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Erschienen in: Cardiovascular Intervention and Therapeutics 2/2015

01.04.2015 | Original Article

Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT)

verfasst von: 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

Erschienen in: Cardiovascular Intervention and Therapeutics | Ausgabe 2/2015

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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.
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Metadaten
Titel
Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT)
verfasst von
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
Publikationsdatum
01.04.2015
Verlag
Springer Japan
Erschienen in
Cardiovascular Intervention and Therapeutics / Ausgabe 2/2015
Print ISSN: 1868-4300
Elektronische ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-014-0279-z

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