ROMICATⅡ试验结果引争议

7月25日《新英格兰医学杂志》发表的ROMICATⅡ试验结果显示，对于可能存在急性冠状动脉综合征的患者，与标准ED评价相比，采用心脏计算机断层扫描血管造影(CCTA)作为分诊策略的一部分，有助于提高临床决策的效率及缩短住院时间，但这种方法并未提高诊断准确性，而且增加了放射暴露，还可能高估了节省的费用，因为该研究仅纳入了在正常工作时间就诊的患者[www.nejm.org/doi/full/10.1056/NEJMoa1201161]。

加州大学旧金山分校妇女心血管服务中心主任Rita F. Redberg博士在针对该研究及另一项类似研究撰写的随刊述评中指出，这两项研究的基本假设是一些诊断性检查必须在这些低危或中危患者从急诊科出院之前进行。这种假设未经证实且可能没有根据。进行任何检查的基本原则都应该是，与不检查相比，检查能够改善结局，而在这两项研究中，没有证据表明所进行的检查有助于改善结局。

Redberg博士还是《内科学文献》(Archives of Internal Medicine)的编辑，该杂志从几年前开始表现出“越少越好(Less Is More)”的特色。Redberg博士表示，这些研究表明，与应激试验相比，CCTA可在更短的时间内完成。在确定心电图结果和肌钙蛋白水平正常后，不做进一步诊断性检查就让这些患者出院甚至更快。因此，在缺乏获益和明确风险证据的情况下，应避免对急诊科的低危或中危急性冠状动脉综合征患者进行常规检查。

爱思唯尔  版权所有

By: CATHERINE HACKETT, Cardiology News Digital Network

Using cardiac computed tomography angiography as part of a triage strategy in patients with possible acute coronary syndromes improved the efficiency of clinical decision making and shortened hospital stays in the ROMICAT II trial, but it increased radiation exposure and did not save any money, compared with standard ED evaluation.

That’s according to the final report of the Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography study, published July 25 in the New England Journal of Medicine [www.nejm.org/doi/full/10.1056/NEJMoa1201161]. We reported the preliminary results, presented by Dr. Udo Hoffmann of Massachusetts General Hospital in Boston at the annual meeting of the American College of Cardiology in Chicago in March 2012.

The experts we interviewed for the story noted that the cardiac computed tomography angiography (CCTA) testing did not improve diagnostic accuracy, but did expose the patients' radiation exposure, and probably overestimated the cost savings because the study included only those patients presenting during regular work hours.

Dr. Rita F. Redberg, professor of medicine and director of Women's Cardiovascular Services at the University of California, San Francisco, expanded on those themes in an editorial in response to both the ROMICAT II article and another, similar trial published in the journal in April.

“The underlying assumption of [these two studies] is that some diagnostic test must be performed before discharging these low-to-intermediate-risk patients from the emergency department. This assumption is unproven and probably unwarranted. The rationale for any test, as compared with no testing, should be that it will lead to an improved outcome, and here there is no evidence that the tests performed led to improved outcomes.”

Dr. Redberg, who as editor of the Archives of Internal Medicine started its "Less Is More" feature a couple of years ago, acknowledging that the studies showed that a CCTA can be done in less time than a stress test. She added that "it is even faster to discharge these patients without any additional diagnostic test after determining that their ECG findings and troponin levels are normal. Thus, with no evidence of benefit and definite risks, routine testing in the emergency department of patients with a low-to-intermediate risk of acute coronary syndromes should be avoided." Dr. Redberg is also on the editorial board of Cardiology News.