EBC MAIN Trial Compares Provisional Single Stent Strategy Versus Double Stenting in True Bifurcation Left Main Disease

May 18, 2021—PCR, organized of the virtual EuroPCR 2021 conference, announced that findings were presented from the European Bifurcation Club Left Main (EBC MAIN) trial which evaluated use of a provisional single stent versus upfront double stenting in 467 patients with true bifurcation distal left main disease.

According PCR, only one other randomized trial, DKCRUSH-V (n = 482), has addressed the same research question, showing better outcomes with an upfront two-stent strategy, more specifically the double-kissing crush technique.

As noted in the PCR press release, in terms of methodology, two aspects need to be considered for the correct interpretation of the EBC MAIN trial results. First, both left anterior descending artery and circumflex ostia were affected by significant disease on angiography in all included patients. Second, as a strategy trial, the EBC MAIN did not compare the implantation of one versus two stents. Instead, it compared a provisional single stent strategy, which could entail extension to two stents under prespecified procedural conditions, with an upfront assignment to use a two-stent technique.

According to PCR, investigators found no difference in terms of the studied clinical outcomes between the planned single stenting and the upfront use of two-stent techniques. Of note, 22% of patients randomized to a planned single-stent strategy were ultimately treated with two stents.

The primary composite endpoint of 1-year death, myocardial infarction, and target lesion revascularization occurred at the rate of 14.7% in the provisional group versus 17.7% in the upfront two-stent group (hazard ratio 0.8; 95% CI, 0.5–1.3). No significant difference was detected for any of the individual components of the primary endpoint. The rates of stent thrombosis were similar: 1.7% in the provisional arm and 1.3% in patients treated with upfront double stenting.

PCR advised that it is important to understand how EBC MAIN could be perceived as practice-changing, given the overall neutral results. These findings occurred with the backdrop of the 2018 European Society of Cardiology Guidelines on myocardial revascularization that recommend preferably to use double-kissing crush (an upfront two-stent technique) over a planned single-stent strategy (provisional) in true left main bifurcations (class of recommendation IIb, level of evidence B). This recommendation was largely based on the results of a single randomized study, the DKCRUSH-V trial. In this respect, the EBC MAIN trial adds important new data that deviate from the previously available randomized evidence on this topic.

Additionally, the study investigators highlighted that the neutral findings of 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 these findings is compounded by earlier 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, stated PCR.