The European Bifurcation Club randomised trial of stepwise provisional stenting versus Drug Coated Balloon therapy for non-left main true coronary bifurcations: The EBC DCB Trial.

Abstract

Background: Drug eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomised control data has shown the non-inferiority of drug-coated balloons (DCB) versus 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 non-left main bifurcation disease is non-inferior to a DES strategy for Target Bifurcation Failure (TBF) at 1 year.

Strategy design: The EBC DCB trial is a non-blinded, investigator-initiated, randomised control trial that will recruit 750 patients with non-left main bifurcations requiring revascularisation. 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 randomised 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 TBF is a composite of cardiovascular death, target bifurcation myocardial infarction or target bifurcation revascularisation. Patients will be followed up at 6 months, 1, 3, 5 and 8 years. If non-inferiority is met, superiority will be tested.

Summary: EBC DCB is an open label, multi-centre, 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).