Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graftinge Among Patients with Unprotected Left Main Coronary Artery Disease in the New-Generation Drug-Eluting Stents Era (From the CREDO-Kyoto PCI/CABG Registry Cohort-3)

概要

Percutaneous Coronary Intervention Versus Coronary
Artery Bypass Graftinge Among Patients with
Unprotected Left Main Coronary Artery Disease in the
New-Generation Drug-Eluting Stents Era (From the
CREDO-Kyoto PCI/CABG Registry Cohort-3)
,

Ko Yamamoto, MDa, Hiroki Shiomi, MDa *, Takeshi Morimoto, MD, MPHb, Kazushige Kadota, MDc,
Tomohisa Tada, MDd, Yasuaki Takeji, MDa, Yukiko Matsumura-Nakano, MDa,
Yusuke Yoshikawa, MDa, Kazuaki Imada, MDe, Takenori Domei, MDe, Kazuhisa Kaneda, MDf,
Ryoji Taniguchi, MDg, Natsuhiko Ehara, MDh, Ryuzo Nawada, MDi, Masahiro Natsuaki, MDj,
Kyohei Yamaji, MDe, Mamoru Toyofuku, MDk, Naoki Kanemitsu, MDl, Eiji Shinoda, MDm,
Satoru Suwa, MDn, Atsushi Iwakura, MDo, Toshihiro Tamura, MDp, Yoshiharu Soga, MDq,
Tsukasa Inada, MDr, Mitsuo Matsuda, MDs, Tadaaki Koyama, MDt, Takeshi Aoyama, MDu,
Yukihito Sato, MDg, Yutaka Furukawa, MDh, Kenji Ando, MDe, Fumio Yamazaki, MDv,
Tatsuhiko Komiya, MDw, Kenji Minatoya, MDx, Yoshihisa Nakagawa, MDy, and Takeshi Kimura, MDa,
On behalf of the CREDO-Kyoto PCI/CABG Registry Cohort-3 investigators
Long-term safety of percutaneous coronary intervention (PCI) as compared with coronary
artery bypass grafting (CABG) is still controversial in patients with unprotected left main
coronary artery disease (ULMCAD), and there is a scarcity of real-world data on the comparative long-term clinical outcomes between PCI and CABG for ULMCAD in new-generation drug-eluting stents era. The CREDO-Kyoto PCI/CABG registry Cohort-3
enrolled 14927 consecutive patients undergoing first coronary revascularization with PCI
or isolated CABG between January 2011 and December 2013, and we identified 855
patients with ULMCAD (PCI: N = 383 [45%], and CABG: N = 472 [55%]). The primary
outcome measure was all-cause death. Median follow-up duration was 5.5 (interquartile
range: 3.9 to 6.6) years. The cumulative 5-year incidence of all-cause death was not significantly different between the PCI and CABG groups (21.9% vs 17.6%, Log-rank p = 0.13).
After adjusting confounders, the excess risk of PCI relative to CABG remained insignificant for all-cause death (HR, 1.00; 95% CI, 0.68 to 1.47; p = 0.99). There were significant
excess risks of PCI relative to CABG for myocardial infarction and any coronary revascularization (HR, 2.07; 95% CI, 1.30 to 3.37; p = 0.002, and HR, 2.96; 95% CI, 1.96 to 4.46;
a
Department of Cardiovascular Medicine, Kyoto University Graduate
School of Medicine, Kyoto, Japan; bDepartment of Clinical Epidemiology,
Hyogo College of Medicine, Nishinomiya, Japan; cDepartment of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan; dDepartment of Cardiology, Shizuoka General Hospital, Shizuoka, Japan; eDepartment of
Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan; fDepartment
of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan; gDepartment of
Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan; hDepartment of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan; iDepartment of Cardiology,
Shizuoka City Shizuoka Hospital, Shizuoka, Japan; jDepartment of Cardiovascular Medicine, Saga University, Saga, Japan; kDepartment of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama,
Japan; lDepartment of Cardiovascular Surgery, Japanese Red Cross
Wakayama Medical Center, Wakayama, Japan; mDepartment of Cardiology, Hamamatsu Rosai Hospital, Hamamatsu, Japan; nDepartment of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan;
o
Department of Cardiovascular Surgery, Tenri Hospital, Tenri, Japan; pDepartment of Cardiology, Tenri Hospital, Tenri, Japan; qDepartment of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan;
r
Department of Cardiovascular Center, Osaka Red Cross Hospital, Osaka,
Japan; sDepartment of Cardiology, Kishiwada City Hospital, Kishiwada,
Japan; tDepartment of Cardiovascular Surgery, Kobe City Medical Center

0002-9149/© 2021 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.amjcard.2020.12.078

