Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
North Karelia Central Hospital
546 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria33
- 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
- Liver cirrhosis with portal hypertension
- Active cancer in the past 12 months
- Previous spontaneous ICH (at any time)
- Previous traumatic ICH within the past 12 months
- Presence of known brain arteriovenous malformation
- Moderate to severe ischemic stroke within the past 6 months
- Nondeferrable major surgery on dual antiplatelet therapy
- Recent major surgery or trauma within 30 days before PCI
- Minor Criteria
- Age >75 years
- Moderate CKD (eGFR 30-59 ml/min)
- Hemoglobin 110-129 g/l for men and 110-119 g/l for women
- Spontaneous bleeding requiring hospitalization or transfusion within the past 12 - months not meeting major criterion
- Long term use of oral nonsteroidal antiinflammatory drugs or steroids
- Any ischemic stroke at any time not meeting major criterion
- 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 99. 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 Criteria11
- 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
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Interventions
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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04814212