TY - JOUR
T1 - Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention
T2 - Insights from the TAILOR-PCI Trial
AU - Madan, Mina
AU - Abbott, J. Dawn
AU - Lennon, Ryan
AU - So, Derek Y.F.
AU - Macdougall, Andrea M.
AU - McLaughlin, Mary Ann
AU - Murthy, Vishakantha
AU - Saw, Jacqueline
AU - Rihal, Charanjit
AU - Farkouh, Michael E.
AU - Pereira, Naveen L.
AU - Goodman, Shaun G.
N1 - Publisher Copyright:
© 2022 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2022/6/21
Y1 - 2022/6/21
N2 - BACKGROUND: TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to decreased Clopidogrel Response After Percutaneous Coronary Intervention) studied genotype-guided selection of antiplatelet therapy after percutaneous coronary intervention versus conventional therapy with clopidogrel. The presence of CYP2C19 loss-of-function alleles in patients treated with clopidogrel may be associated with increased risk for ischemic events. We report a prespecified sex-specific analysis of genotyping and associated cardiovascular outcomes from this study. METHODS AND RESULTS: Associations between sex and major adverse cardiac events (MACE: cardiovascular death, myo-cardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding at 12 months were analyzed using Cox proportional-hazards models. Among 5276 randomized patients, loss-of-function carriers were observed in ≈36% of both sexes, and >80% of carriers were heterozygotes. At 12 months, after adjustment for baseline differences, risks of MACE (HR, 1.28 [0.97 to 1.68]; P=0.088) and BARC bleeding (hazard ratio [HR], 1.36 [0.91 to 2.05]; P=0.14) were comparable among women and men. There were no significant interactions between sex and treatment strategy for MACE interaction P value (Pint =0.59) or BARC bleeding (Pint =0.47) nor for sex and genotype (MACE Pint =0.15, and BARC bleeding Pint =0.60). CONCLUSIONS: CYP2C19 loss-of-function alleles were present in ≈1 in 3 women and men. Women had similar adjusted risks of MACE and bleeding as men following percutaneous coronary intervention. Genotype-guided therapy did not significantly reduce the risk of MACE or bleeding relative to conventional therapy for both sexes.
AB - BACKGROUND: TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to decreased Clopidogrel Response After Percutaneous Coronary Intervention) studied genotype-guided selection of antiplatelet therapy after percutaneous coronary intervention versus conventional therapy with clopidogrel. The presence of CYP2C19 loss-of-function alleles in patients treated with clopidogrel may be associated with increased risk for ischemic events. We report a prespecified sex-specific analysis of genotyping and associated cardiovascular outcomes from this study. METHODS AND RESULTS: Associations between sex and major adverse cardiac events (MACE: cardiovascular death, myo-cardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding at 12 months were analyzed using Cox proportional-hazards models. Among 5276 randomized patients, loss-of-function carriers were observed in ≈36% of both sexes, and >80% of carriers were heterozygotes. At 12 months, after adjustment for baseline differences, risks of MACE (HR, 1.28 [0.97 to 1.68]; P=0.088) and BARC bleeding (hazard ratio [HR], 1.36 [0.91 to 2.05]; P=0.14) were comparable among women and men. There were no significant interactions between sex and treatment strategy for MACE interaction P value (Pint =0.59) or BARC bleeding (Pint =0.47) nor for sex and genotype (MACE Pint =0.15, and BARC bleeding Pint =0.60). CONCLUSIONS: CYP2C19 loss-of-function alleles were present in ≈1 in 3 women and men. Women had similar adjusted risks of MACE and bleeding as men following percutaneous coronary intervention. Genotype-guided therapy did not significantly reduce the risk of MACE or bleeding relative to conventional therapy for both sexes.
KW - TAILOR-PCI
KW - genotype
KW - sex differences
UR - http://www.scopus.com/inward/record.url?scp=85132295407&partnerID=8YFLogxK
U2 - 10.1161/JAHA.121.024709
DO - 10.1161/JAHA.121.024709
M3 - Article
C2 - 35699175
AN - SCOPUS:85132295407
SN - 2047-9980
VL - 11
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 12
M1 - e024709
ER -