J Am Coll Cardiol. 2014;63(25 Pt A):2805-16.
A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial.
제1저자 박경우 · 교신저자 김효수
소속 (21)
- Seoul National University Hospital, Seoul, Republic of Korea.
- Dankook University Hospital, Cheonan, Republic of Korea.
- Busan National University Hospital, Busan, Republic of Korea.
- Presbyterian Medical Center, Jeonju, Republic of Korea.
- Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea.
- Ulsan University Hospital, Ulsan, Republic of Korea.
- Samsung Changwon Hospital, Changwon, Republic of Korea.
- Chonnam National University Hospital, Gwangju, Republic of Korea.
- Boramae Medical Center, Seoul, Republic of Korea.
- Chungbuk National University Hospital, Cheongju, Republic of Korea.
- Wonju Christian Hospital, Wonju, Republic of Korea.
- Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
- Dong-A Medical Center, Busan, Republic of Korea.
- St. Vincent's Hospital, Suwon, Republic of Korea.
- Gangnam Severance Hospital, Seoul, Republic of Korea.
- Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
- Daegu Catholic University Medical Center, Daegu, Republic of Korea.
- Daegu Fatima Hospital, Daegu, Republic of Korea.
- Gyeongsang National University Hospital, Jinju, Republic of Korea.
- Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: ihchae@snu.ac.kr.
- Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.
Abstract
OBJECTIVES This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI).
BACKGROUND PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents.
METHODS We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD.
RESULTS At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352).
CONCLUSIONS At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Keywords
all-comers trialclinical outcomedrug-eluting stent(s)percutaneous coronary intervention
그 밖의 정보
- 출판 형태
- Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
- 저널
- Journal of the American College of Cardiology · eISSN 1558-3597
- 전자 출판
- 2014-05-07
- MeSH
- Antineoplastic Agents · Chromium Alloys · Chromium Compounds · Coronary Angiography · Coronary Stenosis / diagnostic imaging / drug therapy · Drug-Eluting Stents* · Everolimus · Female · Follow-Up Studies · Humans · Immunosuppressive Agents / therapeutic use · Male · Middle Aged · Percutaneous Coronary Intervention / methods · Platelet Aggregation Inhibitors / therapeutic use · Platinum Compounds · Prospective Studies · Prosthesis Design · Republic of Korea · Single-Blind Method · Sirolimus / analogs & derivatives / therapeutic use · Treatment Outcome
- Substances
- Antineoplastic Agents · Chromium Alloys · Chromium Compounds · Immunosuppressive Agents · Platelet Aggregation Inhibitors · Platinum Compounds · Everolimus · zotarolimus · Sirolimus
- 데이터
- ClinicalTrials.gov: NCT01267734