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Biomedical subjects

Desmond Julian

Publications and source records attributed to Desmond Julian.

13 recordsLinked to original sources
PubMed2006

The impact of guideline compliant medical therapy on clinical outcome in patients with stable angina: findings from the Euro Heart Survey of stable angina.

AIMS: The European Society of Cardiology published guidelines for the management of stable angina in 1997, with the objective of promoting an evidence-based approach to the condition. This study focuses on the impact of guideline compliant medical treatment on clinical outcome in patients with stable angina. METHODS AND RESULTS: The Euro Heart Survey of Stable Angina is a multicentre prospective observational study conducted between 2002 and 2003. Patients with a clinical diagnosis of stable angina by a cardiologist were enrolled and follow-up was conducted at 1 year. The primary outcome of interest was death or myocardial infarction (MI). The increasing intensity of guideline compliant medical therapy was quantified by means of a simple treatment score based on the use of guideline advocated therapies: antiplatelets, statins, and beta-blockers. A total of 3779 patients were included in the initial survey. Increasing intensity of guideline compliant therapy at initial assessment was associated with a reduction in death and MI during follow-up in patients with angina and confirmed coronary disease (HR 0.68; 95% CI 0.49-0.95 per unit increase in treatment score). All cardiovascular events were also significantly reduced in this subgroup (HR 0.82; 95% CI 0.69-0.97). The benefits of guideline compliant therapy were only observed in patients with objective evidence of coronary disease. CONCLUSION: Guideline compliant medical therapy improves clinical outcome in patients with stable angina and objective evidence of coronary disease.

Analysis of Variance↗
PubMed2006

Gender differences in the management and clinical outcome of stable angina.

BACKGROUND: We sought to examine the impact of gender on the investigation and subsequent management of stable angina and to assess gender differences in clinical outcome at 1 year. METHODS AND RESULTS: The Euro Heart Survey of Stable Angina enrolled patients with a clinical diagnosis of stable angina on initial assessment by a cardiologist. Baseline clinical details and cardiac investigations planned or performed within a 4-week period of the assessment were recorded, and follow-up data were collected at 1 year. A total of 3779 patients were included in the survey; 42% were female. Women were less likely to undergo an exercise ECG (odds ratio, 0.81; 95% CI, 0.69 to 0.95) and less likely to be referred for coronary angiography (odds ratio, 0.59; 95% CI, 0.48 to 0.72). Antiplatelet and statin therapies were used significantly less in women than in men, both at initial assessment and at 1 year, even in those in whom coronary disease had been confirmed. Women with confirmed coronary disease were less likely to be revascularized than their male counterparts and were twice as likely to suffer death or nonfatal myocardial infarction during the 1-year follow-up period (hazard ratio, 2.09; 95% CI, 1.13 to 3.85), even after multivariable adjustment for age, abnormal ventricular function, severity of coronary disease, and diabetes. CONCLUSIONS: Significant gender bias has been identified in the use of investigations and evidence-based medical therapy in stable angina. Women were also less likely to be revascularized. The observed bias is of particular concern in light of the adverse prognosis observed among women with stable angina and confirmed coronary disease.

Aged↗
PubMed2006

Predicting prognosis in stable angina--results from the Euro heart survey of stable angina: prospective observational study.

OBJECTIVES: To investigate the prognosis associated with stable angina in a contemporary population as seen in clinical practice, to identify the key prognostic features, and from this to construct a simple score to assist risk prediction. DESIGN: Prospective observational cohort study. SETTING: Pan-European survey in 156 outpatient cardiology clinics. PARTICIPANTS: 3031 patients were included on the basis of a new clinical diagnosis by a cardiologist of stable angina with follow-up at one year. MAIN OUTCOME MEASURE: Death or non-fatal myocardial infarction. RESULTS: The rate of death and non-fatal myocardial infarction in the first year was 2.3 per 100 patient years; the rate was 3.9 per 100 patient years in the subgroup (n = 994) with angiographic confirmation of coronary disease. The clinical and investigative factors most predictive of adverse outcome were comorbidity, diabetes, shorter duration of symptoms, increasing severity of symptoms, abnormal ventricular function, resting electrocardiogaphic changes, or not having any stress test done. Results of non-invasive stress tests did not significantly predict outcome in the population who had tests done. A score was constructed using the parameters predictive of outcome to estimate the probability of death or myocardial infarction within one year of presentation with stable angina. CONCLUSIONS: A score based on the presence of simple, objective clinical and investigative variables makes it possible to discriminate effectively between very low risk and very high risk patients and to estimate the probability of death or non-fatal myocardial infarction over one year.

Angina Pectoris↗
PubMed2005

The clinical characteristics and investigations planned in patients with stable angina presenting to cardiologists in Europe: from the Euro Heart Survey of Stable Angina.

