Randomised Comparison of Culotte- versus Double Kissing Crush Stenting in de novo non-left Main Coronary Bifurcation Lesions: Rationale and Design of the Bifurcation Bad Krozingen trial-3 (BBK-3).

Abstract

Whether culotte or double kissing (DK)-crush stenting is the superior systematic 2-stent technique in non-left main bifurcation lesions is unclear. The BBK-3 (unique identifier NCT04192760) is a multicenter, prospective, randomized controlled trial to test the hypothesis that culotte stenting reduces maximal percent diameter restenosis at 9-month follow-up compared to DK-crush stenting in de-novo non-left main coronary bifurcation lesions using approved, third-generation drug-eluting stents (DES). A total of 400 patients will be randomized in a 1:1 ratio to receive a two-stent strategy. The primary study endpoint is the maximal percent diameter in-stent restenosis within the bifurcation at 9 months, assessed by quantitative coronary angiography. Secondary endpoints include target lesion revascularization (TLR), the composite of death and myocardial infarction, emergent cardiac bypass surgery and TLR (MACE) at 12 months. BBK-3 will assist in the identification of the preferable, contemporary 2-stent strategy in the treatment of de-novo non-left main coronary bifurcation lesions.