Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2014-06-27

AUTHORS

Masato Nakamura, Toshiya Muramatsu, Hiroyoshi Yokoi, Hisayuki Okada, Masahiko Ochiai, Satoru Suwa, Hidenari Hozawa, Kazuya Kawai, Masaki Awata, Hiroaki Mukawa, Hiroshi Fujita, Nobuo Shiode, Ryuta Asano, Yoshiaki Tsukamoto, Takahisa Yamada, Yoshio Yasumura, Hiroshi Ohira, Akira Miyamoto, Hiroaki Takashima, Takayuki Ogawa, Yutaka Matsuyama, Shinsuke Nanto, On behalf of the J-DESsERT investigators

ABSTRACT

The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an “oculo-stenotic reflex” bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices. More... »

PAGES

103-114

Journal

Author Affiliations

  • Division of Cardiovascular Medicine, Toho University School of Medicine, Ohashi Medical Center, 2-17-6 Ohashi, 153-8515, Meguro-ku, Tokyo, Japan
  • Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, 230-8765, Yokohama-shi, Kanagawa, Japan
  • Cardiovascular Medicine Center, Fukuoka Sanno Hospital, 3-6-45 Momochihama, Sawara-ku, 814-0001, Fukuoka-shi, Fukuoka, Japan
  • Department of Cardiology, Seirei Hamamatsu General Hospital, 2-12-12 Sumiyoshi, Naka-ku, 430-8558, Hamamatsu-shi, Shizuoka, Japan
  • Division of Cardiology and Cardiac Catheterization Laboratories, Showa University Northern Yokohama Hospital, 35-1 Chigasakichuo, Tsuzuki-ku, 224-8503, Yokohama-shi, Kanagawa, Japan
  • Department of Cardiology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, 410-2295, Izunokuni-shi, Shizuoka, Japan
  • Division of Cardiology, Ayase Heart Hospital, 3-12-10 Yanaka, 120-0006, Adachi-ku, Tokyo, Japan
  • Division of Cardiology, Chikamori Hospital, 1-1-16 Okawasuji, 780-8522, Kochi-shi, Kochi, Japan
  • Kansai Rosai Hospital Cardiovascular Center, 3-1-69 Inabaso, 660-8511, Amagasaki-shi, Hyogo, Japan
  • Department of Cardiology, Ogaki Municipal Hospital, 4-86 Minaminokawa-cho, 503-8502, Ogaki-shi, Gifu, Japan
  • Division of Cardiology, Japanese Red Cross Kyoto Daini Hospital, 355-5 Kamanzadorimarutamachiagaruharuobi-cho, Kamigyo-ku, 602-8026, Kyoto-shi, Kyoto, Japan
  • Division of Cardiology, Tsuchiya General Hospital, 3-30 Nakajima-cho, Naka-ku, 730-8655, Hiroshima-shi, Hiroshima, Japan
  • Department of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, 183-0003, Fuchu-shi, Tokyo, Japan
  • Department of Cardiology, Kawasaki Saiwai Hospital, 31-27 Omiya-cho, Saiwai-ku, 212-0014, Kawasaki-shi, Kanagawa, Japan
  • Division of Cardiology, Osaka General Medical Center, 3-1-56 Mandaihigashi, Sumiyoshi-ku, 558-8558, Osaka-shi, Osaka, Japan
  • Cardiovascular Division, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, 540-0006, Osaka-shi, Osaka, Japan
  • Department of Cardiology, Edogawa Hospital, 2-24-18 Higashikoiwa, 133-0052, Edogawa-ku, Tokyo, Japan
  • Department of Cardiology, Kikuna Memorial Hospital, 4-4-27 Kikuna, Kohoku-ku, 222-0011, Yokohama-shi, Japan
  • Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, 480-1195, Nagakute-shi, Aichi, Japan
  • Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishishinbashi, 105-8461, Minato-ku, Tokyo, Japan
  • Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, 111-0033, Bunkyo-ku, Tokyo, Japan
  • Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, 565-0871, Suita-shi, Osaka, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12928-014-0279-z

    DOI

    http://dx.doi.org/10.1007/s12928-014-0279-z

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1029364812

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/24969222


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