Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent
Study context
- Population
- Patients with ischemic heart disease with de novo native coronary artery lesions undergoing percutaneous coronary intervention (PCI)randomized
- Participants
- 2,400 patients
- Planned comparison
- DynamX bioadaptor vs Resolute Onyx stent
- Primary endpoint
- Freedom from TLF (CV death, target vessel MI or ischemia-driven target lesion revascularization); noninferiority
- Follow-up
- 1 year
Methodological detailsrationale and design, single-blind, registry-based, non-inferiority, 20 sites in Sweden, Baseline: age 68 years; 25% STEMI, 37% NSTEMI, Powered secondary endpoints tested sequentially for superiority from 6 months to 5 years: Target lesion failure (TLF), target vessel failure, TLF in acute coronary syndrome (ACS), Angina symptoms, function and quality of life assessed by Seattle Angina Questionnaire-short version
- Rationale and design
- Single-blind
- Registry-based
- Non-inferiority
- 20 sites in Sweden
- Baseline: age 68 years; 25% STEMI, 37% NSTEMI
- Powered secondary endpoints tested sequentially for superiority from 6 months to 5 years: TLF, target vessel failure, TLF in ACS
- Angina symptoms, function and quality of life assessed by Seattle Angina Questionnaire-short version
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. Am Heart J. Published 2 August 2024. doi:10.
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