SUPPLEMENTAL MATERIAL
Supplemental Methods
Definition of Diabetes
Diabetes was defined as treatment with oral hypoglycemic agents and/or insulin, prior
clinical diagnosis of diabetes, fasting plasma glucose >=126mg/dl, non-fasting plasma glucose
>=200mg/dl, plasma blood glucose level 2 hours after oral glucose tolerance test >=200mg/dl, or
glycated hemoglobin level >=6.5%.
Definitions of Secondary Endpoints
Acute device success was defined to be achieved when all the study stents attempted were
successfully deployed in a given lesion with residual diameter stenosis <50%. Duration of the index
procedure was measured by the time interval between insertion and removal of the guiding catheter.
Procedure success on a patient level was defined as successful dilatation of at least one target-lesion
with residual diameter stenosis <50% without any major in-hospital complications including death,
MI, or stroke.
A TLR was considered clinically indicated if angiography during follow-up showed a
diameter stenosis greater than or equal to 50 percent (core laboratory quantitative coronary
angiographic assessment) and if one of the following occurred: (1) a positive history of recurrent
angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG
changes) or during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal
results of any invasive functional diagnostic test (e.g. fractional flow reserve); (4) a target lesion
revascularization with a diameter stenosis greater than 70% even in the absence of the
above-mentioned ischemic signs or symptoms.
Scheduled staged PCI procedures declared during the index hospitalization were not included
in any coronary revascularization during follow-up. Death was regarded as cardiac in origin unless
obvious non-cardiac causes could be identified. Any death during the index hospitalization for the
randomized PCI procedure was regarded as cardiac death. MI and ST were defined according to the
Academic Research Consortium definitions1. Procedure-related MI was regarded as present with
creatinine kinase (CK) MB fraction >=3 times upper limit of normal after PCI procedure or total CK
>=3 times upper limit of normal in the absence of CKMB measurement. Stroke during follow-up
was defined as ischemic or hemorrhagic stroke requiring hospitalization with symptoms lasting >24
hours. Hospitalization for heart failure was defined as hospitalization due to worsening heart failure
requiring intravenous drug therapy. A device-oriented composite included cardiac death,
target-vessel MI, and TLR, while a patient-oriented composite included all-cause death, MI, and any
repeat coronary revascularization2. Target-lesion failure was defined as the composite of cardiac
death, target-vessel MI, or ischemia-driven TLR, while target-vessel failure was defined as the
composite of cardiac death, MI, or ischemia-driven TVR3. Major adverse cardiac events were
defined as the composite of cardiac death, MI, or ischemia-driven TLR3.
Reference
1. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in
randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020-1029.
2. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri
L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, on behalf of the
Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized
definitions. Circulation. 2007;115:2344-2351.
3. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton
CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ. Everolimus-eluting versus paclitaxel-eluting
stents in coronary artery disease. N Engl J Med. 2010;362:1663-1674.
Supplemental Appendix
Supplemental Appendix A. List of the participating centers and the investigators in the
angiographic substudy
Caress Sappro Tokeidai Memorial Hospital: Kazushi Urasawa, Ryoji Koshida
Caress Sappro Hokko Memorial Hospital: Yoichi Nozaki
Hokkaido Social Insurance Hospital: Keiichi Igarashi, Jungo Furuya
Sendai Kosuei Hospital: Naoto Inoue, Kaname Takizawa
Sendai Open Hospital: Atsushi Kato
Fukushima Medical University Hospital: Yasuchika Takeishi, Kazuhiko Nakazato
Saiseikai Kurihashi Hospital: Yoshimi Ota, Atsushi Honda
Juntendo University Hospital: Hiroyuki Daida, Katsumi Miyauchi
Sakakibara Memorial Hospital: Tetsuya Sumiyoshi, Ryuta Asano
NTT Medical Center Tokyo: Masao Yamasaki
The Cardiovascular Institute Hospital: Junji Yajima, Ryuichi Funada
Mitsui Memorial Hospital: Kengo Tanabe, Masanori Taniwaki
Teikyo University Hospital: Akiyoshi Miyazawa, Ken Kozuma, Nobuaki Suzuki
Tokyo Women's Medical University Hospital: Nobuhisa Hagiwara, Fumiaki Mori
Itabashi Chuo General Hospital: Hiroshi Ohta
Tokai University Hospital: Yoshihiro Morino
Yokohama City University Medical Center: Kazuo Kimura, Kiyoshi Hibi
University of Fukui Hospital: Jong-Dae Lee, Akira Nakano
Juntendo University Shizuoka Hospital: Satoru Suwa
Shizuoka City Shizuoka Hospital: Tomoya Onodera, Ryosuke Takeuchi
Shizuoka General Hospital: Osamu Doi, Satoshi Kaburagi
Hamamatsu Medical Center: Masakazu Kobayashi, Yohei Takayama
Tosei General Hospital: Hiroshi Asano
Nagoya Daini Red Cross Hospital: Haruo Hirayama, Mamoru Nanasato, Yasushi Tatematsu
Toyota Memorial Hospital: Hisashi Umeda
Nagoya Kyoritsu Hospital: Toru Aoyama
Fujita Health University Hospital: Yukio Ozaki, Hiroyuki Naruse
Nagai Hospital: Kozo Hoshino
Mie University Hospital: Takashi Tanigawa
Yokkaichi Social Insurance Hospital: Masaki Kawamura
Shiga University of Medical Science Hospital: Takashi Yamamoto
Kyoto University Hospital: Takeshi Kimura, Hiroki Shiomi
National Hospital Organization Kyoto Medical Center: Mitsuru Abe
Kyoto Second Red Cross Hospital: Hiroshi Fujita
Osaka City General Hospital: Akira Itoh, Kazuhiro Osawa
Osaka Saiseikai Noe Hospital: Shunsuke Take, Shiho Koyama
Osaka City University Hospital: Minoru Yoshiyama, Satoshi Nishimura
Osaka Red Cross Hospital: Tsukasa Inada, Fujio Hayashi
Sumitomo Hospital: Yuji Yasuga, Nobuhiro Mitsusada
Higashisumiyoshi Morimoto Hospital: Yuji Sakanoue
Kansai Denryoku Hospital: Katsuhisa Ishii, Kazuaki Kataoka
Kobe University Hospital: Junya Shite, Hirotoshi Hariki
Hyogo Prefectural Amagasaki Hospital: Yoshiki Takatsu, Ryoji Taniguchi
Hyogo College of Medicine Hospital: Motomaru Masutani
Japanese Red Cross Society Wakayama Medical Center: Takashi Tamura, Hiroki Sakamoto
Wakayama Medical University Hospital: Takashi Akasaka, Hironori Kitabata
Kurashiki Central Hospital: Kazushige Kadota, Hiroyuki Tanaka
Okayama University Hospital: Hiroshi Ito, Yoshiki Hata
Fukuyama Cardiovascular Hospital: Seiichi Haruta, Hideo Takebayashi
Chikamori Hospital: Kazuya Kawai, Shuichi Seki
University Of Occupational And Environmental Health Japan: Shinjo Sonoda, Yoshitaka Muraoka
Kurume University Hospital: Takafumi Ueno, Seiji Kanaya
Kokura Memorial Hospital: Masashi Iwabuchi, Shinichi Shirai
Saiseikai Kumamoto Hospital: Koichi Nakao
Kumamoto Rousai Hospital: Toshiyuki Matsumura, Sei Nakata
Miyazaki Medical Association Hospital: Yoshisato Shibata, Nehiro Kuriyama