TY - JOUR
T1 - Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation
AU - NIPPON Investigators
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 - Ozaki, Yukio
N1 - Publisher Copyright:
© 2017
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.
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.
KW - biodegradable polymer
KW - drug-eluting stent(s)
KW - dual antiplatelet therapy
KW - net adverse clinical and cerebrovascular event(s)
KW - stent thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85020865128&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85020865128&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2017.04.019
DO - 10.1016/j.jcin.2017.04.019
M3 - Article
C2 - 28641838
AN - SCOPUS:85020865128
SN - 1936-8798
VL - 10
SP - 1189
EP - 1198
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 12
ER -