BACKGROUND It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm. METHODS We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause. RESULTS The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P = 0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P = 0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P = 0.82). CONCLUSIONS Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized.
INTRODUCTION Atrial fibrillation (AF) increases the risk of thromboembolic events, including ischemic stroke, by promoting clot formation in the left atrial appendage (LAA). 1 The risk of stroke in patients with AF varies widely depending on age, clinical variables, and cardiac structure or function. Accordingly, several stroke risk stratification systems for AF patients have been developed, with the CHA 2 DS 2 VASc scale being the
Background The aim of this study is to examine the relationship between time in therapeutic range (TTR) and clinical outcomes in heart failure (HF) patients in sinus rhythm (SR) treated with warfarin. Methods and Results We used data from the Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Trial (WARCEF) to assess the relationship of TTR with the WARCEF primary outcome (ischemic stroke, intracerebral hemorrhage, or death); with death alone; ischemic stroke alone; major hemorrhage alone; and net clinical benefit (primary outcome and major hemorrhage combined). Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR, low TTR, and aspirin patients, with TTR being treated as a time-dependent covariate. 2,217 patients were included in the analyses, among whom 1,067 were randomized to warfarin and 1,150 were randomized to aspirin. The median (IQR) follow-up duration was 3.6 (2.0–5.0) years. Mean (±SD) age was 61±11.3 years, with 80% being men. The mean (±SD) TTR was 57% (±28.5%). Increasing TTR was significantly associated with reduction in primary outcome (adjusted p<0.001), death alone (adjusted p=0.001), and improved net clinical benefit (adjusted p<0.001). A similar trend was observed for the other two outcomes but significance was not reached (adjusted p=0.082 for ischemic stroke, adjusted p=0.109 for major hemorrhage). Conclusions In HF patients in SR, increasing TTR is associated with better outcome and improved net clinical benefit. Patients in whom good quality anticoagulation can be achieved may benefit from the use of anticoagulants. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00041938.
Typical jump and complete SP elimination are associated with a better outcome. A 2-electrode approach is as effective as > 2 electrode approach. The electrophysiological profile of patients in whom complete SP elimination was achieved may differ from that of patients in whom only SP modification was possible.
Purpose To assess the effects of CNA on syncope recurrences in patients with VVS Methods The Roman 1 study was a prospective, randomized, investigator-initiated trial comparing CNA versus optimal standard therapy in patients with asystolic VVS. Patients were included if they had documented symptomatic cardioinhibitory or mixted spontaneous VVS (at least 3 seconds of asystole), frequent and/or severe symptoms (at least one syncope or 3 presyncopal events during preceding 12 months or very severe syncope in the past, leading to injury) and positive atropine test (>30% increase in sinus rate). CNA was performed using RF ablation of the ganlionated plexi from the left and right atrium. Follow-up lasted 2 years. Primary endpoint was time to first syncope recurrence. One of secondary endpoints were changes in quality of life (QoL) assessed using dedicated questionnaire The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary. Results 48 patients (17 males, mean age 38±10, 24 – CNA group, 24 – control group) entered the study. Baseline demographic and clinical characteristics were similar in both groups. The primary end-point – syncope recurrence, occurred in 2 (8%) patients from the CNA group versus 12 (50%) controls (p=0.00037, see Kaplan-Meier curve). QoL significantly improved in the CNA group (30±10 vs 10±7 points, p=0.0001) whereas remained stable in controls (31±10 vs 30±10 points, p=0.5501). Conclusion(s) This is the first randomized study documenting efficacy of CNA in patients with asystolic VVS. Larger studies are needed to confirm these findings. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Centre of Postgraduate Medical Education
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