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

N/ANot Yet RecruitingNCT06822322

Ceric Sàrl750 enrolled

Overview

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.

The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial. Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included. Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

750

Interventions

Percutaneous Coronary AngioplastyPROCEDURE

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.

Stepwise Provisional Stent StrategyDEVICE

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).

Drug Coated Balloon StrategyDEVICE

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.

Cross-Over Stepwise Provisional Stent StrategyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1) * Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following: * ≥70% angiographic MV and SB diameter stenosis * Positive non-invasive testing for ischaemia * Positive coronary physiology for ischaemia * Significant SB as described by diameter stenosis ≥50% and all of the following: * SB length ≥73mm * SB diameter ≥2.5mm * Absence of another SB emerging distally from the MV * Non-dominant circumflex artery, if SB is a diagonal branch. Exclusion criteria * Patients \<18 years old * STEMI \<48 hours * Cardiogenic shock * Chronic total occlusion involving target bifurcation vessels * In-stent restenosis * Patient life expectancy \<12 months * \>2 other coronary lesions (target or non-target) planned for treatment * SYNTAX score \>32 * Platelet count ≤50x109/mm3 * Left ventricular ejection fraction ≤20% * Participation in another investigational drug or device study * Patient unable to give informed consent

Outcomes

Primary Outcomes

Bifurcation Orientated Composite Endpoint (BOCE)

The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation

Time frame: At 1-year, after the day of enrollment

Secondary Outcomes

Bifurcation Orientated Composite Endpoint (BOCE)

BOCE non-inferiority and superiority

Time frame: At 3, 5 and 8-years

Individual components of the Primary Endpoint

* cardiovascular death * target bifurcation-related myocardial infarction * target bifurcation revascularisation