ABSTRACT
AIM: The urgency of the study is determined by the lack of data necessary in order to assess the safety of prolonged use of proton pump inhibitors (PPI) in patients with IHD combined with anti-aggregant therapy. The aim of the study was to study the relationship between the use of PPI and the risk of thrombotic complications in patients undergoing planned procedures of percutaneous coronary interventions (PCI) and receiving dual antiplatelet therapy. MATERIALS AND METHODS: The study is a prospective register of patients who successfully underwent planned percutaneous coronary intervention (PCI). The effect of PPI (omeprazole and pantoprazole) on the frequency of the combined end point cardiovascular death, ACS, AI, TIA, peripheral arterial thrombosis and PE was assessed using the Log-Rank criterion, as well as in a multivariate analysis (Cox proportional risk regression model). RESULTS: A total of 391 patients were included in the study (23.1% women, mean age 61.2 years ± 10.4 years). The median duration of follow-up was 18 months. During this period of time, 34 adverse events were recorded. Log-Rank analysis showed that the proportion of patients without adverse events in the omeprazole group was significantly lower in comparison with patients who did not receive PPI (0.56 vs. 0.84, Log-Rank p=0.003), and for pantoprazole no such pattern was found (0.89 against 0.84, Log-Rank p=0.21). The average level of residual platelet reactivity (ORT), as well as the number of patients with high ORT (> 208 PRU), did not differ significantly between the groups of omeprazole, pantoprazole and the group of patients not receiving PPI. According to multivariate analysis, omeprazole was an independent predictor of thrombotic complications after a planned PCI (OR 3.75, 95% confidence interval 1.72-8.17, p=----0.0009). CONCLUSION: Long-term use of omeprazole (at least 30 days) is an independent predictor of thrombotic complications in patients who underwent planned PCI.
Subject(s)
Acute Coronary Syndrome/surgery , Coronary Restenosis/prevention & control , Gastrointestinal Hemorrhage , Myocardial Ischemia/drug therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Proton Pump Inhibitors , Acute Coronary Syndrome/etiology , Aged , Coronary Restenosis/diagnosis , Coronary Restenosis/etiology , Drug Therapy, Combination/methods , Female , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/prevention & control , Humans , Long Term Adverse Effects/chemically induced , Long Term Adverse Effects/prevention & control , Male , Middle Aged , Myocardial Ischemia/complications , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Prognosis , Prospective Studies , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/adverse effects , Registries/statistics & numerical data , Risk Adjustment , RussiaABSTRACT
The VerifyNow assay is based upon the ability of activated platelets to cross-link beads coated with fibrinogen. However, fibrinogen is an abundant protein of blood, and therefore it may affect test results by competing with fibrinogen of beads for binding to platelets. To test this assumption, we assessed the influence of artificial alteration of fibrinogen level in blood samples obtained from donors (n = 9) and patients on clopidogrel therapy (n = 8) on the results of the VerifyNow P2Y12 assay. Fibrinogen level was altered by adding to blood samples 1/10 volume of fibrinogen solution (10.56 g/liter) or corresponding buffer. Relative to baseline, addition of buffer significantly increased platelet reactivity, whereas addition of fibrinogen decreased it. Analysis of the relationship between change in platelet reactivity values (dBase and dPRU) and change in fibrinogen concentration (dFg) revealed strong negative correlations: dBase = -63.3 × dFg - 27.1 (r = -0.924, p < 0.0005) and dPRU = -54.4 × dFg - 21.8 (r = -0.764, p < 0.0005). Thus, the results of our experiments suggest that: (i) blood fibrinogen strongly influences results of the VerifyNow P2Y12 assay, and (ii) correcting for fibrinogen effect may be needed to improve the accuracy of the test in the measuring of antiplatelet effect of clopidogrel therapy.
