Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT).

In the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT), abciximab reduced ischemic complications of stent implantation at 30 days and 6 months. The responsible mechanisms remain unclear. We sought to determine if abciximab decreases ischemic complications by decreasing the incidence of angiographic complications during coronary stenting.

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

Background: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards.

Methods: From November 2001 through January 2002, we interviewed officials at U.

Patient outcomes after fibrinolytic therapy for acute myocardial infarction at hospitals with and without coronary revascularization capability.

Objectives: This study evaluated clinical outcomes in patients with acute myocardial infarction (MI) treated with fibrinolytic therapy in hospitals with and without coronary revascularization capability.

Background: Patients with MI may have better outcomes when admitted to certain hospitals with coronary revascularization capability. Development of regional heart care centers for the treatment of MI has been proposed.

Evaluating the costs and effectiveness of cardiovascular therapies: who cares about economic analyses?

The field of cardiovascular medicine is providing important insights about how the costs and effectiveness of diagnostic and therapeutic technologies are managed. As health-care budgets have taken up more of the economy and as employers and patients have become concerned about the escalating costs of health care, we have entered an era in which individual practitioners must become concerned with the costs of a service relative to its benefits. Further, increasing numbers of effective therapies in a time when finances are notably constrained, we clearly cannot use all effective therapies in all patients.

Randomized COMparison of platelet inhibition with abciximab, tiRofiban and eptifibatide during percutaneous coronary intervention in acute coronary syndromes: the COMPARE trial. Comparison Of Measurements of Platelet aggregation with Aggrastat, Reopro, and Eptifibatide.

Background: The relative anti-aggregatory effects of currently prescribed platelet glycoprotein IIb/IIIa receptor antagonists during and after percutaneous coronary intervention for acute coronary syndromes have not been established.

Methods And Results: We randomized 70 acute coronary syndrome patients undergoing percutaneous coronary intervention to receive abciximab, eptifibatide, or tirofiban at doses used in the Evaluation of Platelet IIb/IIIa Inhibitor for STENTing (EPISTENT), Platelet glycoprotein IIb/IIIa in Unstable angina Receptor Suppression Using Integrilin Therapy (PURSUIT), and Platelet Receptor Inhibition in ischemic Syndrome Management in Patients Limited by Unstable Signs and symptoms (PRISM-PLUS)/Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis (RESTORE) trials, respectively. Platelet aggregation (PA) in response to 20 micro mol/L of adenosine diphosphate was measured with turbidimetric aggregometry in both D-phenylalanyl-L-prolyl-L-arginine chloromethylketone and citrate-anticoagulated blood early (15 and 30 minutes) and late (4, 12, and 18 to 24 hours) after drug initiation.

Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] Trial).

For patients undergoing nonurgent coronary stent implantation, blockade of the glycoprotein IIb/IIIa receptor with eptifibatide reduces the incidence of ischemic complications. We evaluated the interaction of eptifibatide with diabetes in patients who underwent this procedure by analyzing the 1-year outcomes of those enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial (466 diabetic and 1,595 nondiabetic patients). At 1 year, the composite end point of death, myocardial infarction (MI), or target vessel revascuarlization (TVR) was higher in diabetic patients (24.

Relationship between activated clotting time during percutaneous intervention and subsequent bleeding complications.

Background: Approximately 50% of percutaneous coronary interventions in the United States are performed with unfractionated heparin and no IIb/IIIa agent. The operator must weigh the risks and benefits of more intensive anticoagulation during these percutaneous interventions. This study helps clarify the relationship between patient and procedural factors, such as the intensity of heparin anticoagulation as measured by activated clotting time (ACT), and the risk of blood loss and bleeding complications.

Prognostic implications of abnormalities in renal function in patients with acute coronary syndromes.

Background: Outcomes in patients with mild to moderate renal function (RF) abnormalities presenting with acute coronary syndromes (ACS) are not well defined.

Methods And Results: A convenience sample of 4 ACS trial databases including all enrolled patients was assessed to determine 30- and 180-day outcomes. The 4 trials were Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb, GUSTO-III, Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT), and Platelet IIb/IIIa Antagonism for the Reduction of Acute coronary syndrome events in a Global Organization Network (PARAGON-A).

Comparison of omapatrilat and enalapril in patients with chronic heart failure: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE).

