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Genotype-guided selection of oral P2Y12 inhibitor therapy no better than standard therapy after PCI for ACS or stable CAD
Clinical Question
Does genotype-guided selection of oral P2Y12 inhibitor therapy improve outcomes in adults who undergo percutaneous coronary intervention for acute coronary syndrome or stable coronary artery disease?
Bottom line
Genotype-guided selection of oral P2Y12 inhibitor therapy is nonsuperior to conventional clopidogrel therapy in preventing adverse ischemic events and bleeding episodes in adults following percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) or stable coronary artery disease (CAD 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
Patients who are genetically poor metabolizers of the hepatic cytochrome P450 enzyme CYP2C19 may be unable to transform the prodrug form of clopidogrel to its active metabolite, thus resulting in a higher incidence of ischemic events following PCI. These investigators identified 5302 adults, 18 years or older, with ACS or stable CAD who were undergoing PCI with a planned 12 months of dual antiplatelet therapy. Eligible patients randomly received assignment (concealed allocation) to either a genotype-guided therapy group using point-of-care genotyping or conventional therapy without prospective genotyping. Those individuals in the intervention group who were genetically identified as poor metabolizers of clopidogrel were prescribed ticagrelor or prasugrel for maintenance therapy. All patients in the control group received clopidogrel. All patients in both groups also received aspirin (81 mg daily). Individuals masked to treatment group assignment assessed all outcomes, including the primary outcome of a composite of all bad things, including cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. Secondary outcomes included major or minor bleeding episodes. Complete follow-up occurred for 95% of patients at 12 months. Using intention-to-treat analysis, there was no significant difference in the primary outcome between the intervention and control groups (4.4% vs 5.3%, respectively). Similarly, there was no significant difference in the primary outcome between at-risk carriers of the gene for poor metabolizer versus the control group (4.0% vs 5.9%, respectively). There were also no significant group differences in major or minor bleeding episodes
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
gene guided therapy
The group that received a gene directed therapy did do better [non significant]. but I wonder if the trial continues that differences won't come out .
p2y12 in acs
no better than clopidrogel