OBJECTIVES: To assess health status in high-risk subjects undergoing noncardiac vascular surgery in the United States. METHODS: Health status data were collected as part of a pharmacoeconomic (PE) substudy from a clinical trial in noncardiac vascular surgery patients. The analysis population consisted of subjects (mean age = 70.0) from the primary clinical analysis population of U.S. subjects who consented to participate in the PE substudy. Health status was measured using the 12-item Short-Form Health Survey (SF-12 acute, version 1) at baseline and post-operative Day 30. Physical and mental component summary scores (PCS and MCS) were calculated using published scoring algorithms. RESULTS: Of the 370 subjects in the U.S. clinical population, 229 subjects (62%) provided information on the SF-12. Differences in the distribution of age, gender, race, and index procedures were similar in both clinical and PE substudy samples. Mean scores were 30.6 (SD = 10.7) at baseline and 32.8 (10.6) at Day 30 for the PCS; corresponding scores were 50.3 (12.4) and 50.4 (10.5) for the MCS. There was a slight improvement in the mean change from baseline for the PCS and no real improvement for the MCS. The proportion of patients whose SF-12 scores improved from baseline was 54.2% and 45.9% for the PCS and MCS, respectively. Mean baseline SF-12 scores on the PCS for these subjects were noticeably lower than those from the general U.S. population norms aged 65-74 (PCS mean = 43.9, SD = 9.3) and from other common chronic diseases. CONCLUSIONS: The data suggest a marginal improvement in PCS, but not MCS scores at post-operative Day 30. A longer follow-up may have been necessary to detect a noticeable improvement in health status. High-risk patients undergoing noncardiac vascular surgery have relatively low levels of physical functioning and well-being compared with many other diseases.