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

NCT ID: NCT00698607

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2014-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E6

Everolimus-eluting stent 6-month clopidogrel therapy

Group Type: EXPERIMENTAL

Everolimus-eluting stent (Xience or Promus)

Intervention Type: DEVICE

Use everolimus-eluting stent in the treatment of coronary stenosis

6-month clopidogrel therapy

Intervention Type: DRUG

Use clopidogrel for 6 months

S6

Sirolimus-eluting stent 6-month clopidogrel therapy

Group Type: ACTIVE_COMPARATOR

Sirolimus-eluting stent (Cypher)

Intervention Type: DEVICE

Use sirolimus-eluting stent in the treatment of coronary stenosis

6-month clopidogrel therapy

Intervention Type: DRUG

Use clopidogrel for 6 months

E12

Everolimus-eluting stent 12-month clopidogrel therapy

Group Type: EXPERIMENTAL

Everolimus-eluting stent (Xience or Promus)

Intervention Type: DEVICE

Use everolimus-eluting stent in the treatment of coronary stenosis

12-month clopidogrel therapy

Intervention Type: DRUG

Use clopidogrel for 12 months

S12

Sirolimus-eluting stent 12-month clopidogrel therapy

Group Type: ACTIVE_COMPARATOR

Sirolimus-eluting stent (Cypher)

Intervention Type: DEVICE

Use sirolimus-eluting stent in the treatment of coronary stenosis

12-month clopidogrel therapy

Intervention Type: DRUG

Use clopidogrel for 12 months

Interventions

Everolimus-eluting stent (Xience or Promus)

Use everolimus-eluting stent in the treatment of coronary stenosis

Intervention Type: DEVICE

Sirolimus-eluting stent (Cypher)

Use sirolimus-eluting stent in the treatment of coronary stenosis

Intervention Type: DEVICE

6-month clopidogrel therapy

Use clopidogrel for 6 months

Intervention Type: DRUG

12-month clopidogrel therapy

Use clopidogrel for 12 months

Intervention Type: DRUG

Other Intervention Names

Xience; Promus; Cypher; Plavix; Plavix

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

3. Subject must have significant coronary artery stenosis (>50% by visual estimate)

4. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.

5. Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.

1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.

2. Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria

1. The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media

2. Systemic (intravenous) Sirolimus, everolimus use within 12 months.

3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.

5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

6. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.

7. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.

8. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

9. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

10. Patients who have received any stent implantation in the target vessel prior to enrollment.

11. Patients with LVEF<25% or those with cardiogenic shock

12. Patients with myocardial infarction within 72 hours

13. Creatinine level ≥ 3.0mg/dL or dependence on dialysis.

14. Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).

1. Patients with significant left main coronary artery stenosis

2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents

3. Target lesions with chronic total occlusion

4. True bifurcation lesions requiring two stents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

Hyo-Soo Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Yangsoo Jang, MD, PhD

Role: STUDY_CHAIR

Yonsei University

Jung-Han Yoon, MD, PhD

Role: STUDY_CHAIR

Yonsei Univercity Wonju hospital

Ahn Tae-Hoon, MD, PhD

Role: STUDY_CHAIR

Gachon Kil Medical Center

Hyun-Cheol Kwon, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

In-Ho Chae, MD, PhD

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Young-Jin Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Kyoo-Rok Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kandong Sacred heart Hospital

Si-Hoon Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Women's University Hospital

Myeong-Ho Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Hyuk-Moon Kwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Dong-Woon Chun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Health Insurance Service Ilsan Hospital

Byung-Ok Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University Sanggye Hospital

Do-Sun Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Taek-Jong Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Woo-Young Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Borame Hospital

Jae-Hun Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Kangnam Sacred Heart Hospital

Locations

Seoul National University Hospital

Seoul, 28 Yongon Dong, Jongro Gu, South Korea

Countries

South Korea

References

Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.

Reference Type: DERIVED

PMID: 32588238 (View on PubMed)

Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.

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Reference Type: DERIVED

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Reference Type: DERIVED

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Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Hong MK, Gwon HC, Ahn T, Chae IH, Yoon JH, Kim HS, Jang Y; EXCELLENT investigators. Comparison of neointimal hyperplasia and peri-stent vascular remodeling after implantation of everolimus-eluting versus sirolimus-eluting stents: intravascular ultrasound results from the EXCELLENT study. Int J Cardiovasc Imaging. 2013 Aug;29(6):1229-36. doi: 10.1007/s10554-013-0199-5. Epub 2013 Mar 3.

Reference Type: DERIVED

PMID: 23456359 (View on PubMed)

Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.

Reference Type: DERIVED

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Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Gwon HC, Jang YS, Kim HS. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011 Oct 25;58(18):1844-54. doi: 10.1016/j.jacc.2011.07.031.

Reference Type: DERIVED

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Reference Type: DERIVED

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Other Identifiers

EXCELLENT

Identifier Type: -

Identifier Source: org_study_id