OBJECTIVES
We sought to test the hypothesis that C-reactive protein, a marker of inflammation, would correlate positively with coronary calcium, a marker of atherosclerosis, in postmenopausal women.
...BACKGROUND
High sensitivity testing for C-reactive protein (hsCRP) has recently been shown in large population studies to predict cardiac events in asymptomatic postmenopausal women. Coronary calcification determined by electron beam computerized tomography (EBCT) has also been suggested to be predictive of cardiac events in women.
METHODS
We performed hsCRP testing and determined calcium scores by EBCT in 172 asymptomatic postmenopausal women (mean age: 64.5 ± 7.9 years) at risk for cardiac disease. Risk factors were determined by history, physical, electrocardiogram, exercise testing, and lipoprotein profiles.
RESULTS
Calcium scores ranged from 0 to 2618. For analysis, calcium scores were divided into three groups; none (0 to 10), minimal (>10 to 50), and significant (>50). Overall, there was no significant positive relationship between hsCRP level and calcium score. Specifically, the hsCRP levels (mg/dl) were 0.24 ± 0.43, 0.33 ± 0.47 and 0.17 ± 0.32 (medians 0.11, 0.15, and 0.06) for women with none, minimal, and significant coronary calcification, respectively. In subgroup analysis, a similar lack of positive association was observed after stratification by smoking status and by hormone replacement therapy use, two factors known to increase hsCRP.
CONCLUSIONS
In contrast to our a priori hypothesis, we found no evidence of a positive association between hsCRP and calcium score by EBCT. These data thus raise the possibility that hsCRP and EBCT calcium score reflect different pathologic processes, an issue with implications for coronary artery disease screening.
Objectivts. The aim of this study was to test the hypothesis that atherosclerotic plaque in the thoracic aorta detected by transesophageal echocardiography is a marker for coronary artery disease.
...Background. Previous pathologic and roentgenographic studies have suggested a relation between aortic plaque and coronary artery disease but have lacked clinical utility.
Methods. We performed transesophageal echocardiography on 61 patients (30 women and 31 men aged 22 to 83 years mean 60 ± 14) who had previously undergone cardiac catheterization with coronary angiography. The clinical indications for angiography were angina (n = 26), valvular heart disease (n = 17), positive noninvasive evaluation for ischemia without angina (n = 6), postmyocardial infarction (n = 5), familial hypercholesterolemia (n = 4), coronary cameral fistula (n = 1), atrial myxoma (n = 1) and suspected aortic dissection (n = 1). All patients underwent transesophageal echocardiography with Imaging of the thoracic aorta. The criteria used to diagnose atherosclerotic plaque on transesophageal echocardiography were the presence of linear or focal increased echodensity with lumen irregularity and thickening or calcification of the aortic intima.
Results. In 41 of the 61 patients, obstructive coronary artery disease was detected by angiography in at least one vessel (>50% left main coronary artery stenosis or >70% stenosis in the left anterior descending, right coronary or left circumflex artery distribution). In 37 of the 41, atherosclerotic plaque was detected in the thoracic aorta by transesophageal echocardiography. Twenty of the 61 patients had normal coronary angiographic findings or nonobstructive lumen irregularities. In 2 of these 20 patients, plaque was detected in the thoracic aorta on transesophageal echocardiography. The presence of aortic plaque on transesophageal study had a sensitivity of 90% and a specificity of 90% for angiographically proved obstructive coronary artery disease. The positive predictive value of aortic plaque for obstructive coronary artery disease was 95% and the negative predictive value was 82%.
Conclusions. The detection of atherosclerotic plaque in the thoracic aorta by transesophageal ecbocardiography appears to be a marker for the identification of obstructive coronary artery disease and deserves further investigation.
