학술논문
Abstract 14715: Higher Incidence of Ischemic and Bleeding Events in Pre-specified Registry Subset of Nobori Dual Antiplatelet Therapy as Appropriate Duration (NIPPON) Randomized Trial
Document Type
Academic Journal
Author
Shinke, Toshiro; Nakamura, Masato; Iijima, Raisuke; Ako, Junya; Okada, Hisayuki; Ito, Yoshiaki; Ando, Kenji; Anzai, Hitoshi; Tanaka, Hiroyuki; Ueda, Yasunori; Takiuchi, Shin; Nishida, Yasunori; Ohira, Hiroshi; Kawaguchi, Katsuhiro; Kadotani, Makoto; Niinuma, Hiroyuki; Omiya, Kazuto; Morita, Takashi; Zen, Kan; Yasaka, Yoshinori; Inoue, Kenji; Ishiwata, Sugao; Ochiai, Masahiko; Hamasaki, Toshimitsu; Yokoi, Hiroyoshi
Source
Circulation. Nov 14, 2017 136(Suppl_1 Suppl 1):A14715-A14715
Subject
Language
English
ISSN
0009-7322
Abstract
Introduction: A number of randomized trials have been conducted to explore the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation. Mostly, however, observed event rate in patients enrolled into randomization was lower than anticipated.Hypothesis: The patients’ subset who were excluded from randomization for DAPT duration might have higher risk of ischemic and bleeding events.Methods: NIPPON trial is a multi-center randomized trial to test the non-inferiority of 6 months DAPT compared with 18 months DAPT following NOBORI stent in terms of the net clinical benefits. A total of 3773 patients were enrolled to randomization arm. Among the screened patients, 257 were assigned to pre-specified registry arm due to under hemodialysis, concomitant use of anticoagulation or 2 stent implantation to bifurcation lesion. Kaplan-Meier (KM) analysis was done to estimate net adverse clinical and cerebrovascular events (NACCE) defined as the composite of all cause death, myocardial infarction, stroke, or major bleeding (modified Replace criteria or BARC criteria 3 or 5).Results: The KM estimated probability of the NACCE at 3 years was 29.1 % with registry arm and 5.7 % with randomized arm (P<0.0001, HR: 4.92, 95%CI: 3.49 - 6.95) (Figure). All cause death was 20.0 % with registry arm and 5.7 % with randomized arm (P<0.0001, HR: 8.47, 95%CI: 5.44 -13.2). The incidence of stroke was also significantly different (3.3% vs. 1.3%; P=0.02, HR: 2.80, 95%CI: 1.11 - 7.07). Major bleeding was 5.5 % with registry arm and 1.6 % with randomized arm (p=0.0004, HR 3.14; 95%CI: 1.60 - 6.15).Conclusion: In the clinical trial assessing DAPT duration, the patients’ subset who were excluded from randomization might develop higher incidence of both ischemic and bleeding events. Further clinical trials are warranted to generate real world evidence of optimal DAPT duration in each specified patient’s category.