22 May 2014, Paris, France: The value of analysing published clinical trials and the benefit of informed discussion were highlighted yesterday when the ACCOAST trial data were discussed in a new session format--Will this trial change my practice?-- at EuroPCR 2014. ACCOAST trial results demonstrate that pre-treatment with prasugrel in NSTEMI patients undergoing percutaneous coronary intervention (PCI) is inferior to treatment with the drug after angiography. Several other trials are also being scrutinised in the same format, which ends with a discussion with the audience members on whether the trial results would change their practice or not.
Speaking on the value of the session format, panellist Andreas Baumbach, University of Bristol, UK, said: "There is a need to translate what we read in published journals as trials, ie. the science, to what it means for the practitioner on a daily basis. What does it actually mean when a trial says that this treatment is better, or not, than another one. What does this information finally mean for the patient I am treating? This format is trying to get knowledgeable people, including a trialist, to talk about the specifics of the trial as it is published in order to tease out the data from it that are most relevant for our practice."
The session encourages practitioners to compare the population treated in the trial to the population they treat in daily practice. It also encourages practitioners to question whether the technique used is comparable to the one they employ, and to analyse the endpoints that have been chosen in the trial in order to see if they are relevant for patients.
The ACCOAST trial evaluated the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography, if percutaneous coronary intervention (PCI) was indicated. Investigators studied 4,033 patients with NSTE acute coronary syndromes and a positive troponin level who were scheduled to undergo coronary angiography within two to 48 hours after randomisation. Patients were randomly assigned to receive prasugrel before the angiography (pre-treatment group, 30mg loading dose) or placebo (control group). When PCI was indicated, an additional 30mg of prasugrel was given in the pre-treatment group at the time of PCI and 60mg of prasugrel was given in the control group.
Reviewing the ACCOAST trial data, Peter Juni, Clinical Trials Unit and Institute of Social and Preventative Medicine, University of Bern, Switzerland, said: "In NSTE-ACS patients managed invasively within 48 hours of admission, pre-treatment with prasugrel did not reduce major ischaemic events through 30 days, but increased major bleeding complications."
Andreas Baumbach added, "The ACCOAST trial is a wonderful trial that has tried to answer the clinically relevant question of whether pre-treatment with prasugrel would be beneficial to patients. The study was conducted within a practice environment that was situated with rapid access to a cath lab, showed that there is no benefit for pre-treatment with this half dose of prasugrel. It also showed more bleeding events in patients who received this dose. There are a number of very interesting questions about this trial, the main being that we are not sure whether we can extrapolate these results to pre-treatment with other drugs that have been shown to be beneficial in other trials."
With regard to how the ACCOAST results applied to clinical practice, Baumbach noted that judging by the show of hands in yesterday's session, the majority of the audience would not change their current practice. "The trial is relevant, but we need new trials to see whether we can advance the treatment for those patients," he said.
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