Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease–2
Study context
- Population
- Indian patients with DM and multi-vessel disease with indication for coronary revascularization (inclusion criteria similar to FREEDOM)planned
- Participants
- 1,800 patients
- Planned comparison
- Supraflex Cruz vs Xience stents; ticagrelor vs prasugrel
- Primary endpoint
- Target lesion failure, non-inferiority Supraflex Cruz vs Xience (expected event rate 11%, non-inferiority margin 4.5%)
- Follow-up
- one-year
Methodological detailsdesign paper, prospective, open-label, multi-centre, 2 × 2 factorial, non-inferiority, Follow-up through five years, Pooled percutaneous coronary interventions (PCI) arm vs coronary artery bypass graft (CABG) compared for major adverse cardiac events (MACE) (all-cause death, nonfatal MI or stroke) at one-year and yearly up to five years against a performance goal of 21.6% from the FREEDOM CABG arm, Ticagrelor vs prasugrel: composite of death, MI, stroke and Bleeding Academic Research Consortium (BARC) major bleeding at one-year (expected event rate 15%, non-inferiority margin 5%)
- Design paper
- Prospective
- Open-label
- Multi-centre
- 2 × 2 factorial
- Non-inferiority
- Follow-up through five years
- Pooled PCI arm vs CABG compared for MACE (all-cause death, nonfatal MI or stroke) at one-year and yearly up to five years against a performance goal of 21.6% from the FREEDOM CABG arm
- Ticagrelor vs prasugrel: composite of death, MI, stroke and BARC major bleeding at one-year (expected event rate 15%, non-inferiority margin 5%)
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease–2. Am Heart J. Published 28 October 2022. doi:10.
Summarised from the published abstract; every number is checked against it