Derek Y F So, George A Wells, Marie Lordkipanidzé, Aun Yeong Chong, Marc Ruel, Louis P Perrault, Michel R Le May, Louise Sun, Diem Tran, Marino Labinaz, Christopher Glover, Juan Russo, Mélanie Welman, Vincent Chan, Lily Chen, Jordan Bernick, Fraser Rubens, Jean-Francois Tanguay
{"title":"接受替格瑞洛治疗的急性冠状动脉综合征患者早期与延迟搭桥手术：快速冠脉搭桥随机开放标签非劣效性试验","authors":"Derek Y F So, George A Wells, Marie Lordkipanidzé, Aun Yeong Chong, Marc Ruel, Louis P Perrault, Michel R Le May, Louise Sun, Diem Tran, Marino Labinaz, Christopher Glover, Juan Russo, Mélanie Welman, Vincent Chan, Lily Chen, Jordan Bernick, Fraser Rubens, Jean-Francois Tanguay","doi":"10.1001/jamasurg.2024.7066","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Perioperative bleeding is a major concern in patients receiving ticagrelor for acute coronary syndromes (ACS) when coronary artery bypass graft (CABG) surgery is required.</p><p><strong>Objective: </strong>To evaluate whether early CABG surgery at 2 to 3 days after ticagrelor cessation is noninferior to waiting 5 to 7 days.</p><p><strong>Design, setting, and participants: </strong>RAPID CABG was a noninferiority, open-label randomized trial with 6 months of follow-up. Participants were patients with ACS who had received ticagrelor and required CABG. Patients were enrolled in tertiary centers in Canada between January 2016 and March 2021. Data were analyzed from March 2021 to December 2023.</p><p><strong>Intervention: </strong>Early or delayed CABG.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was based on noninferiority comparison of class 3 or 4 universal definition of perioperative bleeding (UDPB). Noninferiority was prespecified as 8% between groups. Twelve-hour chest tube drainage was reported as a noninferiority comparison. Other bleeding, ischemic, and length-of-stay outcomes were assessed for superiority.</p><p><strong>Results: </strong>Among 143 randomized patients, the median (IQR) age was 65 (58-72) years; there were 117 male patients (82%) and 26 female (18%). Of these, 123 patients (86.0%) underwent surgery in the allocated time frame (per protocol). The median (IQR) time to surgery was 3 (2-3) days in the early group and 6 (5-7) days in the delayed group (P < .001). In a per-protocol analysis, severe or massive UDPB occurred in 3 of 65 early-group patients (4.6%) and 3 of 58 patients (5.2%) in the delayed group (between-group difference, -0.6%; 95% CI, -8.3% to 7.1%; P = .03 for noninferiority). Median (IQR) chest tube drainage was 470 (330-650) mL vs 495 (380-610) mL (between-group difference -25 mL; 95% CI, -111.25 to 35; P = .01 for noninferiority). Median (IQR) hospital stay was 9 (7-13) days and 12 (10-15) days for the early and delayed groups (P < .001).</p><p><strong>Conclusion and relevance: </strong>This study found that an early surgical strategy, 2 to 3 days after ticagrelor cessation, was noninferior in incurring perioperative bleeding. The data support a reduction in the delay between ticagrelor cessation and CABG surgery and may decrease hospital length of stay.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02668562.</p>","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":"387-394"},"PeriodicalIF":15.7000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840690/pdf/","citationCount":"0","resultStr":"{\"title\":\"Early vs Delayed Bypass Surgery in Patients With Acute Coronary Syndrome Receiving Ticagrelor: The RAPID CABG Randomized Open-Label Noninferiority Trial.\",\"authors\":\"Derek Y F So, George A Wells, Marie Lordkipanidzé, Aun Yeong Chong, Marc Ruel, Louis P Perrault, Michel R Le May, Louise Sun, Diem Tran, Marino Labinaz, Christopher Glover, Juan Russo, Mélanie Welman, Vincent Chan, Lily Chen, Jordan Bernick, Fraser Rubens, Jean-Francois Tanguay\",\"doi\":\"10.1001/jamasurg.2024.7066\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Perioperative bleeding is a major concern in patients receiving ticagrelor for acute coronary syndromes (ACS) when coronary artery bypass graft (CABG) surgery is required.</p><p><strong>Objective: </strong>To evaluate whether early CABG surgery at 2 to 3 days after ticagrelor cessation is noninferior to waiting 5 to 7 days.</p><p><strong>Design, setting, and participants: </strong>RAPID CABG was a noninferiority, open-label randomized trial with 6 months of follow-up. Participants were patients with ACS who had received ticagrelor and required CABG. Patients were enrolled in tertiary centers in Canada between January 2016 and March 2021. Data were analyzed from March 2021 to December 2023.