The American journal of cardiology
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Randomized Controlled Trial Multicenter Study
Gender Differences in the Risk of Adverse Outcomes in Patients With Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction.
Atrial fibrillation (AF) is associated with an increased risk for adverse events in patients with heart failure with preserved ejection fraction (HFpEF), but it is currently unknown if gender differences in these outcomes exist. To explore this hypothesis, we examined gender differences in the associations of AF with adverse outcomes in 3,385 (mean age 69 ± 9.6 years, 49% male, 89% white) patients with HFpEF from the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Baseline AF cases were identified by self-reported history, medical record review, and baseline electrocardiogram data. ⋯ The association between AF and hospitalization was stronger in women (HR 1.63, 95% CI 1.40 to 1.91) than men (HR 1.37, 95% CI 1.18 to 1.58; p-interaction = 0.032). Although significant interactions were not observed for the other outcomes, we appreciated that the risk estimates were higher for women compared with men. In conclusion, AF increases the risk for adverse cardiovascular outcomes in patients with HFpEF, and the presence of this arrhythmia in women possibly is associated with a greater risk for adverse events than men.
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Randomized Controlled Trial Multicenter Study
Management of Major Bleeding in Patients With Atrial Fibrillation Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]).
Non-vitamin K antagonist oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the management of bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major bleeding in the setting of community use of NOACs. ⋯ At follow-up, 126 NOAC-treated (46%) and 29 warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major bleeding are similar in warfarin and NOAC-treated patients in clinical practice. However, NOAC-related bleeds require less blood product administration and rarely require factor replacement.
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Randomized Controlled Trial
Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials).
There are limited data on the efficacy and safety of triglyceride (TG)-lowering agents in women. We conducted subgroup analyses of the effects of icosapent ethyl (a high-purity prescription form of the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on TG levels (primary efficacy variable) and other atherogenic and inflammatory parameters in a total of 215 women with a broad range of TG levels (200-2000 mg/dl) enrolled in two 12-week placebo-controlled trials: MARINE (n = 18; placebo, n = 18) and ANCHOR (n = 91; placebo, n = 88). ⋯ Icosapent ethyl was well tolerated, with adverse-event profiles comparable with findings in the overall studies. In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study.
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Randomized Controlled Trial Comparative Study
Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial).
The objective of this study was to compare outcomes in women after surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for SAVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. ⋯ Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared with women undergoing SAVR, with both cohorts experiencing improved quality of life. Further studies specifically in women are warranted to validate these findings.
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Randomized Controlled Trial Multicenter Study
Pharmacoinvasive and Primary Percutaneous Coronary Intervention Strategies in ST-Elevation Myocardial Infarction (from the Mayo Clinic STEMI Network).
The effectiveness of a pharmacoinvasive strategy consisting of fibrinolysis and transfer for percutaneous coronary intervention (PCI) compared to primary PCI (PPCI) in patients presenting to non-PCI-capable hospitals with ST-elevation myocardial infarction (STEMI) is not well defined. We analyzed data from the Mayo Clinic STEMI database of patients treated with a pharmacoinvasive strategy (favored in those presenting early after symptom onset) or PPCI in a regional STEMI network from 2004 to 2012. A total of 364 and 1,337 patients were included in the pharmacoinvasive and PPCI groups, respectively. ⋯ In multivariate analyses adjusting for age, gender, and other variables for which the 2 groups differed at baseline, there was no significant difference between the 2 strategies for 30-day (hazard ratio 0.66, 95% confidence interval 0.36 to 1.21) or overall mortality (hazard ratio 0.84, 95% confidence interval 0.63 to 1.12). Shorter door-to-balloon time was associated with increased effectiveness of PPCI (p for trend = 0.015), but there was no difference between the 2 strategies even when considering only the patients with door-to-balloon time in the lowest quartile. In conclusion, fibrinolysis followed by transfer for PCI represents a reasonable alternative when PPCI is not readily available especially in patients presenting early after symptom onset.