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

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.

Conditions

• Coronary Artery Disease

Interventions

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

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

Sponsors & Collaborators

• Central Hospital of Lapland

  collaborator UNKNOWN

• Kuopio University Hospital

  collaborator OTHER

• Central Finland Hospital District

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Oulu University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• Päijät Häme Central Hospital

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• Centre Hospitalier de La Rochelle

  collaborator OTHER

• Hospital Universitario de Cabuenes

  collaborator OTHER

• University Hospital Carl Gustav Carus

  collaborator OTHER

• University Hospital, Saarland

  collaborator OTHER

• North Karelia Central Hospital

  lead OTHER

Principal Investigators

• Tuomas T Rissanen, MD, PhD · North Karelia Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2026-01-01

Completion

2028-01-01

Countries

• Finland
• France
• Germany
• United Kingdom

Study Locations