Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery
Do‐Yoon Kang, Sang‐Hyup Lee, Se-Whan Lee, Cheol Hyun Lee, Choongki Kim, Ji-Yong Jang, Nihar Mehta, Jun‐Hyok Oh, Young–Rak Cho, Kyung Ho Yoon, Sung Gyun Ahn, Jung‐Hee Lee, Deok‐Kyu Cho, Yongcheol Kim, Jeong‐Su Kim, G. Cho, Kyusup Lee, Hanbit Park, Mutlu Vural, Young‐Hyo Lim, Kyoung-Ha Park, Bong‐Ki Lee, Jong‐Young Lee, Hyun-Woo Park, Yong‐Hoon Yoon, Jae‐Hwan Lee, Seung‐Yul Lee, Kyung Woo Park, Jeehoon Kang, Hyun Kuk Kim, Si‐Hyuck Kang, Jae Hyoung Park, In‐Cheol Choi, Chang Sik Yu, Sung-Cheol Yun, Duk‐Woo Park, Myeong‐Ki Hong, Seung‐Jung Park, Jung‐Sun Kim, Jung-Min Ahn, Jung-Min Ahn, Seung-Jung Park, Duk-Woo Park, Do-Yoon Kang, Chang Sik Yu, In-Cheol Choi, Jung-Sun Kim, Myeong-Ki Hong, Sang-Hyup Lee, Se-Whan Lee, Cheol Hyun Lee, Choongki Kim, Ji-Yong Jang, Nihar Mehta, Jun-Hyok Oh, Yong Rak Cho, Kyung Ho Yoon, Sung Gyun Ahn, Deok-Kyu Cho, Yongcheol Kim, Jeongsu Kim, Gyeong Hun Cho, Kyu-Sup Lee, Hanbit Park, Mutlu Vural, Ishak Yilmaz, Irfan Sahin, Young-Hyo Lim, Kyoung-Ha Park, Bong-Ki Lee, Jong-Young Lee, Hyun-Woo Park, Yong-Hoon Yoon, Seung-Yul Lee, Jae-Hwan Lee, Jung-Hee Lee, Kyung-Woo Park, Jeehoon Kang, Hyun Kuk Kim, Si-Hyuck Kang, Jae-Hyoung Park
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).