Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry
Authors' conclusion
A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.
Study context
- Population
- Patients treated with the Ultimaster coronary stent
- Participants
- 551 vs 35,389
- Comparison
- Ultimaster stent in CENTURY II trial vs e-ULTIMASTER registry
- CII-UMn = 551
- E-ULTIMASTER (e-UM)n = 35,389reference
Methodological detailspropensity-weighted analysis, independent clinical event committee adjudication, All major events adjudicated by an independent clinical event committee in both studies
- Propensity-weighted analysis
- Independent clinical event committee adjudication
- All major events adjudicated by an independent clinical event committee in both studies
Primary result
As reported in the abstract
Clinical outcomes (excluding periprocedural myocardial infarction (MI)) · 1 year
CII-UM vs e-UMHazard ratio (95% CI)P value
All-cause death
0.55(0.26–1.20)
P = 0.14Cardiac death
0.71(0.29–1.72)
P = 0.45Target lesion failure
1.18(0.78–1.78)
P = 0.44Target vessel MI
0.76(0.24–2.38)
P = 0.63Target vessel revascularization, significantly higher in CII-UM
1.78(1.23–2.56)
P = 0.002Further findings
Baseline CAD complexity
- More complex CAD in e-UM (more ACS, multivessel disease, left main, arterial or venous grafts, chronic total occlusions)
- P < 0.005 for all
Original publication
Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry. Am Heart J. Published 15 March 2023. doi:10.
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