Clinical trial NCT05731687: Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
Official title: Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Bifurcation Lesion
Keywords: Coronary bifurcation lesion
Coronary artery disease
Drug-eluting balloon
Percutaneous coronary intervention
Lead sponsor: Cathreine BV
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
name: Albert Schweitzer Hospital
name: Onze Lieve Vrouwe Gasthuis
name: Maasstad Hospital
name: The Elisabeth-TweeSteden Hospital
name: St. Antonius Hospital
name: Frisius Medisch Centrum
name: Meander Medical Center
name: VieCuri Medical Centre
name: Haga Hospital
name: Rijnstate Hospital
name: Jeroen Bosch Ziekenhuis
First posted: 2023-02-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy
Primary purpose: TREATMENT

Brief summary: The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation.

Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies.

The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach.

Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow \< Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry.

Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.


Eligibility criteria: Inclusion Criteria:

* Significant de novo bifurcation lesion (main vessel and side branch diameter ≥ 2.5mm, diameter stenosis of the main vessel ≥ 70% and of the side branch ≥ 50% or in intermediate stenosis FFR ≤ 0.80 or iFR ≤ 0.89)
* Stable coronary artery disease or stabilized acute coronary syndrome
* Age ≥ 18 years
* Acceptable candidate for treatment with a drug eluting stent

Exclusion Criteria:

* Unstable clinical condition
* Previous PCI with stent implantation in the target lesion(s)
* Known comorbidity with a life expectancy of \<2 year
* Active bleeding requiring medical attentions (BARC \>2 at index PCI)
* Pregnancy
* Unable to provide consent for any other reason
* Participation in another stent or drug trial
* Known hypersensitivity or allergy for asprin, clopidogrel, ticagrelor, prasugrel, cobalt chromium, sirolimus, to excipients with phospholipid or related origins.

Primary outcomes:
measure: Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
timeFrame: Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year
Secondary outcomes:
measure: Procedural success
timeFrame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
measure: Target vessel failure (TVF)
timeFrame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
measure: Major adverse cardiac events (MACE)
timeFrame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
measure: Individual components of MACE and TVF
timeFrame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
measure: Periprocedural MI
timeFrame: 48 hours after the Percutaneous Coronary Intervention (PCI)
measure: Major intraprocedural complications
timeFrame: The end of the PCI
measure: Probable and definite stent thrombosis
timeFrame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization
measure: Major bleeding, defined as BARC type 2-5
timeFrame: Discharge after the PCI
measure: Contrast volume used during the PCI procedure
timeFrame: The end of the PCI
measure: Radiation exposure of the patient, measured in DAP and AirKerma
timeFrame: The end of the PCI
measure: Procedural time, measured in minutes, defined as time from first to last procedural angiography image
timeFrame: The end of the PCI
measure: Total procedural costs (in euro's) per patient stratified to treatment group
timeFrame: The end of the PCI
measure: Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)
timeFrame: The end of the PCI
measure: Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)
timeFrame: The end of the PCI
measure: Dissections in the proximal and distal main branch and side branch, measured using intracoronary imaging (OCT or IVUS)
timeFrame: The end of the PCI
measure: Core Lab Assessed initial TIMI flow main branch and side branch
timeFrame: During the Coronary Angiography (CAG), before the PCI
measure: Core Lab Assessed Lesion Length (in mm)
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed percentage diameter stenosis main branch and side branch
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed reference diameter (in mm) proximal main branch and side branch
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch
timeFrame: During the CAG, before the PCI
measure: The severity of calcification main branch and side branch, Core Lab Assessed
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed Bifurcation angle
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed syntax I score as absolute value
timeFrame: During the CAG, before the PCI
measure: Bifurcation medina score
timeFrame: During the CAG, before the PCI
measure: Core Lab Assessed final TIMI flow main branch and side branch
timeFrame: The end of the PCI
measure: Core Lab Assessed residual dissection (type A-F) after PCI in the main branch and/or side branch
timeFrame: The end of the PCI
measure: Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI
timeFrame: The end of the PCI
measure: Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI
timeFrame: The end of the PCI
measure: Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI
timeFrame: The end of the PCI
measure: Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI
timeFrame: The end of the PCI
measure: Core Lab Assessed Procedural coronary thrombus
timeFrame: The end of the PCI
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: North- Brabant
Study officials:
References: