American heart journal
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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.
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American heart journal · Mar 2018
Randomized Controlled Trial Multicenter StudyRationale and design of the comparison between a P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients undergoing implantation of coronary drug-eluting stents (SMART-CHOICE): A prospective multicenter randomized trial.
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients undergoing percutaneous coronary intervention (PCI), but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. It is unclear whether P2Y12 inhibitor monotherapy might maintain anti-ischemic efficacy while reducing the bleeding risk compared with DAPT after implantation of the current generation of drug-eluting stents (DES). ⋯ The SMART-CHOICE trial aims to examine the non-inferiority of monotherapy with one of any available oral P2Y12 inhibitors versus conventional DAPT of an identical P2Y12 inhibitor plus aspirin in a broad spectrum of patients receiving representative current-generation DES.
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American heart journal · Mar 2018
Randomized Controlled Trial Multicenter StudyDesign of DISCO-Direct or Subacute Coronary Angiography in Out-of-Hospital Cardiac Arrest study.
Acute coronary syndrome is a common cause of out-of-hospital cardiac arrest (OHCA). In patients with OHCA presenting with ST elevation, immediate coronary angiography and potential percutaneous coronary intervention (PCI) after return of spontaneous circulation are recommended. However, the evidence for this invasive strategy in patients without ST elevation is limited. Observational studies have shown a culprit coronary artery occlusion in about 30% of these patients, indicating the electrocardiogram's (ECG's) limited sensitivity. The aim of this study is to determine whether immediate coronary angiography and subsequent PCI will provide outcome benefits in OHCA patients without ST elevation. ⋯ This randomized clinical study will evaluate the effect of immediate coronary angiography after OHCA on 30-day survival in patients without ST elevation on their first recorded ECG.
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American heart journal · Jan 2018
Randomized Controlled Trial Multicenter StudyA multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.
Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. ⋯ REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018.