Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation randomized study

Byeong Keuk Kim, Dong Ho Shin, Myeong Ki Hong, Hun Sik Park, Seung Woon Rha, Gary S. Mintz, Jung Sun Kim, Je Sang Kim, Seung Jin Lee, Hee Yeol Kim, Bum Kee Hong, Woong Chol Kang, Jin Ho Choi, Yangsoo Jang

Research output: Contribution to journalArticle

70 Citations (Scopus)

Abstract

Background-There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. Methods and Results-After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUSguided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). Conclusions-Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention.

Original languageEnglish
Article numbere002592
JournalCirculation: Cardiovascular Interventions
Volume8
Issue number7
DOIs
Publication statusPublished - 2015 May 1

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Stents
Angiography
Drug-Eluting Stents
Myocardial Infarction
zotarolimus
Multicenter Studies
Confidence Intervals
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Kim, Byeong Keuk ; Shin, Dong Ho ; Hong, Myeong Ki ; Park, Hun Sik ; Rha, Seung Woon ; Mintz, Gary S. ; Kim, Jung Sun ; Kim, Je Sang ; Lee, Seung Jin ; Kim, Hee Yeol ; Hong, Bum Kee ; Kang, Woong Chol ; Choi, Jin Ho ; Jang, Yangsoo. / Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation randomized study. In: Circulation: Cardiovascular Interventions. 2015 ; Vol. 8, No. 7.
@article{eb47113a551444b4bec1d6220582d703,
title = "Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation randomized study",
abstract = "Background-There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. Methods and Results-After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUSguided group (0{\%}) and the angiography-guided group (1.0{\%}; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6{\%} versus 7.1{\%}; P=0.035; hazard ratio, 0.35; 95{\%} confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0{\%}) than in the angiography-guided group (2.0{\%}; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0{\%} versus 5.7{\%}; P=0.45). Conclusions-Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention.",
author = "Kim, {Byeong Keuk} and Shin, {Dong Ho} and Hong, {Myeong Ki} and Park, {Hun Sik} and Rha, {Seung Woon} and Mintz, {Gary S.} and Kim, {Jung Sun} and Kim, {Je Sang} and Lee, {Seung Jin} and Kim, {Hee Yeol} and Hong, {Bum Kee} and Kang, {Woong Chol} and Choi, {Jin Ho} and Yangsoo Jang",
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journal = "Circulation: Cardiovascular Interventions",
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Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation randomized study. / Kim, Byeong Keuk; Shin, Dong Ho; Hong, Myeong Ki; Park, Hun Sik; Rha, Seung Woon; Mintz, Gary S.; Kim, Jung Sun; Kim, Je Sang; Lee, Seung Jin; Kim, Hee Yeol; Hong, Bum Kee; Kang, Woong Chol; Choi, Jin Ho; Jang, Yangsoo.

In: Circulation: Cardiovascular Interventions, Vol. 8, No. 7, e002592, 01.05.2015.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation randomized study

AU - Kim, Byeong Keuk

AU - Shin, Dong Ho

AU - Hong, Myeong Ki

AU - Park, Hun Sik

AU - Rha, Seung Woon

AU - Mintz, Gary S.

AU - Kim, Jung Sun

AU - Kim, Je Sang

AU - Lee, Seung Jin

AU - Kim, Hee Yeol

AU - Hong, Bum Kee

AU - Kang, Woong Chol

AU - Choi, Jin Ho

AU - Jang, Yangsoo

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background-There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. Methods and Results-After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUSguided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). Conclusions-Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention.

AB - Background-There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. Methods and Results-After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUSguided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). Conclusions-Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention.

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