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.
True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
≥70% angiographic MV and SB diameter stenosis
Positive non-invasive testing for ischaemia
Positive coronary physiology for ischaemia
Patients <18 years old
STEMI <48 hours
Cardiogenic shock
Chronic total occlusion involving target bifurcation vessels
Parallel
Percutaneous Coronary Angioplasty
Procedure/SurgeryA 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 Strategy
DeviceIn 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 Strategy
DeviceIn 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 Strategy
DeviceFollowing 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.
Bifurcation Orientated Composite Endpoint (BOCE)
The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation
Bifurcation Orientated Composite Endpoint (BOCE)
BOCE non-inferiority and superiority
Individual components of the Primary Endpoint
* cardiovascular death * target bifurcation-related myocardial infarction * target bifurcation revascularisation
Safety Composite Endpoint
\- Safety Composite Endpoint defined as: * BARC bleeding (2/3/5) * Definite stent/lesion thrombosis * Stroke * MI * All-cause mortality
Individual components of the Safety Composite Endpoint
* BARC bleeding (2/3/5) * Definite stent/lesion thrombosis * Stroke * MI * All-cause mortality
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Ceric Sàrl
Lead sponsor
European Cardiovascular Research Center
Collaborator
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