Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial

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• 作者：Dr ; Prof Holger Thiele ; MD^a ; ^{thielh@medizin.uni-leipzig.de} ; Prof Jochen Wö ; hrle ; MD^b ; Prof Rainer Hambrecht ; MD^c ; Harald Rittger ; MD^d ; Ralf Birkemeyer ; MD^e ; Prof Bernward Lauer ; MD^f ; Petra Neuhaus ; PhD^g ; Oana Brosteanu ; PhD^g ; Peter Sick ; MD^h ; Marcus Wiemer ; MDⁱ ; Prof Sebastian Kerber ; MD^j ; Klaus Kleinertz ; MD^k ; Ingo Eitel ; MD^a ; Steffen Desch ; MD^a ; ^&Dagger ; ; Prof Gerhard Schuler ; MD^a ; ^&Dagger ;
• 刊名：The Lancet
• 出版年：2012
• 期刊代码：182_01406736
• 类别：med
• 出版时间：10-16 March, 2012
• 卷：379
• 期：9819
• 页码：923-931
• 文件大小：325 K

摘要

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Summary

Background

Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial.

Methods

The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0路25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0路125 渭g/kg per min (maximum 10 渭g/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with , .

Findings

Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7路0%vs 7路6%; odds ratio [OR] 0路91; 95%CI 0路64-1路28; p=0路58). The incidence of death (4路5%vs 3路6%; 1路24; 0路78-1路97; p=0路36) and reinfarction (1路8%vs 1路8%; 1路0; 0路51-1路96; p=0路99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2路4%vs 4路1%; 0路57; 0路33-0路97; p=0路04). None of the secondary endpoints or safety measures differed significantly between groups.

Interpretation

In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated.

Funding

Lilly, Germany. University of Leipzig鈥擧eart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).