Coronary Artery Disease
Conditions
Keywords
Complex Coronary Bifurcation, Upfront 2-stenting, Upfront Drug-coated Balloon, Side Branch, Prognosis
Brief summary
A prospective, multi-center, open-label, randomized controlled, superiority trial. The aim of the study is to compare clinical outcomes between upfront 2-stenting strategy versus upfront drug-coated balloon (DCB)-based hybrid strategy in patients with complex coronary bifurcation with clinically relevant side branch lesions.
Detailed description
Among complex coronary artery lesions, percutaneous coronary intervention (PCI) for true bifurcation lesions has been challenging to perform and associated with a higher risk of mortality, unplanned repeat revascularization or stent thrombosis.15-17 Although current guidelines recommend 1-stenting with provisional side branch approach as an initial treatment strategy for the bifurcation lesions based on previous trials,11,12,18-22 there are studies that demonstrate better or similar outcomes with the upfront 2-stenting strategy.3,4,21,23 Of note, these trials that have favored upfront 2-stenting strategy have shown a tendency for better efficacy of 2-stenting as the severity of bifurcation lesions increases.3,4,21,23 Considering that the discrepancy among study results could be attributable to the complexity of true bifurcation lesions, it can be argued that 1-stenting with provisional SB approach by conventional balloon dilatation shows limitations in dealing with severely complex true bifurcation lesions. During provisional stenting, unplanned side branch stenting is associated with worse clinical outcomes.24 In addition, SB failure occurred more frequently than main vessel failure in both 1-stenting and 2-stenting group.25 Considering these results, there have been some studies trying to demonstrate the effect of drug-coated balloon (DCB) angioplasty at side branch during the PCI for bifurcation lesions.5,26 In the most recent trial, DCB angioplasty yielded better results compared to conventional simple balloon dilatation.5 Thus, for true bifurcation lesions, upfront DCB-based hybrid strategy could serve as a good alternative treatment strategy that improves clinical outcomes for patients with complex coronary bifurcation lesion with clinically relevant side branch. On this background, this trial sought to compare the clinical outcomes between upfront DCB-based hybrid strategy and upfront 2-stenting strategy in patients with complex coronary bifurcation with clinically relevant side branch.
Interventions
OTHERUpfront DCB-based hybrid strategy
In upfront DCB-based hybrid strategy group, stepwise provisional strategy with side branch DCB angioplasty will be performed according to the follow standardized procedural steps. In this group, provisional stenting strategy will be performed in accordance with the European Bifurcation Club (EBC) consensus. Bail-out stenting will be performed using operator's preferred technique (e.g. T, TAP, culotte) when there will be one of the following after hybrid strategy: \<TIMI 3 flow in the side branch, severe (\>90%) ostial pinching, or flow-limiting dissection.
OTHERUpfront 2-stenting strategy
In upfront 2-stenting strategy group, systematic planned 2-stenting will be performed according to EBC recommendations. The stent technique will be at the discretion of the operator but could be one of culotte, DK-culotte, mini-crush, DK-crush, T or TAP.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Intervention model description
A prospective, multi-center, open-label, randomized controlled, superiority trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 19 years of age * Patients with acute or chronic coronary syndrome intended for percutaneous coronary intervention (PCI) * Patients with de novo complex coronary bifurcation with clinically relevant side branch. Definition of complex coronary bifurcation with clinically relevant side branch is true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length ≥10mm and should meet at least one of the below criteria. i. Left main bifurcation with side branch stenosis severity ≥70% by visual estimation ii. Non-left main bifurcation with side branch reference vessel diameter ≥2.75mm and stenosis severity ≥90% by visual estimation * Subject who can verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion criteria
* Hemodynamically unstable condition (SBP \<90 mmHg even after administration of vasopressor, ventricular arrhythmias, or cardiogenic shock) * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) * Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms. * Severe left ventricular systolic dysfunction (ejection fraction \<30%) * Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin. * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Unwillingness or inability to comply with the procedures described in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Event (MACE) | 1 year after last patient enrollment | MACE (a composite of death, MI, clinically-driven target-vessel revascularization), according to the Academic Research Consortium (ARC) II-consensus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related MI (myocardial infarction) | 1 year after last patient enrollment | Procedure-related MI (myocardial infarction), defined by ARC II definition |
| Stent thrombosis | 1 year after last patient enrollment | Stent thrombosis, defined by ARC II definition |
| Unplanned revascularization (clinically-driven) | 1 year after last patient enrollment | Unplanned revascularization (clinically-driven) |
| Target-vessel revascularization (clinically-driven) | 1 year after last patient enrollment | Target-vessel revascularization (clinically-driven) |
| Cerebrovascular accidents (ischemic or hemorrhagic) | 1 year after last patient enrollment | Cerebrovascular accidents (ischemic or hemorrhagic) |
| Bleeding (BARC 2, 3, or 5) | 1 year after last patient enrollment | Bleeding (BARC 2, 3, or 5) |
| Cardiac death | 1 year after last patient enrollment | Cardiac death |
| Any MI (myocardial infarction) | 1 year after last patient enrollment | Any MI, defined by Fourth Universal definition of M |
| Spontaneous MI (myocardial infarction) | 1 year after last patient enrollment | Spontaneous MI (myocardial infarction), defined by Fourth Universal definition of MI |
| Seattle Angina Questionnaire (SAQ) (angina severity) | 1 year after last patient enrollment | Seattle Angina Questionnaire (SAQ) (angina severity) |
| Procedure-related complications during index procedure | 1 year after last patient enrollment | Procedure-related complications during index procedure |
| All-cause death | 1 year after last patient enrollment | All-cause death |
Countries
South Korea
Contacts
Primary ContactYoung Bin Song, MD, PhD
Backup ContactJoo Myung Lee, MD, MPH, PhD
Outcome results
None listed