Individual acute-phase bleeding and thrombotic risk balance assessment in patients undergoing percutaneous coronary intervention for acute myocardial infarction.

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.

Practical Assessment of the Tradeoff between Fatal Bleeding and Coronary Thrombotic Risks using the Academic Research Consortium for High Bleeding Risk Criteria.

AIMS: We aimed to establish a practical method for the assessment of tradeoff between thrombotic and bleeding risks. METHODS: We aimed to investigate the balance between bleeding risk and coronary thrombotic risk according to the number of the Academic Research Consortium for high bleeding risk (ARC-HBR) criteria in the multicenter prospective ST/non-ST elevation myocardial infarction (STEMI/NSTEMI) registry (N=12,093). Patients were divided as follows by the number of ARC-HBR criteria fulfilled: group 0, 0 major with ≤ 1 minor (N=6,792); group 1, 1 major with 0 minor (N=1,705); group 2, 0 major with ≥ 2 minors (N=790); group 3, 1 major with ≥ 1 minor (N=1,709); group 4, 2 majors with ≥ 0 minors (N=861); and group 5, ≥ 3 majors with ≥ 0 minor (N=236). We assessed the acute-phase absolute risk differences between bleeding and coronary thrombotic events in each group. RESULTS: At 7-day follow-up, all patients (groups 0-5) had a higher risk of major bleeding than that of any myocardial infarction (MI). Patients at ARC-HBR (groups 1-5) had a balanced risk between fatal MI and fatal bleeding, whereas patients at non-ARC-HBR (group 0) had a higher risk of fatal MI than that of fatal bleeding. CONCLUSIONS: All STEMI/NSTEMI patients have a relatively high risk of major bleeding as compared with the risk of any MI in the acute phase. The ARC-HBR criteria would be a practical tool for assessing the tradeoff between fatal bleeding and fatal MI risks. This practical assessment would be helpful for the optimal decision-making of appropriate treatment strategy considering the balance between bleeding and coronary thrombotic risks.

[Assessment of risk factors for adverse events due to pemetrexed in patients with reduced renal function].

Pemetrexedis a key drug in the first and second -line therapy for non-small-cell lung cancer. It exhibits an increased area under the plasma drug concentration-time curve, and it has a prolonged half -life when administered to patients with reduced renal function, resulting in a high frequency of neutropenia. Accordingly, pemetrexed is administered to these patients with caution. Herein, we retrospectively investigated the background characteristics of patients with a creatinine clearance rate (Ccr) of<45 mL/min, who experienced severe adverse events due to pemetrexed. Thirty-eight patients with a Ccr of <45 mL/min were administered pemetrexed. Of these patients, 13 (34%) developed severe adverse events (≥Grade 3) such as neutropenia, thrombocytopenia, and nausea. Multiple logistic regression analysis revealed that a Ccr of <30 mL/min (p= 0.033) and the concomitant use of non-steroidal anti-inflammatory drugs (p=0.012) were significant risk factors for adverse events. Therefore, whenever possible, pemetrexed administration should be avoided in patients with a Ccr of <30 mL/ min and in those receiving concomitant non-steroidal anti-inflammatory drugs.

Epidemiology of heart failure in Asia.

Heart failure (HF) is a global epidemic in health care and a leading cause of mortality and morbidity worldwide. In Asian countries, causes of mortality and morbidity have shifted or have been shifting from infectious diseases and/or nutritional deficiencies to lifestyle-related diseases, such as cardiovascular disease, cancers and diabetes, in conjunction with the transition from developing to developed countries during the past decades (so-called "the epidemiologic transition"). Because the effect of this epidemiologic transition varies among countries, the etiology, prevalence, management and outcomes of HF also differ among the countries. Thus, we need to assemble and comprehensively analyze the available evidence to date for daily HF practice in Asia and to systematically conduct future epidemiologic approaches to establishing appropriate prevention programs against the burden of HF in Asia. This review article will briefly update the epidemiology of HF in Asia.

Gender differences in the clinical characteristics and outcomes of patients with vasospastic angina--a report from the Japanese Coronary Spasm Association.

BACKGROUND: Accumulating evidence has demonstrated the gender differences in the clinical characteristics and outcomes of patients with ischemic heart disease. However, it remains to be elucidated whether it is also the case for vasospastic angina (VSA). METHODS AND RESULTS: We enrolled a total of 1,429 VSA patients (male/female, 1090/339; median age 66 years) in our nationwide multicenter registry by the Japanese Coronary Spasm Association. As compared with male patients, female patients were characterized by older age (median 69 vs. 66 years), lower incidence of smoking (20% vs. 72%) and less significant organic stenosis (9% vs. 16%) (all P=0.001). Multivariate analysis demonstrated that the predictors of major adverse cardiac events (MACE) were considerably different by genders; women were more associated with age and electrical abnormalities, whereas men with structural abnormalities. Overall 5-year MACE-free survival was comparable between both genders. However, when the patients were divided into 3 groups by age [young (<50 years), middle-aged (50-64 years) and elderly (≥65 years)], the survival was significantly lower in the young female group (young 82%, middle-aged 92%, elderly 96%, P<0.01), where a significant interaction was noted between age and smoking. In contrast, the survival was comparable among the 3 age groups of male patients. CONCLUSIONS: These results indicate that there are gender differences in the characteristics and outcomes of VSA patients, suggesting the importance of gender-specific management of the disorder.

Myocardial contrast echocardiography assessment of acute changes in collateral perfusion of contralateral coronary artery with coronary flow reserve after coronary angioplasty.

BACKGROUND: Coronary flow velocity reserve (CFVR) is used to evaluate the severity of epicardial and intramyocardial coronary artery disease. Collateral flow to an adjacent compromised myocardial territory may influence the CFVR of a specific artery. METHODS: To assess the impact of collateral flow on CFVR, we measured CFVR and assessed perfusion area (PA) with myocardial contrast echocardiography in the right coronary arteries of 18 patients with total/subtotal occlusion of the left anterior descending coronary artery before and after angioplasty. A total of 10 patients had well-developed collaterals emerging from the right coronary artery (group I) and 8 patients did not (group II). Using a Doppler-tipped guidewire, we measured CFVR, which is defined as the ratio of papaverine-induced hyperemic average peak velocity of coronary flow to baseline. RESULTS: Before angioplasty of the left anterior descending coronary artery, CFVR was significantly reduced in group I compared with group II (2.35 +/- 0.47 vs 3.26 +/- 0.54, P < .01). Baseline average peak velocity in group I before angioplasty was significantly greater than that after angioplasty (23.7 +/- 11.6 vs 19.2 +/- 9.7 cm/s, P < .05). After angioplasty, CFVR immediately increased in group I to 3.46 +/- 0.54 ( P < .001). The increase in CFVR was well correlated with the decrement in PA after angioplasty (r = 0.883, P < .001). CONCLUSION: The CFVR of an artery that supplies extensive collaterals is limited because of an elevation in the baseline resting flow velocity. This restriction in CFVR improves proportionally with decreases in PA that occurs after angioplasty of the ipsilateral coronary artery. These data suggest that PA, in addition to coronary artery structure, influences CFVR.