Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- North Karelia Central Hospital
- Enrollment
- 546
- Locations
- 14
- Primary Endpoint
- The composite of MACE and BARC type 2-5 bleeding episodes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. 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 in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.
Investigators
Tuomas Rissanen
Head of Heart Center
North Karelia Central Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Inability to give written consent
- •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 composite of MACE and BARC type 2-5 bleeding episodes
Time Frame: 12 months
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.
Secondary Outcomes
- The composite of MACE and BARC2-5 bleedings(24 and 36 months)
- The composite of TLR (Target-lesion revascularization) and BARC2-5 bleedings(12, 24 and 36 months)
- TLF(12, 24 and 36 months)
- The composite of TVF (Target-vessel failure) and BARC2-5 bleedings(12, 24 and 36 months)
- The composite of TLF (Target-lesion failure) and BARC2-5 bleedings(12, 24 and 36 months)
- Stroke (ischemic or hemorrhagic) or TIA(12, 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)
- Cardiovascular mortality(12, 24 and 36 months)
- TLR(12, 24 and 36 months)
- Myocardial infarction(12, 24 and 36 months)
- TVF(12, 24 and 36 months)
- Acute vessel closure as defined by the international consensus criteria for definite/probable stent thrombosis(12, 24 and 36 months)
- The composite of TLR (Target-lesion revascularization) and BARC3-5 bleedings(12, 24 and 36 months)
- Hospitalization for urgent revascularization(12, 24 and 36 months)