Masato Nakamura1, Toshiya Muramatsu2, Hiroyoshi Yokoi3, Hisayuki Okada4, Masahiko Ochiai5, Satoru Suwa6, Hidenari Hozawa7, Kazuya Kawai8, Masaki Awata9, Hiroaki Mukawa10, Hiroshi Fujita11, Nobuo Shiode12, Ryuta Asano13, Yoshiaki Tsukamoto14, Takahisa Yamada15, Yoshio Yasumura16, Hiroshi Ohira17, Akira Miyamoto18, Hiroaki Takashima19, Takayuki Ogawa20, Shigenori Ito21, Yutaka Matsuyama22, Shinsuke Nanto23. 1. 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. 2. Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8765, Japan. 3. Department of Cardiovascular Medicine Center, Fukuoka Sanno Hospital, 3-6-45 Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka 814-0001, Japan. 4. Department of Cardiology, Seirei Hamamatsu General Hospital, 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu-shi, Shizuoka 430-8558, Japan. 5. Division of Cardiology and Cardiac Catheterization Laboratories, Showa University Northern Yokohama Hospital, 35-1 Chigasakichuo, Tsuzuki-ku, Yokohama-shi, Kanagawa 224-8503, Japan. 6. Department of Cardiology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-shi, Shizuoka 410-2295, Japan. 7. Division of Cardiology, Ayase Heart Hospital, 3-12-10 Yanaka, Adachi-ku, Tokyo 120-0006, Japan. 8. Division of Cardiology, Chikamori Hospital, 1-1-16 Okawasuji, Kochi-shi, Kochi 780-8522, Japan. 9. Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan. 10. Department of Cardiology, Ogaki Municipal Hospital, 4-86 Minaminokawa-cho, Ogaki-shi, Gifu 503-8502, Japan. 11. Division of Cardiology, Japanese Red Cross Kyoto Daini Hospital, 355-5 Kamanzadorimarutamachiagaruharuobi-cho, Kamigyo-ku, Kyoto-shi, Kyoto 602-8026, Japan. 12. Division of Cardiology, Tsuchiya General Hospital, 3-30 Nakajima-cho, Naka-ku, Hiroshima-shi, Hiroshima 730-8655, Japan. 13. Department of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003, Japan. 14. Department of Cardiology, Kawasaki Saiwai Hospital, 31-27 Omiya-cho, Saiwai-ku, Kawasaki-shi, Kanagawa 212-0014, Japan. 15. Division of Cardiology, Osaka General Medical Center, 3-1-56 Mandaihigashi, Sumiyoshi-ku, Osaka-shi, Osaka 558-8558, Japan. 16. Cardiovascular Division, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka-shi, Osaka 540-0006, Japan. 17. Department of Cardiology, Edogawa Hospital, 2-24-18 Higashikoiwa, Edogawa-ku, Tokyo 133-0052, Japan. 18. Department of Cardiology, Kikuna Memorial Hospital, 4-4-27 Kikuna, Kohoku-ku, Yokohama-shi, Kanagawa 222-0011, Japan. 19. Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute-shi, Aichi 480-1195, Japan. 20. Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan. 21. Division of Cardiology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya-shi, Aichi 464-0071, Japan. 22. Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 111-0033, Japan. 23. Nishinomiya Hospital Affairs, Nishinomiya Municipal Central Hospital, 8-24 Hayashida-cho Nishinomiya-shi, Hyogo 663-8014, Japan.
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.
RCT Entities:
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 diabeticpatients. METHODS: In the largest trial of its kind, 1724 DMpatients 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.