Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCathreine BV
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid DEB approach with drug-eluting balloon
Other interventionIf a patient is randomized to the hybrid DEB approach, lesion preparation of the SB with non-compliant balloon (NC) is mandatory before DEB application. The application of DEB can be performed if acceptable result of the lesion preparation is obtained (at least TIMI III flow and no flow limiting dissection). The drug- eluting balloon used in this study is the CE- marked Magic Touch Sirolimus Coated Balloon Catheter (Concept Medical, Gujarat, India). The size of the DEB is measured on a ratio 1:1 on reference diameter of the SB. The DEB balloon is inflated for 60 seconds, or two times more than 30 seconds if long duration inflations are not possible. Finally low pressure kissing inflation with the same DEB in place, and Proximal Optimization Therapy (POT) are performed. In case of SB occlusion, or flow limiting dissections in non-Left Main (LM) bifurcations and \< TIMI 3 flow or 70-99% residual stenosis in LM bifurcations, cross- over to two-stent technique is performed.
Two-stent strategy
Other interventionWhen randomized to the conventional two-stent strategy, TAP/T or Culotte stenting is performed. First lesion preparation of the SB is mandatory. The drug-eluting stent (Supraflex stent) can be placed in the SB if acceptable result of the lesion preparation is obtained and is measured on a 1:1 ratio on reference diameter of the SB. Finally, kissing inflation and POT are mandatory.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Hybrid DEBOther 1 intervention
Group B: Two-stent strategyOther 1 intervention
Trial outcomes
Primary outcomes
1
Composite of all-cause death, periprocedural or spontaneous myocardial infarction (MI) and/or target vessel revascularization (TVR)
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
Time frame
Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 yearSecondary outcomes
1
Procedural success
Procedural success defined as successful stent delivery with final core lab (defined as TIMI flow of III, angiographic in-stent MB and SB diameter stenosis ≤30%, or ≤50% after DEB in the side branch) and absence of in-hospital major adverse cardiac and cerebrovascular events (MACCE, defined as all cause death, spontaneous MI, TVR, stoke) at discharge, 12 months and the anticipated median 2 year
Time frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization2
Target vessel failure (TVF)
Target vessel failure (TVF), defined as cardiac death, target vessel spontaneous MI, TVR at discharge, 12 months and the anticipated median 2 year
Time frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization3
Major adverse cardiac events (MACE)
Major adverse cardiac events (MACE), defined as all-cause death, spontaneous MI, repeat revascularization at discharge, 12 months and the anticipated median 2 year
Time frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization4
Individual components of MACE and TVF
Individual components of MACE and TVF (All-cause death, cardiac death, periprocedural of spontaneous MI, target vessel revascularization, target vessel spontaneous MI) at discharge, 12 months and the anticipated median 2 year
Time frame
Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomizationSponsors and contacts
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Cathreine BV
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborator
Albert Schweitzer Hospital
Collaborator
Onze Lieve Vrouwe Gasthuis
Collaborator
Maasstad Hospital
Collaborator
The Elisabeth-TweeSteden Hospital
Collaborator
St. Antonius Hospital
Collaborator
Frisius Medisch Centrum
Collaborator
Meander Medical Center
Collaborator
VieCuri Medical Centre
Collaborator
Haga Hospital
Collaborator
Rijnstate Hospital
Collaborator
Jeroen Bosch Ziekenhuis
Collaborator
Source ClinicalTrials.gov