Coronary disease & ACSRandomised controlled trial
Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions
- Randomised controlled trial
- investigator-initiated
- open-label
- multicentre
- parallel-group
- 35 hospitals in 11 European countries
Events adjudicated by an independent clinical events committee
Authors' conclusion
In a European population with true left main stem bifurcation coronary disease requiring intervention, there was no difference in major adverse cardiovascular events between stepwise provisional and systematic dual-stent strategies at 3 years.
Study context
- Population
- Patients undergoing PCI for unprotected true left main bifurcation lesions; mean age 71 years, 23% women
- Participants
- 467 patients
- Comparison
- Stepwise provisional vs systematic dual-stent strategy
- Stepwise provisionaln = 230
- Dual-stentn = 237reference
- Primary endpoint
- MACE:
- All-cause mortality
- All MI
- Clinically driven target lesion revascularization
- Follow-up
- 3 years
Primary result
As reported in the abstract
Hazard ratio
0.75
95% CI 0.53–1.07
P = 0.11
Events by treatment group
Stepwise provisional vs Dual-stent
HR 0.75 (95% CI 0.53–1.07); P = 0.11
Further findings
| Outcome | Stepwise provisional | Dual-stent | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Target lesion revascularization · 3 years | 8.3% | 15.6% | 0.50 (0.29–0.86) | P = 0.013 | |
| 0.20.5125Hazard ratio (log scale) |
All-cause mortality and MI · 3 years
- No significant difference in all-cause mortality (stepwise provisional vs dual-stent)
- 10.0% versus 13.1%
- No significant difference in MI (stepwise provisional vs dual-stent)
- 12.2% versus 11.0%
Primary end point by side vessel diameter and lesion length (subgroup interaction)
- Interaction with side vessel diameter; smaller vessels (<3.25 mm) favour provisional
- P = 0.009
- Interaction with side vessel lesion length; shorter lesions (<10 mm) favour provisional
- P = 0.005
Original publication
Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions. Circulation. Published 5 February 2025. doi:10.1161/circulationaha.124.071153
Summarised from the published abstract; every number is checked against it