Waters David D, Ku Ivy
Division of Cardiology, San Francisco General Hospital, San Francisco, California 94114, USA.
J Am Coll Cardiol. 2009 Oct 6;54(15):1434-7. doi: 10.1016/j.jacc.2009.05.062.
That statins should be prescribed for patients before hospital discharge after an episode of acute coronary syndrome (ACS) is a Level of Evidence: 1A recommendation of the American College of Cardiology/American Heart Association Joint Task Force. This level of recommendation is based upon 2 clinical trials: the MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering) and PROVE-IT (Pravastatin or Atorvastatin Evaluation and Infection Therapy) trials. In the MIRACL trial, 3,086 patients with unstable angina or non-Q-wave myocardial infarction were randomized within 4 days of the event to atorvastatin 80 mg/day or to placebo and followed for 16 weeks. The primary composite end point occurred in 14.8% of atorvastatin patients and 17.4% of placebo patients, a 16% relative risk reduction (p = 0.048). In the PROVE-IT trial, 4,162 patients hospitalized with an ACS within the preceding 10 days were randomized to atorvastatin 80 mg/day or pravastatin 40 mg/day and were followed for a mean of 24 months. The primary event rate was 22.4% in the atorvastatin group and 26.3% in the pravastatin group, a 16% relative risk reduction (p = 0.005). A strong trend toward a reduction in total mortality was seen in the atorvastatin group (2.2% vs. 3.2%, p = 0.07). Using a composite end point of death, myocardial infarction, and rehospitalization for ACS, the difference between the treatment groups is already statistically significant at 30 days and remains so throughout the follow-up period. Comprehensive treatment programs in ACS patients that include initiation of statins before hospital discharge have been shown to improve outcomes such as recurrent myocardial infarction and total mortality at 1 year. Guidelines prove their utility when their implementation improves outcomes across a broad population at risk, such as in this instance.
对于急性冠状动脉综合征(ACS)发作后的患者,在出院前应开具他汀类药物,这是美国心脏病学会/美国心脏协会联合特别工作组证据等级为1A的推荐。这一推荐等级基于两项临床试验:MIRACL(强化降胆固醇降低心肌缺血)试验和PROVE-IT(普伐他汀或阿托伐他汀评估与感染治疗)试验。在MIRACL试验中,3086例不稳定型心绞痛或非Q波心肌梗死患者在事件发生后4天内被随机分为阿托伐他汀80毫克/天组或安慰剂组,并随访16周。主要复合终点在阿托伐他汀组患者中的发生率为14.8%,在安慰剂组患者中的发生率为17.4%,相对风险降低了16%(p = 0.048)。在PROVE-IT试验中,4162例在过去10天内因ACS住院的患者被随机分为阿托伐他汀80毫克/天组或普伐他汀40毫克/天组,并平均随访24个月。阿托伐他汀组的主要事件发生率为22.4%,普伐他汀组为26.3%,相对风险降低了16%(p = 0.005)。阿托伐他汀组总死亡率有明显下降趋势(2.2%对3.2%,p = 0.07)。使用死亡、心肌梗死和因ACS再次住院的复合终点,治疗组之间的差异在30天时已具有统计学意义,并在整个随访期内一直保持。已证明,在ACS患者中实施包括出院前开始使用他汀类药物在内的综合治疗方案,可改善1年内复发性心肌梗死和总死亡率等结局。当指南的实施能改善广泛的高危人群的结局时,就证明了其效用,就像在这种情况下一样。