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

NCT00698607 | Completed Phase 4 DMC

• 1 other identifier: EXCELLENT
• Study Type: interventional
• Target: 1,466
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives

• 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

Keywords

Everolimus; Sirolimus; drug eluting stent; Clopidogrel

Outcome Measures

Primary Outcomes (2)

• In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.

  9 months

• 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

  12 months

Secondary Outcomes (15)

• All death

  5 years

• Cardiac death

  5 Years

• Myocardial infarction

  5 years

• Target vessel revascularization (TVR) (all and ischemia-driven)

  5 years

• Target lesion revascularization (TLR) (all and ischemia-driven)

  5 years

Study Arms (4)

E6

EXPERIMENTAL

Everolimus-eluting stent 6-month clopidogrel therapy

Device: Everolimus-eluting stent (Xience or Promus); Drug: 6-month clopidogrel therapy

S6

ACTIVE COMPARATOR

Sirolimus-eluting stent 6-month clopidogrel therapy

Device: Sirolimus-eluting stent (Cypher); Drug: 6-month clopidogrel therapy

E12

EXPERIMENTAL

Everolimus-eluting stent 12-month clopidogrel therapy

Device: Everolimus-eluting stent (Xience or Promus); Drug: 12-month clopidogrel therapy

S12

ACTIVE COMPARATOR

Sirolimus-eluting stent 12-month clopidogrel therapy

Device: Sirolimus-eluting stent (Cypher); Drug: 12-month clopidogrel therapy

Interventions

Everolimus-eluting stent (Xience or Promus) DEVICE

Use everolimus-eluting stent in the treatment of coronary stenosis

Also known as: Xience, Promus

E12; E6

Sirolimus-eluting stent (Cypher) DEVICE

Use sirolimus-eluting stent in the treatment of coronary stenosis

Also known as: Cypher

S12; S6

6-month clopidogrel therapy DRUG

Use clopidogrel for 6 months

Also known as: Plavix

E6; S6

12-month clopidogrel therapy DRUG

Use clopidogrel for 12 months

Also known as: Plavix

E12; S12

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years of age.
• 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.
• Subject must have significant coronary artery stenosis (\>50% by visual estimate)
• 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.
• Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.
• Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
• Target lesion(s) must be amenable for percutaneous coronary intervention

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
• Systemic (intravenous) Sirolimus, everolimus use within 12 months.
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
• An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
• 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).
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Patients who have received any stent implantation in the target vessel prior to enrollment.
• Patients with LVEF\<25% or those with cardiogenic shock
• Patients with myocardial infarction within 72 hours
• Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
• Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
• Patients with significant left main coronary artery stenosis

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Abbott: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (9)

• Lee JM, Park KW, Han JK, Yang HM, Kang HJ, Koo BK, Bae JW, Woo SI, Park JS, Jin DK, Jeon DW, Oh SK, Park JS, Kim DI, Hyon MS, Jeon HK, Lim DS, Kim MG, Rha SW, Her SH, Hwang JY, Kim S, Choi YJ, Kang JH, Moon KW, Jang Y, Kim HS. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries). Am J Cardiol. 2014 Nov 1;114(9):1329-38. doi: 10.1016/j.amjcard.2014.07.065. Epub 2014 Aug 12.

  PMID: 25217457 RESULT

• 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.

  PMID: 32588238 DERIVED

• 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.

  PMID: 31642213 DERIVED

• Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.

  PMID: 30475845 DERIVED

• Park KW, Rhee TM, Kang HJ, Koo BK, Gwon HC, Yoon JH, Lim DS, Chae IH, Han KR, Ahn T, Jeong MH, Jeon DW, Jang YS, Kim HS. Randomized Prospective Comparison of Everolimus-Eluting vs. Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention - 3-Year Clinical Outcomes of the EXCELLENT Randomized Trial. Circ J. 2018 May 25;82(6):1566-1574. doi: 10.1253/circj.CJ-17-0677. Epub 2017 Sep 30.

  PMID: 28966335 DERIVED

• 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.

  PMID: 23456359 DERIVED

• 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.

  PMID: 22179532 DERIVED

• 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.

  PMID: 22018294 DERIVED

• Park KW, Yoon JH, Kim JS, Hahn JY, Cho YS, Chae IH, Gwon HC, Ahn T, Oh BH, Park JE, Shim WH, Shin EK, Jang YS, Kim HS. Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial. Am Heart J. 2009 May;157(5):811-817.e1. doi: 10.1016/j.ahj.2009.02.008.

  PMID: 19376305 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hyo-Soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

• Yangsoo Jang, MD, PhD

  Yonsei University

  STUDY CHAIR

• Jung-Han Yoon, MD, PhD

  Yonsei Univercity Wonju hospital

  STUDY CHAIR

• Ahn Tae-Hoon, MD, PhD

  Gachon Kil Medical Center

  STUDY CHAIR

• Hyun-Cheol Kwon, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

• In-Ho Chae, MD, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

• Young-Jin Choi, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

• Kyoo-Rok Han, MD, PhD

  Kandong Sacred heart Hospital

  PRINCIPAL INVESTIGATOR

• Si-Hoon Park, MD, PhD

  Ewha Women's University Hospital

  PRINCIPAL INVESTIGATOR

• Myeong-Ho Chung, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Hyuk-Moon Kwon, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

• Dong-Woon Chun, MD, PhD

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Byung-Ok Kim, MD, PhD

  Inje University Sanggye Hospital

  PRINCIPAL INVESTIGATOR

• Do-Sun Lim, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Taek-Jong Hong, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Woo-Young Chung, MD, PhD

  Borame Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Hun Chung, MD, PhD

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 15, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (1)