Design and rationale for the treatment effects of provisional side branch stenting and DK crush stenting techniques in patients with unprotected distal left main coronary artery bifurcation lesions (DKCRUSH V) Trial

Abstract Background Provisional stenting (PS) is effective for great majority of patients with coronary bifurcation lesions. Double kissing (DK) crush approach demonstrated significant reduction of target lesion revascularization (TLR) for patients with more complex bifurcation lesion when compared with PS. Furthermore, DK crush technique was associated with lower rate of composite major adverse cardiac event (MACE), revascularization and stent thrombosis (ST) for patients with unprotected distal left main coronary artery bifurcation lesions (ULMb), compared to culotte stenting approach. The DKCRUSH V trial is designed to elucidate the benefits of DK crush over PS in patients with ULMb. Study design DKCRUSH V is a randomized, prospective, multinational clinical trial designed to evaluate the efficacy and safety of DK crush over PS for patients with ULMb. Subjects with Medina 1,1,1 or 0,1,1 ULMb will be randomized in a 1:1 fashion to PS or DK crush. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary endpoint, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2012 and was completed in December 2015; 484 patients were randomized. The trial will continue until at least 56 adjudicated primary endpoints occur. Conclusions The DKCRUSH V study is investigating if DK crush approach versus PS will reduce the incidence of TLF in patients with symptomatic ULMb.