Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent

Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.

Abstract

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.

Trial registration: ClinicalTrials.gov NCT03218787 NCT03815175 NCT03355742.

Publication types

  • Clinical Trial Protocol
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / drug therapy*
  • Aspirin / administration & dosage*
  • Aspirin / adverse effects
  • Canada
  • Cause of Death
  • Drug Administration Schedule
  • Drug-Eluting Stents* / adverse effects
  • Everolimus / administration & dosage*
  • Hemorrhage / chemically induced
  • Hemorrhage / prevention & control
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Myocardial Infarction / prevention & control*
  • Percutaneous Coronary Intervention
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / adverse effects
  • Prospective Studies
  • Purinergic P2Y Receptor Antagonists / administration & dosage*
  • Purinergic P2Y Receptor Antagonists / adverse effects
  • Stroke
  • Thrombosis
  • United States

Substances

  • Immunosuppressive Agents
  • Platelet Aggregation Inhibitors
  • Purinergic P2Y Receptor Antagonists
  • Everolimus
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT03218787
  • ClinicalTrials.gov/NCT03815175
  • ClinicalTrials.gov/NCT03355742