It's okay to Start with just one stent for bifurcation lesions: EBC Trials
Denmark: Using a systematic culotte strategy in bifurcation lesions showed no benefit over provisional stenting; follow-up data from two trials have shown.
The European Bifurcation Club (EBC) researchers presented their findings at the EuroPCR 2023. The findings support that starting with a single stent is okay as the stepwise, provisional approach to PCI offers similar outcomes compared with a strategy in which two stents are the plan from the outset.
At three years, the EBC MAIN trial showed no differences in the primary composite of myocardial infarction (MI), death, and revascularization between the two tactics for left main (LM) bifurcations. TLR rates, however, favoured the stepwise, provisional arm.
Five-year findings from EBC TWO showed no advantage for routine culotte over provisional stenting in non-LM bifurcations. The findings were simultaneously published in EuroIntervention.
In the EBC MAIN, 467 patients from 11 European countries were randomized to either a stepwise, provisional strategy or systematic dual-stent approach (Resolute Onyx; Medtronic) to LM bifurcations. The choice of technique (T/TAP, DK-minicrush, culotte) was left to the operator's discretion, but the kissing balloon technique and proximal optimization were mandated in both groups. 22% ultimately received a second stent in the provisional group.
Key findings include:
- At 3 years, the combined rate of death, MI, and revascularization was similar for provisional versus systematic dual stenting (23% versus 29%). Also similar were death (10% versus 13%) and MI (12% versus 11%).
- The TLR rate was significantly lower with the provisional strategy (8% versus 14%); irrespective of which approach was used, most of these repeat interventions occurred in the ostium of the circumflex.
- In the provisional group, in addition to having less TLR, nearly four in five patients avoided a second stent; resulting in lower X-ray dose, shorter procedure time, and fewer resources used with the stepwise strategy.
The EBC TWO trial included 200 European patients with non-LM bifurcations. They were randomized to provisional versus culotte stenting with a Nobori device (Terumo Corporation). All had a side-branch diameter ≥ 2.5 mm and side-branch lesion length > 5 mm. Only 16% of the patients randomly assigned to the provisional cohort had side-branch stents.
Key findings include:
- At 1-year follow-up, the primary endpoint of MACE was similar for the provisional and systematic culotte groups (7.7% vs 10.3%).
- In the newly released 5-year follow-up, this similarity was maintained (18.4% vs 23.7%), with no individual differences for all-cause death, MI, or TVR. Nor was there an interaction based on whether side-branch lesion length was above or below the cut point of 10 mm.
- Bifurcation-related adverse cardiac events (acute vessel closure, probable or definite stent thrombosis, type 1 MI, or revascularization) were rare and equally distributed between the two groups (5.8% vs 7.2%).
"The provisional strategy should continue to be the default approach for true bifurcation disease," the authors concluded.
References:
(1) Hildick-Smith D. The European Bifurcation Club Left Main Coronary Stent study - a randomised comparison of stepwise provisional versus systematic dual stenting strategies (EBC MAIN): 3 year results. Presented at: EuroPCR 2023. May 16, 2023. Paris, France.
(2) Arunothayaraj S, Behan MW, Lefèvre T, et al. Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial. EuroIntervention. 2023;Epub ahead of print.
