Coronary Artery Disease
Conditions
Keywords
drug-coated balloon, paclitaxel, small native vessel coronary artery disease, coronary stenoses
Brief summary
Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.
Detailed description
Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up. As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months. Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.
Interventions
DEVICEPercutaneous Coronary Intervention with DCB and DAPT
* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with: * PCI with DCB on native arteries with diameters \< 3 mm. * Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI. syndrome or silent angina with an indication for PCI. * If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \> 30% or flow-limiting coronary dissections. * All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure. * Capacity to understand and sign the written informed consent. * If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of DCB therapy | 1 year | Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 1 year | Incidence of Cardiac death |
| All-cause mortality | 1 year | Incidence of All-cause mortality |
| Target vessel myocardial infarction | 1 year | Incidence of Target vessel myocardial infarction |
| New target lesion revascularization (TLR) | 1 year | Incidence of New target lesion revascularization (TLR) |
| Target vessel failure (TVF) | 1 year | Incidence of Target vessel failure (TVF) |
| Major bleeding | 1 year | Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5 |
| Minor bleeding | 1 year | Anemia, defined as Hb\<12g/dL for women and \<13g/dL for men |
| 1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days) | 1 year | safety analysis of short DAP (dual antiplatelet therapy) in terms of thrombotic risk after PCI |
Countries
Italy, Portugal, Spain
Outcome results
None listed