Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
DEBATE
1 other identifier
interventional
546
4 countries
14
Brief 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. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Sep 2022
Longer than P75 for not_applicable coronary-artery-disease
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedNovember 9, 2023
November 1, 2023
3.3 years
March 22, 2021
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months
Secondary Outcomes (17)
The composite of MACE and BARC2-5 bleedings
24 and 36 months
MACE
12, 24 and 36 months
BARC2-5 bleedings
12, 24 and 36 months
BARC3-5 bleedings
12, 24 and 36 months
Total mortality
12, 24 and 36 months
- +12 more secondary outcomes
Study Arms (2)
Drug-coated balloon (DCB)
EXPERIMENTALThe coronary lesions fulfilling the inclusion criteria and randomized to the DCB group.
Drug-eluting stent (DES)
ACTIVE COMPARATORThe coronary lesions fulfilling the inclusion criteria and randomized to the DES group.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
- +18 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North Karelia Central Hospitallead
- Central Hospital of Laplandcollaborator
- Kuopio University Hospitalcollaborator
- Central Finland Hospital Districtcollaborator
- Helsinki University Central Hospitalcollaborator
- Turku University Hospitalcollaborator
- Oulu University Hospitalcollaborator
- Tampere University Hospitalcollaborator
- Satakunta Central Hospitalcollaborator
- Päijät Häme Central Hospitalcollaborator
- Norfolk and Norwich University Hospitals NHS Foundation Trustcollaborator
- Centre Hospitalier de La Rochellecollaborator
- Hospital Universitario de Cabuenescollaborator
- University Hospital Carl Gustav Caruscollaborator
- University Hospital, Saarlandcollaborator
Study Sites (14)
Central Hospital of Central Finland
Jyväskylä, Central Finland, 40620, Finland
Central Hospital of Lapland
Rovaniemi, Lapland, 96400, Finland
Kuopio University Hospital
Kuopio, Northern Savonia, 70210, Finland
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
Helsinki University Hospital
Helsinki, Uusimaa, 00029, Finland
North Karelia Central Hospital
Joensuu, 80210, Finland
Central Hospital of Päijät-Häme
Lahti, Finland
Oulu university hospital
Oulu, Finland
Satakunta Central Hospital
Pori, Finland
Tampere Heart Hospital
Tampere, Finland
Centre Hospitalier La Rochelle
La Rochelle, France
University Hospital of Carl Gustav Carus
Dresden, Germany
University Hospital of Saarland
Homburg, Germany
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuomas T Rissanen, MD, PhD
North Karelia Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization to the study groups is done using the Random generator in blocks of 20 without stratification
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Heart Center
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
September 1, 2022
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
November 9, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share