Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial
Study context
- Population
- All-comers with coronary artery disease undergoing percutaneous coronary intervention (PCI)enrolled and randomized 1:1
- Participants
- 3,141 participants
- Planned comparison
- Biodegradable polymer biolimus A9 Biomatrix Alpha stent to the biodegradable polymer sirolimus eluting Combo stent
- Biomatrix Alpha stentn = 1,568
- Combo stentn = 1,573
- Primary endpoint
- Target lesion failure (TLF): composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization
- Follow-up
- Within 12 months
Methodological details3 Danish University Hospitals in Western Denmark, Clinically driven event detection; no planned follow up, rationale and study design
- 3 Danish University Hospitals in Western Denmark
- Clinically driven event detection; no planned follow up
- Rationale and study design
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Trial conduct
- Trial ran from August 14, 2019 to March 19, 2023
Original publication
Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial. Am Heart J. Published 25 January 2025. doi:10.
Summarised from the published abstract; every number is checked against it