Program on the surgical control of the hyperlipidemias (POSCH): Design and methodology

Henry Buchwald, John P. Matts, Laurie L. Fitch, Richard L. Varco, Gilbert S. Campbell, Malcolm Pearce, Albert Yellin, Robert D. Smink, Henry S. Sawin, Christian T. Campos, Betty J. Hansen, John M. Long

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

Abstract

The Program on the Surgical Control of the Hyperlipidemias (POSCH) is a prospective, randomized, controlled, multi-center, secondary, atherosclerosis intervention trial. POSCH addresses the therapeutic arm of the lipid-atherosclerosis theory, i.e. whether lowering of plasma cholesterol is directly related to a reduction in atherosclerosis risk. In this trial, lipid modification is accomplished by the partial ileal bypass operation. Between 1975 and 1983, 838 patients were randomized into this study. All patients were between 30 and 64 years of age, had survived one and only one electrocardiogram and enzyme-documented myocardial infarction; and had a total plasma cholesterol of at least 220 mg/dl or a low density lipoprotein (LDL)-cholesterol of at least 140 mg/dl if the total plasma cholesterol was between 200 and 219 mg/dl after a minimum of 6 weeks of dietary fat and cholesterol restriction. The primary response variable in POSCH is overall mortality. Secondary endpoints include fatal and non-fatal myocardial infarctions, serial electrocardiographic changes, and, most importantly, sequential coronary arteriography changes. The minimum follow-up is currently planned to be 7 years. Study analyses will be made primarily on the "intention to treat" basis. This paper is the first detailed presentation of POSCH design and methodology. Included are descriptions of study design, implementation, and data collection, including data processing, quality assurance/quality surveillance, and patient safety monitoring. POSCH seeks to demonstrate a significant reduction in overall mortality by lipid modification and to validate the use of coronary arteriographic change as a surrogate endpoint for change in coronary heart disease risk.

Original languageEnglish (US)
Pages (from-to)1111-1127
Number of pages17
JournalJournal of Clinical Epidemiology
Volume42
Issue number12
DOIs
StatePublished - 1989

Keywords

  • Atherosclerosis
  • Cholesterol
  • Hyperlipidemia
  • Partial ileal bypass
  • Post myocardial infarction
  • Randomized clinical trial

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