Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE)

Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study

We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Taxus stent; Device: Vision stent

Detailed Description

Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.

The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.

We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Hyoen-Cheol Gwon, MD,PhD; Phone Number: 82-2-3410-3418; Email: hcgwon@skku.edu
    • Contact: Young Bin Song, MD; Phone Number: 82-2-3410-3419; Email: youngbin.song@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
• planned target lesion number =< 2
• reference diameter 2.75 - 4.0 mm
• lesions can be fully covered by one 28 mm or shorter stent

Exclusion Criteria:

• unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
• ostial target lesion (within 5 mm of ostium)
• angiographic evidence of thrombus within target lesion
• calcified lesions which cannot be successfully predilated
• instent restenosis
• multi-vessel intervention more than 2 lesions
• atherectomy is planned before stenting
• bifurcation lesion that needs side branch ballooning or stenting
• Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
• ST-elevation myocardial infarction within the preceding 72 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Taxus stent group	Device: Taxus stent; Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
Active Comparator: 2; Vision stent group	Device: Vision stent; Stenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
MACE and stent thrombosis by the criteria of Academic Research Consortium	2 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: February 25, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Estimate): February 26, 2009
• Last Update Submitted That Met QC Criteria: February 25, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Angioplasty, Transluminal, Percutaneous Coronary; Paclitaxel-eluting stent; Vision stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2008-07-014