American heart journal
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American heart journal · Mar 2010
Randomized Controlled Trial Multicenter Study Comparative StudyRivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study.
Atrial fibrillation (AF), the most common significant cardiac arrhythmia, increases the risk of stroke, particularly in the elderly. Warfarin is effective in reducing stroke risk but is burdensome to patients and is difficult to control. Rivaroxaban is an oral direct factor Xa inhibitor in advanced development as an alternative to warfarin for the prevention and treatment of thromboembolic disorders. ⋯ The ROCKET AF study will determine the efficacy and safety of rivaroxaban as an alternative to warfarin for the prevention of thromboembolism in patients with AF.
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American heart journal · Feb 2010
Multicenter Study Comparative StudyAre quality improvements associated with the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) program sustained over time? A longitudinal comparison of GWTG-CAD hospitals versus non-GWTG-CAD hospitals.
Previous reports have demonstrated that participation in GWTG-CAD, a national quality initiative of the American Heart Association, is associated with improved guideline adherence for patients hospitalized with CAD. We sought to establish whether these benefits from participation in GWTG-CAD were sustained over time. ⋯ Hospitals participating in GWTG-CAD had modestly superior acute cardiac care and secondary prevention measures performance relative to non-GWTG-CAD. These benefits of GWTG-CAD participation were sustained over time and independent of hospital characteristics.
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American heart journal · Dec 2009
Randomized Controlled Trial Multicenter StudyRationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.
Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. ⋯ Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.
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American heart journal · Nov 2009
Randomized Controlled Trial Multicenter StudyDesign and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST).
Long-term oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and most patients with atrial fibrillation. When these patients undergo percutaneous coronary intervention with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to increase the risk of bleeding complications. Unfortunately, there are no prospective data available to resolve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with indications of both chronic anticoagulation therapy and percutaneous intervention to prevent thrombotic complications (eg, stent thrombosis) without increasing the risk of bleeding. ⋯ No prospective randomized study has yet addressed the issue of optimal antiplatelet therapy in patients with chronic oral anticoagulant therapy undergoing coronary stenting. Therefore, the WOEST trial will help to define new guidelines for patients with indication for chronic anticoagulation who need coronary stenting.
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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.