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Coronary Artery DiseaseDEBATENCT04814212

Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

A study testing Percutaneous coronary intervention using drug-coated balloon and Percutaneous coronary intervention using drug-eluting stent in people with Coronary Artery Disease, run by North Karelia Central Hospital at 14 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. 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?
Percutaneous coronary intervention using drug-coated balloon and Percutaneous coronary intervention using drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
546 participants
Where
14 sitesin 4 countries
Study dates
1 Sep 2022to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 major or two minor bleeding risk criteria of Academic Research Consortium (ARC)
  • Major Criteria
  • Long-term oral anticoagulation
  • Severe or end stage chronic kidney disease (CKD) (estimated glomerular - filtration rate [eGFR] <30 ml/min)
Show all 33Show fewer
  • Hemoglobin <110 g/l
  • Spontaneous bleeding requiring hospitalization and transfusion in the past 6 months
  • Moderate to severe baseline thrombocytopenia (platelet count <100 x 10e9/L)
  • Chronic bleeding diathesis
  • Liver cirrhosis with portal hypertension
  • Active cancer in the past 12 months
  • Previous spontaneous ICH (at any time)
  • Previous traumatic ICH within the past 12 months
  • Presence of known brain arteriovenous malformation
  • Moderate to severe ischemic stroke within the past 6 months
  • Nondeferrable major surgery on dual antiplatelet therapy
  • Recent major surgery or trauma within 30 days before PCI
  • Minor Criteria
  • Age >75 years
  • Moderate CKD (eGFR 30-59 ml/min)
  • Hemoglobin 110-129 g/l for men and 110-119 g/l for women
  • Spontaneous bleeding requiring hospitalization or transfusion within the past 12 - months not meeting major criterion
  • Long term use of oral nonsteroidal antiinflammatory drugs or steroids
  • Any ischemic stroke at any time not meeting major criterion
  • Either of the following:
  • Stabile angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. In stable patients prior PCI, the evidence of ischemia is needed acquired either by perfusion imaging or by pressure wire measurement (FFR) during coronary angiography unless the coronary stenosis is > 90% in diameter.
  • 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. percentil or at least 50% rise in hs-tnt between two samples taken 1-3 hours apart.
  • At least one of the following:
  • ≥1 de novo lesions in native coronary arteries or bypass vein grafts
  • Reference diameter of the vessel is 2.0-5.0mm'
  • Lesion length ≤ 40mm
  • Lesion or lesions are suitable for PCI

Who cannot join

  • Inability to give written consent
  • STEMI
  • Reference diameter of the vessel is <2.0mm or >5.0 mm
  • Bifurcation lesion requiring the stenting of either of the branches after predilatation (TIMI<3 or significant recoil >30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation)
  • Dissection affecting the flow (TIMI<3) or significant recoil (>30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation
  • in-stent restenosis
Show all 11Show fewer
  • Chronic total occlusion
  • Life expectancy < 12 months
  • Cardiogenic shock at the arrival to the coronary angiography
  • Uncertainty about neurological recovery e.g. after resuscitation
  • Need for bypass surgery by heart team decision

Trial locations and contacts

14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Tuomas Rissanen, MD, PhD contact