AIMS: The Euro Heart Survey of Stable Angina set out to prospectively study the presentation and management of patients with stable angina as first seen by a cardiologist in Europe, with particular reference to adherence to existing guidelines and regional variability in patient presentation and initial assessment. METHODS AND RESULTS: Consecutive outpatients with a clinical diagnosis by a cardiologist of stable angina were enrolled in the study and 3779 patients were included in the analysis. The average age was 61 years and 58% were male. The majority of patients (88%) had mild to moderate angina, CCS class I or II. Despite a high prevalence of recognized risk factors, 27% did not have cholesterol and 33% did not have glucose measured within 4 weeks of assessment. The resting ECG was abnormal in 41% of patients. An exercise ECG was performed or planned as part of initial investigation in 76% of patients and 18% had a stress imaging test such as perfusion scanning or stress echo. A coronary angiogram was performed or planned in 41%, and 64% had an echo. The time from assessment to investigation varied widely, particularly for angiography. One in 10 patients had neither any form of stress test nor angiography, with marked regional variation. Availability of invasive facilities increased the likelihood of both non-invasive and invasive investigations. Those with more severe symptoms or longer duration of symptoms or a positive non-invasive test were more likely to have angiography. In multivariable analysis, a positive stress test was the strongest predictor of the use of angiography, associated with a six-fold increase in the likelihood of invasive investigation. However, gender and availability of facilities were also predictive. CONCLUSION: Considerable variation in features at presentation and use of investigations has been identified in the stable angina population in Europe. The evaluation of biochemical cardiovascular risk factors was suboptimal. Overall rates of non-invasive investigation for angina and the clinical appropriateness of factors predictive of the use of invasive investigation were broadly in line with guidelines. However, the influence of access to facilities, and marked international variation in rates and timing of investigation suggest that factors unrelated to clinical need are also influential in the management of patients with stable angina.

Aged↗
PubMed2005

The initial management of stable angina in Europe, from the Euro Heart Survey: a description of pharmacological management and revascularization strategies initiated within the first month of presentation to a cardiologist in the Euro Heart Survey of Stable Angina.

AIMS: In order to assess adherence to guidelines and international variability in management, the Euro Heart Survey of Newly Presenting Angina prospectively studied medical therapy, percutaneous coronary intervention (PCI), and surgery in patients with new-onset stable angina in Europe. METHODS AND RESULTS: Consecutive patients, 3779 in total, with a clinical diagnosis of stable angina by a cardiologist were enrolled. After initial assessment by a cardiologist, 78% were treated with aspirin, 48% with a statin, and 67% with a beta-blocker. ACE-inhibitors were prescribed by the cardiologist in 37% overall. Revascularization rates were low, with only 501 (13%) patients having PCI or coronary bypass surgery performed or planned. However, when restricted to patients with coronary disease documented within 4 weeks of assessment, over 50% had revascularization performed or planned. Among other factors, the national rate of angiography and availability of invasive facilities significantly predicted the likelihood of revascularization, OR 2.4 and 2.0, respectively. CONCLUSION: This survey shows a shortfall between guidelines and practice with regard to the use of evidence-based drug therapy and evidence that revascularization rates are strongly influenced by non-clinical, in addition to clinical, factors.

Analysis of Variance↗
PubMed2004

Issues in regulatory guidelines for data monitoring committees.

As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.

Clinical Trials Data Monitoring Committees↗
PubMed2001

Experience collecting interim data on mortality: an example from the RALES study.

INTRODUCTION: The Randomized Aldactone Evaluation Study (RALES) randomized 822 patients to receive 25 mg spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes. Randomization began on March 24, 1995; recruitment was completed on December 31, 1996; follow-up was scheduled to continue through December 31, 1999. Evidence of a sizeable benefit on mortality emerged early in the RALES. The RALES data safety monitoring board (DSMB), which met semiannually throughout the trial, used a prespecified statistical guideline to recommend stopping for efficacy. At the DSMB's request, its meetings were preceded by an 'endpoint sweep', that is, a census of all participants to confirm their vital status. METHODS: We used computer simulation to evaluate the effect of the sweeps. RESULTS: The sweeps led to an estimated 5 to 8% increase in the number of reported deaths at the fourth and fifth interim analyses. The data crossed the statistical boundary at the fifth interim analysis. If investigators had reported all deaths within the protocol-required 24-h window, the DSMB might have recommended stopping after the fourth interim analysis. DISCUSSION: Although endpoint sweeps can cause practical problems at the clinical centers, sweeps are very useful if the intervals between patient visits or contact are long or if endpoints require adjudication by committee, reading center, or central laboratory. CONCLUSION: We recommend that trials with interim analyses institute active reporting of the primary endpoints and endpoint sweeps.

Journal Article↗