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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.

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제1저자 박경우 · 교신저자 김효수

소속 (21)
  1. Seoul National University Hospital, Seoul, Republic of Korea.
  2. Dankook University Hospital, Cheonan, Republic of Korea.
  3. Busan National University Hospital, Busan, Republic of Korea.
  4. Presbyterian Medical Center, Jeonju, Republic of Korea.
  5. Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea.
  6. Ulsan University Hospital, Ulsan, Republic of Korea.
  7. Samsung Changwon Hospital, Changwon, Republic of Korea.
  8. Chonnam National University Hospital, Gwangju, Republic of Korea.
  9. Boramae Medical Center, Seoul, Republic of Korea.
  10. Chungbuk National University Hospital, Cheongju, Republic of Korea.
  11. Wonju Christian Hospital, Wonju, Republic of Korea.
  12. Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
  13. Dong-A Medical Center, Busan, Republic of Korea.
  14. St. Vincent's Hospital, Suwon, Republic of Korea.
  15. Gangnam Severance Hospital, Seoul, Republic of Korea.
  16. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
  17. Daegu Catholic University Medical Center, Daegu, Republic of Korea.
  18. Daegu Fatima Hospital, Daegu, Republic of Korea.
  19. Gyeongsang National University Hospital, Jinju, Republic of Korea.
  20. Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: ihchae@snu.ac.kr.
  21. 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