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PRAGUE-7: No additional benefit from early administration of abciximab in PCI
A loading dose of abciximab did not reduce outcomes at 30 days compared with conventional therapy.
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European Society of Cardiology Congress 2009
Abciximab administered prior to percutaneous coronary intervention was not associated with an improvement in outcomes.
Researchers for the PRAGUE-7 trial enrolled 80 patients with acute MI complicated by cardiogenic shock. Patients were assigned to a loading dose of abciximab (ReoPro, Eli Lilly and Co.) prior to undergoing PCI or conventional therapy with the abciximab administration during the subsequent PCI procedure. The combined endpoint was the outcome of death, reinfarction, stroke or new renal failure within 30 days.
According to the study results, PCI was successful in 90% of the abciximab group and 87.5% of the conventional control group. There was no difference between abciximab group and the conventional care group for the primary endpoint of death, reinfarction, stroke, or new renal failure at 30 days (42.5% vs. 27.5%, P=.24). The combined endpoint was reached in 17 patients in the abciximab group vs. 11 in the conventional care group. There were no differences in mortality between treatment groups (P=.82). There was also no difference in ejection fraction among the surviving members of the cohort (P=.31), and no differences in myocardial blush grade or thrombolysis in TIMI-flow following PCI were reported.
“This study did not show any benefit from routine preprocedural abciximab when compared with a selective abciximab use during the procedure,” the researchers concluded in the study abstract.
The lack of statistical power in the study was a chief concern of discussant Antoine Lafont, MD, PhD, a cardiologist at the Hôpital Européen Georges Pompidou in Paris.
“For both questionable internal validity and lack of power, these results cannot be conclusive with regards to the hypothesis,” he wrote in a discussant report accompanying his presentation. “Ten years after the SMASH trial, they remind us that evaluating therapeutic strategies in patients with cardiogenic shock complicating acute MI is still a huge challenge for trialists.”
Widimsky P. Session 1850-1851. Presented at: European Society of Cardiology Congress; Aug. 29 – Sept. 1, 2009; Barcelona.
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