General Hospital, Kobe, Japan; uDivision of Cardiology, Shimada Municipal Hospital, Shimada, Japan; vDepartment of Cardiovascular Surgery,
Shizuoka City Shizuoka Hospital, Shizuoka, Japan; wDepartment of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Japan; xDepartment of Cardiovascular Surgery, Kyoto University Graduate School of
Medicine, Kyoto, Japan; and yDepartment of Cardiovascular Medicine,
Shiga University of Medical Science, Shiga, Japan. Manuscript received
October 11, 2020; revised manuscript received and accepted December 31,
2020.
Disclosures: Dr. Shiomi reports honoraria from Abbott Vascular, and Boston Scientific. Dr. Morimoto reports honoraria from Bayer and Kowa, and
expert witness from Boston Scientific and Sanofi. Dr. Ehara reports honoraria
from Abbott Vascular, Bayer, Boston Scientific, Medtronic, and Terumo. Dr.
Furukawa reports honoraria from Bayer, Kowa, and Sanofi. Dr. Nakagawa
reports research grant from Abbott Vascular and Boston Scientific, and honoraria from Abbott Vascular, Bayer, and Boston Scientific. Dr. Kimura reports
honoraria from Abbott Vascular, Astellas, AstraZeneca, Bayer, Boston Scientific, Kowa, and Sanofi. The remaining authors have nothing to disclose.
Funding: This work was supported by an educational grant from the
Research Institute for Production Development (Kyoto, Japan).
*Corresponding author: Tel: +81-75-751-4255; fax: +81-75-751-3299.
E-mail address: hishiomi@kuhp.kyoto-u.ac.jp (H. Shiomi).

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The American Journal of Cardiology (www.ajconline.org)

p < 0.001), whereas there was no significant excess risk of PCI relative to CABG for stroke
(HR, 0.85; 95% CI, 0.50 to 1.41; p = 0.52). In conclusion, there was no excess long-term
mortality risk of PCI relative to CABG, while the excess risks of PCI relative to CABG
were significant for myocardial infarction and any coronary revascularization in the present study population reflecting real-world clinical practice in Japan. © 2021 Elsevier
Inc. All rights reserved. (Am J Cardiol 2021;145:47−57)

Percutaneous coronary intervention (PCI) has widely
spread in daily clinical practice as an alternative therapy to
coronary artery bypass grafting (CABG) in patients with
unprotected left main coronary artery disease (ULMCAD).1,2 Based on the favorable results in several randomized clinical trials, PCI is recommended in patients with
ULMCAD as a class I for those with low SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score,
or as a class IIa for those with intermediate SYNTAX score
in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guideline,
and as a class IIa for those with low SYNTAX score or nonbifurcation ULMCAD in the American College of Cardiology/American Heart Association guideline.3−8 However,
long-term safety of PCI in patients with ULMCAD is still
controversial. The EACTS has withdrawn the support for
the European Society of Cardiology/EACTS guideline recommendations regarding revascularization for ULMCAD
due to concerns of higher long-term risks for all-cause death
and myocardial infarction in the PCI arm reported in the 5year follow-up of the EXCEL (Evaluation of Xience versus
Coronary Artery Bypass Surgery for Effectiveness of Left
Main Revascularization) trial.5 In addition, previous randomized clinical trials have excluded high-risk patients
such as those with heart failure, and severe chronic kidney
disease, and some observational studies have suggested that
PCI compared with CABG was associated with higher mortality risk in such high-risk patients.9−12 At present, there is
still a scarcity of real-world data on the comparative longterm clinical outcomes between PCI and CABG for ULMCAD in contemporary new-generation drug-eluting stents
(DES) era. We, therefore, reported the long-term clinical
outcomes of PCI compared with CABG in patients with
ULMCAD in the new-generation DES era from a large
observational database of patients undergoing first coronary
revascularization in Japan.
Methods
The Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/CABG registry
Cohort-3 is a physician-initiated, noncompany-sponsored,
multicenter registry enrolling consecutive patients who
underwent first coronary revascularization with PCI or isolated CABG without combined non-coronary surgery
among 22 Japanese centers between January 2011 and
December 2013 (Supplemental Appendix). The relevant
ethics committees in all the participating centers approved
the study protocol. Because of the retrospective enrollment,
written informed consents from the patients were waived;
however, we excluded those patients who refused participation in the study when contacted for follow-up. This

strategy is concordant with the guidelines of the Japanese
Ministry of Health, Labor and Welfare.
A total of 14,927 patients who had undergone first coronary revascularization with PCI or isolated CABG (PCI:
N = 13307, and CABG: N = 1620) were enrolled in the
CREDO-Kyoto PCI/CABG registry Cohort-3 (Supplemental Figure 1). In consistent with the report from the
CREDO-Kyoto PCI/CABG registry Cohort-2, we further
excluded those patients who refused study participation
(N = 60), acute myocardial infarction (N = 5510), and without ULMCAD (N = 8502), and identified 855 patients with
ULMCAD for the comparison of long-term clinical outcomes between PCI and CABG (Figure 1).13
The primary outcome measure of this study was all-cause
death. ...