+358505998022

tuomas.rissanen@siunsote.fi

Alma Räsänen, MD contact

alma.rasanen@siunsote.fi

14 sites in 4 countries

Finland10 sites, 10 recruiting

  • Helsinki University Hospital

    Helsinki, Uusimaa, 00029

    Mikko Minkkinen, MD, PhD, mikko.j.minkkinen@hus.fi

    Mikko Minkkinen, MD, PhD

    Not yet recruiting

  • North Karelia Central Hospital

    Joensuu, 80210

    Tuomas Rissanen, MD, PhD, tuomas.rissanen@siunsote.fi

    Tuomas Rissanen, MD, PhD

    Recruiting

  • Central Hospital of Central Finland

    Jyväskylä, Central Finland, 40620

    Tuukka Joki, MD, tuukka.joki@ksshp.fi

    Tuukka Joki, MD

    Not yet recruiting

  • Kuopio University Hospital

    Kuopio, Northern Savonia, 70210

    Jussi Kärkkäinen, MD, PhD, jussi.karkkainen@kuh.fi

    Jussi Kärkkäinen, MD, PhD

    Not yet recruiting

  • Central Hospital of Päijät-Häme

    Lahti

    Essi Pikkarainen, MD, essi.pikkarainen@phhyky.fi

    Essi Pikkarainen, MD

    Recruiting

  • Oulu university hospital

    Oulu

    Matti Niemelä, MD, PhD, matti.niemela@ppshp.fi

    Matti Niemelä, MD, PhD

    Not yet recruiting

  • Satakunta Central Hospital

    Pori

    Giannakis Toris, MD, giantoris@gmail.com

    Giannakis Toris, MD

    Not yet recruiting

  • Central Hospital of Lapland

    Rovaniemi, Lapland, 96400

    Annika Olli, MD, annika.olli@lshp.fi

    Annika Olli, MD

    Not yet recruiting

  • Tampere Heart Hospital

    Tampere

    Olli Kajander, MD, PhD, olli.kajander@sydansairaala.fi

    Olli Kajander, MD, PhD

    Not yet recruiting

  • Turku University Hospital

    Turku, Southwest Finland, 20521

    Tuomas Kiviniemi, MD, PhD, tuomas.kiviniemi@tyks.fi

    Tuomas Kiviniemi, MD, PhD

    Not yet recruiting

Other trials in Finland

Germany2 sites, 2 recruiting

  • University Hospital of Carl Gustav Carus

    Dresden

    Norman Manger, MD, PhD, norman.mangner@tu-dresden.de

    Norman Manger, MD, PhD

    Not yet recruiting

  • University Hospital of Saarland

    Homburg

    Bruno Scheller, MD, PhD, Bruno.Scheller@uks.eu

    Bruno Scheller, MD, PhD

    Not yet recruiting

Other trials in Germany

France1 site, 1 recruiting

  • Centre Hospitalier La Rochelle

    La Rochelle

    Ludovic Meunier, MD, ludomeunier017@gmail.com

    Ludovic Meunier, MD

    Not yet recruiting

Other trials in France

United Kingdom1 site, 1 recruiting

  • Norfolk and Norwich University Hospital Nhs Foundation Trust

    Norwich

    Simon Eccleshall, MD, simon.eccleshall@nnuh.nhs.uk

    Johannes Reinhold, MD

    Not yet recruiting

Other trials in United Kingdom

About this study

The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Read the detailed description

Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known.

Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing.

The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Being tested
Percutaneous coronary intervention using drug-coated balloon, Percutaneous coronary intervention using drug-eluting stent
Keywords
drug-coated balloon, drug eluting stent, coronary artery disease, acute coronary syndrome, percutaneous coronary intervention, DCB, DES, drug coated balloon, drug-eluting stent, drug-eluting balloon, high bleeding risk, HBR
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.

  • Percutaneous coronary intervention using drug-coated balloonDevice

    Also called DCB

    SeQuent Please (BBraun) + tailored antithrombotic regimen:

    1. Stable patients without OAC: perioperative SAPT (preferably) or perioperative DAPT followed by lifelong SAPT
    2. Stable patients with OAC: perioperative SAPT (preferably) or perioperative DAPT and lifelong OAC
    3. ACS patients without OAC: 1-month DAPT followed by lifelong SAPT
    4. ACS patients with OAC: perioperative DAPT followed by 1-month SAPT and lifelong OAC

  • Percutaneous coronary intervention using drug-eluting stentDevice

    Also called DES

    Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic), Xience Pro S (Abbott) or Promus Elite (Boston Scientific) or any other DES can also be used provided that it has a CE mark for 1-month DAPT, combined with tailored antithrombotic regimen:

