Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)

This study is currently recruiting participants.
Verified December 2013 by North Karelia Central Hospital
Sponsor:
Collaborators:
Kuopio University Hospital Heart Center, Finland
Helsinki University Hospital Heart Center, Finland
Turku University Hospital Heart Center, Finland
Central Hospital of Jyväskylä, Finland
Information provided by (Responsible Party):
Tuomas Rissanen, North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT01781546
First received: January 29, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.


Condition Intervention
Coronary Artery Disease
Procedure: drug-eluting balloon (DEB)
Procedure: bare-metal stent (BMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Drug-Eluting Balloon in Stable and Unstable Angina: a Randomized Controlled Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR)) [ Time Frame: At 9 months ] [ Designated as safety issue: No ]
    In stable patients, the evidence of ischemia is acquired either by non-invasive testing (for example stress ECG or perfusion imaging) or by pressure wire measurement (FFR) during coronary angiography.

  • ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: At 9 months ] [ Designated as safety issue: No ]
  • Failure to treat the lesion [ Time Frame: During PCI ] [ Designated as safety issue: No ]
    The failure to deliver the randomized treatment (DEB or BMS) to the target lesion is defined as a failure to treat the lesion.


Other Outcome Measures:
  • Control angiography and OCT imaging [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    30 patients (15 from each group) will be randomly invited to a control angiography and OCT imaging to asses the rate of restenosis and endothelial healing.

  • MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR)) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  • ID-TLR (Ischemia Driven Target Lesion Revascularisation) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drug-eluting balloon (DEB)
Patients treated with drug-eluting balloon (DEB). Provisional stenting with BMS is permitted in case of a flow-limiting dissection or significant recoil (>30% in main branch and >50% side-branch), Includes both stable CAD and ACS patients.
Procedure: drug-eluting balloon (DEB)
The length of the DEB is chosen so that the lesion and 2mm from both ends are covered by the DEB. If needed, several DEBs can be used to cover the whole lesion. The diameter of the DEB and the pressure used is chosen so that the balloon-artery -ratio is 0.8-1.0. In case of a flow limiting dissection, significant recoil or coronary perforation, a provisional BMS is implanted (stent-artery -ratio 1.1) and the post dilatation is performed if indicated (the lesion length is >20mm or stent malapposition is suspected).
Other Name: SeQuent Please (B Braun, Germany, diameter 2,25-4.0mm)
Active Comparator: bare-metal stent (BMS)
Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.
Procedure: bare-metal stent (BMS)
The BMS is implanted after predilatation (stent-artery -ratio 1.1) to cover the whole lesion and the postdilatation is performed if indicated (the lesion length >20mm or stent malapposition is suspected).
Other Name: Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)

Detailed Description:

Stenting has reduced the need of revascularization procedures in stable CAD and ACS as compared to POBA. The use of stents is favored in stable CAD and in ACS according the the present ESC guidelines. However, especially in patients on warfarin or in patients at a high bleeding risk, stenting (and the use of DES in particular) is not recommended because of the longer DAPT required. In these patients, BMS may be used to shorten the duration of DAPT. However, there are problems associated with the treatment using BMS. First of all, a considerable high rate of restenosis is associated with stenting with BMS. Furthermore, stenting may be complicated by the "no-reflow" phenomenon, a coronary dissection or the closure of side branch during the treatment of bifurcation lesions. Implantation of a stent also exposes the patient to stent thrombosis. In contrast, these problems may be avoided by the use of DEB with the provisional BMS strategy.

The use of DEB has already been established in the treatment of ISR. Despite the lack of data of RCTs, DEB is already widely used in a variety of clinical situations in which stenting is not desirable. These situations include for example anticoagulation treatment, a high bleeding risk, poor compliance regarding medication, small vessels, bifurcation lesions, long and/or calcified lesions, in case of a marked variation in the vessel reference caliber, in long lesions and in patients with ACS. The all-comer registry data is promising but only hypothesis generating. Thus, it would be very important and ethical to test the efficacy of DEB in a wider patient population in a randomized controlled study.

