We had little experience in coronary intervention with recently introduced newer drug-eluting stent (DES) platforms, despite great anticipation, and optimal duration of dual antiplatelet therapy (DAPT) for these stent systems still needs to be established. Herein, we plan the HOST-coronary intervention with next-generation drug-eluting stent platforms and abbreviated dual antiplatelet therapy (HOST-IDEA) trial to compare single antiplatelet therapy (SAPT) after 3-month DAPT with 12-month DAPT in all-comers undergoing coronary intervention with third-generation DES with the thinnest struts. P2Y12 inhibitor treatment is added to aspirin during the 3-months period after the stenting, and this abbreviated duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1 randomized stratification. Net adverse clinical events (NACEs), a composite of cardiac death, target vessel related myocardial infarction, clinically-drivent target lesion revascularization, definite or probable stent thrombosis and major bleeding is a primary endpoint for evaluating safety and efficacy of the difference of DAPT duration. 1-year target lesion failure (TLF) as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization will be identified as a secondary ischemic outcome. 1-year major bleeding events classified as BARC type 3 or 5 bleeding events will be identified as a secondary bleeding outcome. With this trial, you will be able to get clear insight on the behavior of newer DES platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated in the selected patients, and it might be helpful to those who need it.
Every antiplatelet-naïve patient undergoing an elective procedure will be given 300 mg aspirin and loading dose of one of P2Y12 receptor inhibitors (e.g., 600 mg clopidogrel, 60 mg prasugrel or 180 mg ticagrelor) preferably ≥2 hours before the intervention. These loading doses can be waived for chronic antiplatelet users, and prasugrel or ticagrelor can be used instead of clopidogrel. Choice for P2Y12 inhibitors will be left to responsible physicians' discretion, and this decision will be based on the patient/lesional characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,173
Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting
Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting
Busan Paik Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
SoonChunHyang University Cheonan Hospital
Cheonan, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gwangju Christian Hospital
Gwangju, South Korea
Ewha Womans University Medical Center Mokdong Hospital
Seoul, South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea
Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
...and 2 more locations
NACEs (net adverse clinical events)
a composite of cardiac death, target vessel-related non-fatal myocardial infarction, clinically-driven target lesion revascularization, definite or probable stent thrombosis, and major bleeding
Time frame: post-stenting 12 months
TLF (target lesion failure)
a composite of cardiac death, target vessel-related non-fatal myocardial infarction, and clinically-driven target lesion revascularization
Time frame: post-stenting 12 months
Major bleeding
Major bleeding events classified as BARC type 3 or 5 bleeding events
Time frame: post-stenting 12 months
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