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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Taxus stent; Device: Vision stent

• Registration Number: NCT00852215
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

• Study Start: 2008-08
• Status Verified: 2009-02
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-25
• Last Update Submitted: 2009-02-25
• Study First Posted: 2009-02-26
• Last Update Posted: 2009-02-26
• Primary Completion: 2009-07
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Taxus stent	Taxus stent group
2	Vision stent	Vision stent group

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)	1 year

Secondary Outcome Measures

Name	Time	Method
MACE and stent thrombosis by the criteria of Academic Research Consortium	2 years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of