Program on Surgical Control of Hyperlipidemias (POSCH)
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether a profound reduction in serum cholesterol level, induced and maintained
      by partial ileal bypass, would prevent a second heart attack among men and women who had one
      myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.
    

Detailed description: 
      BACKGROUND:

      The correlative evidence linking elevated cholesterol to increased risk of cardiovascular
      disease is incontrovertible. Animal studies have shown that significant reductions in disease
      in humans may be forthcoming if blood lipids are reduced from elevated levels. Beginning in
      the 1960s, some patients had undergone a surgical bypass procedure for hyperlipidemia.
      Patients were selected for surgery after dietary management had been carried out for three
      years. The average serum cholesterol concentrations decreased markedly and the decrease was
      sustained.

      This grant-supported clinical trial attempted to determine the effect on cardiovascular
      morbidity and mortality of the partial ileal bypass in patients who had suffered a myocardial
      infarction within the previous 5 years and who had serum cholesterol over 220 mg deciliter
      (200 mg if LDL cholesterol was over l40 mg).

      DESIGN NARRATIVE:

      Randomized, non-blind, fixed sample study with a control group and an experimental group of
      equal size. The experimental group received a partial ileal bypass and diet therapy to reduce
      serum cholesterol and triglycerides. The control group was given conventional medical therapy
      exclusive of cholesterol-lowering drugs. The primary endpoint was death due to any cause.
      Secondary endpoints included death due to atherosclerosis and morbidity from recurrent
      myocardial infarction, unstable angina, cerebrovascular accident. Other secondary endpoints
      included coronary artery bypass surgery, percutaneous transluminal coronary angioplasty,
      cardiac transplantation, and peripheral vascular surgery.

      Beginning in January 1993, long-term morbidity and mortality follow-up are continuing through
      December 1997 under grant support (R01HL49522). Follow-up includes tracking morbidity and
      mortality by an annual telephone survey and review of patient records, including death and
      autopsy results. In addition, mortality and morbidity will be correlated with lipid changes
      and existing arteriographic results. The long-term course of control patients treated with
      the AHA Phase II Diet counseling will be assessed and the long-term side effects of partial
      ileal bypass will be evaluated.
    

Intervention name(s): jejunoileal bypass; diet, fat-restricted
Intervention type(s): Procedure; Behavioral
Allocation: Randomized
Primary purpose: Prevention