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Coronary Artery DiseaseDEBUTNCT01781546

Drug-Eluting Balloon in Stable and Unstable Angina

A study testing drug-eluting balloon (DEB) and bare-metal stent (BMS) in people with Coronary Artery Disease, run by North Karelia Central Hospital at 4 sites in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
drug-eluting balloon (DEB) and bare-metal stent (BMS)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
4 sitesFinland
Study dates
22 May 2013to 16 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 19Show fewer
  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

4 sites in 1 country.

Finland4 sites

  • Helsinki University Hospital Heart Center

    Helsinki

  • North Karelia Central Hospital

    Joensuu, 80210

  • Kuopio University Hospital

    Kuopio, 70210

  • Turku University Hospital

    Turku

Other trials in Finland

About this study

Official title: Drug-Eluting Balloon in Stable and Unstable Angina: a Randomized Controlled Non-inferiority Trial

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.

Read the 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.

Being tested
drug-eluting balloon (DEB), bare-metal stent (BMS)
Keywords
drug eluting balloon, bare metal stent, coronary artery disease, acute coronary syndrome, percutaneous coronary intervention, DEB, BMS
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug-eluting balloon (DEB)Procedure or surgery

    Also called SeQuent Please (B Braun, Germany, diameter 2,5-4.0mm)

    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).

  • bare-metal stent (BMS)Procedure or surgery

    Also called Integrity stent (Medtronic, USA, diameter 2,5-4,0mm)

    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).

Study groups in NCT01781546
Study groupRoleWhat they receive
drug-eluting balloon (DEB)ExperimentalPatients 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.
Receives: Procedure: drug-eluting balloon (DEB)
bare-metal stent (BMS)Active comparatorPatients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.
Receives: Procedure: bare-metal stent (BMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 9 months

  2. ID-TLR (Ischemia Driven Target Lesion Revascularisation)

    Measured: at 36 months

Secondary outcomes (2)

  1. ID-TLR (Ischemia Driven Target Lesion Revascularisation)

    Measured: At 9 months

  2. 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.

    Measured: During PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2013 (estimated)
  2. Study start22 May 2013
  3. Primary completion16 Jan 2018
  4. Study completion16 Jan 2018

Why it stopped: suspeded due to slow recruitment, terminated due to interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01781546
Sponsor's protocol ID
DEBUT
Acronym
DEBUT
Status last verified
Jan 2018
First submitted
29 Jan 2013
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31204115

Questions about this trial

What is this clinical trial studying?

A study testing drug-eluting balloon (DEB) and bare-metal stent (BMS) in people with Coronary Artery Disease, run by North Karelia Central Hospital at 4 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: suspeded due to slow recruitment, terminated due to interim analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01781546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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