Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy

NCT05731687 | Recruiting DMC

• 1 other identifier: 21112022
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Bifurcation Lesion

Keywords

Coronary bifurcation lesion; Coronary artery disease; Drug-eluting balloon; Percutaneous coronary intervention

Outcome Measures

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

  Anticipated median 2 year follow-up after the date of randomization, with a minimum follow-up in all subjects of 1 year

Secondary Outcomes (31)

• Procedural success

  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

• Major adverse cardiac events (MACE)

  Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization

• Individual components of MACE and 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)

Study Arms (2)

Hybrid DEB

OTHER

Patients randomized to hybrid DEB group will receive application of DEB in the side branch.

Other: Hybrid DEB approach with drug-eluting balloon

Two-stent strategy

OTHER

Patients randomized to two-stent strategy will receive implantation of a second DES in the side branch, using Culotte or TAP/T technique.

Other: Two-stent strategy

Interventions

Hybrid DEB approach with drug-eluting balloon OTHER

If 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.

Hybrid DEB

Two-stent strategy OTHER

When 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.

Two-stent strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cathreine BV: lead
• 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

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

Related Publications (1)

• Dillen DMM, Vlaar PJ, Vermeer AJE, Paradies V, van Kuijk JP, Vink MA, Oemrawsingh RM, Hofma SH, Magro M, Remkes WS, de Smet BJGL, van Rees JB, Somi S, Halim J, Zimmermann FM, Wijnbergen IF, Tijssen JGP, Tonino PAL, Teeuwen K. Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study. Am Heart J. 2023 Dec;266:168-175. doi: 10.1016/j.ahj.2023.09.010. Epub 2023 Oct 6.

  PMID: 37806333 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Koen Teeuwen, MD, PhD

CONTACT

040- 2398360; koen.teeuwen@catharinaziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blinded study. The patients are blinded for the allocated therapy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Koen Teeuwen, MD, PhD, Principal Investigator

Model Details: Patients will be randomized in a 1:1 ratio to either hybrid DEB approach or two-stent strategy

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 16, 2023
• Study Start: March 21, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)