Accepted Manuscript Usefulness of Intravascular Ultrasound Guidance in Percutaneous Coronary Intervention with Second-generation Drug-eluting Stents for Chronic Total Occlusions (From the Multicenter Korean Chronic Total Occlusion [K-CTO] Registry) Sung-Jin Hong , MD Byeong-Keuk Kim , MD Dong-Ho Shin , MD Jung-Sun Kim , MD Myeong-Ki Hong , MD Hyeon-Cheol Gwon , MD Hyo-Soo Kim , MD Cheol Woong Yu , MD Hun Sik Park , MD In-Ho Chae , MD Seung-Woon Rha , MD Seung-Hwan Lee , MD Moo-Hyun Kim , MD Seung-Ho Hur , MD Yangsoo Jang , MD PII:
S0002-9149(14)01220-X
DOI:
10.1016/j.amjcard.2014.05.027
Reference:
AJC 20486
To appear in:
The American Journal of Cardiology
Received Date: 7 April 2014 Revised Date:
27 May 2014
Accepted Date: 27 May 2014
Please cite this article as: Hong S-J, Kim B-K, Shin D-H, Kim J-S, Hong M-K, Gwon H-C, Kim H-S, Yu CW, Park HS, Chae I-H, Rha S-W, Lee S-H, Kim M-H, Hur S-H, Jang Y, , Usefulness of Intravascular Ultrasound Guidance in Percutaneous Coronary Intervention with Second-generation Drug-eluting Stents for Chronic Total Occlusions (From the Multicenter Korean Chronic Total Occlusion [K-CTO] Registry), The American Journal of Cardiology (2014), doi: 10.1016/j.amjcard.2014.05.027. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Usefulness of Intravascular Ultrasound Guidance in Percutaneous Coronary Intervention with Second-generation Drug-eluting Stents for Chronic Total Occlusions
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(From the Multicenter Korean Chronic Total Occlusion [K-CTO] Registry)
Sung-Jin Hong, MDa, Byeong-Keuk Kim, MDa, Dong-Ho Shin, MDa, Jung-Sun Kim, MDa, Myeong-Ki Hong, MDa,b, Hyeon-Cheol Gwon, MDc, Hyo-Soo Kim, MDd, Cheol Woong Yu, MDe, Hun Sik Park, MDf, In-Ho Chae, MDg, Seung-Woon Rha, MDh, Seung-Hwan Lee, MDi,
SC
Moo-Hyun Kim, MDj, Seung-Ho Hur, MDk, Yangsoo Jang, MDa,b, for the K-CTO Registry.
a
M AN U
The first two authors contributed equally to this work. Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea; b
Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul,
Korea; cSamsung Medical Center, Seoul, Korea; dSeoul National University Hospital, Seoul, Korea; eSejong General Hospital, Bucheon, Korea; fKyungpook National University Hospital,
TE D
Taegu, Korea; gSeoul National University Bundang Hospital, Seongnam-si, Korea; hKorea University Guro Hospital, Seoul, Korea; iWonju Severance Christian Hospital, Wonju, Korea; Dong-A University Hospital, Busan, Korea; kDongsan Medical center, Daegu, Korea
EP
j
AC C
Running title: IVUS for CTO
Corresponding author: Yangsoo Jang, MD, PhD Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, 120-752 Seoul, South Korea Telephone: 82-2-2228-8460 / Fax: 82-2-393-2041 / E-mail: [email protected]
1
ACCEPTED MANUSCRIPT Abstract Despite the usefulness of intravascular ultrasound (IVUS) in percutaneous coronary intervention (PCI), the impact of IVUS guidance on clinical outcomes, particularly for
RI PT
chronic total occlusions (CTO) intervention, has rarely been studied. We sought to investigate the clinical usefulness of IVUS-guided CTO intervention with second-generation drugeluting stent implantation (DES). Between 2007 and 2009, 2568 patients were enrolled in the
SC
Korean-CTO Registry and 534 patients with successful implantation of second-generation DES were analyzed. IVUS-guided PCI was performed on 206 patients (39%). Clinical
M AN U
outcomes at 2 year were compared between the IVUS-guidance group and the angiographyguidance group in 201 propensity-score matched pairs. Primary endpoint was the occurrence of definite or probable stent thrombosis. Clinical characteristics were similar between both groups after matching. At 2 year, the IVUS-guidance group showed significantly less stent
TE D
thrombosis than the angiography-guidance group (0% vs. 3.0%, p = 0.014) and a lower trend toward myocardial infarction (1.0% vs. 4.0%, p = 0.058). Target lesion revascularization (TLR) and major adverse cardiovascular event (MACE) rates were similar. However, a
EP
significant interaction was observed between the use of IVUS and lesion length for predicting the TLR (p = 0.037), suggesting usefulness of IVUS in long lesion (≥3 cm) relative to short
AC C
lesion CTO. In conclusion, although IVUS-guided CTO PCI was not associated with a reduction in overall MACE, IVUS-guidance appears to be associated with a reduction of stent thrombosis and myocardial infarction compared with angiography-guided CTO PCI. Additionally, TLR occurred less frequently in the IVUS-guidance group, especially for long lesions.
