat]; AT: 1.4±0.3, 1.6±0.5 [L/min]; VE: 74.9±20.0, 72.6±17.9 [L/min]. All spirometric variables worsened after 11.2 months: VC: 4.3±1.1 vs. 3.8±0.8 [L], p<0.0005, FVC: 4.2±1.1 vs. 3.8±1.0 p<0.005 [L], FEV1: 3.1±0.8 vs. 2.8±0.7 [L], p<0.01. In spironolactone treated group after 11.2 months BNP concentrations were significantly lower: Q1: 54, Q2: 83, Q3: 100 vs. Q1: 42, Q2: 93; Q3: 184 ng/L (p=0.025) and aldosterone levels were markedly increased: Q1: 216, Q2: 266; Q3:443 vs. Q1: 169; Q2: 228; Q3:294 ng/dL (p=0.0007). Conclusions In patients with permanent atrial fibrillation cardiopulmonary exercise responses were markedly abnormal, but exercise capacity was increased after spironolactone treatment. Deterioration of spirometry results might be due to beta-blocker treatment. In spironolactone treated group BNP levels were significantly lower what may correspond to its heart failure protective activity.

Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial

EP Europace ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. 1487-1494 ◽  
Author(s):  
Katharina Schoene ◽  
Arash Arya ◽  
Friederike Grashoff ◽  
Helge Knopp ◽  
Alexander Weber ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Radiofrequency Ablation ◽  
Energy Levels ◽  
Randomized Study ◽  
Posterior Wall ◽  
Drop Out ◽  
Peak Temperature ◽  
Drop Out Rate ◽  
Higher Power

Abstract Aims The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes. Methods and results Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA− group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA−. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA− (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA− required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3–13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541. Conclusion This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure.

scholarly journals Safety performance of rivaroxaban versus warfarin in patients with atrial fibrillation and advanced chro­nic kidney disease

Kardiologiia ◽  
2020 ◽  
Vol 60 (11) ◽  
pp. 94-100
Author(s):  
M. I. Chashkina ◽  
D. A. Andreev ◽  
N. L. Kozlovskaya ◽  
Z. K. Salpagarova ◽  
A. Yu. Suvorov ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Treatment Group ◽  
Kidney Disease ◽  
Randomized Study ◽  
Minor Bleeding ◽  
Emergency Admissions ◽  
Treatment Groups ◽  
Stage 4 ◽  
Warfarin Treatment

Aim To evaluate safety of using rivaroxaban in patients with stage 4 chronic kidney disease (CKD) or transient, stable decline of glomerular filtration rate (GFR) to 15–29 ml /min / 1.73 m2 in the presence of atrial fibrillation (AF).Material and methods This multicenter prospective, randomized study included patients admitted to cardiology departments from 2017 through 2019. Of 10 224 admitted patients 109 (3 %) patients with AF and stage 4 CKD or a stable decline of GFR to 15–29 ml /min / 1.73 m2 were randomized at 2:1 ratio to the rivaroxaban 15 mg /day (n=73) treatment group or to the warfarin treatment group (n=36). The primary endpoint was development of BARC and ISTH major, minor, and clinically relevant minor bleeding. Mean follow-up duration was 18 months.Results Patients receiving warfarin had a significantly higher incidence of BARC (n=26 (72.2 %) vs. n=31 (42.4 %), р<0.01) and ISTH (n=22 (61.1 %) vs. n=27 (36.9 %), p<0.01) minor bleeding and all ISTH clinically relevant (minor clinically relevant and major bleedings) n=10 (27.7 %) vs. n=8 (10.9 %), р=0.03]. The number of repeated hospitalizations was 65 (43% of patients) in the rivaroxaban treatment group and 27 (48% of patients) in the warfarin treatment group (р=0.57), including 24 (36.9 %) and 11 (40.7 %) emergency admissions in the rivaroxaban and warfarin treatment groups, respectively (р=0.96). Significant improvement of changes in creatinine clearance and GFR (by CKD-EPI and Cockroft-Gault) was observed in the rivaroxaban treatment group.Conclusion The study provided evidence for a more beneficial safety profile of rivaroxaban compared to warfarin in patients with AF and advanced CKD.

Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial

2021 ◽  
pp. 1-7
Author(s):  
Wern Yew Ding ◽  
Gregory Y.H. Lip ◽  
Alena Shantsila
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Post Hoc Analysis ◽  
Time In Therapeutic Range ◽  
All Cause Mortality ◽  
Post Hoc ◽  
Moderate Renal Failure

