Trial results contradict ESC guidance recommending two-stent technique
New findings from the European Bifurcation Club Left Main (EBC MAIN) trial suggest no difference in 1-year clinical outcomes of a planned single-stent versus upfront two-stent strategy for true bifurcation distal left main disease.
The neutral trial results, presented Tuesday at EuroPCR 2021, are set against the backdrop of the 2018 European Society of Cardiology (ESC) guidelines on myocardial revascularization recommendation to preferably use double-kissing crush – an upfront two-stent technique – over a planned single-stent strategy – provisional strategy – in true left main bifurcations.
This ESC recommendation is largely based on the results of a single randomized study, the DKCRUSH-V trial, noted the authors of the new study, adding that new data from the EBC MAIN trial differ from previously available randomized trial evidence.
“In our opinion, the provisional approach should remain the philosophy of choice in the majority of left main stem bifurcation procedures,” Goran Stankovic, MD, PhD, of the University Clinical Center of Serbia, said during a press conference.
Stankovic said that none of the primary or secondary endpoints resulted in statistically significant differences, but noted that procedure time, X-ray dose and consumables favored the stepwise provisional approach.
“Symptomatic improvement was excellent and equal in each group,” he said, adding that 22% of patients randomized to a planned single-stent strategy were ultimately treated with two stents.
However, Stankovic noted that the use of a second stent in patients as part of the provisional strategy should not be seen as a complication but rather part of a layered stepwise strategy.
“The advantage of the stepwise strategy is therefore that it does not pre-judge the anatomical requirements,” he said. “The approach is layered, sequential, and the procedure is complete when a good result is obtained at any stage in the sequence.”
The multi-center EBC MAIN trial addressed the issue of provisional single stent versus upfront double stenting in 467 patients with true bifurcation distal left main disease. Patients were recruited from 31 centers in 11 European countries and were randomly allocated to either a stepwise layered provisional stent strategy or a systematic dual stenting strategy.
“The primary message is that no difference in terms of the studied clinical outcomes was noted between the planned single stenting and the upfront use of two-stent techniques,” said Stankovic.
The primary – a composite endpoint of 1-year death, myocardial infarction and target lesion revascularization – occurred at the rate of 14.7% in the provisional versus 17.7% in the upfront two-stent group (hazard ratio [HR] 0.8, 95% confidence interval [CI] 0.5 – 1.3), the team noted.
Furthermore, no significant difference was detected for any of the individual components of the primary endpoint, they noted. Secondary endpoints were death (3.7% vs 4.2%, p=0.49), myocardial infarction (10.0 vs 10.1%, p=0.91), target lesion revascularization (6.1% vs 9.3%, p=0.16) and stent thrombosis (1.7% vs 1.3%,p=0.72) respectively.
Change in practice?
Given the overall neutral trial results, it is important to understand how EBC MAIN could be perceived as practice-changing, said Stankovic, adding that the neutral findings of the EBC MAIN may provide support for the notion that even in true left main bifurcations, the initial strategy of single stenting is not penalized by worse 1-year outcomes as compared with upfront two-stent techniques.
The clinical value of the findings is compounded by prior evidence from a pooled analysis of the BBC ONE and NORDIC trials, which associated upfront two-stent techniques with a higher long-term mortality risk, as compared with an initial single-stent strategy, said the team.
They noted that patients are treated equally well with a stepwise layered provisional approach, starting with a single stent, as with a more complex dual stent implant, reiterating their position that a stepwise provisional strategy should remain the approach of choice for the majority of left main bifurcation interventions.