Effect of platelet inhibition and / or Lipid lowering in non-ACS-patients with acute chest pain, and high-sensitivity troponin values above the 99th percentile (GRAY-ZONE)

目前的数据库显示，胸痛患者的高/超敏感(hs)/超敏感（us）肌钙蛋白水平高于第99百分位，即使排除了急性冠状动脉综合征（ACS），也预示着未来的心血管事件。正如今年早些时候发表的，在海德堡胸痛科（CPU）连续招募的6个月期间，406名ACS患者和442名非ACS患者被确定，但其肌钙蛋白值高于第99个百分点。令人担忧的是，在这个非acs队列中，450天的事件发生率为14%，仅包括心血管死亡和心肌梗死（MI）。再考虑到血管重建术（搭桥或支架）将发生率提高到22%。毫不奇怪，大多数非acs患者出院时没有接受特异性/预防性治疗（抗血小板或抗脂质），尽管肌钙蛋白阳性值（住院期间任何时间高于第99百分位数的任何值）似乎清楚地表明潜在的心肌缺血。综上所述，通过特异性治疗降低CPU患者死亡率和发病率的需求尚未得到满足，潜力巨大。我们建议阿司匹林抑制血小板或阿托伐他汀降脂可以防止斑块破裂和冠状动脉粥样硬化血栓的叠加。我们计划进行一项对照临床试验：3000名肌钙蛋白阳性患者在急诊室(ER)/ CPU出现急性胸痛，但ACS被排除，将随机分配到阿司匹林和/或阿托伐他汀组与安慰剂组（2x2因子设计）。

Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (ACS) was ruled out. As published earlier this year, during a 6-month period of consecutive recruitment at the chest pain unit (CPU) Heidelberg, 406 patients with ACS and 442 patients without ACS, but an hs troponin value above the 99th percentile were identified. Alarmingly, the 450- day event-rate in this non-ACS cohort was 14% -comprising only cardiovascular death and myocardial infarction (MI). Considering also revascularization (bypass or stent) raised event rate to 22%. Not surprisingly, most of these non-ACS-patients were discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although ¿positive¿ troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in CPU patients by specific therapy. We propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. We plan to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with acute chest pain, but an ACS was ruled out, will be assigned randomly to Aspirin and/ or Atorvastatin versus placebo (2x2 factorial design).