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

Summary

Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.

Conditions

• Coronary Artery Disease (non-left Main)
• Coronary Bifurcation Lesion

Interventions

PROCEDURE

Percutaneous Coronary Angioplasty

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.

DEVICE

Stepwise Provisional Stent Strategy

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).

DEVICE

Drug Coated Balloon Strategy

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.

DEVICE

Cross-Over Stepwise Provisional Stent Strategy

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.

Sponsors & Collaborators

• European Cardiovascular Research Center

  collaborator NETWORK

• Ceric Sàrl

  lead INDUSTRY

Principal Investigators

• David HILDICK-SMITH, Prof., MD · Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-31

Primary Completion

2028-05-31

Completion

2035-08-31