Abstract
Background. Few lipid/atherosclerosis intervention trials have assessed the impact of cholesterol reduction on peripheral arterial disease. The 838 patients evaluated in the Program of on the Surgical Control of the Hyperlipidemias (POSCH) trial represent more than the total number of patients in the seven previously reported studies. Methods. Peripheral arterial disease in POSCH was assessed by progression of clinical disease, serial changes in the systolic blood pressure ankle/brachial index (ABI), and changes on sequential peripheral arteriograms. Results. At the time of formal closure of the POSCH trial on July 19, 1990, claudication or limb-threatening ischemia was exhibited in 72 of 417 control group (CG) patients and in 54 of 421 intervention group (IG) patients (IG relative risk [RR] 0.702, 95% confidence interval [CI] 0.169 to 1.000, p = 0.049). With additional follow- up evaluation to September 30, 1994, clinical peripheral arterial disease was evident in 91 CG patients and 64 IG patients (RR 0.656, 95% CI 0.200 to 0.903, p = 0.009). At the 5-year follow-up evaluation, an ABI of less than 0.95 was present in 41 of 120 CG patients and in 24 patients, all of whom had an ABI of 0.95 or greater at baseline (RR in the IG of 0.557, 95% CI 0.360 to 0.863, p < 0.01). No appreciable differences were noted in the progression or regression of arteriographic peripheral arterial disease between the two groups. Conclusions. Effective cholesterol reduction in POSCH led to statistically significant differences between the control and the intervention groups in the development of clinically evident peripheral arterial disease and in the ABI values, but not in the peripheral arteriograms. Additional studies need to assess the correlation between peripheral arterial changes and coronary arterial changes and clinical atherosclerosis events. Intervention trials that study peripheral arterial disease have intrinsic value in the evaluation of the impact of risk factor modification on progression of atherosclerotic peripheral arterial disease.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 672-679 |
| Number of pages | 8 |
| Journal | Surgery |
| Volume | 120 |
| Issue number | 4 |
| DOIs | |
| State | Published - 1996 |
Bibliographical note
Funding Information:FEW IJPID/ATHEROSCLEROSIS INTERVENTION trials to date have included assessment of peripheral arterial disease. The number of these trials is far fewer than the number of comparable studies of atherosclerotic coronary heart disease and carotid artery disease. The first peripheral Supported by grants R01-HL-15265 and R01-HL-49522 from the National Heart, Lung, and Blood Institute. Presented at the Fifty-thirdA nnual Meetingo f the Central SurgicalA s-sociation, Minneapolis,M inn., March 8-10, 1996. Reprint requests: Henry Buchwald, MD, PhD, Universityo f Minnesota Hospital, Box 290, Minneapolis,M N 55455. aFor members of the POSCH Group, see Appendix. Copyright 9 1996 by Mosby-Year Book, Inc. 0039-6060/96/$5.00 + 0 11/6/75173 vascular lipid/atherosclerosis intervention trial was reported in 1967 by Ost and Stenson. 1 This trial was uncontrolled and consisted of 31 patients. In 1983 Duffield et al. 2 published the first randomized controlled clinical trial of peripheral arterial disease treated by lipid modification. This study was limited to 24 patients. Only in the Program on the Surgical Control of the Hyperlipidemias (POSCH) report of 1990 was a substantive number of patients assessed. 3 The 838 patients evaluated in POSCH are more than the total number of patients in all of the previously reported lipid/atherosclerosis peripheral vascular intervention trials), 2, 4-8 Peripheral arterial disease is ultimately judged by the degree of claudication present or the threat of limb loss.
