Coronary Artery Disease
Conditions
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Paclitaxel-eluting stent, Vision stent
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.
Interventions
DEVICETaxus 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
DEVICEVision 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
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| MACE and stent thrombosis by the criteria of Academic Research Consortium | 2 years |
Countries
South Korea
Contacts
Primary ContactHyeon-Cheol Gwon, MD,PhD
Backup ContactYoung Bin Song, MD
Outcome results
None listed