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)
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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