Ƶ

Early CABG After Stopping Ticagrelor is Possible -- But is It Ready for Prime-Time?

— RAPID CABG shows non-inferority of shorter wait; expert advises caution for real-world practice

Ƶ MedicalToday

Early coronary bypass graft (CABG) -- less than 5 days after ticagrelor (Brilinta) cessation -- proved noninferior to waiting up to 7 days after stopping the antiplatelet in terms of severe or massive perioperative bleeding, according to the results from the RAPID CABG trial.

In the trial of patients with acute coronary syndrome (ACS) who required non-emergency CABG, severe or massive perioperative bleeding occurred in 4.6% of patients who underwent early CABG at 2-3 days after stopping ticagrelor, which is in line with guidance, versus 5.2% in patients who underwent CABG at 5-7 days after stopping ticagrelor, or in line with (P=0.0253 for non-inferiority), reported Derek Yiu Fai So, MD, of the University of Ottawa Heart Institute in Ottawa, Ontario, Canada, during a press conference at the American Heart Association virtual meeting.

So and colleagues also found that hospital length of stay for the early CABG group averaged 9 days versus 12 days in the delayed CABG group.

The results "may influence future iterations of North American guidelines, and reduce waiting prior to bypass surgery, and strengthen the level of evidence in European and Asian guidelines," he stated.

However, the findings should be treated with caution, said AHA spokesperson and study discussant Joanne Chikwe, MD, of Cedars-Sinai Medical Center in Los Angeles.

"There are inherent challenges in conducting trials in cardiac surgery...it is very hard to recruit patients for these trials," she said. "Cardiac surgery is not as common as hypertension where it is much easier to conduct a trial with 16,000 persons and have some very meaningful endpoints."

In "cardiac surgery, you are tied to a much smaller number of patients [so] you have to be extremely thoughtful about the study design," Chikwe said. "It almost a given that you will need to use surrogate endpoints, and choice of surrogate endpoints can determine ... [if] the trial will find ... in favor or against what you are looking at."

She called the RAPID CABG results "helpful," but pointed out that "a small number of events in the aggressive early-intervention arm could have made the trial go a different way."

"I think physicians may want to see a larger powered trial to be convinced that they should change their practice," she added.

Ticagrelor requires a washout period before surgery can take place. So explained that, after 48-72 hours, the potency of ticagrelor after stopping remains about the level of clopidogrel (Plavix), while after 120 hours, it has baseline antiplatelet potency. The question is, how long can some of ACS patients wait before surgery, he noted.

Recruited adult patients (about age 65; around 80% men) had ACS -- unstable angina, ST-segment elevation myocardial infarction (STEMI), non-STEMI -- and were taking ticagrelor. Patients were more or less evenly split between the early CABG group (2-3 days) and delayed CABG group (5-7 days). After some patients withdrew from the study arms, there were 65 patients in the early group and 58 in the delayed group for the per-protocol analysis.

The primary outcome was severe/massive bleeding by Universal Definition of Perioperative Bleeding (UDBP) class 3 or 4, including blood transfusions of more than 5 units of red cells or plasma within 24 hours of surgical closure; chest tube drainage of over 1,000 mL in the first 12 hours; and re-operation for bleeding.

So and colleagues reported that in the early CABG group, patients underwent the procedure on day 3 after stopping ticagrelor, while in the delayed CABG group, the average time to surgery was 6 days post-ticagrelor.

  • author['full_name']

    Ed Susman is a freelance medical writer based in Fort Pierce, Florida, USA.

Disclosures

So disclosed relationships with Spartan Biosciences, AggreDyne, Roche Diagnostics, Fujimori Kogyo, Bayer Canada, AstraZeneca Canada, Servier Canada, and HLS Therapeutics.

Chikwe disclosed no relationships with industry.

Primary Source

American Heart Association

So D, et al "RAPID CABG - A Randomized Study Of Early Versus Standard Coronary Artery Bypass Surgery Among Patients Presenting With Acute Coronary Syndromes Treated With Ticagrelor" AHA 2021.