Zyllt in coronary atherosclerosis patients after coronary artery bypass graft surgery. Preliminary results of an open, randomized, comparative ZEUS Study

Aim. To compare clopidogrel and acetylsalicylic acid (ASA) on vasculo-platelet and coagulation hemostasis; to assess the prevalence of laboratory resistance to these agents; and to study 3-month prognosis in coronary heart disease (CHD) patients after coronary artery bypass graft (CABG) surgery.

Material and methods. In total, 94 CHD patients, 45-72-year-old males with initially elevated platelet aggregation with ADPH 5mM (PAADPH) and adrenalin 10 mcg/ml (PAAdr), were randomized into two treatment groups, receiving clopidogrel (75 mg/d; n=44) or ASA (75-100 mg/d; n=50). In all participants, parameters of vasculo-platelet and coagulation hemostasis were measured before CABG, 12-14 days and 3 months after CABG. The patients not responding to two-week monotherapy were regarded as resistant. During three-month follow-up period, the incidence of adverse coronary events and pharmacotherapy complications were assessed.

Results. Positive dynamics of vasculo-platelet and coagulation hemostasis was observed during clopidogrel or ASA treatment: fibrinogen level was significantly lower in clopidogrel group that in ASA group; 12-14 days and 3 months after CABG, induced PAADPH intensity was significantly reduced in 100% of the patients receiving clopidogrel; no laboratory resistance was observed. No cases of unstable angina, acute myocardial infarction, or death were registered. In those receiving ASA, induced PAADPH was elevated in 24% (n=12) 12-14 days and 3 months after CABG (ASA-resistant subjects), and in 76% (n=38) in reduced by three times (ASA-sensitive subjects). Major or minor hemorrhages, allergic reactions to clopidogrel or ASA were not registered.

Conclusion. In patients after CABG, no cases of laboratory resistance to Clopidogrel ("Zyllt", KRKA) were registered; moreover, cardiovascular prognosis was better in clopidogrel group.

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