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

Official title

Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry

Overview

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.

Interventions

• Other Hybrid DEB approach with drug-eluting balloon
  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
• Other Two-stent strategy
  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.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Procedural success [Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization]
• Target vessel failure (TVF) [Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization]
• Major adverse cardiac events (MACE) [Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization]
• Individual components of MACE and TVF [Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization]
• Periprocedural MI [Time frame: 48 hours after the Percutaneous Coronary Intervention (PCI)]
• Major intraprocedural complications [Time frame: The end of the PCI]
• Probable and definite stent thrombosis [Time frame: Discharge, 12 months and the anticipated median 2 year follow-up after the date of randomization]
• Major bleeding, defined as BARC type 2-5 [Time frame: Discharge after the PCI]
• Contrast volume used during the PCI procedure [Time frame: The end of the PCI]
• Radiation exposure of the patient, measured in DAP and AirKerma [Time frame: The end of the PCI]
• Procedural time, measured in minutes, defined as time from first to last procedural angiography image [Time frame: The end of the PCI]
• Total procedural costs (in euro's) per patient stratified to treatment group [Time frame: The end of the PCI]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Catharina Hospital — Eindhoven

Publications

• 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 PMID 37806333

Identifiers

NCT: NCT05731687 · 21112022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