Comparing drug-coated balloons and drug-eluting stents for patients at high bleeding risk undergoing heart procedures
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
This study is testing whether drug-coated balloons can be just as effective as drug-eluting stents for heart patients at high risk of bleeding, while also using less medication after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 546 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | North Karelia Central Hospital Academic / other |
| Locations | 14 sites (Jyväskylä, Central Finland and 13 other locations) |
| Trial ID | NCT04814212 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with stable coronary artery disease or acute coronary syndrome who are at high risk of bleeding. The hypothesis is that using DCB with a shorter duration of dual antiplatelet therapy (DAPT) is non-inferior to the traditional DES approach with longer DAPT. The study will involve patients who meet specific bleeding risk criteria and will assess outcomes related to safety and efficacy. If non-inferiority is established, the study will further evaluate whether DCB offers superior benefits over DES.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have significant bleeding risk factors and require percutaneous coronary intervention.
Not a fit: Patients without major or minor bleeding risk criteria or those who do not require PCI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for patients at high risk of bleeding during heart procedures.
How similar studies have performed: Previous studies have shown non-inferiority of DCB compared to other treatments in specific patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * 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: 1. 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. 2. 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 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
Where this trial is running
Jyväskylä, Central Finland and 13 other locations
- Central Hospital of Central Finland — Jyväskylä, Central Finland, Finland (Not_yet_recruiting)
- Central Hospital of Lapland — Rovaniemi, Lapland, Finland (Not_yet_recruiting)
- Kuopio University Hospital — Kuopio, Northern Savonia, Finland (Not_yet_recruiting)
- Turku University Hospital — Turku, Southwest Finland, Finland (Not_yet_recruiting)
- Helsinki University Hospital — Helsinki, Uusimaa, Finland (Not_yet_recruiting)
- North Karelia Central Hospital — Joensuu, Finland (Recruiting)
- Central Hospital of Päijät-Häme — Lahti, Finland (Recruiting)
- Oulu university hospital — Oulu, Finland (Not_yet_recruiting)
- Satakunta Central Hospital — Pori, Finland (Not_yet_recruiting)
- Tampere Heart Hospital — Tampere, Finland (Not_yet_recruiting)
- Centre Hospitalier La Rochelle — La Rochelle, France (Not_yet_recruiting)
- University Hospital of Carl Gustav Carus — Dresden, Germany (Not_yet_recruiting)
- University Hospital of Saarland — Homburg, Germany (Not_yet_recruiting)
- Norfolk and Norwich University Hospital Nhs Foundation Trust — Norwich, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Tuomas T Rissanen, MD, PhD — North Karelia Central Hospital
- Study coordinator: Tuomas Rissanen, MD, PhD
- Email: tuomas.rissanen@siunsote.fi
- Phone: +358505998022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.