Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation

NIPPON Investigators

研究成果: Article

28 引用 (Scopus)

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Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. Background The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. Methods The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. Results NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of −2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). Conclusions Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227)

元の言語English
ページ(範囲)1189-1198
ページ数10
ジャーナルJACC: Cardiovascular Interventions
10
発行部数12
DOI
出版物ステータスPublished - 26-06-2017

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Drug-Eluting Stents
Polymers
Therapeutics
Confidence Intervals
Myocardial Infarction
Hemorrhage
Intention to Treat Analysis
Mortality
Tokyo
Acute Coronary Syndrome
Group Psychotherapy
Stents
Japan
Stroke

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

これを引用

@article{9b61085a29394440a70f73df38e9117a,
title = "Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation",
abstract = "Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. Background The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. Methods The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. Results NACCE occurred in 34 patients (2.1{\%}) receiving short-term DAPT and 24 patients (1.5{\%}) receiving long-term DAPT (difference 0.6{\%}, 95{\%} confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95{\%} CI was inside the specified margin of −2{\%}, noninferiority of short-term DAPT was confirmed. Mortality was 1.0{\%} with short-term DAPT versus 0.4{\%} with long-term DAPT, whereas myocardial infarction was 0.2{\%} versus 0.1{\%}, and major bleeding was 0.7{\%} versus 0.7{\%}, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95{\%} CI: 0.86 to 2.43). Conclusions Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227)",
author = "{NIPPON Investigators} and Masato Nakamura and Raisuke Iijima and Junya Ako and Toshiro Shinke and Hisayuki Okada and Yoshiaki Ito and Kenji Ando and Hitoshi Anzai and Hiroyuki Tanaka and Yasunori Ueda and Shin Takiuchi and Yasunori Nishida and Hiroshi Ohira and Katsuhiro Kawaguchi and Makoto Kadotani and Hiroyuki Niinuma and Kazuto Omiya and Takashi Morita and Kan Zen and Yoshinori Yasaka and Kenji Inoue and Sugao Ishiwata and Masahiko Ochiai and Toshimitsu Hamasaki and Hiroyoshi Yokoi and Hisayuki Okada and Yoshiaki Ito and Hidehiko Hara and Kenji Ando and Hitoshi Anzai and Hiroyuki Tanaka and Yasunori Ueda and Shin Takiuchi and Yasunori Nishida and Hiroshi Ohira and Katsuhiro Kawaguchi and Makoto Kadotani and Hiroyuki Niinuma and Kazuto Omiya and Takashi Morita and Kan Zen and Yoshinori Yaita and Kenji Inoue and Sugao Ishiwata and Masahiko Ochiai and Itaru Takamisawa and Junji Yajima and Takayuki Ishihara and Shigeru Nakamura and Kenshi Fujii",
year = "2017",
month = "6",
day = "26",
doi = "10.1016/j.jcin.2017.04.019",
language = "English",
volume = "10",
pages = "1189--1198",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "12",

}

Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. / NIPPON Investigators.

:: JACC: Cardiovascular Interventions, 巻 10, 番号 12, 26.06.2017, p. 1189-1198.

研究成果: Article

TY - JOUR

T1 - Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation

AU - NIPPON Investigators

AU - Nakamura, Masato

AU - Iijima, Raisuke

AU - Ako, Junya

AU - Shinke, Toshiro

AU - Okada, Hisayuki

AU - Ito, Yoshiaki

AU - Ando, Kenji

AU - Anzai, Hitoshi

AU - Tanaka, Hiroyuki

AU - Ueda, Yasunori

AU - Takiuchi, Shin

AU - Nishida, Yasunori

AU - Ohira, Hiroshi

AU - Kawaguchi, Katsuhiro

AU - Kadotani, Makoto

AU - Niinuma, Hiroyuki

AU - Omiya, Kazuto

AU - Morita, Takashi

AU - Zen, Kan

AU - Yasaka, Yoshinori

AU - Inoue, Kenji

AU - Ishiwata, Sugao

AU - Ochiai, Masahiko

AU - Hamasaki, Toshimitsu

AU - Yokoi, Hiroyoshi

AU - Okada, Hisayuki

AU - Ito, Yoshiaki

AU - Hara, Hidehiko

AU - Ando, Kenji

AU - Anzai, Hitoshi

AU - Tanaka, Hiroyuki

AU - Ueda, Yasunori

AU - Takiuchi, Shin

AU - Nishida, Yasunori

AU - Ohira, Hiroshi

AU - Kawaguchi, Katsuhiro

AU - Kadotani, Makoto

AU - Niinuma, Hiroyuki

AU - Omiya, Kazuto

AU - Morita, Takashi

AU - Zen, Kan

AU - Yaita, Yoshinori

AU - Inoue, Kenji

AU - Ishiwata, Sugao

AU - Ochiai, Masahiko

AU - Takamisawa, Itaru

AU - Yajima, Junji

AU - Ishihara, Takayuki

AU - Nakamura, Shigeru

AU - Fujii, Kenshi

PY - 2017/6/26

Y1 - 2017/6/26

N2 - Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. Background The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. Methods The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. Results NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of −2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). Conclusions Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227)

AB - Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. Background The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. Methods The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. Results NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of −2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). Conclusions Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227)

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U2 - 10.1016/j.jcin.2017.04.019

DO - 10.1016/j.jcin.2017.04.019

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EP - 1198

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 12

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