Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02601157

Collaborator

B. Braun Korea Co., Ltd. (Industry)

2,152

Enrollment

Locations

Arms

179.3

Patients Per Site

Study Details

Study Description

Brief Summary

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.

With a 2x2 factorial design for patients of stable angina or silent ischemia, the investigators formulate a head-to-head randomized comparison between sirolimus-eluting Orsiro stent with biodegradable polymer and polymer-free stent platform with the same antiproliferative agent, Coroflex ISAR stent system. At the same time, clopidogrel 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. 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 primary efficacy outcome. And in addition to TLF, definite or probable stent thrombosis and major bleeding events will also be counted as a composite outcome of net adverse clinical events (NACEs) to comprehensively adjudicate the efficacy and safety outcomes according to the difference of DAPT duration.

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Unstable Angina Non-ST Segment Elevation Myocardial Infarction	Device: CX-ISAR Device: Orsiro Drug: 3-months DAPT Drug: 1-year DAPT	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2152 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orsiro SES/3-months DAPT As an one of experimental arms in 2x2 factorial design, patients allocated to this group will be implanted with Orisro sirolimus-eluting stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.	Device: Orsiro Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, abluminal coatings with biodegradable polymer. Other Names: Orsiro sirolimus-eluting stents Drug: 3-months DAPT Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting Other Names: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting
Active Comparator: Orsiro SES/1-year DAPT As an one of comparator arms in 2x2 factorial design, patients allocated to this group will be implanted with Orisro sirolimus-eluting stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.	Device: Orsiro Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, abluminal coatings with biodegradable polymer. Other Names: Orsiro sirolimus-eluting stents Drug: 1-year DAPT Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting Other Names: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting
Experimental: CX-ISAR/3-months DAPT As an one of experimental arms in 2x2 factorial design, patients allocated to this group will be implanted with Coroflex ISAR (CX-ISAR) sirolimus-eluting stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.	Device: CX-ISAR Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface. Other Names: Coroflex ISAR sirolimus-eluting stents Drug: 3-months DAPT Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting Other Names: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting
Active Comparator: CX-ISAR/1-year DAPT As an one of comparator arms in 2x2 factorial design, patients allocated to this group will be implanted with Coroflex ISAR (CX-ISAR) sirolimus-eluting stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.	Device: CX-ISAR Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface. Other Names: Coroflex ISAR sirolimus-eluting stents Drug: 1-year DAPT Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting Other Names: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting

Outcome Measures

Primary Outcome Measures

TLF (target lesion failure) [post-stenting 12 months]
composite end-point of cardiac death, target lesion-related non-fatal myocardial infarction, clinically-driven target lesion revascularization
NACEs (net adverse clinical events) [post-stenting 12 months]
TLF + definite or probable stent thrombosis, major bleeding

Secondary Outcome Measures

definite or probable stent thrombosis and major bleeding [post-stenting 12 months]
stent thrombosis or major bleeding as a safety measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with de novo stenotic lesions who are suitable for coronary stenting with drug-eluting stent

Exclusion Criteria:

1. High risk profiles for ischemic adverse events such as A. ST-segment elevation myocardial infarction (STEMI) B. Patients with cardiogenic shock or concomitant severe decompensated heart failure C. Myocardial infarction or stent thrombosis in spite of the maintenance of antiplatelet therapy D. Restenosis in stented segments or previous sites of balloon angioplasty 2. Patients who cannot follow allocated DAPT schedule due to the planned surgery or elective procedure within 3 months after the stenting 3. Recent history of major surgery or evident events of gastrointestinal bleeding within 1 month from the procedure 4. Patients on anticoagulation therapy with warfarin or other anticoagulants 5. Life expectancy less than 1 year (such as malignancies or other chronic systemic diseases) 6. Pregnant women 7. Past history of allergy or other contraindications for the following medications/materials: aspirin, clopidogrel, heparin, cobalt chromium, sirolimus

Contacts and Locations

Locations

	Site	City	Country
1	Busan Paik Hospital	Busan	Korea, Republic of
2	Kosin University Gospel Hospital	Busan	Korea, Republic of
3	SoonChunHyang University Cheonan Hospital	Cheonan	Korea, Republic of
4	Chonnam National University Hospital	Gwangju	Korea, Republic of
5	Gwangju Christian Hospital	Gwangju	Korea, Republic of
6	Ewha Womans University Medical Center Mokdong Hospital	Seoul	Korea, Republic of
7	Hallym University Kangdong Sacred Heart Hospital	Seoul	Korea, Republic of
8	Kangnam Sacred Heart Hospital	Seoul	Korea, Republic of
9	Korea University Guro Hospital	Seoul	Korea, Republic of
10	Kyung Hee University Hospital at Gangdong	Seoul	Korea, Republic of
11	Seoul National University Hospital	Seoul	Korea, Republic of
12	Ajou University Hospital	Suwon	Korea, Republic of