News Release

Combination therapy does not appear to benefit cardiac patients before heart catheter procedure

Peer-Reviewed Publication

JAMA Network

Patients with acute myocardial infarction (MI - heart attack) who are referred for percutaneous coronary intervention (such as angioplasty and stent placement in the coronary artery) do not have a reduction in the amount of damaged heart tissue when administered two drugs compared with a single drug to restore blood flow, according to a study in the February 25 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, "In hospitals with catheterization facilities, primary percutaneous coronary interventions (PCIs) are better then thrombolysis (drug therapy used to dissolve blood clots) in patients with ST-segment elevation acute MI. Specifically designed randomized trials have also shown that patients with acute MI presenting at hospitals without catheterization facilities benefit more from PCI performed after transfer to centers with catheterization laboratories than from on-site thombolysis."

Adnan Kastrati, M.D., from Deutsches Hezzentrum, Technische Universitat, Munich, Germany, and colleagues from the Bavarian Reperfusion Alternatives Evaluation (BRAVE) Study Investigators, assessed whether early administration of the combination of the drugs reteplase plus abciximab produces better reduction of infarct size compared with abciximab alone in patients with acute MI referred for PCI. The study, conducted from May 3, 2001 through June 2, 2003, included 253 patients who were admitted to 13 community hospitals without catheterization facilities (n=186) and to 5 hospitals with catheterization facilities (n=67), within 12 hours of symptoms of an acute MI. Patients randomly received either the combination of reteplase and abciximab (n=125) or abciximab (n=128) alone. All patients were then transferred for PCI. Infarct size was later determined by imaging from a single-photon emission computed tomography (SPECT).

"The final infarct size of the left ventricle, the primary end point of the trial, was 13 percent in the reteplase plus abciximab group and 11.5 percent in the abciximab group," the researchers report. "The mean (average) difference in final infarct size of the left ventricle between the reteplase plus abciximab group and the abciximab group was 1.3 percent." The researchers noted that several hours after the drug administration, patients receiving the combination therapy had superior blood flow through the blocked artery. The researchers also found, "the cumulative 6-month incidence of the composite end point (death, recurrent MI, or stroke) was also comparable between the two treatment groups, whereas there was a trend toward more major bleeding events with reteplase plus abciximab."

"In conclusion, the findings of this trial show that early administration of reteplase plus abciximab does not lead to a reduction of infarct size compared with abciximab alone in patients with acute MI referred for PCI. In addition, clinical outcome was not improved by combination therapy." (JAMA. 2004;291:947-954. Available post-embargo at JAMA.com)

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Editor's Note: Co-author Dr. Albert Schomig received research grants for the Department of Cardiology from Boston Scientific, Bristol-Myers Squibb, Cordis/Johnson & Johnson, Guidant, Hoffmann-LaRoche, and Lilly. This study was supported by grants from Deutsches Herzzentrum, Munich, Germany, as well as by unrestricted research grants from Lilly Deutschland GmbH, Bad Homburg, Germany, and Hoffman-LaRoche AG, Grenzach-Wyhlen, Germany.

EDITORIAL: COUPLING DRUG AND CATHETER THERAPY FOR MYOCARDIAL INFARCTION

In an accompanying editorial, A. Michael Lincoff, M.D., from The Cleveland Clinic Foundation, Cleveland, writes that reperfusion (restoration of blood flow) strategies for acute MI remain subject to considerable limitations because of the potential side effects of the medications and the limited availability and delays in mobilizing catheterization laboratory teams.

"For the physician treating patients with MI, primary PCI remains the reference standard for acute reperfusion therapy. The strategy of pharmacologic pretreatment before PCI remains unproven and cannot yet be recommended routinely. If long delays are unavoidable before reperfusion can be achieved by primary PCI, however, clinical judgment may compel a facilitated PCI approach (using medications before PCI), particularly for high-risk patients. Under those circumstances, the results of this randomized comparison between different regimens suggest that abciximab alone is at least as effective, with less bleeding risk, than the combination of Gp IIb/IIIa blockade and reduced-dose fibrinolysis (abciximab and reteplase). The results of ongoing pivotal clinical trials should help to provide more definitive insights into how best to facilitate PCI during acute MI." (JAMA. 2004;291:1000 - 1001. Available post-embargo at JAMA.com)

Editor's Note: Dr. Lincoff receives research funding from Eli Lilly, Centocor, and Millennium Pharmaceuticals.


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