한빛사논문
Do-Yoon Kang MD a∗, Sang-Hyup Lee MD b∗, Se-Whan Lee MD c, Cheol Hyun Lee MD d, Choongki Kim MD e, Ji-Yong Jang MD f, Nihar Mehta MD g, Jun-Hyok Oh MD h, Young Rak Cho MD i, Kyung Ho Yoon MD j, Sung Gyun Ahn MD k, Jung-Hee Lee MD k, Deok-Kyu Cho MD l, Yongcheol Kim MD l, Jeongsu Kim MD m, Gyeong Hun Cho MD n, Kyu-Sup Lee MD o, Hanbit Park MD p, Mutlu Vural MD q, Young-Hyo Lim MD r, Kyoung-Ha Park MD s, Bong-Ki Lee MD t, Jong-Young Lee MD u, Hyun-Woo Park MD v, Yong-Hoon Yoon MD w, Jae-Hwan Lee MD w, Seung-Yul Lee MD x, Kyung Woo Park MD y, Jeehoon Kang MD y, Hyun Kuk Kim MD z, Si-Hyuck Kang MD aa, Jae-Hyoung Park MD bb, In-Cheol Choi MD cc, Chang Sik Yu MD dd, Sung-Cheol Yun PhD ee, Duk-Woo Park MD a, Myeong-Ki Hong MD b, Seung-Jung Park MD a, Jung-Sun Kim MD b, Jung-Min Ahn MD a the ASSURE DES Investigators†
aDivision of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
bDivision of Cardiology, Severance Hospital, Seoul, Korea
cPyeongtaek St Mary’s Hospital, Pyeongtaek, Korea
dDivision of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea
eDivision of Cardiology, Ewha Womans University Seoul Hospital, Seoul, Korea
fDivision of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Korea
gDivision of Cardiology, Jaslok Hospital, Mumbai, India
hDivision of Cardiology, Pusan National University Hospital, Busan, Korea
iDivision of Cardiology, Dona-A University Hospital, Busan, Korea
jDivision of Cardiology, Wonkwang University Hospital, Iksan, Korea
kDivision of Cardiology, Wonju Severance Christian Hospital, Wonju, Korea
lYonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, Korea
mCardiovascular Center, Haeundae Bumin Hospital, Busan, Korea
nDivision of Cardiology, Chonnam National University Hospital and Medical School, Gwangju, Korea
oDivision of Cardiology, The Catholic University of Korea Daejeon St Mary's Hospital, Daejeon, Korea
pDivision of Cardiology, Gangneung Asan Hospital, Gangneung, Korea
qDivision of Cardiology, Bagcilar Education and Training Hospital, Istanbul, Türkiye
rDivision of Cardiology, Hanyang University Seoul Hospital, Seoul, Korea
sDivision of Cardiology, Hallym University Sacred Heart Hospital, Seoul, Korea
tDivision of Cardiology, Kangwon National University Hospital, Chuncheon, Korea
uDivision of Cardiology, Kangbuk Samsung Hospital, Seoul, Korea
vDivision of Cardiology, Soonchunhyang University Hospital Bucheon, Bucheon, Korea
wDivision of Cardiology, Chungnam National University Sejong Hospital, Sejong, Korea
xDivision of Cardiology, CHA University Bundang Medical Center, Bundang, Korea
yCardiovascular Center, Department of Internal Medicine, Seoul National University Hospital and Seoul National University College of Medicine, Seoul, Korea
zDivision of Cardiology, Chosun University Hospital, Gwangju, Korea
aaDivision of Cardiology, Seoul National University Bundang Hospital, Bundang, Korea
bbDivision of Cardiology, Korea University Anam Hospital, Seoul, Korea
ccDepartment of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
ddDepartment of Surgery, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea
eeDivision of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
∗Drs. D.-Y. Kang and S.-H. Lee contributed equally to this work.
Address for correspondence: Dr Jung-Min Ahn
†A full list of the investigators in the ASSURE DES trial is provided in the Supplemental Appendix
Abstract
Background: Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited.
Objectives: This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation.
Methods: We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery.
Results: A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027).
Conclusions: Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548).
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