Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation
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), wh...
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| Published in | JACC. Cardiovascular interventions Vol. 10; no. 12; pp. 1189 - 1198 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
26.06.2017
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| Subjects | |
| Online Access | Get full text |
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| Abstract | 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.
The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear.
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.
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).
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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| AbstractList | 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.
The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear.
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.
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).
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)
[Display omitted] 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.OBJECTIVESThe 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.The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear.BACKGROUNDThe optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear.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.METHODSThe 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.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).RESULTSNACCE 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).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).CONCLUSIONSSix 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). 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 ) 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. The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. 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. 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). 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 | Serikawa, Takeshi Ogawa, Takayuki Yamazaki, Seiji Yoshikawa, Ryohei Ashida, Kazuhiro Inoue, Kenji Doi, Naofumi Shindo, Naohisa Zen, Kan Fujii, Kenshi Ikemoto, Tomokazu Okada, Masaharu Oshima, Masao Misu, Kazuhiko Tojo, Taiki Yano, Shoji Honye, Junko Houzawa, Hidenori Nakamura, Masato Miyauchi, Katsumi Kato, Masayuki Ebisawa, Soichiro Hara, Hidehiko Yaita, Yoshinori Terai, Hidenobu Takagi, Takuro Yasuda, Satoshi Ashikaga, Takashi Inoue, Takumi Uehara, Hiroki Mizuno, Koichi Yamashita, Jun Yoshiyama, Minoru Ono, Shiro Kawata, Masahito Ninomiya, Kenji Shibata, Yoshisato Kijima, Yoichi Ando, Jiro Mori, Chikara Toma, Masanao Yokoi, Yoshiaki Okamura, Takayuki Yamagishi, Masakazu Tanaka, Hiroyuki Oumi, Tetsuo Iijima, Raisuke Otsuka, Yoritaka Ueno, Takafumi Takamisawa, Itaru Takagi, Yuichiro Ueda, Yasunori Jinno, Yasushi Yoshioka, Jiro Suzuki, Takeshi Takashima, Hiroaki Onishi, Yuko Hara, Hisao Ishizaka, Nobukazu Takano, Hitoshi Tanabe, Kengo Ishiwata, Sugao Shimomura, Hideki Kadotani, Makoto Nozaki, Yoichi Yasaka, Yoshinori Doijiri, Tatsuki Ochiai, Masahiko Yo |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28641838$$D View this record in MEDLINE/PubMed |
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| Contributor | Ogawa, Takayuki Yoshikawa, Ryohei Ashida, Kazuhiro Inoue, Kenji Doi, Naofumi Shindo, Naohisa Zen, Kan Fujii, Kenshi Ikemoto, Tomokazu Okada, Masaharu Oshima, Masao Misu, Kazuhiko Tojo, Taiki Honye, Junko Houzawa, Hidenori Miyauchi, Katsumi Hara, Hidehiko Yaita, Yoshinori Takagi, Takuro Yasuda, Satoshi Ashikaga, Takashi Inoue, Takumi Mizuno, Koichi Yamashita, Jun Ono, Shiro Kawata, Masahito Kijima, Yoichi Ando, Jiro Yokoi, Yoshiaki Okamura, Takayuki Tanaka, Hiroyuki Oumi, Tetsuo Ueno, Takafumi Takamisawa, Itaru Takagi, Yuichiro Ueda, Yasunori Jinno, Yasushi Suzuki, Takeshi Hara, Hisao Ishizaka, Nobukazu Takano, Hitoshi Ishiwata, Sugao Kadotani, Makoto Nozaki, Yoichi Doijiri, Tatsuki Ochiai, Masahiko Yokoi, Hiroyoshi Ohira, Hiroshi Morita, Takashi Munemasa, Mitsuru Niinuma, Hiroyuki Ito, Yoshiaki Hikichi, Yutaka Sakamoto, Hiroshi Noma, Shigetaka Yasumura, Yoshio Kamihata, Hiroshi Ishihara, Takayuki Inoue, Ichiro Ando, Kenji Kongoji, Ken Mukawa, Hiroaki Kamiya, Haruo Michishita, Ichiro Kawaguchi, Katsuhiro Ajioka, Masayoshi Anzai, Hitoshi Hirayama, Haruo |
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| Copyright | 2017 Copyright © 2017. Published by Elsevier Inc. |
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| Keywords | RCT biodegradable polymer CI net adverse clinical and cerebrovascular event(s) ITT HR BARC drug-eluting stent(s) dual antiplatelet therapy DES stent thrombosis PCI PH NACCE MI DAPT confidential interval myocardial infarction Bleeding Academic Research Consortium randomized controlled trial percutaneous coronary intervention intention to treat hazard ratio proportional hazard |
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| Snippet | The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term... Abstract Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the... |
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| SubjectTerms | Absorbable Implants Acute Coronary Syndrome - complications Acute Coronary Syndrome - diagnosis Acute Coronary Syndrome - mortality Acute Coronary Syndrome - therapy Aged Aspirin - administration & dosage Aspirin - adverse effects biodegradable polymer Cardiovascular Clopidogrel Coronary Artery Disease - complications Coronary Artery Disease - diagnosis Coronary Artery Disease - mortality Coronary Artery Disease - therapy Drug Administration Schedule Drug Therapy, Combination drug-eluting stent(s) Drug-Eluting Stents dual antiplatelet therapy Female Hemorrhage - chemically induced Humans Intention to Treat Analysis Japan Kaplan-Meier Estimate Male Middle Aged Myocardial Infarction - etiology Myocardial Infarction - mortality net adverse clinical and cerebrovascular event(s) Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Percutaneous Coronary Intervention - mortality Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Polymers - chemistry Proportional Hazards Models Prospective Studies Prosthesis Design Risk Factors stent thrombosis Stroke - etiology Stroke - mortality Ticlopidine - administration & dosage Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Time Factors Treatment Outcome |
| Title | Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation |
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