In this study we will compare a hybrid DEB strategy with a conventional bailout 2-stent strategy (TAP/T-stenting or Culotte) in patients with a bifurcation lesion with sub-optimal side-branch result. The primary endpoint will be the composite…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether a hybrid approach with DEB is non-inferior to a two-stent
strategy with respect to the primary composite end point of all cause death,
periprocedural or spontaneous myocardial infarction, or target vessel
revascularization at the anticipated median follow-up of 2 years, with a
minimal follow-up of 1 year in each subject.
Secondary outcome
Clinical end points (measured at discharge, 12 months and at anticipated median
follow-up of 2 years)
• Procedural success, defined as successful stent delivery with:
o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of
III.
o Angiographic residual diameter stenosis (DS) <=30% after PCI with DES in MV or
SB and <30% after PCI with DEB in the SB.
o Absence of in-hospital major adverse cardiac and cerebrovascular events
(MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI),
target vessel revascularization (TVR), stroke).
• Target vessel failure (TVF, consisting of cardiac death, target vessel
spontaneous MI, and TVR).
• Major adverse cardiac events (MACE, consisting of all-cause death,
spontaneous MI, and repeat revascularization).
• Individual components of MACE and TVF.
Safety endpoints during index hospitalization
• Incidence of periprocedural MI:
o Type 4a (4th universal def).
• Major intraprocedural complications including type C-F dissections,
perforations, slow flow or no reflow(< TIMI III), thrombus and major side
branch occlusion (>2mm).
• Probable and definite stent thrombosis
• Major bleeding BARC type 2-5
Procedural and economical endpoints during index procedure
• Contrast volume
• Radiation exposure
• Procedural time (time from first to last procedural angiography image)
• Total costs per patient stratified to treatment group
• Cost-effectiveness analysis
Optional Intracoronary imaging endpoints (OCT) and Intravascular Ultrasound
(IVUS) if available
• Percentage of stent expansion in proximal and distal Main Branch (MB) and
Side-Branch (SB)
• Final minimal lumen and stent area (MLA/MSA) post stenting in the proximal
and distal MB and SB
• Incidence and quantification of dissections in the proximal and distal MB and
SB
Angiographic endpoints (Core Lab Assessed):
Pre-procedural assesment
• MB and SB Lesion length, diameter percentage of stenosis (DS), reference
vessel diameter
• moderate to severe coronary calcium
• Bifurcation angle
• Trombus
Final assesment post-stenting after final balloon dilatation
• Final in-stent and in-segment DS residual stenosis post-stenting in the MB
and SB
• Final in-stent and in-segment minimal lumen diameter (MLD) in the MB and SB
• Final in-stent and in-segment acute gain in the MB and SB
Background 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 complex bifurcations with upfront two-stent strategy (Double kiss double
crush technique) or provisional one-stent strategy with bailout stenting
(TAP/T-stenting or Culotte) of the side-branch.(1-5) Current guidelines
generally advise provisional approach with optional upfront two-stent strategy
in highly complex bifurcations.(6-7) However, a two-stent strategy carries
technical difficulties and is associated with increased procedure duration and
costs.
Beside improvement of techniques, outcome of bifurcation lesions have been
significantly improved due to the introduction of drug-eluting stents (DES).
DES have dramatically reduced the incidence of restenosis, in particular in
complex lesions and small vessel diameters. After the revolution of
drug-eluting stents, an emerging device that can optimize outcome in
bifurcation lesions are drug-eluting balloons (DEB).(10) DEB are conventional
semi-compliant angioplasty balloons covered with an anti-proliferative drug,
which is released into the vessel wall during inflation of the balloon. These
DEB have been widely tested for treating neo-intima proliferation after stent
implantation (in stent restenosis) or de novo lesions.(10-11) Several pilot
studies have also successfully investigated a hybrid approach with use of
drug-eluting balloons in addition to the provisional one-stent strategy.(8-9)
This hybrid approach has shown to be safe and feasible, however no large trials
have been performed comparing this with current 2-stent bifurcation strategies.
Study objective
In this study we will compare a hybrid DEB strategy with a conventional bailout
2-stent strategy (TAP/T-stenting or Culotte) in patients with a bifurcation
lesion with sub-optimal side-branch result. The primary endpoint will be the
composite endpoint of death, reinfarction, or target vessel revascularization
after two year follow-up. If the Hybrid PCI technique leads to a non-inferior
outcome of the primary endpoint as compared with the conventional two-stent
strategy, it will lend support to the use of this treatment strategy as part of
the standard approach in patients with bifurcation lesions. This wil lead to
shorter procedure time and thereby less exposure to radiation and contrast and
lower costs. Also there is less chance of in stent thrombosis and restenosis.
Study design
Investigator initiated, randomized controlled, single blinded, multicenter
study
Intervention
Patients in the hybride DEB group will get treatment with DEB in the side
branch. Patients in de two-stent group will get a second stent (DES) in the
side branch.
Study burden and risks
There is a risk of complications related to coronary angiography, regardless of
the treatment (DEB or two-stent). Possible risk associated with DEB are linked
to the use of the balloon catheter during the procedure:
• Coronary spasm
• Coronary dissection or perforation
• (distal) thrombo-embolism
• Restenosis or the side branch
These risks are low and can also happen if a patients is not participating in
this studie.
There is also the risk of the Hybrid DEB technique being inferior to the
two-stent strategy, with a higher risk of restenosis. On the other hand there
is one stent less implanted in the Hybrid DEB group, so lower change of in-
stent thrombosis.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
- > 18 years
- Significant de novo bifurcation lesion (main branch and side branch at least
2.5mm, one or more lesions >= 70% stenosis, side branch lesion >= 50% stenosis
or in case of intermediate stenosis FFR <= 0.80, iFR <=0.89)
- Stable coronary artery disease or stabilized acute coronary syndrome
- Patient is an acceptable candidate for treatment with a drug eluting stent
- Patient is willing and able to cooperate with study procedures and required
follow up visits
- Patient or legal representative had been informed of the nature of the studie
and agrees to its provisions and has provided an EC approved written informed
consent including data privacy authorization.
Exclusion criteria
- < 18 years
- Unstable clinical condition and/or need for emergency revascularization,
including cardiogenic shock
- Previous PCI with stent implantation in the target lesions
- Known comorbidity with a life expectation of <2 year
- Active bleeding requiring medical attentions
- 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 phospholid or
related orgnis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05731687 |
| CCMO | NL82146.100.22 |