Coronary Artery Disease (non-left Main), Coronary Bifurcation Lesion
Conditions
Keywords
non-left coronary bifurcation, drug coated balloon, drug eluted stent
Brief 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.
Detailed description
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).
Interventions
PROCEDUREPercutaneous 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.
DEVICEStepwise 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).
DEVICEDrug 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.
DEVICECross-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
European Cardiovascular Research Center
Ceric Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bifurcation Orientated Composite Endpoint (BOCE) | At 1-year, after the day of enrollment | The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the Primary Endpoint | At 1, 3, 5 and 8-years | * cardiovascular death * target bifurcation-related myocardial infarction * target bifurcation revascularisation |
| Safety Composite Endpoint | At 1, 3, 5 and 8-years | \- 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 | At 1, 3, 5 and 8-years | * BARC bleeding (2/3/5) * Definite stent/lesion thrombosis * Stroke * MI * All-cause mortality |
| Bifurcation Orientated Composite Endpoint (BOCE) | At 3, 5 and 8-years | BOCE non-inferiority and superiority |
| Angina status | At 1, 3, 5 and 8-years | Questionnaire: Seattle Angina Questionnaire - 7 (SAQ-7) Scale Range (Minimum and Maximum Values): 0 to 100 Higher scores indicate a better outcome (better health status, less angina, and better quality of life). |
| Angina index | At 1, 3, 5 and 8-years | No. of antianginals |
| BARC 3 or 5 bleeding rate | At 1, 3, 5 and 8-years | BARC 3 or 5 bleeding rate |
Contacts
Primary ContactBasile GRAVEZ, PhD
Backup ContactLaure MORSIANI, PhD
Outcome results
None listed