Patients with chronic coronary syndromes. Drug-coated balloons, percutaneous coronary intervention, chronic coronary syndromes, antithr ombotic therapy, antiplatelet agents
Conditions
Interventions
Single antiplatelet therapy (SAPT) group (study treatment group)
immediately after PCI with DCB, patients receive clopidogrel (75 mg once daily) as SAPT for 12 months (52 weeks).
Dual antiplatelet therapy (DAPT) group (standard treatment group)
patients receive DAPT (aspirin 81-100 mg once daily and clopidogrel 75 mg oncedaily) for 3 months (13 weeks) after PCI with DCB, followed by SAPT with aspirin (81-100 mg once daily) for 9 months (39 w
Sponsors
Otsuka Fumiyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic coronary syndromes who have undergone successful* PCI with drug-coated balloon (DCB; SeQuent Please Neo) (de novo lesions or restenotic lesions may be enrolled) (*Successful PCI with DCB requires (1) no dissection resulting in angiographic slow flow and (2) residual stenosis of 30% or less on angiography. If more than one lesion is treated in a single PCI, the patient may be enrolled as long as both lesions are successfully treated. Multiple lesions should be at least 5 mm apart between each lesion.) 2. Patients who are at least 18 years of age at the time of informed consent. 3. Patients whose written informed consent has been obtained from the individual.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing PCI with DCB (SeQuent Please Neo) and stent, or with DCB other than SeQuent Please Neo. 2. Patients undergoing PCI within 3 months (13 weeks) prior to PCI with DCB. 3. Patients scheduled for PCI or coronary artery bypass grafting (CABG) for coronary lesions other than the target lesion within 12 months (52 weeks) after PCI using DCB. 4. Patients undergoing PCI with DCB for the diagnosis of acute coronary syndrome in this study. 5. Patients with known allergy, intolerance, or contraindication to aspirin and/or clopidogrel. 6. Patients who have difficulty taking study medication. 7. Patients indicated for oral anticoagulation and taking oral anticoagulants at the time of informed consent or scheduled to start taking oral anticoagulants within 12 months (52 weeks) after PCI with DCB. 8. Patients considered to require continuation of dual antiplatelet therapy (DAPT). 9. Patients requiring continuation of antiplatelet a gents other than study drug (prasugrel, ticlopidine, ticagrelor, cilostazol, and sarpogrelate hydrochloride). 10. Patients with active bleeding at the time of informed consent. 11. Pregnant women, lactating women, or patients who cannot consent to contraception during study participation. 12. Patients expected to be unable to complete the study period. 13. Patients who plan to participate, or are already participating, in other interventional trials during the period of participation in this study. 14. Patients who are deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the composite endpoint of all cause mortality, myocardial infarction, stroke, urgent revascularization, and bleeding events (major and clinically relevant non-major bleeding; BARC 2, 3, 5) at 12 months (52 weeks) after PCI with DCB (to verify non-inferiority of the study treatment group to the standard treatment group). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Win Ratio based on hierarchical composite end point of primary endpoint at 12 months (52 weeks) after PCI (hierarchy in order of all cause mortality, myocardial infarction, stroke, urgent revascularization, major bleeding [BARC 3, 5], and clinically relevant non-major bleeding [BARC 2]) 2. Incidence and time to occurrence of the following clinical endpoints (individual components and combinations) at 12 months (52 weeks) after PCI (1) Death (all cause, cardiovascular, non-cardiovascular, unknown cause) (2) Myocardial infarction (MI) (Spontaneous MI [4th universal definition] or procedure-related MI [SCAI definition], target vessel MI or non-target vessel MI, STEMI or NSTEMI, Q wave MI or non-Q wave MI, stent thrombosis or no stent thrombosis) (3) Stroke (ischemic, hemorrhagic) (4) Urgent revascularization (PCI, CABG) (5) Bleeding (BARC criteria; [BARC 2,3,5, BARC 3,5, BARC 1-5], TIMI criteria; [Major, Minor, Major or Minor, Minimal]) (6) Target lesion revascularization (TLR) (all TLR, clinically driven TLR, not clinically driven TLR, non-TLR) (7) Target vessel revascularization (TVR) (all TVR, clinically driven TVR, not clinically driven TVR, non-TVR) (8) All coronary revascularization (PCI, CABG) (9) Target lesion failures (TLF) (composite endpoint; cardiovascular death, target vessel MI, or clinically driven TLR) (10) Target vessel failure (TVF) (composite endpoint; cardiovascular death, target vessel MI, or TVR) (11) Major adverse cardiovascular events (MACE) (composite endpoint; cardiovascular death, MI, or TLR) (12) Major adverse cardiac or cerebrovascular events (MACCE) (composite endpoint; cardiovascular death, MI, stroke, or any coronary revascularization) (13) Patient-oriented composite endpoint (PoCE) (composite endpoint; all cause death, MI, stroke, or any coronary revascularization) | — |
Contacts
Public ContactFumiyuki Otsuka
Yokohama City University Hospital
Outcome results
None listed