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【medical-news】APEX 研究结果的公布点燃了PCI 争论
3 January 2007
Results of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI) trial are published in this week's issue of the Journal of American Medical Association, opening up discussion of the potential of adjunctive therapies to improve primary percutaneous coronary intervention (PCI) outcomes.
The APEX trial findings, initially unveiled at the American Heart Association scientific sessions in Chicago, Illinois, last November revealed that pexelizumab treatment of acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI failed to reduce mortality and the rate of complications among this group compared with patients treated with PCI alone.
Nevertheless, further investigation of anti-inflammatory approaches to improve reperfusion therapy outcomes is warranted, experts maintained in an accompanying editorial.
Pexelizumab is a humanized monoclonal antibody that blocks the C5 component of the complement system, and preliminary studies suggested that its use as adjunctive therapy in PCI could prevent inflammatory complications that may hamper successful reperfusion, and so reduce associated mortality.
Paul Armstrong (University of Alberta, Edmonton, Canada) and co-investigators in the APEX AMI trial conducted the phase III study in 7545 patients undergoing PCI for STEMI. Patients were randomly assigned to receive pexelizumab prior to PCI and then for the subsequent 24 hours by infusion, or placebo.
The team found there was no difference in mortality at 30 days between pexelizumab- and placebo-treated patients, at 4.06% and 2.92%, respectively. The 30-day composite endpoint of death, cardiac shock, or heart failure was also similar between groups, at 8.99% with pexelizumab and 9.19% with placebo.
Mortality remained low and similar between groups at 90 days, with corresponding rates of 4.93% and 4.51%, as did the composite of death, shock, or heart failure at 10.24% and 10.16%.
"In this large clinical trial of STEMI patients treated with primary PCI and usage of evidence-based therapies, mortality was low and unaffected by administration of pexelizumab," the investigators conclude.
However, John Eikelboom and Martin O'Donnell, both of McMaster University in Hamilton, Ontario, Canada said in the editorial that, despite aiming to enroll only high-risk patients the study included only low-risk individuals based on age, heart rate, blood pressure, and Killip class.
The authors acknowledged that, "notwithstanding the low event rates and low statistical power in APEX AMI study, the lack of benefit of pexelizumab for any of the efficacy outcomes is disappointing."
However, they said that the central hypothesis of modulating inflammatory mediators to improve clinical outcomes by reducing reperfusion injury, "remains worthy of further study."
Furthermore, Eikelboom and O'Donnell questioned the early discontinuation of the study, given that the safety and feasibility of pexelizumab were not in doubt, and that it was not stopped "because of futility."
Noting that the sponsor did delay discontinuation of the study until an agreed number of events had accumulated, representing a more balanced approach than in previous examples, they nevertheless concluded that "the final outcome leaves questions concerning the efficacy of pexelizumab unresolved and certainly is unsatisfactory for patients… , clinicians, and the research community."
JAMA 2007; 297: 43-51
http://www.incirculation.net/NewsItem/APEX-publication-highlights-PCI-inflammation-issue.aspx APEX publication highlights PCI inflammation issue
APEX的发布强调了经皮冠脉介入术炎症问题
3 January 2007
2007年1月3日
Results of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI) trial are published in this week's issue of the Journal of American Medical Association, opening up discussion of the potential of adjunctive therapies to improve primary percutaneous coronary intervention (PCI) outcomes.
pexelizumab对急性心梗疗效评价(APEX AMI)试验结果发表在今周的美国医学协会杂志专栏，引发了关于辅助治疗可能改善直接经皮冠脉介入术结果的讨论。
The APEX trial findings, initially unveiled at the American Heart Association scientific sessions in Chicago, Illinois, last November revealed that pexelizumab treatment of acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI failed to reduce mortality and the rate of complications among this group compared with patients treated with PCI alone.
去年11月在伊利诺州芝加哥举行的美国心脏协会科学会议最早公布了APEX试验的结果。与只行经皮冠脉介入术组相比较，行直接PCI的急性ST段抬高心肌梗死(STEMI)患者采用pexelizumab治疗并不能降低死亡率和并发症发生率。
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作者:admin@医学,生命科学 2011-03-14 17:11
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