<b><i>Background:</i></b> The benefit of anticoagulation therapy in atrial fibrillation (AF) and chronic kidney disease (CKD) remains controversial. We aimed to evaluate the impact of renal function on the quality of anticoagulation control, and the effects of both these factors on outcomes in AF. <b><i>Methods:</i></b> Post hoc analysis of the AMADEUS trial. Trial-related outcomes were adjudicated and we studied the composite of first stroke/major bleeding/all-cause mortality, ischaemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality. <b><i>Results:</i></b> We included 2,282 vitamin K antagonist (VKA)-treated patients {<i>n</i> = 787 (34.5%) females; median age 72 (interquartile ranges [IQR] 64–77) years}. Median follow-up was 365 (IQR 189–460) days. There were 1,922 (84.2%) non-CKD and 360 (15.8%) CKD patients. Renal function was inversely correlated with time-in-therapeutic range (<i>r</i> = −0.047, <i>p</i> = 0.025). There was no statistical difference in terms of crude study outcomes based on renal function. Multivariable regression analysis demonstrated that moderate renal failure with estimated glomerular filtration rate of less than 60 mL/min/1.73 m<sup>2</sup> (<i>p</i> = 0.032) and percentage of time-in-therapeutic range (<i>p</i> = 0.011) were independent predictors for the composite outcome of stroke, major bleeding, and all-cause mortality. <b><i>Conclusion:</i></b> Deteriorated renal function has a small negative impact on the quality of anticoagulation control with VKA which is linked to poor outcomes in AF. However, moderate renal failure itself was an independent risk factor for increased risk of stroke, major bleeding, and all-cause mortality amongst patients with AF.

Abstract 2752: Pulmonary Vein Isolation With And Without Additional Ablation Of Complex Fractionated Electrograms In Paroxysmal Atrial Fibrillation: Long-term Results Of A Prospective Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Treat Analysis

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.

scholarly journals Associations of Atrial Fibrillation Patterns With Mortality and Cardiovascular Events: Implications of the MISOAC-AF Trial

2022 ◽  
Vol 27 ◽  
pp. 107424842110694
Author(s):  
Amalia Baroutidou ◽  
Anastasios Kartas ◽  
Athanasios Samaras ◽  
Andreas S. Papazoglou ◽  
Eleni Vrana ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cox Regression ◽  
Bleeding Events ◽  
Mortality And Morbidity ◽  
Hospitalization Rates ◽  
Kaplan Meier ◽  
Prognostic Implications ◽  
Post Hoc

Aim: This retrospective cohort study aimed to evaluate the prognostic implications of the distinct atrial fibrillation (AF) temporal patterns: first diagnosed, paroxysmal, and persistent or permanent AF. Methods: In this post hoc analysis of the MISOAC-AF trial (NCT02941978), a total of 1052 patients with AF (median age 76 years), discharged from the cardiology ward between 2015 and 2018, were analyzed. Kaplan-Meier and Cox-regression analyses were performed to compare the primary outcome of all-cause mortality, the secondary outcomes of stroke, major bleeding and the composite outcome of cardiovascular (CV) mortality or hospitalization among AF patterns. Results: Of patients, 121 (11.2%) had first diagnosed, 356 (33%) paroxysmal, and 575 (53.2%) persistent or permanent AF. During a median follow-up of 31 months (interquartile range 10 to 52 months), 37.3% of patients died. Compared with paroxysmal AF, patients with persistent or permanent AF had higher mortality rates (adjusted hazard ratio (aHR), 1.37; 95% confidence interval [CI], 1.08-1.74, P = .009), but similar CV mortality or hospitalization rates (aHR, 1.09; 95% CI, 0.91-1.31, P = .35). Compared with first diagnosed AF, patients with persistent or permanent AF had similar mortality (aHR, 1.26; 95% CI, 0.87-1.82, P = .24), but higher CV mortality or hospitalization rates (aHR, 1.35; 95% CI, 1.01-1.8, P = .04). Stroke and major bleeding events did not differ across AF patterns (all P > .05). Conclusions: In conclusion, in recently hospitalized patients with comorbid AF, the presence of persistent or permanent AF was associated with a higher incidence of mortality and morbidity compared with paroxysmal and first diagnosed AF.

scholarly journals Wenxin Keli versus Sotalol for Paroxysmal Atrial Fibrillation Caused by Hyperthyroidism: A Prospective, Open Label, and Randomized Study

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Zhaowei Meng ◽  
Jian Tan ◽  
Qing He ◽  
Mei Zhu ◽  
Xue Li ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Rank Test ◽  
Antithyroid Drugs ◽  
Control Group ◽  
Open Label ◽  
Log Rank Test ◽  
And Control

We aimed to compare effectiveness of Wenxin Keli (WK) and sotalol in assisting sinus rhythm (SR) restoration from paroxysmal atrial fibrillation (PAF) caused by hyperthyroidism, as well as in maintaining SR. We randomly prescribed WK (18 g tid) or sotalol (80 mg bid) to 91 or 89 patients. Since it was not ethical not to give patients antiarrhythmia drugs, no control group was set. Antithyroid drugs were given to 90 patients (45 in WK group, 45 in sotalol group);131I was given to 90 patients (46 in WK group, 44 in sotalol group). Three months later, SR was obtained in 83/91 or 80/89 cases from WK or sotalol groups(P=0.762). By another analysis, SR was obtained in 86/90 or 77/90 cases from131I or ATD groups(P=0.022). Then, we randomly assigned the successfully SR-reverted patients into three groups: WK, sotalol, and control (no antiarrhythmia drug was given) groups. After twelve-month follow-up, PAF recurrence happened in 1/54, 2/54, and 9/55 cases, respectively. Log-Rank test showed significant higher PAF recurrent rate in control patients than either treatment(P=0.06). We demonstrated the same efficacies of WK and sotalol to assist SR reversion from hyperthyroidism-caused PAF. We also showed that either drug could maintain SR in such patients.

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