Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents.
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Lee Seung-Jun, Yu Hee Tae, Lee Yong-Joon, Lee Sang-Hyup, Heo Jung Ho, Ahn Sung Gyun, Shin Sanghoon, Doh Joon-Hyung, Her Ae-Young, Cho Byung-Ryul, Kim Gwang-Sil, Kwon Taek-Geun, Lim Sang-Wook, Shim Jaemin, Jang Ji-Yong, Lee Kyounghoon, Cho Yun-Hyeong, Choi Cheol Ung, Lee Sang-Rok, Park Hyung-Bok, Lee Han Cheol, Kim Seunghwan, Yun Kyeong Ho, Ahn Jong-Hwa, Lee Byoung-Kwon, Cho Deok-Kyu, Kim Song-Yi, Kim Ung, Kang Tae Soo, Choi Seong Huan, Kim Won-Ho, Lee Jin Bae, Rhee Moo-Yong, Kim Jin-Bae, Jo Sang-Ho, Hyun Dae Woo, Kim Daehoon, Kim Tae-Hoon, Hong Sung-Jin, Uhm Jae-Sun, Shin Dong-Ho, Ahn Chul-Min, Kim Byeong-Keuk, Joung Boyoung, Ko Young-Guk, Choi Donghoon, Hong Myeong-Ki, Jang Yangsoo, Pak Hui-Nam, Kim Jung-Sun, ADAPT AF-DES Investigators
Аннотация
METHODS: In this multicenter, randomized, open-label, noninferiority trial in South Korea, we assigned patients with atrial fibrillation who had undergone the implantation of a drug-eluting stent at least 1 year earlier in a 1:1 ratio to receive NOAC monotherapy or combination therapy (NOAC plus clopidogrel). The primary end point was net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major bleeding or clinically relevant nonmajor bleeding at 12 months. The noninferiority margin was 3.0 percentage points.
RESULTS: A total of 960 patients underwent randomization: 482 patients to receive monotherapy and 478 to receive combination therapy. The mean age of the patients was 71.1 years, and 21.4% were women. At 12 months, a primary end-point event had occurred in 46 patients (Kaplan-Meier estimate, 9.6%) in the monotherapy group and in 82 patients (Kaplan-Meier estimate, 17.2%) in the combination-therapy group, for an absolute difference of -7.6 percentage points (95.2% confidence interval [CI], -11.9 to -3.3; P<0.001 for noninferiority) and a hazard ratio of 0.54 (95.2% CI, 0.37 to 0.77; P<0.001 for superiority). Major bleeding or clinically relevant nonmajor bleeding occurred in 25 patients (5.2%) in the monotherapy group and in 63 patients (13.2%) in the combination-therapy group (hazard ratio, 0.38; 95% CI, 0.24 to 0.60).
CONCLUSIONS: Among patients with atrial fibrillation who had undergone implantation of a drug-eluting stent at least 1 year earlier, NOAC monotherapy was noninferior to combination therapy for net adverse clinical events. (Funded by Cardiovascular Research Center and Samjin Pharmaceutical; ADAPT AF-DES ClinicalTrials.gov number, NCT04250116.).