Effect of intravascular ultrasound-guided vs angiography- guided everolimus-eluting stent implantation: The IVUS-XPL randomized clinical trial

IVUS-XPL Investigators

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150 Citations (Scopus)

Abstract

IMPORTANCE:Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. OBJECTIVE:To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. DESIGN, SETTING, AND PARTICIPANTS: The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent≥28 mmin length) between October 2010 and July 2014 at 20 centers in Korea. INTERVENTIONS: Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. RESULTS: One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14%to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32). CONCLUSIONS AND RELEVANCE: Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.

Original languageEnglish
Pages (from-to)2155-2163
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume314
Issue number20
DOIs
Publication statusPublished - 2015 Nov 24

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Stents
Angiography
Randomized Controlled Trials
Drug-Eluting Stents
Myocardial Infarction
Everolimus
Korea
Multicenter Studies
Myocardial Ischemia
Ischemia
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{3a097212bebf4c6e8dabd691670d7592,
title = "Effect of intravascular ultrasound-guided vs angiography- guided everolimus-eluting stent implantation: The IVUS-XPL randomized clinical trial",
abstract = "IMPORTANCE:Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. OBJECTIVE:To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. DESIGN, SETTING, AND PARTICIPANTS: The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent≥28 mmin length) between October 2010 and July 2014 at 20 centers in Korea. INTERVENTIONS: Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. RESULTS: One-year follow-up was complete in 1323 patients (94.5{\%}). Major adverse cardiac events at 1 year occurred in 19 patients (2.9{\%}) undergoing IVUS-guided and in 39 patients (5.8{\%}) undergoing angiography-guided stent implantation (absolute difference, -2.97{\%} [95{\%} CI, -5.14{\%}to -0.79{\%}]) (hazard ratio [HR], 0.48 [95{\%} CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5{\%}]) compared with angiography-guided (33 [5.0{\%}]) stent implantation (HR, 0.51 [95{\%} CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4{\%}) in the IVUS-guided group and 5 patients (0.7{\%}) in the angiography-guided group (HR, 0.60 [95{\%} CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1{\%}) in the angiography-guided stent implantation group (P = .32). CONCLUSIONS AND RELEVANCE: Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.",
author = "{IVUS-XPL Investigators} and Hong, {Sung Jin} and Kim, {Byeong Keuk} and Shin, {Dong Ho} and Nam, {Chung Mo} and Kim, {Jung Sun} and Ko, {Young Guk} and Donghoon Choi and Kang, {Tae Soo} and Kang, {Woong Chol} and Her, {Ae Young} and Yonghoon Kim and Hur, {Seung Ho} and Hong, {Bum Kee} and Hyuckmoon Kwon and Yangsoo Jang and Hong, {Myeong Ki} and Yang, {Joo Young} and Cheon, {Dong Woon} and Lee, {Seung Whan} and Kim, {Byung Ok} and Ahn, {Chul Min} and Chang, {Hyuck Jai} and Choi, {Seong Hoon} and Cho, {Deok Kyu} and Choi, {Eui Young} and Shim, {Ji Young} and Yoon, {Se Jung} and Kim, {Jang Young} and Hong, {Myeong Ki} and Lee, {Sang Gon} and Yoon, {Jung Han} and Jeon, {Dong Woon} and Cho, {Yun Hyeong} and Choi, {Jae Woong} and Rhee, {Sang Jae} and Choi, {Rak Kyeong} and Lee, {Sung Yoon} and Kim, {Won Ho} and Lee, {Nam Ho} and Hong, {Young Joon} and Choi, {Hyun Hee} and Park, {Jong Pil} and Lim, {Sang Wook}",
year = "2015",
month = "11",
day = "24",
doi = "10.1001/jama.2015.15454",
language = "English",
volume = "314",
pages = "2155--2163",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "20",

}

TY - JOUR

T1 - Effect of intravascular ultrasound-guided vs angiography- guided everolimus-eluting stent implantation

T2 - The IVUS-XPL randomized clinical trial

AU - IVUS-XPL Investigators

AU - Hong, Sung Jin

AU - Kim, Byeong Keuk

AU - Shin, Dong Ho

AU - Nam, Chung Mo

AU - Kim, Jung Sun

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Kang, Tae Soo

AU - Kang, Woong Chol

AU - Her, Ae Young

AU - Kim, Yonghoon

AU - Hur, Seung Ho

AU - Hong, Bum Kee

AU - Kwon, Hyuckmoon

AU - Jang, Yangsoo

AU - Hong, Myeong Ki

AU - Yang, Joo Young

AU - Cheon, Dong Woon

AU - Lee, Seung Whan

AU - Kim, Byung Ok

AU - Ahn, Chul Min

AU - Chang, Hyuck Jai

AU - Choi, Seong Hoon

AU - Cho, Deok Kyu

AU - Choi, Eui Young

AU - Shim, Ji Young

AU - Yoon, Se Jung

AU - Kim, Jang Young

AU - Hong, Myeong Ki

AU - Lee, Sang Gon

AU - Yoon, Jung Han

AU - Jeon, Dong Woon

AU - Cho, Yun Hyeong

AU - Choi, Jae Woong

AU - Rhee, Sang Jae

AU - Choi, Rak Kyeong

AU - Lee, Sung Yoon

AU - Kim, Won Ho

AU - Lee, Nam Ho

AU - Hong, Young Joon

AU - Choi, Hyun Hee

AU - Park, Jong Pil

AU - Lim, Sang Wook

PY - 2015/11/24

Y1 - 2015/11/24

N2 - IMPORTANCE:Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. OBJECTIVE:To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. DESIGN, SETTING, AND PARTICIPANTS: The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent≥28 mmin length) between October 2010 and July 2014 at 20 centers in Korea. INTERVENTIONS: Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. RESULTS: One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14%to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32). CONCLUSIONS AND RELEVANCE: Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.

AB - IMPORTANCE:Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. OBJECTIVE:To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. DESIGN, SETTING, AND PARTICIPANTS: The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent≥28 mmin length) between October 2010 and July 2014 at 20 centers in Korea. INTERVENTIONS: Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. RESULTS: One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14%to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32). CONCLUSIONS AND RELEVANCE: Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.

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U2 - 10.1001/jama.2015.15454

DO - 10.1001/jama.2015.15454

M3 - Article

C2 - 26556051

AN - SCOPUS:84948162604

VL - 314

SP - 2155

EP - 2163

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 20

ER -