Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
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
Timeline
- Start
- 2008-06
- Primary completion
- 2013-12
- Completion
- 2014-04
Outcome
Met primary endpoint
paper EES were noninferior to SES in inhibition of LL after stenting PMID 22018294 ↗
paper Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. PMID 22179532 ↗
Publications
- Results Lee JM, Park KW, Han JK, Yang HM, Kang HJ, Koo BK, Bae JW, Woo SI, Park JS, Jin DK, Jeon DW, Oh SK, Park JS, Kim DI, Hyon MS, Jeon HK, Lim DS, Kim MG, Rha SW, Her SH, Hwang JY, Kim S, Choi YJ, Kang JH, Moon KW, Jang Y, Kim HS. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries). Am J Cardiol. 2014 Nov 1;114(9):1329-38. doi: 10.1016/j.amjcard.2014.07.065. Epub 2014 Aug 12.
- Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.
- Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.
- Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.
- Park KW, Rhee TM, Kang HJ, Koo BK, Gwon HC, Yoon JH, Lim DS, Chae IH, Han KR, Ahn T, Jeong MH, Jeon DW, Jang YS, Kim HS. Randomized Prospective Comparison of Everolimus-Eluting vs. Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention - 3-Year Clinical Outcomes of the EXCELLENT Randomized Trial. Circ J. 2018 May 25;82(6):1566-1574. doi: 10.1253/circj.CJ-17-0677. Epub 2017 Sep 30.
- Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Hong MK, Gwon HC, Ahn T, Chae IH, Yoon JH, Kim HS, Jang Y; EXCELLENT investigators. Comparison of neointimal hyperplasia and peri-stent vascular remodeling after implantation of everolimus-eluting versus sirolimus-eluting stents: intravascular ultrasound results from the EXCELLENT study. Int J Cardiovasc Imaging. 2013 Aug;29(6):1229-36. doi: 10.1007/s10554-013-0199-5. Epub 2013 Mar 3.
- Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
- Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Gwon HC, Jang YS, Kim HS. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011 Oct 25;58(18):1844-54. doi: 10.1016/j.jacc.2011.07.031.
- Park KW, Yoon JH, Kim JS, Hahn JY, Cho YS, Chae IH, Gwon HC, Ahn T, Oh BH, Park JE, Shim WH, Shin EK, Jang YS, Kim HS. Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial. Am Heart J. 2009 May;157(5):811-817.e1. doi: 10.1016/j.ahj.2009.02.008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | — | — |