The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent

Abstract

This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33).

Pharmacogenetics in the Treatment of Cardiovascular Diseases and Its Current Progress Regarding Implementation in the Clinical Routine

“…Others prospective, non-RCTs of CYP2C19 genotype-guided clopidogrel therapy with clinical outcomes have been performed. In 2016, our group published a study with the aim of analyzing if the CYP2C19/ABCB1 genotype-guided approach, in which the choice of antiplatelet therapy is based on the genetic test, could reduce the rates of cardiovascular events and bleeding compared to a non-tailored approach in 719 patients (more than 86% with ACS) who had undergone PCI with stent [35,45]. The primary endpoint (composite of cardiovascular death, ACS, or stroke during 12 months after intervention) occurred in 10.1% in the genotyping group and in 14.1% in the control group (HR 0.63, 95% CI (0.41–0.97), p = 0.037).…”

“…According to the authors of this article [7], the level of evidence supporting by CYP2C19 genotype-guided clopidogrel therapy in patients that received PCI is at least as strong as the other genetic tests recommended by the AHA/ACC. Fortunately, several institutions have implemented pharmacogenetic testing for clopidogrel despite the negative recommendation by AHA/ACC [35,45,56,57] and they found improvement in the clinical results of patients [58,59].…”

Influence of Clinically Significant Genes on Antiplatelet Effect of Clopidogrel and Clinical Outcomes in Patients with Acute Coronary Syndrome and Atrial Fibrillation

“…The problem of variability of response to clopidogrel is still relevant, as therapy with ticagrelor and prasugrel is associated with a higher incidence of hemorrhagic complications, is more expensive, more often leads to discontinuation of therapy compared to clopidogrel and, finally, is not the therapy of choice in indications for antiplatelet combination therapy [23,24]. And in consideration of the fact that the genotype-specific approach overcomes the high residual platelet reactivity [25,26] and leads to a reduced incidence of adverse cardiovascular outcomes [25][26][27][28][29][30], it can be used to de-escalate antiplatelet therapy [31]. Therefore, it is very important to evaluate the impact of "non-classical" polymorphisms of CES1, PON1, ABCG2, CYP4F2, CYP3A4, IGTB3, P2Y12, PEAR1, B4GALT2 genes on the antiaggregant effect of clopidogrel and clinical outcomes in patients with ACS and AF to improve the effectiveness and safety of therapy.…”