American heart journal
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American heart journal · Oct 2009
Randomized Controlled Trial Multicenter Study Comparative StudySPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease.
In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points). However, neither trial was powered for superiority for clinical end points, and the routine performance of angiographic follow-up may have artificially exaggerated the absolute benefits of EES. The relative efficacy of these 2 stents in patients with diabetes mellitus also remains controversial. We therefore designed a large-scale randomized trial without angiographic follow-up to further assess the differences between these 2 stent platforms. ⋯ SPIRIT IV is the largest randomized comparison of 2 DES with completed enrollment. The absence of routine angiographic follow-up will allow an accurate assessment of the absolute differences in the clinical safety and efficacy profile between these devices. The magnitude of the study will also permit significant insights to be gained into the relative performance of the 2 stents in important subgroups, including patients with diabetes mellitus.
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American heart journal · Oct 2009
Randomized Controlled Trial Multicenter Study Comparative StudyEarly abciximab administration before transfer for primary percutaneous coronary interventions for ST-elevation myocardial infarction reduces 1-year mortality in patients with high-risk profile. Results from EUROTRANSFER registry.
There are conflicting data on the clinical benefit from early administration of abciximab from a large randomized trial and a registry. However, both sources suggest that a benefit may depend on the baseline risk profile of the patients. We evaluated the role of early abciximab administration in patients with ST-segment-elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention stratified by the STEMI Thrombolysis In Myocardial Infarction (TIMI) risk score. ⋯ Early abciximab administration before transfer for percutaneous coronary intervention in STEMI shows lower mortality at 1-year follow-up. This effect is confined to patients with higher risk profile as defined by TIMI risk score >or=3.
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American heart journal · Oct 2009
Multicenter Study Comparative StudyPractice patterns, outcomes, and end-organ dysfunction for patients with acute severe hypertension: the Studying the Treatment of Acute hyperTension (STAT) registry.
Limited data are available on the care of patients with acute severe hypertension requiring hospitalization. We characterized contemporary practice patterns and outcomes for this population. ⋯ This study highlights heterogeneity in care, BP control, and outcomes of patients hospitalized with acute severe hypertension.
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American heart journal · Oct 2009
Multicenter Study Comparative StudyPrevalence and prognostic significance of incidental cardiac troponin T elevation in ambulatory patients with stable coronary artery disease: data from the Heart and Soul study.
The significance of troponin elevation and clinical utility of troponin testing in ambulatory patients with coronary artery disease (CAD) have not been examined. We sought to investigate the prevalence and prognostic value of cardiac troponin T (cTnT) elevation in a population with stable CAD. ⋯ In ambulatory patients with stable CAD, the prevalence of cTnT elevation was 6.2%. Cardiac troponin T elevation detected using the conventional troponin assay was associated with increased risk of adverse cardiovascular outcomes, but its prognostic value was not incremental over N-terminal pro-B-type natriuretic peptide and echocardiographic evidence of cardiac abnormalities.
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American heart journal · Sep 2009
Randomized Controlled Trial Multicenter StudyThe Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.
The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features.