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

• Published in: JACC. Cardiovascular interventions Vol. 10; no. 12; pp. 1189 - 1198
• Main Authors: Nakamura, Masato, Iijima, Raisuke, Ako, Junya, Shinke, Toshiro, Okada, Hisayuki, Ito, Yoshiaki, Ando, Kenji, Tanaka, Hiroyuki, Takiuchi, Shin, Nishida, Yasunori, Kawaguchi, Katsuhiro, Kadotani, Makoto, Omiya, Kazuto, Morita, Takashi, Yasaka, Yoshinori, Ishiwata, Sugao, Ochiai, Masahiko, Yokoi, Hiroyoshi, Hara, Hidehiko, Ueda, Yasunori, Niinuma, Hiroyuki, Zen, Kan, Yaita, Yoshinori, Inoue, Kenji, Takamisawa, Itaru, Ishihara, Takayuki, Ashida, Kazuhiro, Kongoji, Ken, Shiode, Nobuo, Mukawa, Hiroaki, Komiyama, Kota, Suzuki, Takeshi, Ueno, Takafumi, Yamashita, Jun, Kamiya, Haruo, Fujita, Hiroshi, Ajioka, Masayoshi, Mizuno, Koichi, Hirayama, Haruo, Tojo, Taiki, Kawasaki, Tomohiro, Toyota, Fumitoshi, Michishita, Ichiro, Kamihata, Hiroshi, Ishizaka, Nobukazu, Ashikaga, Takashi, Ozaki, Yukio, Hara, Hisao, Doi, Naofumi, Takano, Hitoshi, Ozawa, Toru, Kikuchi, Arifumi, Kadota, Kazushige, Kijima, Yoichi, Shimada, Yoshihisa, Yumoto, Kazuhiko, Kawajiri, Kenji, Nozaki, Yoichi, Tosaka, Atsushi, Hirose, Mizuki, Takagi, Yuichiro, Takagi, Takuro, Miyauchi, Katsumi, Misu, Kazuhiko, Yasuda, Satoshi, Inoue, Ichiro, Yoshiyama, Minoru, Masuyama, Toru, Tomobuchi, Yoshiaki, Tanabe, Kengo, Wagatsuma, Kenji, Kato, Masayuki, Kawai, Kazuya, Shibata, Yoshisato, Tachibana, Koichi, Yoshioka, Jiro, Mori, Chikara, Kataoka, Toru, Terai, Hidenobu, Onishi, Yuko, Toma, Masanao, Serikawa, Takeshi, Yano, Shoji, Ebisawa, Soichiro, Takashima, Hiroaki, Shimomura, Hideki, Kurumatani, Yoko, Sonoda, Shinjo
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 26.06.2017
• Subjects: 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; 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
• ISSN: 1936-8798; 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2017.04.019

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]