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Overall mortality in the program on the surgical control of the hyperlipidemias
Henry Buchwald1, Stanley E Williams, John P Matts
1Department of Surgery, School of Public Health, University of Minnesota, Minneapolis 55455, USA.
Insights
Long-term results from the Program on the Surgical Control of the Hyperlipidemias (POSCH) show that partial ileal bypass surgery significantly reduced overall mortality. This intervention led to a sustained increase in life expectancy for patients with hyperlipidemia.
Area of Science:
- Cardiovascular Medicine
- Surgical Interventions
- Clinical Trials
Background:
- The Program on the Surgical Control of the Hyperlipidemias (POSCH) was a unique randomized clinical trial investigating the surgical modality of partial ileal bypass for lipid/atherosclerosis management.
- POSCH previously established clinical and arteriographic benefits of normalizing lipid profiles.
- This report focuses on the long-term impact of the intervention on overall mortality, the study's primary endpoint, with a mean follow-up of 18 years.
Purpose of the Study:
- To evaluate the long-term effects of partial ileal bypass on overall mortality.
- To assess the sustained impact of lipid profile normalization on patient survival and life expectancy.
Main Methods:
- Overall mortality data were collected through clinic reports, telephone follow-ups, death certificates, and the US National Death Index.
- Intent-to-treat analysis was employed to compare mortality rates between the intervention and control groups.
- Kaplan-Meier survival analysis and disease-free interval analysis were used to confirm findings.
Main Results:
- The intervention group (partial ileal bypass) experienced a 20% reduction in risk for overall mortality (Risk Ratio 0.8, p=0.07).
- A significantly higher proportion of patients in the intervention group were alive at follow-up (72.0% vs. 65.7%, p=0.05).
- The intervention group demonstrated a gain in life expectancy of 2.7 years.
Conclusions:
- Long-term follow-up data from POSCH confirm that normalizing lipid profiles through partial ileal bypass significantly decreases overall mortality.
- The study demonstrates a persistent and constant increase in life expectancy associated with this lipid-lowering surgical intervention.
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.