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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
drug-eluting balloon (DEB)
bare-metal stent (BMS)
Sponsored by
North Karelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug eluting balloon, bare metal stent, coronary artery disease, acute coronary syndrome, percutaneous coronary intervention, DEB, BMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    10) Prior bleeding (BARC 2-5)

    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 2,5-4,0mm
  • Lesion or lesions are suitable for PCI

Exclusion Criteria:

  • Inability to give written consent
  • STEMI
  • Reference diameter of the vessel is <2,5mm 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)

Sites / Locations

  • Helsinki University Hospital Heart Center
  • North Karelia Central Hospital
  • Kuopio University Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

drug-eluting balloon (DEB)

bare-metal stent (BMS)

Arm Description

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.

Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.

Outcomes

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))
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)

Secondary Outcome Measures

ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Failure to treat the lesion
The failure to deliver the randomized treatment (DEB or BMS) to the target lesion is defined as a failure to treat the lesion.

Full Information

First Posted
January 29, 2013
Last Updated
January 28, 2018
Sponsor
North Karelia Central Hospital
Collaborators
Kuopio University Hospital, University of Helsinki, Turku University Hospital, Central Hospital of Lapland, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01781546
Brief Title
Drug-Eluting Balloon in Stable and Unstable Angina
Acronym
DEBUT
Official Title
Drug-Eluting Balloon in Stable and Unstable Angina: a Randomized Controlled Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
suspeded due to slow recruitment, terminated due to interim analysis
Study Start Date
May 22, 2013 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
January 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital
Collaborators
Kuopio University Hospital, University of Helsinki, Turku University Hospital, Central Hospital of Lapland, Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug eluting balloon, bare metal stent, coronary artery disease, acute coronary syndrome, percutaneous coronary intervention, DEB, BMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug-eluting balloon (DEB)
Arm Type
Experimental
Arm Description
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.
Arm Title
bare-metal stent (BMS)
Arm Type
Active Comparator
Arm Description
Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.
Intervention Type
Procedure
Intervention Name(s)
drug-eluting balloon (DEB)
Other Intervention Name(s)
SeQuent Please (B Braun, Germany, diameter 2,5-4.0mm)
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
bare-metal stent (BMS)
Other Intervention Name(s)
Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)
Intervention Description
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).
Primary Outcome Measure Information:
Title
MACE (Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven target lesion revascularization (ID-TLR))
Description
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.
Time Frame
At 9 months
Title
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame
at 36 months
Secondary Outcome Measure Information:
Title
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame
At 9 months
Title
Failure to treat the lesion
Description
The failure to deliver the randomized treatment (DEB or BMS) to the target lesion is defined as a failure to treat the lesion.
Time Frame
During PCI
Other Pre-specified Outcome Measures:
Title
Control angiography and OCT imaging
Description
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.
Time Frame
At 6 months
Title
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
Title
ID-TLR (Ischemia Driven Target Lesion Revascularisation)
Time Frame
at 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Informed written consent At least one of the following Patient is using oral anticoagulation (warfarin, dabigatran or rivaroxaban) Anemia (hemoglobin below the threshold: < 117g/l in women and < 134 g/l in men) or thrombocytopenia (<100) detected <6 months prior the PCI Active malign disease (metastatic cancer or ongoing radio- or chemotherapy) Prior intracerebral hemorrhage or ischemic stroke Severe kidney or liver dysfunction (eGFR < 30ml/kg/min, liver cirrhosis, BIL >2x over threshold or ALAT >3x over threshold) Elective surgery planned < 12 months after the PCI General frailty for e.g. because of long corticosteroid treatment or generalized cachexia (BMI < 20 kg/m2) Age ≥ 80 years Inability or suspected inability to use DAPT for 12 months Either of the following: 10) Prior bleeding (BARC 2-5) 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 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 2,5-4,0mm Lesion or lesions are suitable for PCI Exclusion Criteria: Inability to give written consent STEMI Reference diameter of the vessel is <2,5mm 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuomas Rissanen, MD, PhD
Organizational Affiliation
North Karelia Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antti Siljander, MD
Organizational Affiliation
North Karelia Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital Heart Center
City
Helsinki
Country
Finland
Facility Name
North Karelia Central Hospital
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31204115
Citation
Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13. Erratum In: Lancet. 2019 Jul 20;394(10194):218.
Results Reference
derived

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Drug-Eluting Balloon in Stable and Unstable Angina

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