Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug eluting balloon, bare metal stent, coronary artery disease, acute coronary syndrome, percutaneous coronary intervention, DEB, BMS
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Informed written consent
At least one of the following
- Patient is using oral anticoagulation (warfarin, dabigatran or rivaroxaban)
- Anemia (hemoglobin below the threshold: < 117g/l in women and < 134 g/l in men) or thrombocytopenia (<100) detected <6 months prior the PCI
- Active malign disease (metastatic cancer or ongoing radio- or chemotherapy)
- Prior intracerebral hemorrhage or ischemic stroke
- Severe kidney or liver dysfunction (eGFR < 30ml/kg/min, liver cirrhosis, BIL >2x over threshold or ALAT >3x over threshold)
- Elective surgery planned < 12 months after the PCI
- General frailty for e.g. because of long corticosteroid treatment or generalized cachexia (BMI < 20 kg/m2)
- Age ≥ 80 years
- Inability or suspected inability to use DAPT for 12 months
Either of the following:
10) Prior bleeding (BARC 2-5)
- Stable angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. Ischemia is documented by the pressure wire measurement (FFR) or by a non-invasive test such as stress ECG test or perfusion imaging
- 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. percentile or at least 50% rise in hs-tnt between two samples taken 3 hours apart
- ≥1 de novo lesions in native coronary arteries or bypass vein grafts
- Reference diameter of the vessel is 2,5-4,0mm
- Lesion or lesions are suitable for PCI
Exclusion Criteria:
- Inability to give written consent
- STEMI
- Reference diameter of the vessel is <2,5mm or >4,0mm
- Bifurcation lesion requiring the stenting of the side branch
- Dissection affecting the flow (TIMI<3) or significant recoil (>30% in main branch, >50% in side branch) after predilatation
- In-stent restenosis
- Life expectancy < 12 months
- Cardiogenic shock at the arrival to the coronary angiography
- Uncertainty about neurological recovery e.g. after resuscitation
- Unprotected left main (LM) lesion
- Chronic total occlusion (CTO)
Sites / Locations
- Helsinki University Hospital Heart Center
- North Karelia Central Hospital
- Kuopio University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
drug-eluting balloon (DEB)
bare-metal stent (BMS)
Patients treated with drug-eluting balloon (DEB). Provisional stenting with BMS is permitted in case of a flow-limiting dissection or significant recoil (>30% in main branch and >50% side-branch), Includes both stable CAD and ACS patients.
Patients treated with bare-metal stent (BMS). Includes both stable CAD and ACS patients.