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

NCT02601157 | Completed Phase 4 DMC

• 1 other identifier: HOST-IDEA trial
• Study Type: interventional
• Target: 2,173
• Locations: 1 country
• Sites: 12

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. 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.

Conditions

Stable Angina; Unstable Angina; Non-ST Segment Elevation Myocardial Infarction

Keywords

stent; polymer; antiplatelet therapy; clopidogrel

Outcome Measures

Primary Outcomes (1)

• 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

  post-stenting 12 months

Secondary Outcomes (2)

• TLF (target lesion failure)

  post-stenting 12 months

• Major bleeding

  post-stenting 12 months

Study Arms (2)

Orsiro SES or CX-ISAR/3-months DAPT

EXPERIMENTAL

Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Corflex ISAR stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.

Drug: 3-months DAPT

Orsiro SES or CX-ISAR/1-year DAPT

ACTIVE COMPARATOR

Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Coroflex ISAR stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.

Drug: 1-year DAPT

Interventions

3-months DAPT DRUG

Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting

Also known as: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting

Orsiro SES or CX-ISAR/3-months DAPT

1-year DAPT DRUG

Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting

Also known as: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting

Orsiro SES or CX-ISAR/1-year DAPT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• B. Braun Korea Co., Ltd.: collaborator

Study Sites (12)

Busan Paik Hospital

Busan, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

SoonChunHyang University Cheonan Hospital

Cheonan, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gwangju Christian Hospital

Gwangju, South Korea

Location

Ewha Womans University Medical Center Mokdong Hospital

Seoul, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (5)

• Han JK, Hwang D, Yang S, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Kim SY, Park SH, Han SH, Kim SH, Shin S, Park K, Lee SJ, Kim JW, Lee N, Kim HS. Abbreviated dual antiplatelet therapy after percutaneous coronary intervention with ultrathin-strut drug-eluting stents in South Korea: 3-year outcomes of the multicentre, randomised HOST-IDEA trial. EClinicalMedicine. 2025 Dec 18;91:103698. doi: 10.1016/j.eclinm.2025.103698. eCollection 2026 Jan.

  PMID: 41509615 DERIVED

• Han JK, Lee K, Park SH, Yang S, Hwang D, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Park SH, Han SH, Kim SH, Kim YH, Lee N, Lee SJ, Shin S, Kim HS. Short-Term DAPT After Complex PCI With Third-Generation DES: A Post Hoc Analysis of the HOST-IDEA Trial. Circ Cardiovasc Interv. 2025 May;18(5):e014623. doi: 10.1161/CIRCINTERVENTIONS.124.014623. Epub 2025 Mar 31.

  PMID: 40160090 DERIVED

• Han JK, Yang S, Hwang D, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Cho JM, Cho J, Bang DW, Lee JH, Lee HC, Kim KJ, Chun WJ, Seo WW, Park WJ, Park SM, Kim JW, Kim HS. Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial. Circ Cardiovasc Interv. 2024 Jul;17(7):e013585. doi: 10.1161/CIRCINTERVENTIONS.123.013585. Epub 2024 May 24.

  PMID: 38786579 DERIVED

• Han JK, Hwang D, Yang S, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Kim SY, Park SH, Han SH, Kim SH, Shin S, Kim YH, Park K, Lee N, Lee SJ, Kim JW, Kim HS. Comparison of 3- to 6-Month Versus 12-Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-Eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial. Circulation. 2023 May 2;147(18):1358-1368. doi: 10.1161/CIRCULATIONAHA.123.064264. Epub 2023 Mar 5.

  PMID: 36871230 DERIVED

• Kim CH, Han JK, Yang HM, Park KW, Lee HY, Kang HJ, Koo BK, Lee N, Cha TJ, Yang TH, Jeong MH, Yoon MH, Lee SU, Lee SJ, Kim JW, Cho JM, Han KR, Pyun WB, Kim HS. Study protocol for a randomised controlled trial: harmonising 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. BMJ Open. 2017 Oct 11;7(10):e016617. doi: 10.1136/bmjopen-2017-016617.

  PMID: 29025834 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Aspirin; Clopidogrel; Prasugrel Hydrochloride; Ticagrelor; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Hyo-Soo Kim, M.D., Ph.D.

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Laboratory & Coronary Intervention

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 10, 2015
• Study Start: January 18, 2016
• Primary Completion: August 14, 2021
• Study Completion: August 14, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

KR (12)