title: Three-year follow-up outcomes of SES and PES in a randomized controlled study stratified by the presence of diabetes mellitus: J-DEsSERT trial.
abstract: BACKGROUND
  Three-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients.
  
  
  METHODS
  In the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES).
  
  
  RESULTS
  There were no significant differences in baseline clinical characteristics aside from hypertension. Incidence of major adverse cardiac cerebrovascular events (MACCE) mainly due to higher target vessel failure (TVF) initially indicated a benefit in SES (MACCE rate at 1 year: SES 9.4%, PES 12.2%, p=0.08); however this had attenuated by the time of the 3-year follow-up (MACCE rate from 1 to 3 years: SES 8.4%, PES 6.1%, p=0.10). A similar pattern was observed in insulin-treated patients: MACCE rate from 1 to 3 years was 10.5% in SES and 6.4% in PES (p=0.25). Angiographic follow-up also resulted in higher major adverse cardiac event (MACE) rates at 1 year (presence 11.5%, absence 8.3%, p=0.04); however by 3 years rates were similar regardless of the presence of angiographic follow-up (MACE rate at 3 years: presence 16.0%, absence 14.5%, p=0.35).
  
  
  CONCLUSIONS
  The superiority of SES over PES in MACCE at 1 year had attenuated by 3-year follow-up. Eventually, the 3-year safety and efficacy profiles were similar regardless of insulin treatment.
authors.affiliation: Department of Cardiovascular Medicine, Toho University School of Medicine, Ohashi Medical Center, 2-17-6 Ohashi Meguroku, Tokyo 180-0023, Japan. Electronic address: masato@oha.toho-u.ac.jp.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8765, Japan.
authors.forename: Toshiya
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Department of Cardiovascular Medicine Center, Fukuoka Sanno Hospital, 3-6-45 Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka 814-0001, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.affiliation: Department of Cardiology, Seirei Hamamatsu General Hospital, 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu-shi, Shizuoka 430-8558, Japan.
authors.forename: Hisayuki
authors.initials: H
authors.lastname: Okada
authors.affiliation: Division of Cardiology and Cardiac Catheterization Laboratories, Showa University Northern Yokohama Hospital, 35-1 Chigasakichuo, Tsuzuki-ku, Yokohama-shi, Kanagawa 224-8503, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ochiai
authors.affiliation: Department of Cardiology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-shi, Shizuoka 410-2295, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Suwa
authors.affiliation: Division of Cardiology, Ayase Heart Hospital, 3-12-10 Yanaka, Adachi-ku, Tokyo 120-0006, Japan.
authors.forename: Hidenari
authors.initials: H
authors.lastname: Hozawa
authors.affiliation: Division of Cardiology, Chikamori Hospital, 1-1-16 Okawasuji, Kochi-shi, Kochi 780-8522, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Kawai
authors.affiliation: Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Awata
authors.affiliation: Department of Cardiology, Ogaki Municipal Hospital, 4-86 Minaminokawa-cho, Ogaki-shi, Gifu 503-8502, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Mukawa
authors.affiliation: Division of Cardiology, Japanese Red Cross Kyoto Daini Hospital, 355-5 Kamanzadorimarutamachiagaruharuobi-cho, Kamigyo-ku, Kyoto-shi, Kyoto 602-8026, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujita
authors.affiliation: Division of Cardiology, Tsuchiya General Hospital, 3-30 Nakajima-cho, Naka-ku, Hiroshima-shi, Hiroshima 730-8655, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shiode
authors.affiliation: Department of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003, Japan.
authors.forename: Ryuta
authors.initials: R
authors.lastname: Asano
authors.affiliation: Department of Cardiology, Kawasaki Saiwai Hospital, 31-27 Omiya-cho, Saiwai-ku, Kawasaki-shi, Kanagawa 212-0014, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Tsukamoto
authors.affiliation: Division of Cardiology, Osaka General Medical Center, 3-1-56 Mandaihigashi, Sumiyoshi-ku, Osaka-shi, Osaka 558-8558, Japan.
authors.forename: Takahisa
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Cardiovascular Division, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka-shi, Osaka 540-0006, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Yasumura
authors.affiliation: Department of Cardiology, Edogawa Hospital, 2-24-18 Higashikoiwa, Edogawa-ku, Tokyo 133-0052, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ohira
authors.affiliation: Department of Cardiology, Kikuna Memorial Hospital, 4-4-27 Kikuna, Kohoku-ku, Yokohama-shi, Kanagawa 222-0011, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Miyamoto
authors.affiliation: Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute-shi, Aichi 480-1195, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Takashima
authors.affiliation: Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Ogawa
authors.affiliation: Division of Cardiology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya-shi, Aichi 464-0071, Japan.
authors.forename: Shigenori
authors.initials: S
authors.lastname: Ito
authors.affiliation: Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 111-0033, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Matsuyama
authors.affiliation: Nishinomiya Hospital Affairs, Nishinomiya Municipal Central Hospital, 8-24 Hayashida-cho Nishinomiya-shi, Hyogo 663-8014, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
mesh_terms: D000368:Aged; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000188:drug therapy*; D054855:Drug-Eluting Stents / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus
keywords: Angiographic follow-up; Diabetes mellitus; Drug eluting stents