Among patients receiving
percutaneous coronary intervention (PCI), the role of a genotype-guided approach for antiplatelet
therapy compared with usual care is unclear. We conducted a Bayesian analysis of the entire TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased
Clopidogrel Response After
Percutaneous Coronary Intervention) randomized clinical trial population to evaluate the effect of the genotype-guided antiplatelet
therapy post-PCI compared with the usual care on the risk of major adverse cardiovascular events (
MACE).
METHODS: The primary outcome for our study was the composite of
MACE (
myocardial infarction,
stroke, and cardiovascular death). Secondary outcomes included cardiovascular death,
stroke,
myocardial infarction,
stent thrombosis, and major/minor
bleeding. Bayesian modeling was used to estimate the probability of clinical benefit of genotype-guided
therapy using (1) noninformative priors (ie, analyzing the TAILOR-PCI trial) and (2) informative priors derived from the ADAPT, POPular Genetics, IAC-PCI, and PHARMCLO trials (ie, analyzing TAILOR-PCI trial in the context of prior evidence). Risk ratio (RR: ratio of cumulative outcome incidence between genotype-guided and conventional therapy group) and 95% credible interval (CrI) were estimated for the study outcomes, and probability estimates for RR <1 were computed.
RESULTS: Using noninformative priors, in TAILOR-PCI the RR for
MACE was 0.78 (95% CrI, 0.55-1.07) in genotype-guided
therapy after PCI, and the probability of RR <1 was 94%. Using noninformative priors, the probability of RR <1 for cardiovascular death (RR, 0.95 [95% CrI, 0.52-1.74]),
stroke (RR, 0.68 [95% CrI, 0.44-1.06]),
myocardial infarction (RR, 0.84 [95% CrI, 0.37-1.89]),
stent thrombosis (RR, 0.75 [95% CrI, 0.37-1.45]), and major or minor
bleeding (RR, 1.22 [95% CrI, 0.84-1.77]) were 57%, 96%, 67%, 81%, and 15%, respectively. Using informative priors, the posterior probability of RR <1 for
MACE, from genotype-guided
therapy, was 99% (RR, 0.69 [95% CrI, 0.57-0.84]). Using informative priors, the posterior probability of RR <1 for cardiovascular death (RR, 0.86 [95% CrI, 0.61-1.19]),
stroke (RR, 0.69 [95% CrI, 0.48-0.99]),
myocardial infarction (RR:0.56 [95% CrI, 0.40-0.78]),
stent thrombosis (RR, 0.59 [95% CrI, 0.38-0.94]), and major or minor
bleeding (RR, 0.84 [95% CrI, 0.70-0.99]) were 81%, 99%, 99%, 99%, and 99%, respectively.
CONCLUSIONS: