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

Cathreine BV

Status: Enrolling

Conditions: Coronary Artery Disease; Coronary Bifurcation Lesion

Treatments: Other: Two-stent strategy; Other: Hybrid DEB approach with drug-eluting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT05731687

21112022

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Hybrid DEB

Other group

Description:

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

Treatment:

Other: Hybrid DEB approach with drug-eluting balloon

Two-stent strategy

Other group

Description:

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

Treatment:

Other: Two-stent strategy