Relation between risk factors and cardiovascular complications in patients with peripheral vascular disease. Results from the A.D.E.P. study

The relationship between risk factors and the onset of cardiovascular events was analyzed in patients suffering from peripheral obstructive arterial disease. One thousand and eleven patients were recruited in 120 Italian centers and participated in a clinical trial on picotamide (A.D.E.P. study), whose results have been previously reported. Patients were followed-up for 18 months and cardiovascular events were recorded. Hypertension (35%), smoking (34%), and diabetes (19%) were the most common risk factors at baseline. During the follow-up period, 246 patients (11.7%) had a cardiovascular event, mainly affecting cerebral, cardiac or peripheral circulation. Thirty-five of these events (14.2%) were fatal. A logistic regression analysis showed in general that hypertension (odds ratio 1.48), an ankle/arm pressure ratio lower than 0.8 (odds ratio 1.42), smoking (odds ratio 1.43), previous vascular surgery (odds ratio 1.35), high white blood cell (WBC) count (odds ratio 1.15 for a difference of 2.0 × 109 WBC/I) and plasma fibrinogen (odds ratio 1.16 for a difference of 1.05 g/l) were significantly associated with a higher incidence of cardiovascular events. In particular, deaths of any origin were more frequent in patients with an ankle/arm pressure ratio below 0.8. High plasma fibrinogen increased the risk of cerebrovascular events, hypertension or coronary heart events and, to a less evident extent, peripheral vascular complications and cerebrovascular events. A history of vascular surgery increased the risk of peripheral vascular complications. Both smoking and a high WBC count showed to be borderline significant risk factors for coronary heart events and the former also for peripheral vascular complications. In male patients (84%), ankle/arm pressure ratio lower than 0.8, high fibrinogen and hypertension were the most important factors for cardiovascular events. This study helps to identify some categories at higher risk of cardiovascular events among patients with peripheral obstructive arterial disease; this finding is useful to plan future trials to decrease the frequency of such complications.