St. Francis Heart Study - Natural History - St. Francis Heart Study - Natural History

Description:

The goal of the trial was to determine the prognostic accuracy of coronary calcification compared with standard coronary disease risk factors in the prediction of atherosclerotic cardiovascular disease (ASCVD) events.

Study Design

Patients Enrolled: 5,585
Mean Follow Up: 4.3 years
Mean Patient Age: Mean age 59
Female: 30

Patient Populations:

Asymptomatic; age 50-70; and no prior history, symptoms, or signs of ASCVD

Exclusions:

Patients on or with indications for lipid-lowering

Primary Endpoints:

Development of ASCVD events

Drug/Procedures Used:

Asymptomatic patients with no prior history, symptoms, or signs of ASCVD were followed prospectively for ASCVD events. Coronary calcium was measured by electron beam computed tomography (EBCT) scanning and the Agatston scoring method. Events were verified by an adjudication committee blinded to the coronary calcium score.

Patients with a high calcium score were invited to participate in a randomized trial of a statin and antioxidant vitamin. Patients in the on-treatment arm of the randomized clinical trial (RCT) were excluded from the calcification study.

Concomitant Medications:

Acetyl salicylic acid (ASA) 81 mg/d in patients in the RCT

Principal Findings:

One or more ASCVD events occurred in 122 subjects (0.6%/year), including 43 nonfatal myocardial infarctions (MIs) or coronary deaths, 62 CABG/PTCA procedures, five nonhemorrhagic strokes, and 12 peripheral vascular surgeries. Baseline calcium score was higher in patients who had an event during follow-up (584 ± 775 with event vs. 142 ± 381 without event, p

Using a calcium score threshold of ≥100, presence of a baseline score ≥100 was associated with a higher incidence of any ASCVD (relative risk [RR] 9.5, 95% confidence interval [CI] 6.5-13.8), all coronary events (8.6% event rate, RR 10.7, 95% CI 7.1-16.3), and MI or coronary death (RR 9.9, 95% CI 5.2-18.9). Other calcium score thresholds were also associated with all coronary events: score ≥0 (3.2% event rate, RR 5.9), score ≥200 (10.5% event rate, RR 8.9), and score ≥600 (14.1% event rate, RR 8.0).

Interpretation:

Among patients with no prior history, symptoms, or signs of ASCVD, development of an ASCVD event was associated with a higher baseline calcium score. The association between the baseline calcium score was independent of standard risk factors in a multivariate model and provided additional risk stratification within the Framingham risk score.

The 2000 ACC/AHA guidelines do not currently recommend use of EBCT screening in asymptomatic populations, due to the low specificity reported at the time the consensus was written with EBCT calcium score in predicting coronary artery disease. The statement did not recommend the use, due to potential for unnecessary tests and procedures in patients who are "false positive" based on the EBCT.

References:

Arad Y, Goodman KJ, Roth M, Newstein D, Guerci AD.Coronary calcification, coronary disease risk factors, C-reactive protein, and atherosclerotic cardiovascular disease events: the St. Francis Heart Study. J Am Coll Cardiol. 2005 Jul 5;46(1):158-65.

Presented at Late-Breaking Clinical Trials, ACC 2003.

Clinical Topics: Dyslipidemia, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Nonstatins, Novel Agents, Statins, Computed Tomography, Nuclear Imaging

Keywords: Stroke, Myocardial Infarction, Coronary Artery Disease, Follow-Up Studies, Tomography, X-Ray Computed, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Calcinosis, Risk Factors, Calcium, Consensus, Vitamins, Research Design, Confidence Intervals


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