American heart journal
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American heart journal · Apr 2018
Randomized Controlled Trial Multicenter Study Comparative StudyRationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial.
The objective is to assess the safety, tolerability, and efficacy of sacubitril/valsartan compared with enalapril in patients with heart failure (HF) with a reduced ejection fraction (EF) stabilized during hospitalization for acute decompensated HF. ⋯ The PIONEER-HF trial will inform clinical practice by providing evidence on the safety, tolerability, and efficacy of in-hospital initiation of sacubitril/valsartan among patients who have been stabilized following an admission for acute decompensated HF with a reduced EF.
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American heart journal · Apr 2018
Randomized Controlled Trial Multicenter Study Comparative StudyBioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX): Rationale and design of the randomized TWENTE IV multicenter trial.
The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent. ⋯ BIONYX is a large-scale, prospective, randomized, international, multicenter trial comparing a novel DES with durable coating versus a reference DES with biodegradable coating in all-comers. The study is the first randomized assessment of the Resolute Onyx stent, which is an often-used DES outside the United States.
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American heart journal · Apr 2018
Randomized Controlled Trial Multicenter Study Comparative StudyPreoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial.
For advanced coronary disease, coronary artery bypass graft (CABG) surgery generally improves patients' symptoms and long-term survival. Unfortunately, some patients experience worse health-related quality of life (HRQL) after CABG. The objective of this study is to report the frequency and risk factors associated with 1-year post-CABG HRQL deterioration.
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American heart journal · Apr 2018
Randomized Controlled Trial Multicenter Study Comparative StudyRationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial.
Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. ⋯ The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.
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American heart journal · Apr 2018
Comparative StudyComparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.
Although outcomes data on transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (Mitraclip) are available via the Transcatheter Valve Therapy (TVT) registry, dissemination of TVT data is often delayed. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) system collects postmarket outcomes data in public medical device reports. We used natural language processing to compare the event rates for TAVR and Mitraclip in the TVT registry and from MAUDE data. ⋯ We demonstrated that natural language processing technology sorted through raw MAUDE data, allowing identification of the most common events associated with TAVR and Mitraclip procedures, and that MAUDE-derived event rates were not statistically significantly different from TVT event rates. This technology has important public health implications because it improves postmarket surveillance of implantable devices and permits rapid and early dissemination of vital information.