The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations

"A Percutaneous Coronary Intervention is used in both arms, with the drug Zotarolimus for stenting strategy and Paclitaxel for balloon strategy.~Coronary guide wires are passed into both the distal main vessel (distal MV) and side branch (SB) and predilation of MV on a 1:1 basis is required.~The device component dilates the vessel lumen by Percutaneous Transluminal Coronary Angioplasty (PTCA), while the drug is intended to reduce the proliferative response associated with restenosis."

In the stepwise provisional stent strategy, stenting of the MV is undertaken with a wire jailed in the SB. Then, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure (kissing balloon inflation ; KBI).

In the drug coated balloon (DCB) strategy, SB is prepared with a balloon at a 1:1 diameter, followed with a 1:1 sized DCB inflation for 60 seconds at nominal pressure. Then, MV is re-evaluated and treated with DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds.

Following Drug Coated Balloon treatment in the Main vessel (MV) in the Drug Coated Balloon Arm, if the result is unacceptable in the MV, with either TIMI\>3 flow and/or dissection propagation, MV stenting is mandatory followed with Kissing Balloon Inflation (KBI), where non-compliant balloons sized to the diameter of the distal main and side branch are sequentially inflated at high pressure, and then simultaneously at low pressure. If the cross-over stent implantation in the MV is used, a further SB treatment with either DCB or stent implantation is used, according to operator preference.