The European bifurcation club randomized trial of stepwise provisional stenting vs drug-coated balloon therapy for nonleft main true coronary bifurcations: The EBC DCB trial.

BACKGROUND

Drug-eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomized control data have shown the noninferiority of drug-coated balloons (DCB) vs stents at 1 year. Possible benefits of DCBs include the lack of a metal prosthesis, absence of stent malapposition, lack of obligate antiplatelet treatment, and maintenance of vessel geometry and function.

HYPOTHESIS: The use of DCBs in the treatment of nonleft main bifurcation disease is noninferior to a DES strategy for Target Bifurcation Failure at 1 year.

STRATEGY

DESIGN

The EBC DCB trial is a nonblinded, investigator-initiated, randomized control trial that will recruit 750 patients with nonleft main bifurcations requiring revascularization. Both main vessel and side branch must have significant atheroma. Subacute (NSTEMI and unstable angina) and elective presentations will be eligible for inclusion. Patients will be randomized to either a step-wise provisional DES or a DCB strategy. Major exclusion criteria include STEMI in the previous 48 hours, chronic total occlusions, and in-stent restenosis. The primary endpoint of Target Bifurcation Failure is a composite of cardiovascular death, target bifurcation myocardial infarction, or target bifurcation revascularization. Patients will be followed up at 6 months, 1, 3, 5, and 8 years. If noninferiority is met, superiority will be tested.

SUMMARY: EBC DCB is an open-label, multicenter, international randomized control trial comparing the use of DCB and DES in the treatment of coronary artery bifurcation disease. The trial is registered at clinicaltrials.gov (NCT06822322).