</p><p><strong>Intervention: </strong>Early or delayed CABG.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was based on noninferiority comparison of class 3 or 4 universal definition of perioperative bleeding (UDPB). Noninferiority was prespecified as 8% between groups. Twelve-hour chest tube drainage was reported as a noninferiority comparison. Other bleeding, ischemic, and length-of-stay outcomes were assessed for superiority.</p><p><strong>Results: </strong>Among 143 randomized patients, the median (IQR) age was 65 (58-72) years; there were 117 male patients (82%) and 26 female (18%). Of these, 123 patients (86.0%) underwent surgery in the allocated time frame (per protocol). The median (IQR) time to surgery was 3 (2-3) days in the early group and 6 (5-7) days in the delayed group (P < .001). In a per-protocol analysis, severe or massive UDPB occurred in 3 of 65 early-group patients (4.6%) and 3 of 58 patients (5.2%) in the delayed group (between-group difference, -0.6%; 95% CI, -8.3% to 7.1%; P = .03 for noninferiority). Median (IQR) chest tube drainage was 470 (330-650) mL vs 495 (380-610) mL (between-group difference -25 mL; 95% CI, -111.25 to 35; P = .01 for noninferiority). Median (IQR) hospital stay was 9 (7-13) days and 12 (10-15) days for the early and delayed groups (P < .001).</p><p><strong>Conclusion and relevance: </strong>This study found that an early surgical strategy, 2 to 3 days after ticagrelor cessation, was noninferior in incurring perioperative bleeding. 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Early vs Delayed Bypass Surgery in Patients With Acute Coronary Syndrome Receiving Ticagrelor: The RAPID CABG Randomized Open-Label Noninferiority Trial.
Importance: Perioperative bleeding is a major concern in patients receiving ticagrelor for acute coronary syndromes (ACS) when coronary artery bypass graft (CABG) surgery is required.
Objective: To evaluate whether early CABG surgery at 2 to 3 days after ticagrelor cessation is noninferior to waiting 5 to 7 days.
Design, setting, and participants: RAPID CABG was a noninferiority, open-label randomized trial with 6 months of follow-up. Participants were patients with ACS who had received ticagrelor and required CABG. Patients were enrolled in tertiary centers in Canada between January 2016 and March 2021. Data were analyzed from March 2021 to December 2023.
Intervention: Early or delayed CABG.
Main outcomes and measures: The primary outcome was based on noninferiority comparison of class 3 or 4 universal definition of perioperative bleeding (UDPB). Noninferiority was prespecified as 8% between groups. Twelve-hour chest tube drainage was reported as a noninferiority comparison. Other bleeding, ischemic, and length-of-stay outcomes were assessed for superiority.
Results: Among 143 randomized patients, the median (IQR) age was 65 (58-72) years; there were 117 male patients (82%) and 26 female (18%). Of these, 123 patients (86.0%) underwent surgery in the allocated time frame (per protocol). The median (IQR) time to surgery was 3 (2-3) days in the early group and 6 (5-7) days in the delayed group (P < .001). In a per-protocol analysis, severe or massive UDPB occurred in 3 of 65 early-group patients (4.6%) and 3 of 58 patients (5.2%) in the delayed group (between-group difference, -0.6%; 95% CI, -8.3% to 7.1%; P = .03 for noninferiority). Median (IQR) chest tube drainage was 470 (330-650) mL vs 495 (380-610) mL (between-group difference -25 mL; 95% CI, -111.25 to 35; P = .01 for noninferiority). Median (IQR) hospital stay was 9 (7-13) days and 12 (10-15) days for the early and delayed groups (P < .001).
Conclusion and relevance: This study found that an early surgical strategy, 2 to 3 days after ticagrelor cessation, was noninferior in incurring perioperative bleeding. The data support a reduction in the delay between ticagrelor cessation and CABG surgery and may decrease hospital length of stay.
期刊介绍：
JAMA Surgery, an international peer-reviewed journal established in 1920, is the official publication of the Association of VA Surgeons, the Pacific Coast Surgical Association, and the Surgical Outcomes Club.It is a proud member of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications.
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