Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 High Bleeding Risk (HBR) Trial: An Open-Label, Randomized, Controlled Trial
Primary resultResult — go to the resultRisk difference −1.65% 1-sided 95% CI 3.74Authors' conclusion
Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent.
Study context
- Population
- Patients at HBR (Academic Research Consortium HBR criteria) undergoing PCI with abbreviated DAPT
- Participants
- 741 patients
- Comparison
- Ultrathin-strut Supraflex Cruz vs thin-strut Ultimaster Tansei stent
- Supraflex Cruzn = 371
- Ultimaster Tansein = 370reference
- Primary endpoint
- Net adverse clinical events:
- CV death
- MI
- Target vessel revascularization
- Stroke
- Major bleeding
- Follow-up
- 1 year
Methodological detailsinvestigator-initiated, open-label, non-inferiority, 11 sites in the Netherlands, Enrolment September 2020 to August 2022
- Investigator-initiated
- Open-label
- Non-inferiority
- 11 sites in the Netherlands
- Enrolment September 2020 to August 2022
Primary result
As reported in the abstract
Risk difference
−1.65%
1-sided 95% CI 3.74
P = 0.02 for noninferiority
Events by treatment group
Supraflex Cruz vs Ultimaster Tansei
risk difference −1.65% (1-sided 95% CI 3.74); P = 0.02 for noninferiority
Original publication
Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial. Circ Cardiovasc Interv. Published 1 October 2024. doi:10.
Summarised from the published abstract; every number is checked against it