title: 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).
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.
authors: Division of Cardiovascular Medicine, Toho University School of Medicine, Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan, masato@oha.toho-u.ac.jp.
authors: Masato
authors: M
authors: Nakamura
authors: Toshiya
authors: T
authors: Muramatsu
authors: Hiroyoshi
authors: H
authors: Yokoi
authors: Hisayuki
authors: H
authors: Okada
authors: Masahiko
authors: M
authors: Ochiai
authors: Satoru
authors: S
authors: Suwa
authors: Hidenari
authors: H
authors: Hozawa
authors: Kazuya
authors: K
authors: Kawai
authors: Masaki
authors: M
authors: Awata
authors: Hiroaki
authors: H
authors: Mukawa
authors: Hiroshi
authors: H
authors: Fujita
authors: Nobuo
authors: N
authors: Shiode
authors: Ryuta
authors: R
authors: Asano
authors: Yoshiaki
authors: Y
authors: Tsukamoto
authors: Takahisa
authors: T
authors: Yamada
authors: Yoshio
authors: Y
authors: Yasumura
authors: Hiroshi
authors: H
authors: Ohira
authors: Akira
authors: A
authors: Miyamoto
authors: Hiroaki
authors: H
authors: Takashima
authors: Takayuki
authors: T
authors: Ogawa
authors: Yutaka
authors: Y
authors: Matsuyama
authors: Shinsuke
authors: S
authors: Nanto
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D020123:Sirolimus / Q000627:therapeutic use*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus