RAPID CABG: Surgery for ACS soon after ticagrelor cessation noninferior to delayed strategy
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Early CABG performed 2 to 3 days after ticagrelor cessation was noninferior to delayed CABG performed at 5 to 7 days for the outcome of severe or massive perioperative bleeding in patients with ACS who required nonemergent surgery.
“Ticagrelor is one of the most often used antiplatelet treatments for patients with acute coronary syndromes, but about 10% of patients after they’ve received ticagrelor subsequently are found to require bypass surgery. One of the biggest concerns is perioperative bleeding,” Derek Y.F. So, MD, FRCPC, FACC, MSc, staff cardiologist and clinician investigator at the University of Ottawa Heart Institute and associate professor in the department of medicine at the University of Ottawa, Canada, said during an American Heart Association Scientific Sessions press conference. “The suggestion in guidelines is that ticagrelor be held for a period of time prior to surgery. However, there’s discordance between ... North American guidelines vs. European and Asian guidelines.”
Current North American guidelines recommend nonurgent CABG be performed at least 5 days after cessation of ticagrelor (Brilinta, AstraZeneca), whereas the 2017 European Society of Cardiology guideline recommends nonurgent CABG be performed at least 3 days after ticagrelor cessation, So said.
So and colleagues conducted the RAPID CABG randomized controlled trial to investigate the benefits of early nonemergent CABG performed 2 to 3 days after ticagrelor cessation compared with delayed nonemergent CABG performed 5 to 7 days after cessation.
The trial enrolled 143 patients with ACS (mean age 64 years; 81% men) who were randomly assigned to undergo early or delayed CABG following ticagrelor cessation.
The early CABG strategy was noninferior to delayed CABG for the primary outcome of perioperative severe or massive bleeding (4.6% vs. 5.2%; P for noninferiority = .0253), So said. The primary outcome was driven by severe bleeding; there were no occurrences of massive bleeding in either group. There were also no differences in TIMI CABG or Bleeding Academic Research Consortium (BARC) type 4 or 5 bleeding; two patients in the early CABG group had TIMI CABG bleeding and two had BARC type 4 bleeding.
When the researchers evaluated ischemic outcomes prior to the assigned surgical date, six patients (8.7%) in the delayed CABG group had complications, with recurrent angina in four, MI in one and ventricular tachycardia in one, prompting earlier CABG.
At 6 months, major adverse CV events, including all-cause death, nonfatal MI, stroke, recurrent angina, stroke or repeat revascularization, occurred in 5.6% of the early CABG group compared with 13% of the delayed CABG group.
Patients in the delayed CABG group had a longer length of stay from randomization to discharge: 12 days vs. nine days after early CABG.
“RAPID CABG is the first and only randomized study to evaluate the safety of early surgery, and we found that an early surgical strategy 2 to 3 days after ticagrelor cessation was noninferior in incurring severe or massive bleeding compared to 5 to 7 days,” So said. “We think that the results of our study might have implications on future North American guidelines by decreasing the time to surgery and increasing the level of evidence for European and Asian guidelines.”
Discussing the trial, Roxana Mehran, MD, professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, said: “Given the small sample size, small number of events and the large noninferiority margin, larger trials are needed to verify these very important and encouraging results.”
Perspective
Back to TopFaisal Bakaeen, MD
The results call into question the current recommendation of waiting at least 5 days that guides the surgical practice in the U.S. Now, in real-world practice, surgeons will always have to factor in the stability of the patient and the risk-to-benefit ratio when choosing the timing of surgery. In that context, I believe that this study provides some reassurance that operating at 3 days instead of after 5 days may be reasonable in semi-elective scenarios. The advantages of operating earlier include reduced hospital length of stay and, intuitively, reduced recurrent ischemic events before surgery.
I think surgeons, cardiologists and, most importantly, patients will see the findings of this trial as welcome news. The trial presents potentially practice-changing information; however, we must remind ourselves that the results are far from conclusive. The numbers were small and there was an almost 10% crossover in both directions between the two groups. I did not see the as-treated analysis results and notably absent are the data on blood and blood product transfusions. I assume that the surgeons and care teams were unblinded to surgery timing and that may have influenced decisions about preoperative antithrombotic management including heparin administration, platelet transfusion and antifibrinolytic therapy. The surgical approach and strategy may have also been influenced, such as taking steps to mitigate the perceived increased risk of bleeding in the early surgery group; for example, more utilization of off-pump CABG and fewer bypass grafts in the early compared with delayed surgery patients. Bypass and operative times and multi-arterial grafting utilization should ideally be similar between the two groups.
I think the RAPID CABG trial is a step in the right direction when it comes to fine-tuning surgical timing in patients who are on ticagrelor. In modern practice, we should be data-driven in our surgical decisions and leverage technology including point-of-care testing to formulate individualized treatment plans. A reversal agent for ticagrelor would be disruptive in that regard and ongoing investigation of filtration therapies are underway.
Collapse
So DYF, et al. LBS.01. Valves, Veins and New Viewpoints in Cardiothoracic Surgery. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).
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