Clinical trial NCT00852215: Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
Official title: Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Paclitaxel-eluting stent
Vision stent
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
timeFrame: 1 year
Secondary outcomes:
measure: MACE and stent thrombosis by the criteria of Academic Research Consortium
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: