Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing - Full Text View

Purpose

Objectives

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.
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

Condition	Intervention	Phase
Coronary Artery Disease	Device: Everolimus-eluting stent (Xience or Promus) Device: Sirolimus-eluting stent (Cypher) Drug: 6-month clopidogrel therapy Drug: 12-month clopidogrel therapy	Phase IV

MedlinePlus related topics:

Aneurysms Coronary Artery Disease Heart Attack

ChemIDplus related topics:

Everolimus Sirolimus Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Target vessel revascularization (TVR) (all and ischemia-driven) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Target lesion revascularization (TLR) (all and ischemia-driven) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Acute success (device, lesion, and procedure) [ Time Frame: Index procedure ] [ Designated as safety issue: Yes ]
Bleeding [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Cerebrovascular accident [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
In-stent LL at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Angiographic pattern of restenosis at 9-month angiographic follow-up [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
In-stent and in-segment % diameter stenosis (%DS) at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
In-stent % volume obstruction (%VO) at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Incomplete stent apposition post index procedure [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1466
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
E6: Experimental Everolimus-eluting stent 6-month clopidogrel therapy	Device: Everolimus-eluting stent (Xience or Promus) Use everolimus-eluting stent in the treatment of coronary stenosis Drug: 6-month clopidogrel therapy Use clopidogrel for 6 months
S6: Active Comparator Sirolimus-eluting stent 6-month clopidogrel therapy	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
E12: Experimental Everolimus-eluting stent 12-month clopidogrel therapy	Device: Everolimus-eluting stent (Xience or Promus) Use everolimus-eluting stent in the treatment of coronary stenosis Drug: 12-month clopidogrel therapy Use clopidogrel for 12 months
S12: Active Comparator Sirolimus-eluting stent 12-month clopidogrel therapy	Device: Sirolimus-eluting stent (Cypher) Use sirolimus-eluting stent in the treatment of coronary stenosis Drug: 12-month clopidogrel therapy Use clopidogrel for 12 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

General Inclusion Criteria:

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.

Angiographically Inclusion Criteria

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

General Exclusion Criteria:

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).

Angiographic Exclusion Criteria

Patients with significant left main coronary artery stenosis
Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
Target lesions with chronic total occlusion
True bifurcation lesions requiring two stents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698607

Contacts


Contact: Kyung-Woo Park, MD, PhD	82-2-2072-0244	kwparkmd@snu.ac.kr

Locations


Korea, Republic of, 28 Yongon Dong, Jongro Gu
	Seoul National University Hospital	Not yet recruiting
	Seoul, 28 Yongon Dong, Jongro Gu, Korea, Republic of, 110-744
	Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr

Sponsors and Collaborators

Seoul National University Hospital

Abbott

Boston Scientific Corporation

Investigators


Study Chair:	Hyo-Soo Kim, MD, PhD	Seoul National University Hospital

Study Chair:	Yangsoo Jang, MD, PhD	Yonsei University Medical Center

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

Principal Investigator:	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	Yongdong Severance Hospital

Principal Investigator:	Dong-Woon Chun, MD, PhD	National Health Insurance Corporation 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	Kangnam Sacred Heart Hospital

More Information

Responsible Party:	Seoul National University Hospital ( Hyo-Soo, Kim )
Study ID Numbers:	EXCELLENT
First Received:	June 15, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00698607
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:

Everolimus

Sirolimus

drug eluting stent

Clopidogrel

Study placed in the following topic categories:

Arterial Occlusive Diseases

Sirolimus

Everolimus

Heart Diseases

Clotrimazole

Myocardial Ischemia

Miconazole

Tioconazole

Vascular Diseases

Ischemia

Arteriosclerosis

Coronary Disease

Clopidogrel

Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Infective Agents

Immunologic Factors

Antineoplastic Agents

Hematologic Agents

Physiological Effects of Drugs

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Anti-Bacterial Agents

Therapeutic Uses

Antifungal Agents

Cardiovascular Diseases

Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Seoul National University Hospital Abbott Boston Scientific Corporation
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00698607