American heart journal
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American heart journal · Oct 2011
Randomized Controlled TrialEXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome.
Comprehensive safety evaluation of new drugs for diabetes mellitus is needed in the area of cardiovascular (CV) outcomes, particularly in populations with high CV risk. Alogliptin, a dipeptidyl peptidase 4 inhibitor, is under development for the treatment of type 2 diabetes mellitus alone or in combination with other antidiabetic therapies. Long-term CV safety of alogliptin is being established in a randomized, placebo-controlled clinical study in patients with acute coronary syndrome (ACS) using an analytical approach that has both an interim and final assessment. ⋯ For both group sequential analyses, the repeated CIs are calculated to insure simultaneous coverage probabilities of 97.5% for the true HR. Study progress: More than 2,000 ACS patients were randomized as of June 2011. EXAMINE will define the CV safety profile of this dipeptidyl peptidase 4 inhibitor in patients at high risk for CV events.
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American heart journal · Oct 2011
ReviewIs the measurement of left ventricular ejection fraction the proper end point for cell therapy trials? An analysis of the effect of bone marrow mononuclear stem cell administration on left ventricular ejection fraction after ST-segment elevation myocardial infarction when evaluated by cardiac magnetic resonance imaging.
The measurement of left ventricular (LV) ejection fraction (LVEF) is a strong predictor of cardiovascular adverse events and mortality in patients with LV dysfunction and has become the most common primary end point in cardiovascular cell therapy trials after ST-segment elevation myocardial infarction (STEMI). Multiple small trials have been performed using bone marrow mononuclear stem cells (BMCs) in this setting with several meta-analyses demonstrating that BMC administration results in a small improvement in LVEF and may attenuate adverse LV remodeling. However, individual trial results have not been uniform, and the measurement of LVEF in these trials has relied on a variety of imaging techniques including LV angiograpnhy, single-photon emission computed tomography, echocardiography, or cardiac magnetic resonance imaging (cMRI). ⋯ The benefit of BMC administration after STEMI on LVEF, LV volumes, and infarct size is small when assessed by cMRI.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyTemporal changes in emergency department triage of patients with acute myocardial infarction and the effect on outcomes.
All patients who present to an emergency department (ED) are triaged. The ED triage score may determine when patients are seen by a physician. Half of patients with acute myocardial infarction (AMI) were given a low priority score in Ontario in 2000/2001. We assessed the appropriateness of ED triage and its association with quality indicators and outcomes in a more recent AMI cohort and compared this with previous findings. ⋯ Emergency department triage of patients with AMI improved substantially over 5 years. For the third of patients with AMI who continue to receive a low priority score, including 25% of patients with STEMI, the associated delays in diagnosis and therapy were greater than previously and were associated with increased hospital LOS and mortality. Given the impact of this initial, cursory assessment, hospital systems should consider monitoring the quality of their ED triage.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyColchicine prevents early postoperative pericardial and pleural effusions.
No preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions. ⋯ Colchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyMode of hospital presentation in patients with non-ST-elevation myocardial infarction: implications for strategic management.
Contemporary non-ST-elevation myocardial infarction-acute coronary syndrome guidelines emphasize early-risk stratification and optimizing therapy including an invasive strategy in high-risk patients. To assess the feasibility of initiating this strategy in the prehospital environment, we examined how such patients are transported to hospital, their risk profile, and the proportion potentially eligible for such a strategy. ⋯ Regional strategies using risk-based triage, early medical therapy, and timely triage to percutaneous coronary intervention centers represents an unrealized opportunity to enhance ST-segment elevation myocardial infarction care.