Fibrinogen and factor VII in the prediction of coronary risk. Results from the PROCAM study in healthy men.

Abstract

Coronary thrombosis is regarded as the final occlusive event in the progress of coronary heart disease (CHD). Disturbances of the hemostatic system may favor this process and thus may indicate increased risk of myocardial infarction. Coagulation and lipid factors were measured in 2116 healthy male participants of the Prospective Cardiovascular Miinster (PROCAM) study. After 6 years of follow-up, 82 coronary events (9 sudden cardiac deaths and 14 fatal and 59 nonfatal myocardial infarctions) were observed. The mean plasma fibrinogen levels of the event and nonevent groups differed by 0.25 g/L (2.88 [SD, 0.68] versus 2.63 [SD, 0.63] g/L, respectively; P=.OO1). The incidence of coronary events in the upper tertile of the plasma fibrinogen distribution was 2.4-fold higher than in the lower tertile. By multiple logistic function analysis, plasma fibrinogen was found to be an independent risk indicator for CHD (P<.05). Individuals in the high serum low-density lipoprotein (LDL) cholesterol tertile who also showed high plasma fibrinogen concentrations had a 6.1-fold increase in coronary risk. Unexpectedly, individuals with low plasma fibrinogen had a low incidence of coronary events even when serum LDL cholesterol was high. The mean factor VIIc activities in the event and nonevent groups did not differ significantly (112.3% [SD, 19.9] and cardiac death appear to be associated with the occurrence of occlusive coronary thrombi.1 -3 One reason favoring or even precipitating thrombus formation might be a thrombogenic state in the patient's blood. Long-term epidemiological studies 410 in healthy persons report increased levels of plasma fibrinogen and factor VIIc in those individuals who develop a coronary event. This might suggest an increase in coagulation activity. To evaluate the possible role of the hemostatic system, plasma fibrinogen and factor VIIc were measured in the Prospective Cardiovascular Miinster (PROCAM) study. 1112 Since that time, plasma fibrinogen and factor VIIc have been determined in more than 10 000 persons who had not suffered from MI or stroke at the time of entry. The results from 2116 men who completed an observation period of 6 years are reported here. Methods Study DesignIn the PROCAM study, apparently healthy employees of Westphalian companies were examined deliberately for car- 11 The examination at onset included each patient's history, physical examination, electrocardiogram (ECG) at rest, and a laboratory blood analysis.The study began in 1979. Two years later the determination of plasma fibrinogen and factor VIIc was included, and 10 581 individuals (7540 men and 3041 women) were recruited ( Table 1). As expected, relevant numbers of MI or coronary heart disease (CHD) death occurred only in men aged 40 years and over. The analysis described below was therefore confined to the 2116 male participants between 40 and 65 years of age without a prior history of MI or stroke who had completed their 6-year follow-up.Diagnostic criteria and the definition of the end points have been p...

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