1-Year Safety of 3-Month Dual Antiplatelet Therapy Followed by Aspirin or P2Y12 Receptor Inhibitor Monotherapy Using a Bioabsorbable Polymer Sirolimus-Eluting Stent

Circ J. 2020 Dec 25;85(1):19-26. doi: 10.1253/circj.CJ-20-0644. Epub 2020 Nov 13.

Abstract

Background: This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Y12inhibitor with aspirin monotherapy 3 months after DAPT.

Methods and results: Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Y12inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; Pnon-inferiority<0.0001). The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y12inhibitor monotherapy groups.

Conclusions: After adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Y12inhibitor and aspirin monotherapy after 3 months DAPT.

Keywords: Aspirin; Drug-eluting stent (DES); Monotherapy; P2Y12 inhibitor; Short dual antiplatelet therapy (DAPT).

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Absorbable Implants
  • Aspirin* / therapeutic use
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Hemorrhage
  • Humans
  • Myocardial Infarction
  • Percutaneous Coronary Intervention*
  • Platelet Aggregation Inhibitors* / therapeutic use
  • Polymers
  • Sirolimus* / therapeutic use
  • Stroke
  • Thrombosis
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Polymers
  • Aspirin
  • Sirolimus