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Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Sponsor: North Karelia Central Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
546
Start Date
2022-09-01
Completion Date
2028-01-01
Last Updated
2023-11-09
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (14)
Central Hospital of Central Finland
Jyväskylä, Central Finland, Finland
Central Hospital of Lapland
Rovaniemi, Lapland, Finland
Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland
North Karelia Central Hospital
Joensuu, 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