- For patients with acute coronary syndrome (ACS) and stable coronary artery disease (CAD), post-percutaneous coronary intervention (PCI) CYP2C19 genotype-guided oral P2Y12 inhibitors do not best clopidogrel at 1 year for ischemic event reduction.
Why this matters
- Editorial: this “largest randomized study to date” may not have achieved statistical significance for its primary endpoint but does “provide many encouraging, hypothesis-generating findings.”
- For the composite primary endpoint (cardiovascular death, myocardial infarction, stroke, stent thrombosis, severe myocardial ischemia) at 12 months, the genotype-guided (4.0%) vs clopidogrel (5.9%) groups did not differ (HR, 0.66; 95% CI, 0.43-1.02).
- They also did not differ for any of 11 prespecified endpoints.
- They also did not differ for the primary safety endpoint (major/minor bleeding; P=.58).
- Similar results in sensitivity analyses.
- Open-label randomized clinical trial, 40 centers in the United States, Canada, South Korea, and Mexico, May 2013-October 2018.
- Of 5302 patients, 2650 received clopidogrel without initial genetic testing and 2652 received genotype-guided therapy (clopidogrel without the CYP2C19 allele or ticagrelor/prasugrel with it).
- The 2650 clopidogrel participants were genotyped at 12 months.
- Analysis was done on final cohort of 1849 patients with the CYP2C19 allele (903 genotype-guided, 946 clopidogrel).
- Funding: NIH.
- Underpowered to detect an effect size
- Provision of genotype-guided therapy was predicated on insurance coverage.