    1. Stable patients without OAC: 1-month DAPT followed by lifelong SAPT
    2. Stable patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and life-long OAC
    3. ACS patients without OAC: 3-month DAPT followed by lifelong SAPT
    4. ACS patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and lifelong OAC
Study groups in NCT04814212
Study groupRoleWhat they receive
Drug-coated balloon (DCB)ExperimentalThe coronary lesions fulfilling the inclusion criteria and randomized to the DCB group.
Receives: Device: Percutaneous coronary intervention using drug-coated balloon
Drug-eluting stent (DES)Active comparatorThe coronary lesions fulfilling the inclusion criteria and randomized to the DES group.
Receives: Device: Percutaneous coronary intervention using drug-eluting stent

What is being measured

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

  1. The composite of MACE and BARC type 2-5 bleeding episodes

    Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR). BARC = Bleeding academic research consortium. 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: 12 months

Secondary outcomes (17)

  1. The composite of MACE and BARC2-5 bleedings

    Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR). BARC = Bleeding academic research consortium. 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: 24 and 36 months

  2. MACE

    Composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)

    Measured: 12, 24 and 36 months

  3. BARC2-5 bleedings

    BARC = Bleeding academic research consortium

    Measured: 12, 24 and 36 months

  4. BARC3-5 bleedings

    BARC = Bleeding academic research consortium

    Measured: 12, 24 and 36 months

  5. Total mortality

    All-cause mortality

    Measured: 12, 24 and 36 months

  6. Cardiovascular mortality

    Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected:

    1. Death caused by acute MI
    2. Death caused by sudden cardiac, including unwitnessed, death
    3. Death resulting from heart failure
    4. Death caused by stroke
    5. Death caused by cardiovascular procedures
    6. Death resulting from cardiovascular hemorrhage
    7. Death resulting from other cardiovascular cause

    Measured: 12, 24 and 36 months

  7. TVF

    Target-vessel failure

    Measured: 12, 24 and 36 months

  8. TLR

    Target-lesion revascularization

    Measured: 12, 24 and 36 months

  9. TLF

    Target-lesion failure

    Measured: 12, 24 and 36 months

  10. Myocardial infarction

    Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)

    Measured: 12, 24 and 36 months

  11. The composite of TVF (Target-vessel failure) and BARC2-5 bleedings

    Target-vessel failure. BARC = Bleeding academic research consortium.

    Measured: 12, 24 and 36 months

  12. The composite of TLF (Target-lesion failure) and BARC2-5 bleedings

    Target-lesion failure. BARC = Bleeding academic research consortium.

    Measured: 12, 24 and 36 months

  13. The composite of TLR (Target-lesion revascularization) and BARC2-5 bleedings

    Target-lesion revascularization. BARC = Bleeding academic research consortium.

    Measured: 12, 24 and 36 months

  14. The composite of TLR (Target-lesion revascularization) and BARC3-5 bleedings

    Target-lesion revascularization. BARC = Bleeding academic research consortium.

    Measured: 12, 24 and 36 months

  15. Acute vessel closure as defined by the international consensus criteria for definite/probable stent thrombosis

    Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)

    Measured: 12, 24 and 36 months

  16. Hospitalization for urgent revascularization

    Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)

    Measured: 12, 24 and 36 months

  17. Stroke (ischemic or hemorrhagic) or TIA

    Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)

    Measured: 12, 24 and 36 months

Timeline

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

  1. First posted24 Mar 2021
  2. Study start1 Sep 2022
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2028 (estimated)

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
Model description
Randomized controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
546 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04814212
Sponsor's protocol ID
DEBATE
Acronym
DEBATE
Status last verified
Nov 2023
First submitted
22 Mar 2021
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention using drug-coated balloon and Percutaneous coronary intervention using drug-eluting stent in people with Coronary Artery Disease, run by North Karelia Central Hospital at 14 sites in 4 countries.

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 33 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: looking for participants now, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Finland, Germany, France, United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Tuomas Rissanen, MD, PhD (+358505998022, tuomas.rissanen@siunsote.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite of MACE and BARC type 2-5 bleeding episodes (time frame: 12 months). 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 NCT04814212.

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 9 Nov 2023.

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