Key words: intravascular ultrasound; drug-eluting stent; percutaneous coronary intervention
2
ACCEPTED MANUSCRIPT Successful percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has been associated with an improvement in angina, left ventricular function, and survival, when compared with failed CTO PCI.1-3 However, an increased risk of stent
RI PT
thrombosis after CTO recanalization with drug-eluting stent (DES) has been suggested because of the delayed reendothelialization, the exposure of deep plaque components, the persistence of well-developed collaterals, and the frequent need of long stenting with higher chances of incomplete stent apposition.4,5 In addition, CTO presents still a higher restenosis
SC
rate than other lesion subsets, even using DES.6 Recent meta-analyses and large population
M AN U
study demonstrated the usefulness of intravascular ultrasound (IVUS) in PCI with DES in the reduction of stent thrombosis and myocardial infarction (MI).7-9 Therefore, IVUS-guided PCI could be more useful in CTO lesions by accurate assessment of stent sizing and treatment of suboptimal stent deployment such as underexpansion, incomplete stent malapposition,
TE D
incomplete lesion coverage, or edge dissections.10 We aimed to investigate the clinical usefulness of IVUS-guided CTO intervention on clinical outcomes from a large cohort of
Methods
EP
patients undergoing PCI with second-generation DES implantation.
AC C
Between January 2007 and December 2009, a total of 2568 patients in which CTO intervention was attempted were enrolled in the Korean-CTO (K-CTO) Registry. The K-CTO registry is an observational online registry that has 26 participating centers in Korea. Patients with CTO diagnosed as stable angina or unstable angina while having a large area of reversible ischemia assessed by using imaging modalities were registered. CTO was defined as an obstruction of a native coronary artery with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 and an estimated duration of at least 3 months based on the clinical history or previous coronary angiography.11,12 The duration of CTO was determined based on 3
ACCEPTED MANUSCRIPT the interval from the last episode of acute coronary syndrome or from the first episode of effort angina consistent with the location of the occlusion in patients without histories of acute coronary syndrome.13,14 All patients had typical symptomatic angina or a positive test in
RI PT
various functional studies evaluating ischemia. Exclusion criteria were presentation with acute MI or cardiogenic shock; undergoing only bare metal stent implantation or balloon angioplasty without DES implantation; CTO lesions with DES restenosis, graft vessel
SC
occlusion, or culprit lesion of acute coronary syndrome within 4 weeks; severe hepatic dysfunction (≥3 times normal reference values); life expectancy
S0002-9149(14)01220-X
DOI:
10.1016/j.amjcard.2014.05.027
Reference:
AJC 20486
To appear in:
The American Journal of Cardiology
Received Date: 7 April 2014 Revised Date:
27 May 2014
Accepted Date: 27 May 2014
Please cite this article as: Hong S-J, Kim B-K, Shin D-H, Kim J-S, Hong M-K, Gwon H-C, Kim H-S, Yu CW, Park HS, Chae I-H, Rha S-W, Lee S-H, Kim M-H, Hur S-H, Jang Y, , Usefulness of Intravascular Ultrasound Guidance in Percutaneous Coronary Intervention with Second-generation Drug-eluting Stents for Chronic Total Occlusions (From the Multicenter Korean Chronic Total Occlusion [K-CTO] Registry), The American Journal of Cardiology (2014), doi: 10.1016/j.amjcard.2014.05.027. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Usefulness of Intravascular Ultrasound Guidance in Percutaneous Coronary Intervention with Second-generation Drug-eluting Stents for Chronic Total Occlusions
RI PT
(From the Multicenter Korean Chronic Total Occlusion [K-CTO] Registry)
Sung-Jin Hong, MDa, Byeong-Keuk Kim, MDa, Dong-Ho Shin, MDa, Jung-Sun Kim, MDa, Myeong-Ki Hong, MDa,b, Hyeon-Cheol Gwon, MDc, Hyo-Soo Kim, MDd, Cheol Woong Yu, MDe, Hun Sik Park, MDf, In-Ho Chae, MDg, Seung-Woon Rha, MDh, Seung-Hwan Lee, MDi,
SC
Moo-Hyun Kim, MDj, Seung-Ho Hur, MDk, Yangsoo Jang, MDa,b, for the K-CTO Registry.
