Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention - TAILOR PCI

May 17, 2021
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Presenter/Author:
Naveen L. Pereira, MBBS, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
National Heart, Lung, and Blood Institute; Mayo Clinic
Date Presented:
05/17/2021
Date Published:
08/25/2020
Date Updated:
05/17/2021
Original Posted Date:
03/28/2020
References

Contribution To Literature:

The TAILOR PCI trial failed to show that a genotype-guided strategy was superior at reducing adverse cardiovascular events compared with standard therapy after PCI.

Description:

The goal of the trial was to evaluate a genotype-guided strategy and escalation of antiplatelet therapy as needed, compared with standard therapy among patients who underwent percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel

Patients undergoing primary PCI for stable or unstable coronary artery disease were randomized to a genotype-guided strategy (n = 2,652) versus standard therapy (n = 2,650). The primary analysis was between 903 subjects with a loss of function allele (*2 or *3) in the genotype-guided group compared with 946 subjects in the standard therapy group with a loss of function allele.

  • Total number of enrollees in primary analysis: 1,849
  • Duration of follow-up: 12 months
  • Median patient age: 62 years
  • Percentage female: 25%
  • Percentage with diabetes: 27%

In the genotype-guided strategy arm, subjects carrying a *2 or *3 allele receive ticagrelor 90 mg twice daily, otherwise clopidogrel 75 mg daily. In the standard therapy arm, subjects receive clopidogrel 75 mg daily and undergo genotyping at 12 months.

Inclusion criteria:

  • PCI for stable coronary artery disease or acute coronary syndrome
  • ≥18 years of age
  • Require 12 months of dual antiplatelet therapy

Exclusion criteria:

  • Unsuccessful index PCI
  • Known CYP2C19 genotype
  • Planned revascularization of any vessel within 30 days or target vessel within 12 months

Other salient features/characteristics:

  • Presentation: stable coronary disease 16%, acute coronary syndrome 84%
  • Procedural medications: bivalirudin 10%, glycoprotein IIb/IIIa inhibitor 9%

Principal Findings:

The primary outcome, cardiovascular death, myocardial infarction, stroke, stent thrombosis, or recurrent ischemia at 12 months (first event) for genotype-guided strategy compared with standard care strategy (hazard ratio [HR] 0.66, p = 0.056). Outcomes were the same among tested subgroups.

Secondary outcomes:

  • TIMI major or minor bleeding at 12 months: similar between treatment groups
  • Time to cardiovascular death, myocardial infarction, stroke, stent thrombosis, or recurrent ischemia at 12 months (multiple recurrent events) for genotype-guided strategy compared with standard care strategy (HR 0.60, p = 0.011)

Extended follow-up:

  • The primary outcome, cardiovascular death, myocardial infarction, stroke, stent thrombosis, or recurrent ischemia for genotype-guided strategy compared with standard care strategy (HR 0.95, p = 0.74)

Interpretation:

Among patients who underwent PCI for stable or unstable coronary artery disease, a genotype-guided strategy was not beneficial compared to standard therapy. The primary outcome of major adverse cardiovascular events was similar between treatment groups at 12 months and during extended follow-up. Bleeding was similar between groups. Instead of considering the time to first event, when the time to multiple recurrent events was considered, there was possible benefit to a genotype-guided strategy to identify patients with loss of function alleles and up-titration of antiplatelet therapy.

References:

Presented by Dr. Naveen L. Pereira at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 17, 2021.

Pereira NL, Farkouh ME, So D, et al. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA 2020;324:761-71.

Presented by Dr. Naveen L. Pereira at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 28, 2020.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: ACC21, acc20, ACC Annual Scientific Session, Acute Coronary Syndrome, Angina Pectoris, Coronary Artery Disease, Genotype, Genotyping Techniques, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stents, Stroke, Thrombosis, Vascular Diseases


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