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Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial

Authors
 Sung-Jin Hong  ;  Byeong-Keuk Kim  ;  Dong-Ho Shin  ;  Chung-Mo Nam  ;  Jung-Sun Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Tae-Soo Kang  ;  Woong-Chol Kang  ;  Ae-Young Her  ;  Yong Hoon Kim  ;  Seung-Ho Hur  ;  Bum-Kee Hong  ;  Hyuckmoon Kwon  ;  Yangsoo Jang  ;  Myeong-Ki Hong 
Citation
 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, Vol.314(20) : 2155-2163, 2015 
Journal Title
 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 
ISSN
 0098-7484 
Issue Date
2015
MeSH
Aged ; Coronary Angiography/adverse effects ; Coronary Angiography/methods* ; Coronary Angiography/mortality ; Drug-Eluting Stents*/adverse effects ; Endovascular Procedures/adverse effects ; Endovascular Procedures/methods* ; Endovascular Procedures/mortality ; Everolimus/administration & dosage* ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/administration & dosage* ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Prosthesis Implantation/methods* ; Prosthesis Implantation/mortality ; Radiography, Interventional*/adverse effects ; Radiography, Interventional*/mortality ; Ultrasonography, Interventional*/adverse effects ; Ultrasonography, Interventional*/mortality
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 mm in 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.
Full Text
https://jamanetwork.com/journals/jama/fullarticle/2469205
DOI
10.1001/jama.2015.15454
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Preventive Medicine and Public Health (예방의학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kwon, Hyuck Moon(권혁문) ORCID logo https://orcid.org/0000-0001-9901-5015
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Nam, Chung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
Shin, Dong Ho(신동호) ORCID logo https://orcid.org/0000-0002-7874-5542
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/156788
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