2023-504340-34-01RecruitingPhase 4
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI (DEBATE)
Wellbeing Services County Of North Karelia Siun Sote10 sites in 3 countries734 target enrollmentStarted: January 11, 2024Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 734
- Locations
- 10
- Primary Endpoint
- The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)
Study Overview
Brief Summary
The purpose of this study is to compare percutaneous coronary intervention using drug-coated balloon (DCB) with drug-eluting stents (DES) in stable coronary artery disease (CAD) or in acute coronary syndromes (ACS) in patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter dual-antiplatelet (DAPT) treatment is non-inferior to the treatment using DES and longer DAPT duration in patients with high bleeding risk.
Study Design
- Allocation
- Randomized
- Primary Purpose
- 12, 24 And 36 Months
- Masking
- Single (Subject)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years, informed written consent, at least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC). 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
- •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.
Outcomes
Primary Outcomes
The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)
The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)
Secondary Outcomes
- The composite of MACE and BARC2-5 bleedings (24 and 36 months)
- MACE 12, 24 and 26 months
- BARC2-5 bleedings 12, 24 and 26 months
- BARC3-5 bleedings 12, 24 and 26 months
- Total mortality 12, 24 and 26 months
- Cardiovascular mortality 12, 24 and 26 months
- Myocardial infarction 12, 24 and 26 months
- TLR 12, 24 and 26 months
- Target-vessel failure (TVF) 12, 24 and 26 months
- Target-lesion failure (TLF) 12, 24 and 26 months
- The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months
- The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months
- The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months
- The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months
- Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis
- Hospitalization for urgent revascularization
- Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months
Investigators
Tuomas T Rissanen
Scientific
Wellbeing Services County Of North Karelia Siun Sote
Study Sites (10)
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