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

Autor: Masato Nakamura, Raisuke Iijima, Junya Ako, Toshiro Shinke, Hisayuki Okada, Yoshiaki Ito, Kenji Ando, Hitoshi Anzai, Hiroyuki Tanaka, Yasunori Ueda, Shin Takiuchi, Yasunori Nishida, Hiroshi Ohira, Katsuhiro Kawaguchi, Makoto Kadotani, Hiroyuki Niinuma, Kazuto Omiya, Takashi Morita, Kan Zen, Yoshinori Yasaka, Kenji Inoue, Sugao Ishiwata, Masahiko Ochiai, Toshimitsu Hamasaki, Hiroyoshi Yokoi, Hidehiko Hara, Yoshinori Yaita, Itaru Takamisawa, Junji Yajima, Takayuki Ishihara, Shigeru Nakamura, Kenshi Fujii, Kazuhiro Ashida, Hiroshi Ota, Masaaki Okutsu, Masao Oshima, Ken Kongoji, Yasushi Jinno, Ryu Shutta, Nobuo Shiode, Tetsuo Oumi, Tatsuki Doijiri, Yoshiaki Yokoi, Takayuki Ogawa, Keizo Kimura, Mitsuru Munemasa, Hiroaki Mukawa, Kota Komiyama, Takeshi Suzuki, Takumi Inoue, Takafumi Ueno, Teruyasu Sugano, Jun Yamashita, Yoshio Yasumura, Haruo Kamiya, Hiroshi Fujita, Kazushi Urasawa, Shiro Ono, Masayoshi Ajioka, Jiro Ando, Koichi Mizuno, Haruo Hirayama, Taiki Tojo, Yuichiro Maekawa, Tomohiro Kawasaki, Takayuki Okamura, Fumitoshi Toyota, Yutaka Hikichi, Ichiro Michishita, Takafumi Yagi, Hiroshi Kamihata, Naohisa Shindo, Nobukazu Ishizaka, Takashi Ashikaga, Yukio Ozaki, Hisao Hara, Hiroshi Sakamoto, Kenji Kada, Naofumi Doi, Junko Honye, Hitoshi Takano, Masahito Kawata, Hidenori Houzawa, Toru Ozawa, Arifumi Kikuchi, Kazushige Kadota, Yoichi Kijima, Tomokazu Ikemoto, Yoshihisa Shimada, Kazuhiko Yumoto, Kenji Kawajiri, Yoichi Nozaki, Masayoshi Sakakibara, Atsushi Tosaka, Shigetaka Noma, Yasushi Wakabayashi, Masaharu Okada, Mizuki Hirose, Yuichiro Takagi, Takuro Takagi, Katsumi Miyauchi, Kazuhiko Misu, Satoshi Yasuda, Ryohei Yoshikawa, Ichiro Inoue, Minoru Yoshiyama, Toru Masuyama, Yoshiaki Tomobuchi, Seiji Yamazaki, Kengo Tanabe, Kenji Wagatsuma, Masayuki Kato, Kazuya Kawai, Yuji Hamazaki, Masakazu Yamagishi, Yoshisato Shibata, Kouki Watanabe, Koichi Tachibana, Hiroshi Wada, Kenji Ninomiya, Hiroshi Suzuki, Jiro Yoshioka, Chikara Mori, Masahiro Sonoda, Toru Kataoka, Hidenobu Terai, Yuko Onishi, Masanao Toma, Takeshi Serikawa, Yoritaka Otsuka, Shoji Yano, Soichiro Ebisawa, Hiroaki Takashima, Hideki Shimomura, Yoko Kurumatani, Shinjo Sonoda, Hiroki Uehara
Rok vydání: 2017
Předmět:
Male
Time Factors
Polymers
medicine.medical_treatment
Myocardial Infarction
Coronary Artery Disease
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
law.invention
0302 clinical medicine
Japan
Randomized controlled trial
Risk Factors
law
Absorbable Implants
Clinical endpoint
Prospective Studies
030212 general & internal medicine
Myocardial infarction
Stroke
Hazard ratio
Drug-Eluting Stents
Middle Aged
Clopidogrel
Intention to Treat Analysis
Treatment Outcome
Drug-eluting stent
Drug Therapy
Combination

Female
Cardiology and Cardiovascular Medicine
medicine.medical_specialty
Ticlopidine
animal structures
Hemorrhage
Prosthesis Design
Drug Administration Schedule
03 medical and health sciences
Percutaneous Coronary Intervention
medicine
Humans
Acute Coronary Syndrome
Aged
Proportional Hazards Models
Aspirin
business.industry
Stent
medicine.disease
Surgery
Conventional PCI
business
Platelet Aggregation Inhibitors
Zdroj: JACC: Cardiovascular Interventions. 10:1189-1198
ISSN: 1936-8798
DOI: 10.1016/j.jcin.2017.04.019
Popis: 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)
Databáze: OpenAIRE