Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing

Summary

Objectives

1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson \& Johnson, Warren, NJ) in the treatment of coronary stenosis.
2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.

Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm)

Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.

Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint

* In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
* Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy

Secondary Endpoint

* All Death
* Cardiac death
* Myocardial infarction
* Target vessel revascularization (TVR) (all and ischemia-driven)
* Target lesion revascularization (TLR) (all and ischemia-driven)
* Stent thrombosis
* Acute success (device, lesion, and procedure)
* Bleeding
* Cerebrovascular accident
* In-stent LL at 9 months
* Angiographic pattern of restenosis at 9-month angiographic follow-up
* In-stent and in-segment % diameter stenosis (%DS) at 9 months
* In-stent % volume obstruction (%VO) at 9 months
* Incomplete stent apposition post index procedure
* Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

Conditions

• Coronary Artery Disease

Interventions

DEVICE

Everolimus-eluting stent (Xience or Promus)

Use everolimus-eluting stent in the treatment of coronary stenosis

DEVICE

Sirolimus-eluting stent (Cypher)

Use sirolimus-eluting stent in the treatment of coronary stenosis

DRUG

6-month clopidogrel therapy

Use clopidogrel for 6 months

DRUG

12-month clopidogrel therapy

Use clopidogrel for 12 months

Sponsors & Collaborators

• Abbott

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Hyo-Soo Kim, MD, PhD · Seoul National University Hospital

• Yangsoo Jang, MD, PhD · Yonsei University

• Jung-Han Yoon, MD, PhD · Yonsei Univercity Wonju hospital

• Ahn Tae-Hoon, MD, PhD · Gachon Kil Medical Center

• Hyun-Cheol Kwon, MD, PhD · Samsung Medical Center

• In-Ho Chae, MD, PhD · Seoul National University Bundang Hospital

• Young-Jin Choi, MD, PhD · Hallym University Medical Center

• Kyoo-Rok Han, MD, PhD · Kandong Sacred heart Hospital

• Si-Hoon Park, MD, PhD · Ewha Women's University Hospital

• Myeong-Ho Chung, MD, PhD · Chonnam National University Hospital

• Hyuk-Moon Kwon, MD, PhD · Yonsei University

• Dong-Woon Chun, MD, PhD · National Health Insurance Service Ilsan Hospital

• Byung-Ok Kim, MD, PhD · Inje University Sanggye Hospital

• Do-Sun Lim, MD, PhD · Korea University Anam Hospital

• Taek-Jong Hong, MD, PhD · Pusan National University Hospital

• Woo-Young Chung, MD, PhD · Borame Hospital

• Jae-Hun Chung, MD, PhD · Hallym University Kangnam Sacred Heart Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2013-12-31

Completion

2014-04-30

Countries

• South Korea

Study Locations