Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Cathreine BV
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Koen Teeuwen
Koen Teeuwen, MD, PhD, Principal Investigator
Cathreine BV
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.
Outcomes
Primary Outcomes
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
Time Frame: Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year
Composite of all-cause death, periprocedural (according to the SCAI/ARC II definition and a secondary analysis according to the 4th universal definition) or spontaneous (according to the 4th universal definition) myocardial infarction (MI) and/or target vessel revascularization (TVR) at the anticipated median 2 year
Secondary Outcomes
- Individual components of MACE and TVF(Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization)
- Major intraprocedural complications(The end of the PCI)
- Dissections in the proximal and distal main branch and side branch, measured using intracoronary imaging (OCT or IVUS)(The end of the PCI)
- Core Lab Assessed initial TIMI flow main branch and side branch(During the Coronary Angiography (CAG), before the PCI)
- Core Lab Assessed residual dissection (type A-F) after PCI in the main branch and/or side branch(The end of the PCI)
- Contrast volume used during the PCI procedure(The end of the PCI)
- Procedural success(Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization)
- Major adverse cardiac events (MACE)(Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization)
- Target vessel failure (TVF)(Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization)
- Periprocedural MI(48 hours after the Percutaneous Coronary Intervention (PCI))
- Core Lab Assessed reference diameter (in mm) proximal main branch and side branch(During the CAG, before the PCI)
- The severity of calcification main branch and side branch, Core Lab Assessed(During the CAG, before the PCI)
- Core Lab Assessed final TIMI flow main branch and side branch(The end of the PCI)
- Core Lab Assessed residual in-stent and in-segment stenosis (in %) after PCI(The end of the PCI)
- Probable and definite stent thrombosis(Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization)
- Major bleeding, defined as BARC type 2-5(Discharge after the PCI)
- Procedural time, measured in minutes, defined as time from first to last procedural angiography image(The end of the PCI)
- Bifurcation medina score(During the CAG, before the PCI)
- Radiation exposure of the patient, measured in DAP and AirKerma(The end of the PCI)
- Total procedural costs (in euro's) per patient stratified to treatment group(The end of the PCI)
- Percentage of stent expansion in proximal and distal main branch and side branch, measured with intracoronary imaging (OCT or IVUS)(The end of the PCI)
- Final minimal lumen and stent area post stenting in the proximal and distal main branch measured with intracoronary imaging (OCT or IVUS)(The end of the PCI)
- Core Lab Assessed Lesion Length (in mm)(During the CAG, before the PCI)
- Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch(During the CAG, before the PCI)
- Core Lab Assessed minimal lumen diameter (in mm) main branch and side branch post PCI(The end of the PCI)
- Core Lab Assessed percentage diameter stenosis main branch and side branch(During the CAG, before the PCI)
- Core Lab Assessed Bifurcation angle(During the CAG, before the PCI)
- Core Lab Assessed syntax I score as absolute value(During the CAG, before the PCI)
- Core Lab Assessed percentage diameter stenosis main branch and side branch post PCI(The end of the PCI)
- Core Lab Assessed acute lumen gain (in mm) main of the branch and side branch after PCI(The end of the PCI)
- Core Lab Assessed Procedural coronary thrombus(The end of the PCI)