1 VA Medical Center and University of Colorado, USA.
2 Pfizer, Inc., New York, USA.
Eur J Prev Cardiol. 2017 Aug;24(12):1294-1296. doi: 10.1177/2047487317708677. Epub 2017 May 15.
Background Early, intensive statin treatment is the standard of care after acute coronary syndrome (ACS). However, the benefit of this approach to prevent major adverse cardiovascular events has been demonstrated in only one randomised, placebo controlled trial. The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial demonstrated that atorvastatin 80 mg daily, compared with placebo, reduced time to first occurrence of death, non-fatal myocardial infarction, resuscitated cardiac arrest, or hospitalisation for unstable angina (stroke not included) during the 16 week period following ACS. However, there were no significant effects on individual components of the composite endpoint except unstable angina. This led some to question whether early, intensive statin treatment reduces 'hard' events after ACS. Aim The burden of coronary heart disease after ACS, and therefore the efficacy of its treatment, depends not only on the occurrence of one ischaemic event, but rather on cumulative events experienced by patients. Accordingly, we conducted a post-hoc analysis of the MIRACL trial to examine the effect of atorvastatin on first as well as recurrent (i.e. total) hard cardiovascular events after ACS (death, myocardial infarction, stroke, and resuscitated cardiac arrest). Methods and Results In the 3086 patients who comprised the MIRACL trial, atorvastatin 80 mg did not reduce time to first hard event compared with placebo (hazard ratio 0.89, 95% confidence interval 0.72-1.10, P = 0.27). However, atorvastatin significantly reduced total hard events (hazard ratio 0.80, 95% confidence interval 0.66-0.97, P = 0.03). To prevent one hard event during the 16 weeks following ACS, only 11 patient-years of treatment with atorvastatin were required. Conclusion Early, intensive treatment with atorvastatin is an efficient intervention to reduce hard cardiovascular events after ACS.
急性冠状动脉综合征（ACS）后，早期强化他汀类药物治疗是标准的治疗方法。然而，只有一项随机、安慰剂对照试验证明了这种方法预防主要不良心血管事件的益处。心肌缺血减少与积极降低胆固醇（MIRACL）试验表明，与安慰剂相比，阿托伐他汀 80mg 每日一次可降低 ACS 后 16 周内首次发生死亡、非致死性心肌梗死、复苏性心脏骤停或不稳定型心绞痛住院（不包括中风）的时间。然而，除不稳定型心绞痛外，对复合终点的个别组成部分没有显著影响。这使得一些人质疑 ACS 后早期强化他汀类药物治疗是否减少“硬”事件。目的：ACS 后冠心病的负担，因此其治疗的疗效，不仅取决于一次缺血事件的发生，还取决于患者经历的累积事件。因此，我们对 MIRACL 试验进行了事后分析，以检查阿托伐他汀对 ACS 后首次和复发性（即总）硬心血管事件（死亡、心肌梗死、中风和复苏性心脏骤停）的影响。方法和结果：在 3086 名组成 MIRACL 试验的患者中，阿托伐他汀 80mg 与安慰剂相比并未减少首次硬事件的时间（风险比 0.89，95%置信区间 0.72-1.10，P=0.27）。然而，阿托伐他汀显著减少了总硬事件（风险比 0.80，95%置信区间 0.66-0.97，P=0.03）。为了在 ACS 后 16 周内预防一次硬事件，仅需要 11 患者年的阿托伐他汀治疗。结论：早期强化阿托伐他汀治疗是减少 ACS 后硬心血管事件的有效干预措施。
