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ESC 2021 - Antiplatelet therapy in high bleeding risk patients with or without OAC therapy

Antiplatelet therapy in high bleeding risk patients with or without oral anticoagulant therapy after coronary stenting – Pre-specified subgroup analysis of the MASTER-DAPT trial.

It is safe and beneficial to stop APT at 1 month in patients with high bleeding risk with or without indication for OAC.

Key Takeaway

  • An abbreviated APT strategy had a consistent and similar effect on NACE and MACCE in patients with or without OAC therapy.
  • Abbreviated APT strategy significantly reduced clinically relevant bleeding risk in high bleeding risk patients with OAC, but no significant reduction was obtained in the OAC population.

Why This Matters

  • The optimal duration of APT remains to be determined in patients at high bleeding risk with and without OAC therapy after coronary artery stenting.
  • In this prespecified subgroup analysis of the MASTER-DAPT trial, treatment effects of abbreviated versus non-abbreviated APT regimens were assessed in patients with post PCI with or without a concomitant indication for OAC.

Study Design

  • The MASTER-DAPT trial was an investigator-initiated, randomized trial performed at 140 hospitals in 30 countries.
  • Patients were randomized into four study groups, following 1-month post-index PCI procedure (Ultimaster/Ultimaster Tansei drug eluting stent), if stable on anti-thrombotic therapy and no ischemic event in the previous month.
  • Key inclusion criteria: (1) Clinical indication for treatment with OAC for ≥12 months; (2) recent (<12 months) nonaccess site bleeding episode(s); (3) previous bleeding episode(s) that required hospitalization; (4) age ≥75 years; (5) systemic conditions associated with increased bleeding risk; (6) anemia or transfusion within 4 weeks before randomization; (7) need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs; (8) malignancy (not skin) considered at high bleeding risk; (9) stroke or transient ischemic attack in the previous 6 months; (10) PRECISE DAPT score ≥25
  • Clinical indication for OAC arm:
    • Abbreviated DAPT regimen: DAPT was discontinued and SAPT was continued for only 5 months and OAC was continued for ≥11 months
    • Non-abbreviated DAPT regimen: DAPT was continued for ≥2 months and, thereafter, SAPT was continued (till 11 months) and OAC was also continued for ≥11 months
  • No clinical indication for OAC arm:
    • Abbreviated DAPT regimen: DAPT was discontinued, and SAPT was continued for ≥11 months
    • Non-abbreviated DAPT regimen: DAPT was continued, ASA for ≥11 months and P2Y12i for ≥5 months
  • Co-primary endpoints measured at 12 months were as follows:
    • NACE, defined as the composite of all-cause death, MI, stroke, and BARC 3 or 5 bleeding events
    • MACCE, expressed as a composite of all-cause death, MI, and stroke as well as major or clinically relevant non major bleeding, defined as a composite of type 2, 3, or 5 BARC bleeding events

Key Results

  • Overall, 4,579 (median age: 70 years) were randomized post-stenting:
    • 1,666 patients had a clinical indication for OAC (abbreviated DAPT group [n = 848] and non-abbreviated DAPT group [n = 818])
    • 2,913 had no indication for OAC (abbreviated DAPT group [n = 1,447] and non-abbreviated DAPT group [n = 1,466])
  • Outcomes among patients with OAC indication:
    • NACE was lower in abbreviated DAPT versus non-abbreviated DAPT arm (HR = 0.83; 95% CI: 0.60–1.15; P = 0.26).
    • MACCE did not differ in the abbreviated DAPT versus non-abbreviated DAPT arm (HR = 0.88; 95% CI: 0.60–1.30; P = 0.53).
    • BARC 2, 3, or 5 bleeding score was lower in abbreviated versus non-abbreviated DAPT arm (HR = 0.83; 95% CI: 0.62–1.12; P = 0.25)
  • Outcomes among patients without an OAC indication:
    • There was no difference between abbreviated and non-abbreviated DAPT groups (HR = 1.01; 95% CI: 0.77–1.33; P = 0.91).
    • MACCE also did not differ between the treatment groups (HR = 1.06; 95% CI: 0.79–1.44; P = 0.67)
    • BARC 2, 3, or 5 bleeding occurred less frequently in the abbreviated vs non-abbreviated arm (HR = 0.55; 95% CI: 0.41–0.74; P <0.001)
  • Landmark/censor-weighted analysis:
    • No difference was found in NACE and MACCE outcomes, but bleeding risk reduced in population with and without OAC in abbreviated DAPT regimen, with a statistical significance in OAC arm.
    • SAPT when stopped after 6 months significantly reduced clinically relevant bleeding without increasing ischemic risk.

Abbreviations

APT, antiplatelet therapy; ASA, acetylsalicylic acid; BARC, Bleeding Academic Research Consortium; CI, confidence interval; HR, hazard ratio; MACCE, major adverse cardiac and cerebral events; NACE, net adverse clinical events; SAPT, single antiplatelet therapy.

Reference

  1. Smits PC. Antiplatelet therapy in high bleeding risk patients with or without oral anticoagulant therapy after coronary stenting – Prespecified subgroup analysis of the MASTER-DAPT trial. Presented at the European Society of Cardiology (ESC) conference on August 29, 2021. [Abstract]
MAT-BH-2300022/v1/Jan2023