Early Versus Late Intervention for Acute Coronary Syndromes Without ST-Segment Elevation

By Mary Ann Moon 2009-09-01

Elsevier Global Medical News
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Immediate intervention for acute coronary syndromes without ST-segment elevation doesn’t appear to be a more beneficial strategy than the usual approach of deferring intervention until the next working day, according to a report in the Sept. 2 issue of JAMA.

In a randomized clinical trial comparing the two approaches, almost all outcomes – the risk for MI, patient mortality, the need for urgent revascularization, and the rate of recurrent ischemia – were similar between patients who underwent immediate catheterization and those whose procedure was postponed until the next working day.

Length of hospital stay was the only outcome significantly affected by speeding up the usual 1-day waiting period before intervention, said Dr. Gilles Montalescot of Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, and his associates.

The researchers compared early versus late intervention in 352 patients with a mean age of 65 years treated at 13 high-volume medical centers in France that had 24-hour facilities for primary PCI. The subjects were randomly assigned to undergo immediate catheterization (median time from presentation, 70 minutes) or the more usual schedule of catheterization on the next working day (median time from presentation, 21 hours).

Blood samples were drawn every 6 hours to measure troponin I and either creatine kinase or CK-MB.

The primary end point – the occurrence of MI, as measured by peak troponin 1 value – did not differ between the two study groups. The probability of MI as measured by the curves of troponin peak values also did not differ, the investigators said (JAMA 2009;302:947-54).

The secondary end point – a composite of all-cause mortality, MI, or urgent revascularization within 1 month – also was not statistically different between patients who underwent immediate intervention (13.7%) and those who underwent deferred intervention (10.2%). The rates of each of these three components individually also were not statistically different.

The rate of recurrent ischemia was not significantly lower with immediate (12%) rather than deferred (19%) intervention, and the composite end point of death, MI, urgent revascularization, or recurrent ischemia was 21% in both groups.

Moreover, “there was no suggestion of a possible benefit with the strategy of immediate catheterization in any subgroup, including the highest-risk subgroups,” Dr. Montalescot and his colleagues said.

“This study demonstrates the feasibility of immediate catheterization and revascularization in patients who present with non–ST segment elevation ACS but does not show that this strategy is superior to catheterization scheduled on the next working day,” they noted.

“The hypothesis that reducing the waiting period for revascularization ... would reduce MI is not confirmed.”

A shorter hospital stay would appear to be an advantage with the earlier intervention, since waiting for even 1 day tends to “consume considerable resources, drugs, and physician and nursing time. However, further economic analyses would be required to assess the cost effectiveness of such strategy in various health care systems,” the investigators added.

This report was presented as a poster at the European Society of Cardiology meeting.

This study was supported in part by Eli Lilly. Dr. Montalescot reported receiving research grant support, consulting fees, or lecture fees from Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Sanofi-Aventis, AstraZeneca, the Medicines Company, Novartis, Schering-Plough, and Pfizer.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

根据9月2日出版的JAMA所刊载的研究成果，对于无ST段抬高的急性冠状动脉综合征患者，与将干预措施推迟到下一个工作日这一常规治疗策略相比，进行即刻干预的治疗策略并未表现出更好的疗效。

 

一项随机临床试验比较了两种方法，疗效指标包括心肌梗死的危险性、患者死亡率、需要进行紧急血运重建情况以及复发性缺血的发生率。结果显示，无论是接受即刻进行冠脉介入的患者，还是那些将上述干预措施推迟到下一个工作日进行的患者，两组患者间几乎所有的疗效指标结果均相似。

 

法国巴黎Pitié-Salpêtrière大学医疗中心的Gilles Montalescot医生及其同事进行了此项研究。他指出，缩短治疗前的1 天等待时间，仅显著影响患者住院时间的长度。

 

纳入研究的352名患者平均年龄65岁，在法国13个可24 h进行直接经皮冠状动脉介入治疗设施的大型医学中心接受治疗。研究对象被随机分到即刻进行冠脉介入组(从临床表现到治疗的中位时间为70 min)或常规预定到下一工作日进行介入组(从临床表现到治疗的中位时间为21 h)。

 

每6 h抽取患者血液标本以检测肌钙蛋白1和肌酸激酶或肌酸激酶同工酶的水平。

 

研究者通过测定肌钙蛋白1的峰值来确定研究主要终点——心肌梗死发生情况，通过测定肌钙蛋白峰值曲线来确定心肌梗死发生几率。研究者指出，两组患者间上述指标结果没有差异(参见JAMA 2009;302:947-54)。

 

研究的次要终点为一个组合指标，包括全因死亡、心肌梗死或在1个月内需要紧急血运重建情况在内的总发生率。结果显示，该指标在即刻干预组(13.7%)和推迟干预组(10.2%)之间没有统计学差异。上述组合指标的3个组份各自的发生率在两组间亦无统计学差异。

 

复发性缺血的发生率在即刻干预组(12%)较推迟干预组(19%)并无显著降低。如以包括死亡、心肌梗死、紧急血运重建或复发性缺血情况在内的总发生率作为研究的复合终点，则两组均为21%。

 

此外，Montalescot医生及其同事提出：“即刻冠脉介入治疗策略在任何亚组中均未提示有可能的治疗益处，在那些最危险的亚组中亦是如此。”

 

他们强调：“本研究结果显示应用即刻冠脉介入和血运重建治疗无ST段抬高的急性冠状动脉综合征患者具有可行性，但该治疗策略并不优于将介入预定到下一工作日的治疗策略。”

 

“通过减少血运重建的等待时间以降低心肌梗死发生的假说并未得到证实。”

 

研究者还指出，缩短住院时间可视为尽早进行干预的优点，因为即使等待1天也意味着“消耗可观的资源、药品以及医生和护士的时间。然而评估此项治疗策略在各种医疗卫生系统中的成本效益仍需进一步的经济分析。”

 

此项研究成果以壁报的形式在欧洲心脏学会年会上展示。

 

此项研究由礼来公司提供部分资金支持。Montalescot医生声明接受了百时美-施贵宝公司、日本第一制药三共株式会社、礼来公司、赛诺菲-安万特制药集团、阿斯利康公司、Medicines公司、诺华公司、先灵葆雅公司以及辉瑞公司提供的研究资金支持、咨询费或演讲费。

 

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Subjects:
cardiology 学科代码:心血管病学