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.

MAT-BH-2300022/v1/Jan2023