Our hypothesis is that DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise having a high bleeding risk. Our study sheds light on the use of DEB in PCI of this challenging patient population. In most previous studies, BMS has been routinely added to the DEB treatment. This strategy seems not to yield any benefit but in contrast causes an increased risk of restenosis as compared to the DEB only strategy with provisional stenting. Finally, the current data on the use of DEB in patients with ACS is scarce and our study gives significant information also on this important issue.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Informed written consent
  • At least one of the following

    1. Patient is using oral anticoagulation (warfarin, dabigatran or rivaroxaban)
    2. Anemia (hemoglobin below the threshold: < 117g/l in women and < 134 g/l in men) or thrombocytopenia (<100) detected <6 months prior the PCI
    3. Active malign disease (metastatic cancer or ongoing radio- or chemotherapy)
    4. Prior intracerebral hemorrhage or ischemic stroke
    5. Severe kidney or liver dysfunction (eGFR < 30ml/kg/min, liver cirrhosis, BIL >2x over threshold or ALAT >3x over threshold)
    6. Elective surgery planned < 12 months after the PCI
    7. General frailty for e.g. because of long corticosteroid treatment or generalized cachexia (BMI < 20 kg/m2)
    8. Age ≥ 80 years
    9. Inability or suspected inability to use DAPT for 12 months
  • Either of the following:

    1. Stable angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. Ischemia is documented by the pressure wire measurement (FFR) or by a non-invasive test such as stress ECG test or perfusion imaging
    2. ACS (UAP or NSTEMI): symptoms of heart ischemia ≥ 20 minutes and ≥ 0,5mm ST-depression or transient ST-elevation or T-wave inversion at least in two adjacent leads and/or a high sensitivity troponin (hs-tnt) rise at least one unit above the 99. percentile or at least 50% rise in hs-tnt between two samples taken 3 hours apart
  • ≥1 de novo lesions in native coronary arteries or bypass vein grafts
  • Reference diameter of the vessel is 2,25-4,0mm
  • Lesion or lesions are suitable for PCI

Exclusion Criteria:

  • Inability to give written consent
  • STEMI
  • Reference diameter of the vessel is <2,25mm or >4,0mm
  • Bifurcation lesion requiring the stenting of the side branch
  • Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation
  • In-stent restenosis
  • Life expectancy < 12 months
  • Cardiogenic shock at the arrival to the coronary angiography
  • Uncertainty about neurological recovery e.g. after resuscitation
  • Unprotected left main (LM) lesion
  • Chronic total occlusion (CTO)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781546

Contacts
Contact: Tuomas Rissanen, MD, PhD tuomas.rissanen@pkssk.fi
Contact: Antti Siljander, MD antti-pekka.siljander@pkssk.fi

Locations
Finland
Helsinki University Hospital Heart Center Recruiting
Helsinki, Finland
Contact: Eeva Palojoki, MD, PhD       Eeva.Palojoki@hus.fi   
Principal Investigator: Eeva Palojoki, MD, PhD         
North Karelia Central Hospital Recruiting
Joensuu, Finland, 80210
Contact: Tuomas Rissanen, MD, PhD       tuomas.rissanen@pkssk.fi   
Principal Investigator: Tuomas Rissanen, MD, PhD         
Central Finland Central Hospital Not yet recruiting
Jyväskylä, Finland, 40620
Contact: Kai Nyman, MD       kai.nyman@ksshp.fi   
Sub-Investigator: Kai Nyman, MD         
Principal Investigator: Jarkko Niva, MD         
Kuopio University Hospital Recruiting
Kuopio, Finland, 70210
Contact: Hannu Romppanen, MD, PhD       hannu.romppanen@kuh.fi   
Contact: Juha Hartikainen, Professor       juha.hartikainen@kuh.fi   
Principal Investigator: Hannu Romppanen, MD, PhD         
Sub-Investigator: Juha Hartikainen, Professor         
Principal Investigator: Antti Siljander, MD         
Turku University Hospital Recruiting
Turku, Finland
Contact: Juhani Airaksinen, Professor       Juhani.Airaksinen@tyks.fi   
Principal Investigator: Juhani Airaksinen, Professor         
Sub-Investigator: Mikko Pietilä, MD, PhD         
Sponsors and Collaborators
North Karelia Central Hospital
Kuopio University Hospital Heart Center, Finland
Helsinki University Hospital Heart Center, Finland
Turku University Hospital Heart Center, Finland
Central Hospital of Jyväskylä, Finland
Investigators
Principal Investigator: Tuomas Rissanen, MD, PhD North Karelia Central Hospital
Principal Investigator: Antti Siljander, MD North Karelia Central Hospital
  More Information

No publications provided

Responsible Party: Tuomas Rissanen, Cardiologist, MD, PhD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01781546     History of Changes
Other Study ID Numbers: DEBUT
Study First Received: January 29, 2013
Last Updated: December 3, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Keywords provided by North Karelia Central Hospital:
drug eluting balloon
bare metal stent
coronary artery disease
acute coronary syndrome
percutaneous coronary intervention
DEB
BMS

Additional relevant MeSH terms:
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 16, 2014