Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions.

BACKGROUND

The optimal coronary stenting technique for true left main bifurcation lesions is uncertain. EBC MAIN (European Bifurcation Club Left Main Trial) aimed to evaluate clinical outcomes of a stepwise provisional strategy compared with a systematic dual-stent approach.

METHODS

EBC MAIN was a randomized, investigator-initiated, open-label, multicenter, parallel-group trial conducted across 35 hospitals in 11 European countries. A total of 467 participants undergoing percutaneous coronary intervention for unprotected true left main bifurcation lesions were randomly assigned to the stepwise provisional strategy (n=230) or an upfront dual-stent approach (n=237). The mean (SD) age was 71 (10) years and 23% of participants were women. The primary end point was a composite of major adverse cardiac events, defined as all-cause mortality, all myocardial infarction, or clinically driven target lesion revascularization. Events were adjudicated by an independent clinical events committee and all analyses were by the intention-to-treat principle.

RESULTS

At 3 years, the primary end point occurred in 54 of 230 (23.5%) stepwise provisional and 70 of 237 (29.5%) dual-stent patients (hazard ratio, 0.75 [95% CI, 0.53-1.07]; =0.11). There was no significant difference in all-cause mortality (10.0% versus 13.1%) or myocardial infarction (12.2% versus 11.0%). However, target lesion revascularization was significantly lower in the stepwise provisional group (8.3% versus 15.6%; hazard ratio, 0.50 [95% CI, 0.29-0.86]; =0.013). In this population, the mean side vessel diameter by quantitative angiography was 2.9 mm, and median side vessel lesion length was 5 mm. Significant interactions were identified between the assigned bifurcation strategy and both side vessel diameter and lesion length with respect to the primary outcome (=0.009 and =0.005, respectively), with smaller vessels (<3.25 mm diameter) and shorter lesions (<10 mm length) favoring the provisional approach.

CONCLUSIONS

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. Target lesion revascularization was significantly less frequent with the stepwise provisional approach, which should be the default strategy for noncomplex left main bifurcation coronary intervention.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT02497014.