American heart journal
-
American heart journal · May 2013
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy.
Major bleeding is a powerful predictor of morbidity and mortality after percutaneous coronary intervention (PCI). To avoid prolonged dual antiplatelet therapy (DAPT), current guidelines recommend using a bare metal stent when PCI is indicated to treat patients at high risk of bleeding. The Biolimus A9-coated BioFreedom is a new stainless steel drug-coated stent devoid of polymer and has been shown to be associated with a low median late-loss of 0.17 mm at 12 months of follow-up. In an animal model, 98% of the drug has diffused into the vessel wall at 1 month. It is therefore reasonable to consider that such a device may have a potential safety advantage, and a lesser dependence on prolonged DAPT than a polymer-coated drug-eluting stent.
-
American heart journal · May 2013
Randomized Controlled Trial Multicenter Study Comparative StudyTreatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial.
PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). ⋯ Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
-
American heart journal · May 2013
Review Meta AnalysisThe outcome of intra-aortic balloon pump support in acute myocardial infarction complicated by cardiogenic shock according to the type of revascularization: a comprehensive meta-analysis.
Despite the recommendations of the current guidelines, scientific evidence continue to challenge the effectiveness of intra-aortic balloon pump (IABP) in acute myocardial infarction (AMI) complicated by cardiogenic shock. Moreover, 2 recent meta-analyses showed contrasting results. The aim of this study is to test the effect of IABP according to the type of therapeutic treatment of AMI: percutaneous coronary intervention (PCI), thrombolytic therapy (TT), or medical therapy without reperfusion. Articles published from January 1, 1986, to December 31, 2012, were collected and analyzed by meta-analysis. ⋯ The results show that IABP support is significantly effective in TT reperfusion but is associated with a significant increase of the inhospital mortality with primary PCI. The comparison of the meta-analyses demonstrates the key role of analysing primary clinical treatments to avoid systematic errors.
-
American heart journal · May 2013
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialCharacteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy.
The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and enrolled subjects. ⋯ Baseline demographic, clinical, and anthropometric characteristics of the randomized cohort are representative of patients in this population with moderate to severe aortic root dilation. The high percentage of young subjects with relatives who have had aortic dissection or surgery illustrates the need for more definitive therapy; we expect that the results of the study and the wealth of systematic data collected will make an important contribution to the management of individuals with Marfan syndrome.
-
American heart journal · May 2013
Randomized Controlled Trial Multicenter StudyContrast-induced acute kidney injury and clinical outcomes after intra-arterial and intravenous contrast administration: risk comparison adjusted for patient characteristics by design.
Direct comparisons between risk of contrast induced acute kidney injury (CI-AKI) after intra-arterial versus intravenous contrast administration are scarce. We estimated and compared the risk of CI-AKI and its clinical course after both modes of contrast administration in patients who underwent both. ⋯ The risk of CI-AKI, and its clinical course was similar after intra-arterial and intravenous contrast media administration, after adjustment by design for patient-related risk factors.