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
Kyung Woo Park, Si-Hyuck Kang, Hyun-Jae Kang, Bon-Kwon Koo, Byoung-Eun Park, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun-Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, Seung-Ho Hur, Jae-Kean Ryu, Bong-Ryul Lee, Yong Whi Park, In-Ho Chae, Hyo-Soo Kim, HOST–ASSURE Investigators, Kyung Woo Park, Si-Hyuck Kang, Hyun-Jae Kang, Bon-Kwon Koo, Byoung-Eun Park, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun-Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, Seung-Ho Hur, Jae-Kean Ryu, Bong-Ryul Lee, Yong Whi Park, In-Ho Chae, Hyo-Soo Kim, HOST–ASSURE Investigators
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).
Keywords: all-comers trial; clinical outcome; drug-eluting stent(s); percutaneous coronary intervention.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed