Randomized trial on early vs. delayed CABG after P2Y12i cessation in patients with ACSNews - Nov. 13, 2021
RAPID CABG: A Randomized Study of Early Versus Standard Coronary Artery Bypass Surgery Among Patients Presenting with Acute Coronary Syndromes Treated With Ticagrelor
Presented at the American Heart Association’s Scientific Sessions 2021 by: Derek YF So, MD - Ottawa, ON, Canada.
Introduction and methods
Aim of the study
Patients with ACS who require non-urgent coronary bypass surgery (CABG) should stop taking ticagrelor several days before the surgery in order to reduce the risk of peri-operative bleeding. Current ACC/AHA guidelines advice interruption of ticagrelor for at least 5 days prior to non-urgent CABG (class I, level B). In contrast, ESC guidelines advice at least 3 days between ticagrelor cessation and non-urgent CABG (class 2a, level B). These recommendations are based on data from retrospective studies and pharmacodynamic studies as no randomized trial data was available on this matter. This physician-initiated, multi-center randomized trial evaluated whether early surgery at 2 to 3 days after ticagrelor cessation is noninferior to delayed surgery at 5 to 7 days after ticagrelor cessation for severe or massive perioperative bleeding in patients with ACS who require non-emergent CABG.
A total of 143 patients aged >18 years with ACS who were treated with ticagrelor and required non-emergent CABG were randomized in a 1:1 ratio to receive early surgery (day 2-3, n=72) or delayed surgery (day 5-7, n=71). Some patients refused surgery and some patients received surgery later or earlier than the assigned window for logistic or medical reasons. The analysis was a per protocol analysis only including patients who were assigned to a specific window and actually received surgery at this specific window (65 patients in the early surgery group and 58 patients in the delayed surgery group).
The primary outcome was severe (class 3) or massive (class 4) bleeding as defined by the Universal Definition of Perioperative Bleeding. Secondary bleeding outcomes included TIMI CABG bleeding, BARC 4 and BARC 5 bleeding. Another secondary outcome included ischemic outcomes defined as CV death, stroke, MI, refractory ischemia or urgent unplanned revascularization.
- Severe or massive perioperative bleeding occurred in 4.6% of patients in the early surgery group and in 5.2% of patients in the delayed surgery group (P=0.0253 for noninferiority).
- There were no significant differences in secondary bleeding outcomes between groups.
- There were numerically more ischemic events in the delayed surgery group compared to the early surgery group, both prior to the assigned surgery date and after 6 months. This translated in a longer median length of stay from randomization to discharge in the delayed surgery group compared to the early surgery group (12 days vs. 9 days).
Derek YF So, MD concluded that this study found that early CABG, 2 to 3 days after ticagrelor cessation, was noninferior to delayed CABG, 5 to 7 days after ticagrelor cessation, for severe or massive perioperative bleeding in patients with ACS who required non-emergent CABG.
The discussant Joanna Chikwe, MD (Los Angeles, CA, USA) found the trial helpful but also expressed some concerns. She said that the trial was small and underpowered for the small number of events that drove the primary finding. She can imagine that physicians want to see a larger powered trial to be convincingly compelled to change their practice.
-Our reporting is based on the information provided at the American Heart Association’s Scientific Sessions 2021-