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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Taxus stent; Device: Vision stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00852215

2008-07-014

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

1

Active Comparator group

Description:

Taxus stent group

Treatment:

Device: Taxus stent

2

Active Comparator group

Description:

Vision stent group

Treatment:

Device: Vision stent