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

November 7, 2023 updated by: Tuomas Rissanen, North Karelia Central Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

546

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Joensuu, Finland, 80210
        • Recruiting
        • North Karelia Central Hospital
        • Contact:
        • Principal Investigator:
          • Tuomas Rissanen, MD, PhD
        • Sub-Investigator:
          • Antti Eranti, MD, PhD
        • Sub-Investigator:
          • Alma Räsänen, MD
      • Lahti, Finland
        • Recruiting
        • Central Hospital of Päijät-Häme
        • Contact:
        • Sub-Investigator:
          • Essi Pikkarainen, MD
        • Sub-Investigator:
          • Birgitta Salmela, MD
      • Oulu, Finland
        • Not yet recruiting
        • Oulu University Hospital
        • Contact:
        • Sub-Investigator:
          • Matti Niemelä, MD, PhD
        • Sub-Investigator:
          • Jarkko Piuhola, MD
      • Pori, Finland
        • Not yet recruiting
        • Satakunta Central Hospital
        • Contact:
        • Sub-Investigator:
          • Giannakis Toris, MD
        • Sub-Investigator:
          • Juha Rummukainen, MD
      • Tampere, Finland
        • Not yet recruiting
        • Tampere Heart Hospital
        • Contact:
        • Sub-Investigator:
          • Olli Kajander, MD, PhD
        • Sub-Investigator:
          • Erkki Ilveskoski, MD, PhD
    • Keski-Suomi
      • Jyväskylä, Keski-Suomi, Finland, 40620
        • Not yet recruiting
        • Central Hospital of Central Finland
        • Contact:
        • Sub-Investigator:
          • Tuukka Joki, MD
        • Sub-Investigator:
          • Jarkko Niva, MD, PhD
    • Lappi
      • Rovaniemi, Lappi, Finland, 96400
        • Not yet recruiting
        • Central Hospital of Lapland
        • Contact:
        • Sub-Investigator:
          • Annika Olli, MD
        • Sub-Investigator:
          • Magnus Hagnäs, MD, PhD
        • Sub-Investigator:
          • Hanna Tormilainen, MD
    • Pohjois-Savo
      • Kuopio, Pohjois-Savo, Finland, 70210
        • Not yet recruiting
        • Kuopio University Hospital
        • Contact:
        • Sub-Investigator:
          • Jussi Kärkkäinen, MD, PhD
        • Sub-Investigator:
          • Hannu Romppainen, MD, PhD
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Not yet recruiting
        • Helsinki University Hospital
        • Contact:
        • Sub-Investigator:
          • Mikko Minkkinen, MD, PhD
        • Sub-Investigator:
          • Johan Lassus, MD, PhD
        • Sub-Investigator:
          • Petri Laine, MD, PhD
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20521
        • Not yet recruiting
        • Turku University Hospital
        • Contact:
        • Sub-Investigator:
          • Tuomas Kiviniemi, MD, PhD
  • France
      • La Rochelle, France
        • Not yet recruiting
        • Centre Hospitalier La Rochelle
        • Contact:
        • Sub-Investigator:
          • Ludovic Meunier, MD
        • Sub-Investigator:
          • Caroline Allix-Beguec, PhD
  • Germany
      • Dresden, Germany
        • Not yet recruiting
        • University Hospital of Carl Gustav Carus
        • Contact:
        • Sub-Investigator:
          • Norman Manger, MD, PhD
        • Sub-Investigator:
          • Axel Linke, MD, PhD
      • Homburg, Germany
        • Not yet recruiting
        • UniversitY Hospital of Saarland
        • Contact:
        • Sub-Investigator:
          • Bruno Scheller, MD, PhD
        • Sub-Investigator:
          • Felix Mahmoud, MD, PhD
  • United Kingdom
      • Norwich, United Kingdom
        • Not yet recruiting
        • Norfolk and Norwich University Hospital NHS Foundation Trust
        • Contact:
        • Sub-Investigator:
          • Johannes Reinhold, MD
        • Sub-Investigator:
          • Simon Eccleshall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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:

  1. 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.
  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. 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug-coated balloon (DCB)
The coronary lesions fulfilling the inclusion criteria and randomized to the DCB group.
Device: Percutaneous coronary intervention using drug-coated balloon

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
Other Names:
  • DCB
Active Comparator: Drug-eluting stent (DES)
The coronary lesions fulfilling the inclusion criteria and randomized to the DES group.
Device: Percutaneous coronary intervention using drug-eluting stent

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
Other Names:
  • DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite of MACE and BARC type 2-5 bleeding episodes
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite of MACE and BARC2-5 bleedings
Time Frame: 24 and 36 months
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.
24 and 36 months
MACE
Time Frame: 12, 24 and 36 months
Composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)
12, 24 and 36 months
BARC2-5 bleedings
Time Frame: 12, 24 and 36 months
BARC = Bleeding academic research consortium
12, 24 and 36 months
BARC3-5 bleedings
Time Frame: 12, 24 and 36 months
BARC = Bleeding academic research consortium
12, 24 and 36 months
Total mortality
Time Frame: 12, 24 and 36 months
All-cause mortality
12, 24 and 36 months
Cardiovascular mortality
Time Frame: 12, 24 and 36 months

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
12, 24 and 36 months
TVF
Time Frame: 12, 24 and 36 months
Target-vessel failure
12, 24 and 36 months
TLR
Time Frame: 12, 24 and 36 months
Target-lesion revascularization
12, 24 and 36 months
TLF
Time Frame: 12, 24 and 36 months
Target-lesion failure
12, 24 and 36 months
Myocardial infarction
Time Frame: 12, 24 and 36 months
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
12, 24 and 36 months
Acute vessel closure as defined by the international consensus criteria for definite/probable stent thrombosis
Time Frame: 12, 24 and 36 months
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
12, 24 and 36 months
Hospitalization for urgent revascularization
Time Frame: 12, 24 and 36 months
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
12, 24 and 36 months
Stroke (ischemic or hemorrhagic) or TIA
Time Frame: 12, 24 and 36 months
Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document will be used (Circulation. 2018;137:2635-2650)
12, 24 and 36 months
The composite of TVF (Target-vessel failure) and BARC2-5 bleedings
Time Frame: 12, 24 and 36 months
Target-vessel failure. BARC = Bleeding academic research consortium.
12, 24 and 36 months
The composite of TLF (Target-lesion failure) and BARC2-5 bleedings
Time Frame: 12, 24 and 36 months
Target-lesion failure. BARC = Bleeding academic research consortium.
12, 24 and 36 months
The composite of TLR (Target-lesion revascularization) and BARC2-5 bleedings
Time Frame: 12, 24 and 36 months
Target-lesion revascularization. BARC = Bleeding academic research consortium.
12, 24 and 36 months
The composite of TLR (Target-lesion revascularization) and BARC3-5 bleedings
Time Frame: 12, 24 and 36 months
Target-lesion revascularization. BARC = Bleeding academic research consortium.
12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Karelia Central Hospital

Collaborators

Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
Norfolk and Norwich University Hospitals NHS Foundation Trust
University Hospital, Saarland
Tampere University Hospital
Central Finland Hospital District
Satakunta Central Hospital
University Hospital Carl Gustav Carus
Hospital Universitario de Cabuenes
Centre Hospitalier de La Rochelle
Central Hospital of Lapland
Päijät Häme Central Hospital

Investigators

  • Principal Investigator: Tuomas T Rissanen, MD, PhD, North Karelia Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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