Background: Combined inhibition of the angiotensin-converting enzyme (ACE) and neutral endopeptidase (NEP) may produce greater benefits in heart failure than ACE inhibition alone.

Methods And Results: We randomly assigned 5770 patients with New York Heart Association class II to IV heart failure to double-blind treatment with either the ACE inhibitor enalapril (10 mg BID, n=2884) or to the ACE-NEP inhibitor omapatrilat (40 mg once daily, n=2886) for a mean of 14.5 months.

Practitioner acceptance of the dofetilide risk-management program.

Study Objective: To assess the opinions and knowledge retention of practitioners after participation in the dofetilide risk-management program.

Design: A 21-item questionnaire.

Setting: A large academic medical center.

Sertraline treatment of major depression in patients with acute MI or unstable angina.

Context: Major depressive disorder (MDD) occurs in 15% to 23% of patients with acute coronary syndromes and constitutes an independent risk factor for morbidity and mortality. However, no published evidence exists that antidepressant drugs are safe or efficacious in patients with unstable ischemic heart disease.

Objective: To evaluate the safety and efficacy of sertraline treatment of MDD in patients hospitalized for acute myocardial infarction (MI) or unstable angina and free of other life-threatening medical conditions.

TARGET versus GUSTO-IV: appropriate use of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes and percutaneous coronary intervention.

Until recently, the selection of which glycoprotein IIb/IIIa inhibitor to use for patients with acute coronary syndromes or those undergoing percutaneous coronary intervention largely reflected physician preference, costs, and any evidence supporting the clinical indication. Clinicians often assumed a class effect for these agents: a benefit observed for one agent in one clinical setting (such as percutaneous coronary intervention) would confer benefit in another (such as non-ST-elevation acute coronary syndromes). The need for evidence to guide treatment selection motivated the design of the Do Tirofiban and ReoPro Give Similar Efficacy Trial (TARGET) and the Global Use of Strategies to Open occluded arteries (GUSTO-IV) trials with abciximab.

The need for a national infrastructure to improve the rational use of therapeutics.

The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to lessen, and yet the ability to assure patients that the benefits of these therapies are known, and that they are without serious side-effects or untoward consequences, eludes the healthcare system. Based on initial experience with a new federal program, the Centers for Education and Research on Therapeutics (CERTs), we propose a national approach to therapeutics education and research, through a public-private partnership that involves academic medical centers, the federal government, industry, and the public.

An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase.

Background: In the Global Utilization of Streptokinase and tPA for Occluded coronary arteries (GUSTO) trial, patients with myocardial infarction who were treated with tissue plasminogen activator (tPA) had a 6.3% 30-day mortality, compared with a mortality of 7.3% among those treated with streptokinase, despite a greater risk of intracranial hemorrhage with tPA.

Inhaled ethyl nitrite gas for persistent pulmonary hypertension of the newborn.

Inhaled nitric oxide is used to alleviate pulmonary hypertension and hypoxaemia, but generates toxic free radicals and oxides of nitrogen (NO(x)), which can cause rebound-hypoxia and additional pulmonary and other morbidity. To address these problems, we assessed the efficacy of inhaled O-nitrosoethanol gas (ENO) as a novel alternative means of providing nitric oxide bioactivity in the treatment of persistent pulmonary hypertension of newborns. We administered ENO over 4 h to seven neonates who required assisted ventilation, and who had an oxygenation index of 25 or more.

Disease management in healthcare organizations: results of in-depth interviews with disease management decision makers.

Background: Despite the widening use of disease management (DM) programs throughout the country, little is understood about the "state of DM" in healthcare systems and managed care organizations.

Objective: To better characterize the range of users of DM in healthcare and to identify critical issues, both present and future, for DM.

Study Design: Qualitative survey.

Sustained ventricular arrhythmias among patients with acute coronary syndromes with no ST-segment elevation: incidence, predictors, and outcomes.

Background: The prognosis of ventricular arrhythmias among patients with non-ST-elevation acute coronary syndromes is unknown. We studied the incidence, predictors, and outcomes of sustained ventricular arrhythmias in 4 large randomized trials of such patients.

Methods And Results: We pooled the datasets of the Global Use of Streptokinase and tPA for Occluded Arteries (GUSTO)-IIb, Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT), Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network (PARAGON)-A, and PARAGON-B trials (n=26 416).