EBC MAIN
Trial question
What is the role of stepwise provisional strategy in patients undergoing PCI for unprotected true left main bifurcation lesions?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 467
467 patients (108 female, 359 male).
Inclusion criteria: patients undergoing PCI for unprotected true left main bifurcation lesions.
Key exclusion criteria: cardiogenic shock; chronic total occlusion of the left anterior descending or left circumflex artery; trifurcation disease with all limbs ≥ 2.75 mm diameter; left main diameter > 5.75 mm.
Interventions
N=230 stepwise provisional strategy (receipt of one stent in the main vessel, with the side vessel treated with kissing balloon inflation).
N=237 systematic dual-stent strategy (receipt of two stents in both vessels).
Primary outcome
Major adverse cardiac events at 3 years
23.5%
29.5%
29.5 %
22.1 %
14.8 %
7.4 %
0.0 %
Stepwise provisional
strategy
Systematic dual-stent
strategy
No significant
difference ↔
No significant difference in major adverse cardiac events at 3 years (23.5% vs. 29.5%; HR 0.75, 95% CI 0.53 to 1.07).
Secondary outcomes
No significant difference in all-cause mortality (10% vs. 13.1%; HR 0.74, 95% CI 0.43 to 1.27).
No significant difference in MI (12.2% vs. 11%; HR 1.09, 95% CI 0.64 to 1.86).
Significant decrease in target lesion revascularization (8.3% vs. 15.6%; HR 0.5, 95% CI 0.29 to 0.86).
Conclusion
In patients undergoing PCI for unprotected true left main bifurcation lesions, stepwise provisional strategy was not superior to systematic dual-stent strategy with respect to major adverse cardiac events at 3 years.
Reference
Sandeep Arunothayaraj, Mohaned Egred, Adrian P Banning et al. Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions. Circulation. 2025 Mar 4;151(9):612-622.
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