American heart journal
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American heart journal · Jun 2015
Randomized Controlled Trial Multicenter StudyEfficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study.
The ODYSSEY COMBO I study (http://clinicaltrials.gov/show/NCT01644175) evaluated efficacy and safety of alirocumab as add-on therapy to stable maximally tolerated daily statin with or without other lipid-lowering therapy in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia. ⋯ Alirocumab treatment achieved a significantly greater reduction in LDL-C and allowed a greater proportion of patients to achieve LDL-C goals, versus placebo after 24 weeks in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia at baseline despite receiving maximally tolerated statin with or without other lipid-lowering therapy. The frequency of treatment-emergent adverse events and study medication discontinuations were generally comparable between treatment groups.
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American heart journal · Jun 2015
Randomized Controlled Trial Multicenter StudyRationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial).
Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients. ⋯ The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up.
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American heart journal · Jun 2015
Multicenter StudyEffect of center catheterization volume on risk of catastrophic adverse event after cardiac catheterization in children.
Procedural volume has been shown to be associated with outcome in cardiac catheterization and intervention in adults. The impact of center-level factors (such as volume) and their interaction with subject- and procedure-level factors on outcome after cardiac catheterization in children is not well described. We hypothesized that higher center catheterization volume would be associated with lower risk of catastrophic adverse events. ⋯ Higher cardiac catheterization laboratory volume was associated with reduced risk of catastrophic adverse outcome in the immediate postcatheterization period in children. The observed benefit of catheterization at a larger volume center may be attributable to transmissible best practices or inextricable benefits of larger systems.
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American heart journal · Jun 2015
Randomized Controlled Trial Multicenter StudyRationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke.
Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke (AIS) in China. ⋯ If proven effective, this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China.