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
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 StudyCharacterization and outcomes of women and men with non-ST-segment elevation myocardial infarction and nonobstructive coronary artery disease: results from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative.
Women with non-ST-segment elevation myocardial infarction (NSTEMI) who undergo coronary angiography have no obstructive coronary lesions more often than men. Sex-specific characteristics and outcomes of patients without obstructive coronary artery disease (CAD) have not been described previously. ⋯ Among NSTE ACS patients undergoing coronary angiography, absence of obstructive CAD is more common in women than men. Although nonobstructive CAD was twice as common among women with NSTEMI, sex differences in characteristics and outcomes were similar to those found with obstructive CAD. Unadjusted in-hospital outcomes of NSTEMI patients with nonobstructive CAD are favorable in both sexes. Whether the underlying pathophysiology of NSTE ACS without documentation of obstructive CAD is different between women and men requires further study.
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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 · Oct 2009
Randomized Controlled Trial Comparative StudyBenefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.
Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. ⋯ This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.