A randomized, controlled trial for risk factor reduction in patients with symptomatic vascular disease: the multidisciplinary Vascular Prevention by Nurses Study (VENUS)

Background Patients with manifest vascular disease are at high risk of a new vascular event or death. Modification of classical risk factors is often not successful. We determined whether the extra care of a nurse practitioner could be beneficial to the cardiovascular risk profile of high-risk patients. Design We conducted a randomized, controlled trial based on the Zelen design. Methods Two hundred and thirty-six patients with manifestations of a vascular disease and who had two or more modifiable vascular risk factors were pre-randomized to receive treatment by a nurse practitioner plus usual care or usual care alone. After 1 year, risk factors were remeasured. The primary endpoint was achievement of treatment goals for blood pressure, lipid, glucose and homocysteine levels, body mass index, and smoking. Results Of the pre-randomized patients, 95 of 119 (80%) in the intervention group and 80 of 117 (68%) in the control group participated in the study. After a mean follow-up of 14 months, the patients in the intervention group achieved significantly more treatment goals than did the patients in the control group (systolic blood pressure 63 versus 37%, total cholesterol 79 versus 61%, low density lipoprotein-cholesterol 88 versus 67%, and body mass index 38 versus 24%). Medication use was increased in both groups and no differences were found in patients' quality of life (SF-36) at follow-up. Conclusion Treatment delivered by nurse practitioners, in addition to a vascular risk factor screening and prevention program, resulted in a better management of vascular risk factors than usual care alone in vascular patients after 1-year follow-up.