Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
Status:
Unknown status
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Objectives
1. To evaluate the safety and long-term effectiveness of coronary stenting with the
Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa
Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting
coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the
treatment of coronary stenosis.
2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with
12-month clopidogrel therapy.
Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the
non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months
duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized
in a two by two factorial manner according to the type of drug eluting stent (EECSS vs.
SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization
will also be stratified per hospital for the presence of DM and the presence of long lesions
(lesion length ≥ 28mm)
Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.
Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4,
and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office
visits.
Primary Endpoint
- In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs.
SECSS.
- Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven
target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months
of clopidogrel therapy
Secondary Endpoint
- All Death
- Cardiac death
- Myocardial infarction
- Target vessel revascularization (TVR) (all and ischemia-driven)
- Target lesion revascularization (TLR) (all and ischemia-driven)
- Stent thrombosis
- Acute success (device, lesion, and procedure)
- Bleeding
- Cerebrovascular accident
- In-stent LL at 9 months
- Angiographic pattern of restenosis at 9-month angiographic follow-up
- In-stent and in-segment % diameter stenosis (%DS) at 9 months
- In-stent % volume obstruction (%VO) at 9 months
- Incomplete stent apposition post index procedure
- Persisting incomplete stent apposition, late-acquired incomplete stent apposition,
aneurysm, thrombosis, and persisting dissection at 9 months