Coronary disease & ACS

Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing percutaneous coronary intervention (PCI)

Am Heart JPublished Randomised controlled trial

Study context

Population
All-comers undergoing PCI, minimal exclusion criteria
Participants
2,107 all-comers
Planned comparison
Polymer-free Cre8 amphilimus-eluting stent vs SYNERGY everolimus-eluting stent; personalized vs standard DAPT duration
Primary endpoint
Stents: device-oriented composite of CV death, target-vessel MI or clinically-driven target-lesion revascularization (non-inferiority) at 12 months; DAPT: net clinical composite of all-cause death, any MI, stroke, urgent target-vessel revascularization or BARC type 2 to 5 bleeding (superiority) at 24 months
Follow-up
12 months (stents); 24 months (DAPT) after PCI
Methodological detailsdesign paper, 2-by-2 factorial, phase IV, prospective, multicentre (14 centres in Italy), investigator-initiated, assessor-blind, non-inferiority (stents), superiority (DAPT duration)
  • Design paper
  • 2-by-2 factorial
  • Phase IV
  • Prospective
  • Multicentre (14 centres in Italy)
  • Investigator-initiated
  • Assessor-blind
  • Non-inferiority (stents)
  • Superiority (DAPT duration)

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI. Am Heart J. Published 10 August 2023. doi:10.1016/j.ahj.2023.08.001

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