Clinical cardiology
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Clinical cardiology · Apr 2017
Observational StudyEfficacy and safety of dabigatran, rivaroxaban, and warfarin for stroke prevention in Chinese patients with atrial fibrillation: the Hong Kong Atrial Fibrillation Project.
Little is known about the comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOAC) compared to warfarin in Chinese atrial fibrillation (AF) patients. Our aim was to compare the ischemic stroke risk reduction and incidence of intracranial hemorrhage (ICH) of warfarin in relation to quality of anticoagulation control (as reflected by time in therapeutic range [TTR]), and to dabigatran and rivaroxaban in a real-world cohort of Chinese AF patients. ⋯ In Chinese AF patients, the benefits of warfarin therapy for stroke prevention and ICH reduction depend on TTR. Of the treatments compared, dabigatran, as well as rivaroxaban 20 mg daily, was associated with lowest ischemic stroke and ICH rates.
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Clinical cardiology · Mar 2017
Randomized Controlled Trial Multicenter StudyRationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial.
Residual cardiovascular risk persists despite statins, yet outcome studies of lipid-targeted therapies beyond low-density lipoprotein cholesterol (LDL-C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High-dose eicosapentaenoic acid (EPA) reduces triglyceride-rich lipoproteins without raising LDL-C. ⋯ Several secondary, tertiary, and exploratory endpoints will be assessed. Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow-up will continue in this event-driven trial until approximately 1612 adjudicated primary-efficacy endpoint events have occurred.
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Clinical cardiology · Feb 2017
Randomized Controlled Trial Multicenter StudyDesign and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial.
Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin-type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long-term PCSK9i use and cognition changes. ⋯ Fifteen hundred cognitively normal patients completing the assessments provided approximately 97% power to demonstrate that the upper 95% confidence interval for the treatment difference in mean change from baseline in SWMSI over time is <20% of the SD of the mean change in the placebo group. An exploratory analysis will compare neurocognitive function in patients with post-baseline low-density lipoprotein cholesterol <25 mg/dL. EBBINGHAUS will evaluate whether the addition of evolocumab to statin therapy affects cognitive function over time in patients with stable cardiovascular disease.
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Clinical cardiology · Feb 2017
Correlation between cardiac rhythm, left atrial appendage flow velocity, and CHA2 DS2 -VASc score: Study based on transesophageal echocardiography and 2-dimensional speckle tracking.
The CHA2 DS2 -VASc score is a classic predictor of stroke in patients with atrial fibrillation (AF). Decreased left atrial appendage flow velocity (LAA-FV) reflects the blood stasis, and left atrial (LA) strain is a manifestation of atrial remodeling. This study aimed to explore the effects of AF rhythm and CHA2 DS2 -VASc score in the development of thrombogenesis and their potential correlation with LAA-FV and LA strain. ⋯ AF rhythm caused a sharp decrease in LAA-FV independent of CHA2 DS2 -VASc score. In SR, the CHA2 DS2 -VASc score correlated negatively with LAA-FV. LA strain was a predictor of LAA-FV in both SR and AF rhythm.
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Clinical cardiology · Oct 2016
Randomized Controlled Trial Multicenter Study Comparative StudyDesign and Rationale of the RE-DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting.
Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest-sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. ⋯ Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ∼ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.