BACKGROUND: The Program on the Surgical Control of the Hyperlipidemias (POSCH), a secondary intervention trial, was the only lipid/atherosclerosis randomized clinical trial that used a surgical modality--partial ileal bypass. POSCH provided solid evidence for the clinical and arteriographic benefits of lipid profile normalization. Few longterm followup reports have been published in this field. This report concerns overall mortality, the primary endpoint of POSCH, with a mean followup of 18 years (range 15.5 to 23.0 years). STUDY DESIGN:Overall mortality data were compiled from reports to the POSCH clinics, followup telephone calls, death certificates, and the US National Death Index. RESULTS: There were 144 deaths in the control group (n = 417) and 120 deaths in the intervention group (n = 421), using intent-to-treat analysis. The risk reduction in the intervention group was 0.201 (20%); the risk ratio was 0.799, or 0.8 (95% confidence intervals, 0.628 to 1.018, p = 0.07). The proportion of patients alive was 65.7% in the control group and 72.0% in the intervention group, for a difference of 6.3% in the intervention group (p = 0.05). Kaplan-Meier survival analysis (p = 0.046) and disease-free intervals analysis at 70% survival (p < 0.001) were confirmatory. The gain in life expectancy in the intervention group was 2.7 years. CONCLUSIONS: Longterm followup POSCH data demonstrate that lipid profile normalization will decrease overall mortality and will maintain a persistent and constant increase in life expectancy.
RCT Entities:
BACKGROUND: The Program on the Surgical Control of the Hyperlipidemias (POSCH), a secondary intervention trial, was the only lipid/atherosclerosis randomized clinical trial that used a surgical modality--partial ileal bypass. POSCH provided solid evidence for the clinical and arteriographic benefits of lipid profile normalization. Few longterm followup reports have been published in this field. This report concerns overall mortality, the primary endpoint of POSCH, with a mean followup of 18 years (range 15.5 to 23.0 years). STUDY DESIGN: Overall mortality data were compiled from reports to the POSCH clinics, followup telephone calls, death certificates, and the US National Death Index. RESULTS: There were 144 deaths in the control group (n = 417) and 120 deaths in the intervention group (n = 421), using intent-to-treat analysis. The risk reduction in the intervention group was 0.201 (20%); the risk ratio was 0.799, or 0.8 (95% confidence intervals, 0.628 to 1.018, p = 0.07). The proportion of patients alive was 65.7% in the control group and 72.0% in the intervention group, for a difference of 6.3% in the intervention group (p = 0.05). Kaplan-Meier survival analysis (p = 0.046) and disease-free intervals analysis at 70% survival (p < 0.001) were confirmatory. The gain in life expectancy in the intervention group was 2.7 years. CONCLUSIONS: Longterm followup POSCH data demonstrate that lipid profile normalization will decrease overall mortality and will maintain a persistent and constant increase in life expectancy.