Ticagrelor cessation: early CABG non-inferior to delayed surgery

Early surgery, 2–3 days after the termination of ticagrelor treatment, was non-inferior to delayed surgery by 5–7 days regarding severe or massive bleeding in patients with acute coronary syndrome (ACS). The RAPID CABG trial was the first randomised controlled study assessing an early coronary artery bypass graft (CABG) surgery strategy in this population [1].

The previous phase 3 PLATO trial (NCT00391872) showed that patients with ACS undergoing CABG surgery within 1 day of ticagrelor termination had higher mortality rates, mostly caused by perioperative bleeding, than patients who had a longer period of ticagrelor cessation before surgery [2]. The current North American guidelines recommend a minimum of 5–7 days between termination of ticagrelor and non-urgent CABG surgery, whereas the ESC supports a minimum waiting period of 3 days for this procedure. Thus, the multicentre, randomised RAPID CABG trial (NCT02668562) assessed the non-inferiority of a 2–3 day ticagrelor cessation period (i.e. early CABG) to a 5–7 day period (i.e. delayed CABG) for perioperative bleeding in patients with ACS.

Participants were randomised 1:1 to early (n=72) or delayed surgery (n=71). The primary outcome was severe or massive perioperative bleeding by Universal Definition of Perioperative Bleeding (UDPB), class 3 or 4. Dr Derek So (University of Ottowa Heart Institute, Canada) presented the 6-month results.

A pre-surgery test demonstrated lower P2Y₁₂ reaction unit (PRU) rates for participants in the early surgery arm compared with the delayed surgery arm (P<0.001). Severe or massive perioperative bleeding occurred in 4.6% and 5.2% of the participants in the early and delayed surgery group, respectively, demonstrating non-inferiority of an early surgery strategy (P=0.025). In addition, other bleeding outcomes, such as TIMI CABG bleeding, BARC 4, or BARC 5, did not feature significant differences between the 2 treatment conditions. Moreover, bleeding and transfusion parameters displayed no differences between the early and delayed surgery strategies. The median length of stay until hospital discharge was 3 days longer in the delayed CABG group (12 days) than in the early CABG group (9 days).

Discussant Prof. Roxanne Mehran (Icahn School of Medicine at Mount Sinai, NY, USA) argued that “the results are important and encouraging. Since the guidelines regarding the timing of P2Y₁₂ antagonist discontinuation before CABG are mostly based on observational studies, this first randomised, well-conducted study addressed an unmet need. However, the small sample size, small number of events, and non-inferiority margin of 8% call for larger trials to verify these results.”

 

1. 
   
   1. So DYF, et al. A Randomized Study of Early vs. Delayed Coronary Artery Bypass among Patients with Acute Coronary Syndromes Treated with Ticagrelor: The RAPID CABG Study. LBS01, AHA Scientific Sessions 2021, 13–15 November.
   2. Held C, et al. J Am Coll Cardiol. 2011;57(6):672–684.

 

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Posted on 14 January, 202231 January, 2024