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Ticagrelor holds no edge over aspirin in CABG patients

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TiCAB convincing for similarity of ticagrelor, aspirin

Because the TiCAB study was about half the size of the planned study, its power was low and yielded a result with wide confidence intervals. Despite that, I do not believe that a further, larger study is warranted. The TiCAB results are sufficient to show that monotherapy with ticagrelor is not superior to monotherapy with aspirin in patients undergoing coronary artery bypass grafting and during the year following surgery. The TiCAB results add to a larger body of evidence indicating ticagrelor’s noninferiority to and lack of superiority to aspirin as monotherapy for patients with coronary artery disease or a history of ischemic stroke or transient ischemic attack.

Dr. Robert F. Storey, professor of cardiology, University of Sheffield, England Mitchel L. Zoler/MDedge News

Dr. Robert F. Storey

How can these two drugs produce similar efficacy outcomes? Aspirin is an effective antiplatelet drug, and evidence also suggests that treatment with opiates such as morphine (Circ Cardiovasc Interv. 2016 Sept;9[9]:e004229) and fentanyl (Circulation. 2018 Jan 16;137[3]:307-9) during and after surgery can interfere with the intestinal absorption of ticagrelor and other oral P2Y12 receptor antagonists, such as clopidogrel and prasugrel.

Another interesting finding in TiCAB was that aspirin and ticagrelor monotherapy produced similar rates of major bleeds. Results from prior studies had raised concerns about ticagrelor’s safety in patients undergoing coronary artery bypass surgery, but the new results show that this may be a problem when patients receive dual antiplatelet therapy but not when they receive ticagrelor monotherapy. Current evidence favors dual antiplatelet therapy to achieve a greater decrease in cardiovascular disease events, but this occurs at the expense of increased bleeding. Larger trials of dual therapy after coronary artery bypass grafting are warranted; further study of monotherapy is not.

Robert F. Storey, MD , is a professor of cardiology at the University of Sheffield (England). He has been a consultant to, and received honoraria and research support from, AstraZeneca, and he has been a consultant to Actelion, Avacta, Bayer, Bristol-Myers Squibb/Pfizer, Haemonetics, Novartis, PlaqueTec, and Thromboserin. He made these comments as designated discussant for the TiCAB report.



– Ticagrelor performed about as well as aspirin did as monotherapy for preventing coronary bypass graft failure during the year following surgery in a randomized, multicenter trial with almost 1,900 patients.

Dr. Heribert Schunkert, professor of cardiology and medical director of the German Heart Center in Munich. Mitchel L. Zoler/MDedge News

Dr. Heribert Schunkert

Ticagrelor monotherapy also produced about the same number of major bleeding events as did aspirin monotherapy, Heribert Schunkert, MD, said at the American Heart Association scientific sessions. There were two limitations of the trial: The incidence of cardiovascular disease events that served as the efficacy endpoint for the study was less than what Dr. Schunkert and his associates expected, and they enrolled about half the projected number of patients because the study lost industry support and then, a couple of years later, showed a relentlessly neutral result leading to early termination of recruitment, said Dr. Schunkert, professor of cardiology and medical director of the German Heart Center in Munich.

The TiCAB (Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG) trial randomized 1,893 patients during 2013-2017 who underwent CABG at any of 26 centers in Austria, Germany, or Switzerland. Eligible patients underwent surgery for three-vessel disease, left main disease, or had two-vessel disease plus a left ventricular ejection fraction of less than 50%. About 31% of patients had unstable angina or non-ST elevation MI, with the remaining 69% having stable angina. The study included 931 patients who received 90 mg oral ticagrelor (Brilinta) b.i.d. plus aspirin placebo, and 928 who received 100 mg aspirin once daily plus ticagrelor placebo. The study medications began prior to surgery.

The study’s primary efficacy endpoint was the combined rate of cardiovascular death, MI, stroke, or need for revascularization by 1 year after surgery. This occurred in 9.7% of the ticagrelor patients and in 8.2% of those who received aspirin, a difference that was not statistically significant. Several secondary efficacy endpoints examined also showed a neutral result. The primary safety measure was the incidence of major bleeds by the Bleeding Academic Research Consortium criteria, which occurred in 3.7% of the ticagrelor patients and 3.2% of those on aspirin, not a statistically significant difference. After the year of follow-up about 85% of patients in both treatment arms remained on their assigned regimen, Dr. Schunkert said.

TiCAB received funding from AstraZeneca, which markets ticagrelor (Brilinta). Dr. Schunkert has received honoraria and research support from, and has been a speaker on behalf of, AstraZeneca. He has also received honoraria from Amgen, Bayer Vital, Boehringer Ingelheim, Daiichi Sankyo, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Servier.

SOURCE: Schunkert H et al. AHA 2018, Abstract 19561.

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