a
M AN U
The first two authors contributed equally to this work. Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea; b
Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul,
Korea; cSamsung Medical Center, Seoul, Korea; dSeoul National University Hospital, Seoul, Korea; eSejong General Hospital, Bucheon, Korea; fKyungpook National University Hospital,
TE D
Taegu, Korea; gSeoul National University Bundang Hospital, Seongnam-si, Korea; hKorea University Guro Hospital, Seoul, Korea; iWonju Severance Christian Hospital, Wonju, Korea; Dong-A University Hospital, Busan, Korea; kDongsan Medical center, Daegu, Korea
EP
j
AC C
Running title: IVUS for CTO
Corresponding author: Yangsoo Jang, MD, PhD Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, 120-752 Seoul, South Korea Telephone: 82-2-2228-8460 / Fax: 82-2-393-2041 / E-mail: [email protected]
1
ACCEPTED MANUSCRIPT Abstract Despite the usefulness of intravascular ultrasound (IVUS) in percutaneous coronary intervention (PCI), the impact of IVUS guidance on clinical outcomes, particularly for
RI PT
chronic total occlusions (CTO) intervention, has rarely been studied. We sought to investigate the clinical usefulness of IVUS-guided CTO intervention with second-generation drugeluting stent implantation (DES). Between 2007 and 2009, 2568 patients were enrolled in the
SC
Korean-CTO Registry and 534 patients with successful implantation of second-generation DES were analyzed. IVUS-guided PCI was performed on 206 patients (39%). Clinical
M AN U
outcomes at 2 year were compared between the IVUS-guidance group and the angiographyguidance group in 201 propensity-score matched pairs. Primary endpoint was the occurrence of definite or probable stent thrombosis. Clinical characteristics were similar between both groups after matching. At 2 year, the IVUS-guidance group showed significantly less stent
TE D
thrombosis than the angiography-guidance group (0% vs. 3.0%, p = 0.014) and a lower trend toward myocardial infarction (1.0% vs. 4.0%, p = 0.058). Target lesion revascularization (TLR) and major adverse cardiovascular event (MACE) rates were similar. However, a
EP
significant interaction was observed between the use of IVUS and lesion length for predicting the TLR (p = 0.037), suggesting usefulness of IVUS in long lesion (≥3 cm) relative to short
AC C
lesion CTO. In conclusion, although IVUS-guided CTO PCI was not associated with a reduction in overall MACE, IVUS-guidance appears to be associated with a reduction of stent thrombosis and myocardial infarction compared with angiography-guided CTO PCI. Additionally, TLR occurred less frequently in the IVUS-guidance group, especially for long lesions.
Key words: intravascular ultrasound; drug-eluting stent; percutaneous coronary intervention
2
ACCEPTED MANUSCRIPT Successful percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has been associated with an improvement in angina, left ventricular function, and survival, when compared with failed CTO PCI.1-3 However, an increased risk of stent
RI PT
thrombosis after CTO recanalization with drug-eluting stent (DES) has been suggested because of the delayed reendothelialization, the exposure of deep plaque components, the persistence of well-developed collaterals, and the frequent need of long stenting with higher chances of incomplete stent apposition.4,5 In addition, CTO presents still a higher restenosis
SC
rate than other lesion subsets, even using DES.6 Recent meta-analyses and large population
M AN U
study demonstrated the usefulness of intravascular ultrasound (IVUS) in PCI with DES in the reduction of stent thrombosis and myocardial infarction (MI).7-9 Therefore, IVUS-guided PCI could be more useful in CTO lesions by accurate assessment of stent sizing and treatment of suboptimal stent deployment such as underexpansion, incomplete stent malapposition,
TE D
incomplete lesion coverage, or edge dissections.10 We aimed to investigate the clinical usefulness of IVUS-guided CTO intervention on clinical outcomes from a large cohort of
Methods
EP
patients undergoing PCI with second-generation DES implantation.
AC C
Between January 2007 and December 2009, a total of 2568 patients in which CTO intervention was attempted were enrolled in the Korean-CTO (K-CTO) Registry. The K-CTO registry is an observational online registry that has 26 participating centers in Korea. Patients with CTO diagnosed as stable angina or unstable angina while having a large area of reversible ischemia assessed by using imaging modalities were registered. CTO was defined as an obstruction of a native coronary artery with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 and an estimated duration of at least 3 months based on the clinical history or previous coronary angiography.11,12 The duration of CTO was determined based on 3
ACCEPTED MANUSCRIPT the interval from the last episode of acute coronary syndrome or from the first episode of effort angina consistent with the location of the occlusion in patients without histories of acute coronary syndrome.13,14 All patients had typical symptomatic angina or a positive test in
RI PT
various functional studies evaluating ischemia. Exclusion criteria were presentation with acute MI or cardiogenic shock; undergoing only bare metal stent implantation or balloon angioplasty without DES implantation; CTO lesions with DES restenosis, graft vessel
SC
occlusion, or culprit lesion of acute coronary syndrome within 4 weeks; severe hepatic dysfunction (≥3 times normal reference values); life expectancy
