21 Sep Switching to Prasugel in Plavix Non-Responders Improved PCI Outcomes
MedicalResearch.com Interview with:
Renato Valenti, MD
David Antoniucci, MD
Cardiology Department; Careggi Hospital
Florence; Italy
Medical Research: What is the background for this study?
Response: Previous data have shown that high residual platelet reactivity in patients receiving clopidogrel is associated with high risk of ischemic events and cardiac death after PCI at short- and long-term follow-up. Clopidogrel nonresponders patients of the REsponsiveness to CLOpidogrel and StEnt thrombosis (RECLOSE-2) ACS study received an increased dose of clopidogrel or switched to ticlopidine under light transmittance aggregometry (LTA) adenosine diphosphate (ADP) test guidance. Despite some decrease of ADP test after treatment adjustment, there was no improvement on clinical outcome. Currently no evidence exists that the achievement of an optimal platelet aggregation inhibition in clopidogrel nonresponders modifies the risk profile of these patients. The RECLOSE-3 study invesigated if a new antiplatet therapy with prasugrel in clopidogrel nonresponders can modify the risk profile of these patients and improve the outcome in term of cardiac mortality.
From the RECLOSE-3 registry we identified 302 consecutive patients who were clopidogrel nonresponders. Nonresponders switched to prasugrel therapy. Due to the nonrandomized study design the clinical outcome of clopidogrel nonresponders switched to prasugrel (from RECLOSE-3 study) was compared with the historical cohort of clopidogrel nonresponders of the RECLOSE-2 ACS (248 patients) study. The primary endpoint of the study was cardiac mortality. The 2-year cardiac mortality rate was 4.0% in the RECLOSE-3 group and 9.7% in the RECLOSE-2 group (p=0.007). The difference in 2-year cardiac mortality remained also considering exclusively patients with ACS on admission: 3.2% and 9.7%, respectively, p=0.023.At the final model of multivariable analysis, prasugrel treatment was inversely related to the risk of 2-year cardiac death (HR 0.32; p=0.036) after adjusting for ACS and other well known covariates related to the outcome.
Medical Research: What are the main findings?
Response: The main finding of the RECLOSE-3 study is that nonresponsiveness to clopidogrel may be a “modifiable risk factor” for cardiac death after PCI. Prasugrel treatment overcomes nonresponsiveness to clopidogrel and results in thrombotic risk similar to the one of clopidogrel responders.
Medical Research: What should clinicians and patients take away from your report?
Response: Three major messages:
1) An optimal platelet aggregation inhibition is one important “link” with a good clinical outcome.
2) Platelet reactivity assessment is useful to guide and for “tailoring” the antiplatelet therapy.
3) We have the capability to manage the nonresponsiveness to clopidogrel, both for ACS and non-ACS patients.
Medical Research: What recommendations do you have for future research as a result of this study?
Response: The results of this study support the benefit for further studies of a tailored therapy using new antithrombotic agents. Anyway, I think that ethical issues make the possibility of performing a randomized study using clopidogrel in the control arm in clopidogrel nonresponders unlikely.
Citation:
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Renato Valenti, MD, & David Antoniucci, MD (2015). Switching to Prasugel in Plavix Non-Responders Improved PCI Outcomes
Last Updated on September 21, 2015 by Marie Benz MD FAAD