Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.
Ann Surg. 2010 Jun;251(6):1034-40. doi: 10.1097/SLA.0b013e3181deb4d0.
To present the longest follow-up report of any lipid-atherosclerosis intervention trial.
The Program on the Surgical Control of the Hyperlipidemias (POSCH), a secondary, clinical/arteriographic, randomized controlled trial, was the first lipid-atherosclerosis trial to demonstrate unequivocally that low density lipoprotein cholesterol reduction reduced the incidence of coronary heart disease death and myocardial infarction.
We report POSCH 25 years follow-up for overall mortality, specific cause of death, and certain subgroup analyses, as well as a prediction for increase in life expectancy derived from the POSCH database, supplemented by the 2006 National Death Index, 1989-2006.
There were 838 patients randomized in POSCH (421 surgery, 417 control). At 25 years follow-up, the difference in the restricted mean survival and the logrank (Mantel-Haenszel) statistic was statistically significant, with survival probabilities of 0.57 (surgery) and 0.51 (controls). Cause of death data indicated a significant increase in cardiovascular deaths in the control group; cancer deaths were also greater in the control group but this was not significant. The most compelling subgroup analysis was a significant increase in survival, starting at 5 years after randomization, in the surgery group for patients with an ejection fraction > or = 50%, with relative probabilities of 0.61 (surgery) and 0.51 (control). The estimated incremental increase in life expectancy over more than 25 years of follow-up was 1.0 year overall and 1.7 years in the cohort with an ejection fraction > or = 50%.
A 25-year mortality follow-up in POSCH shows statistically significant gains in overall survival, cardiovascular disease-free survival, and life expectancy in the surgery group compared with the control group.
呈现最长的任何脂质-动脉粥样硬化干预试验的随访报告。
外科控制高脂血症计划(POSCH)是一项二级临床/动脉造影随机对照试验,是第一个明确表明低密度脂蛋白胆固醇降低可降低冠心病死亡和心肌梗死发生率的脂质-动脉粥样硬化试验。
我们报告了 POSCH 25 年的总体死亡率、特定死因和某些亚组分析的随访结果,以及根据 POSCH 数据库预测的预期寿命增加,该数据库辅以 2006 年国家死亡指数,1989-2006 年。
POSCH 共纳入 838 例患者(421 例手术,417 例对照组)。25 年随访时,限制平均生存时间和对数秩(Mantel-Haenszel)统计差异具有统计学意义,手术组的生存率为 0.57,对照组为 0.51。死因数据表明对照组心血管死亡率显著增加;对照组的癌症死亡率也更高,但无统计学意义。最具说服力的亚组分析显示,随机分组 5 年后手术组的存活率显著增加,射血分数≥50%的患者相对存活率为 0.61(手术组)和 0.51(对照组)。预计超过 25 年随访的预期寿命增量为 1.0 年,射血分数≥50%的患者为 1.7 年。
POSCH 的 25 年死亡率随访显示,与对照组相比,手术组在总体生存率、无心血管疾病生存率和预期寿命方面均有统计学显著获益。