Objective To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk ...cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. Design A search of the publicly available FDA database was performed for all cardiovascular devices that received premarket approval from 1 January 2000 to 31 December 2010. For each study listed in the premarket approval documents, a Medline search was conducted to obtain the corresponding publication. Main outcome measures Clinical trial characteristics, primary endpoints, and safety and efficacy results in the FDA documents and corresponding publications. Results 106 cardiovascular devices received premarket approval from 1 January 2000 to 31 December 2010. FDA premarket approval documents for these devices contained 177 studies, of which 86 (49%) had been published by 1 January 2013. These 86 publications corresponded to 60 distinct devices. The mean time from FDA approval to publication in a peer reviewed journal was 6.5 months (range −4.8-7.5 years). In 22 (26%) of the 86 compared studies the number of participants enrolled in the study differed in the FDA summary and the corresponding publications. Of 152 primary endpoints identified in the FDA documents, in the corresponding publications three (2%) were labeled as secondary, 43 (28%) were unlabeled, and 15 (10%) were not found. Among the primary results, 69 (45%) were identical, 35 (23%) were similar, 17 (11%) were substantially different, and 31 (20%) could not be compared. Conclusions Many clinical trials for high risk cardiovascular devices approved by the FDA remain unpublished. Even when trials are published, the study population, primary endpoints, and results can differ substantially from data submitted to the FDA.
Background The optimal strategy for the diagnosis of coronary artery disease (CAD) in women is not well defined. We compared the cost-effectiveness of several strategies for diagnosing CAD in women ...with chest pain.
Methods We performed decision and cost-effectiveness analyses with simulations of 55-year-old ambulatory women with chest pain. With a Markov model, simulations of patients underwent exercise electrocardiography, exercise testing with thallium scintigraphy, exercise echocardiography, angiography, or no workup.
Results Diagnosis with angiography cost less than $17,000 per quality-adjusted life-year compared with exercise echocardiography if the patient had definite angina and less than $76,000 per life-year if she had probable angina. If she had nonspecific chest pain, diagnosis with exercise echocardiography increased life-years compared with no testing.
Conclusions Cost-effectiveness of first-line diagnostic strategy for diagnosis of CAD in women varies mostly according to pretest probability of CAD. Diagnosis of coronary artery disease with angiography is cost-effective in 55-year-old women with definite angina. In 55-year-old women with probable angina, diagnosis with angiography would increase quality-adjusted life-years but significantly increase costs. Use of exercise echocardiography as a first-line diagnosis for CAD is cost effective in 55-year-old women with probable angina and nonspecific chest pain. (Am Heart J 1999;137:1019-27.)
OBJECTIVES
This study sought to determine the relationship of lipoprotein(a) (Lp(a)) and other cardiac risk factors to coronary atherosclerosis as measured by calcification of coronary arteries in ...asymptomatic postmenopausal women.
BACKGROUND
Lipoprotein(a) is considered a risk factor for coronary heart disease. Coronary calcium deposition is believed to be a useful noninvasive marker of coronary atherosclerosis in women. However, to our knowledge, there are no reports of the relationship of Lp(a) to coronary calcium in postmenopausal women.
METHODS
In 178 asymptomatic postmenopausal women (64 ± 8 years), we measured Lp(a) and other cardiac risk factors: age, hypertension, diabetes, low-density lipoprotein cholesterol, smoking status, body mass index, physical activity level and duration of hormone replacement therapy. Electron-beam computed tomography was done to measure coronary calcium (calcium score). We analyzed the relationship between calcium score and cardiac risk factors using multivariate analysis.
RESULTS
Although calcium score correlated with traditional risk factors of age, diabetes, hypertension and smoking, it did not correlate with Lp(a) in the asymptomatic postmenopausal women. Similar multivariate analyses were done in the subjects age >60 years and in the subjects with significant coronary calcium deposit (calcium score ≥50). These analyses also have failed to show an association of levels of Lp(a) with coronary calcium deposits.
CONCLUSIONS
We conclude that in asymptomatic postmenopausal women, Lp(a) levels do not correlate with coronary atherosclerosis as measured by coronary calcium deposits.
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