Heart Protection Study, Clinical Trial Service Unit and Epidemiological Studies Unit, Richard Doll Building, University of Oxford, Old Road Campus, Roosevelt Dr, Oxford OX3 7LF, UK.
J Vasc Surg. 2007 Apr;45(4):645-654; discussion 653-4. doi: 10.1016/j.jvs.2006.12.054.
The Heart Protection Study (HPS) provides an opportunity to assess directly the effects of cholesterol-lowering therapy on major vascular events (defined as myocardial infarction, coronary death, stroke, or revascularization) in patients with peripheral arterial disease (PAD). In addition, the effects on peripheral vascular events (ie, non-coronary revascularization, aneurysm repairs, major amputations or PAD deaths) can be assessed.
6748 UK adults with PAD and 13,788 other high-risk participants were randomly allocated to receive 40 mg simvastatin daily or matching placebo, yielding an average LDL cholesterol difference of 1.0 mmol/L (39 mg/dL) during a mean of 5 years.
For participants with PAD, allocation to simvastatin was associated with a highly significant 22% (95% CI 15-29) relative reduction in the rate of first major vascular event following randomisation (895 [26.4%] simvastatin-allocated vs 1101 [32.7%] placebo-allocated; P < .0001), which was similar to that seen among the other high-risk participants. The absolute reduction in first major vascular event was 63 (SE 11) per 1000 patients with PAD and 50 (SE 7) per 1000 without pre-existing PAD. Overall, among all participants, there was a 16% (5-25) relative reduction in the rate of first peripheral vascular event following randomisation (479 [4.7%] simvastatin vs 561 [5.5%] placebo), largely irrespective of baseline LDL cholesterol and other factors. This effect chiefly reflects a 20% (8-31) relative reduction in non-coronary revascularization procedures (334 [3.3%] vs 415 [4.0%]; P = .002).
HPS demonstrates the benefits of cholesterol-lowering statin therapy in patients with PAD, regardless of their presenting cholesterol levels and other presenting features. Allocation to 40 mg simvastatin daily reduces the rate of first major vascular events by about one-quarter, and that of peripheral vascular events by about one-sixth, with large absolute benefits seen in participants with PAD because of their high vascular risk. Consequently, statin therapy should be considered routinely for all patients with PAD.
心脏保护研究（HPS）提供了一个直接评估降胆固醇治疗对周围动脉疾病（PAD）患者主要血管事件（定义为心肌梗死、冠心病死亡、中风或血管重建）影响的机会。此外，还可以评估其对周围血管事件（即非冠状动脉血管重建、动脉瘤修复、大截肢或PAD死亡）的影响。
6748名英国成年PAD患者和13788名其他高危参与者被随机分配，每天接受40毫克辛伐他汀或匹配的安慰剂，在平均5年的时间里，低密度脂蛋白胆固醇平均差异为1.0毫摩尔/升（39毫克/分升）。
对于PAD患者，随机分组后分配到辛伐他汀组的患者首次发生主要血管事件的发生率相对降低了22%（95%置信区间15 - 29），具有高度显著性（辛伐他汀组895例[26.4%]，安慰剂组1101例[32.7%]；P <.0001），这与其他高危参与者的情况相似。每1000例PAD患者首次主要血管事件的绝对降低率为63（标准误11），每1000例无PAD病史的患者为50（标准误7）。总体而言，在所有参与者中，随机分组后首次周围血管事件的发生率相对降低了16%（5 - 25）（辛伐他汀组479例[4.7%]，安慰剂组561例[5.5%]），很大程度上与基线低密度脂蛋白胆固醇及其他因素无关。这种效应主要反映了非冠状动脉血管重建手术相对降低了20%（8 - 31）（334例[3.3%]对415例[4.0%]；P =.002）。
HPS证明了降胆固醇他汀类药物治疗对PAD患者有益，无论其当前胆固醇水平及其他临床表现如何。每天服用40毫克辛伐他汀可使首次主要血管事件的发生率降低约四分之一，周围血管事件的发生率降低约六分之一，由于PAD患者血管风险高，因此在他们身上可看到显著的绝对获益。因此，应考虑对所有PAD患者常规进行他汀类药物治疗。
