Abbreviated or Standard Antiplatelet Therapy After PCI in Diabetic Patients at High Bleeding Risk

JACC Cardiovasc Interv. 2024 Nov 25;17(22):2664-2677. doi: 10.1016/j.jcin.2024.08.030.

Abstract

Background: Abbreviated antiplatelet therapy (APT) reduces bleeding without increasing ischemic events in largely unselected high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI). Diabetes mellitus (DM) is associated with higher ischemic risk, and its impact on the safety and effectiveness of abbreviated APT in HBR PCI patients remains unknown.

Objectives: This study sought to investigate the comparative effectiveness of abbreviated (1 month) vs standard (≥3 months) APT in HBR patients with and without DM after biodegradable polymer sirolimus-eluting coronary stent implantation.

Methods: This was a prespecified analysis from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen) trial, which randomized 4,579 HBR patients (1,538 [34%] with DM) to abbreviated (n = 2,295) or standard (n = 2,284) APT. The coprimary outcomes were net adverse clinical events (NACEs; composite of all-cause death, myocardial infarction, stroke, and major bleeding), major adverse cardiac or cerebral events (MACCEs; all-cause death, myocardial infarction, and stroke), and major or clinically relevant nonmajor bleeding at 11 months.

Results: HBR patients with DM had higher risks of MACCEs (HR: 1.28; 95% CI: 1.00-1.63) and similar net adverse or bleeding events compared with nondiabetic subjects. Abbreviated compared with standard APT was associated with similar NACEs and MACCEs (Pinteraction = 0.47 and 0.59, respectively) and reduced major or clinically relevant nonmajor bleeding (Pinteraction = 0.55) irrespective of diabetes status.

Conclusions: MACCE and NACE rates were similar, and bleeding rates were lower with abbreviated APT in patients with or without diabetes. Therefore, diabetes status did not modify the treatment effects of abbreviated vs standard APT in HBR patients after biodegradable polymer sirolimus-eluting coronary stent implantation. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Keywords: diabetes mellitus; dual antiplatelet therapy; high bleeding risk; percutaneous coronary intervention.

Publication types

  • Randomized Controlled Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / mortality
  • Coronary Artery Disease* / therapy
  • Diabetes Mellitus* / diagnosis
  • Drug Administration Schedule
  • Drug-Eluting Stents*
  • Female
  • Hemorrhage* / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / mortality
  • Platelet Aggregation Inhibitors* / administration & dosage
  • Platelet Aggregation Inhibitors* / adverse effects
  • Prosthesis Design
  • Risk Assessment
  • Risk Factors
  • Sirolimus / administration & dosage
  • Sirolimus / adverse effects
  • Time Factors
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT03023020