RESUMO
Background: Individualized treatment approach based on pre-procedural precise risk balance assessment between bleeding and thrombosis would be desirable for patients with myocardial infarction (MI) undergoing emergent percutaneous coronary intervention (PCI) in this ultra-short dual antiplatelet therapy era. We aimed to develop and validate a quick thrombosis/bleeding risk-balance assessment tool. Methods: We developed and validated a novel thrombosis/bleeding risk-balance assessment tool using individual patient data from the prospective multicenter MI registry. Individual risks of thrombosis and bleeding within 7 days of the index PCI were estimated using a multinomial logistic regression model. The model was developed in the derivation cohort (4554 patients enrolled during 2003-2009) and validated in the validation cohort (2215 patients during 2010-2014). Results: A total of 6769 patients (66 ± 12 years, 5175 men) were eligible in this analysis. Predictive performance of the multinomial logistic regression models for bleeding and thrombosis assessed by calibration plots was good both in the derivation and validation cohorts. The net predicted probability (NPP) was defined as predicted probability of bleeding event (%) - predicted probability of thrombotic event (%). The NPP successfully stratified patients into those with a higher risk of bleeding than thrombosis and those with a higher risk of thrombosis than bleeding. This finding was consistent between the derivation and validation cohorts. Conclusions: We have established the risk balance assessment model for bleeding and thrombosis. Pre-procedural quick and precise assessment of the risk balance may help a decision making of procedural strategy and antithrombotic regimens in STEMI/non-STEMI patients undergoing PCI.
RESUMO
PureSorb-Q40 (water-soluble type CoQ10 powder, CoQ10 content is 40 w/w%; hereinafter referred to as P40) is reported in the single-dose human and rat studies to have a greater absorption rate and absorbed volume of CoQ10 even taken postprandially, than those of regular CoQ10, which is lipid-soluble and generally taken in the form of soft-gel capsules. Thus, it was anticipated that the serum CoQ10 level might be higher with P40 tablets than with soft-gel capsules, even for the same dose of CoQ10. In the present study, in order to confirm the safety and measure the serum CoQ10 level for the case of an excessive dose of P40, a double-blinded Placebo controlled comparative study was conducted on 46 healthy volunteers and they were randomly divided into two groups. The P40 tablets or placebo were repeatedly taken by the volunteers. As the result of the study, for the group of taking 2250 mg/d of P40 (that is, 900 mg/d of CoQ10) for 4 consecutive wk, the serum CoQ10 level peaked at 2 wk after the start of intake at 8.79 +/- 3.34 microg/mL, and at 4 wk, it was at the level of 8.33 +/- 4.04 microg/mL. At 2 wk from withdrawal of intake, the serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. The serum CoQ10 levels at these three points were significantly higher than those of the first day of intake and the Placebo group, which had no significant change throughout the study. Furthermore, P40 intake did not cause any significant changes in symptoms or clinical laboratory results as assessed by physical, hematological, blood biochemical or urinalysis tests. Physician examinations also did not reveal any abnormalities. These results confirm that P40 is an extremely safe material and it can produce better absorption of CoQ10.