Prevalence of Hepatitis A Immunity and Decision-tree Analysis Among Men Who Have Sex With Men and Are Living With Human Immunodeficiency Virus in Tokyo.

BACKGROUND: Hepatitis A virus (HAV) can be sexually transmitted. However, the level of HAV immunity among patients living with human immunodeficiency virus (HIV) in Japan is unknown. Determining the epidemiology of HAV infections among men who have sex with men (MSM) and who are living with HIV is essential for an HAV vaccination program. This study examined HAV immunity in patients living with HIV and applied the decision-tree analysis to explore the factors of immunoglobulin G (IgG)-hepatitis A (HA) antibodies in MSM living with HIV. METHODS: We examined the presence of IgG-HA antibodies among patients living with HIV from January to December 2017 in The Hospital of The Institute of Medical Science, The University of Tokyo. We recorded each patient's age, sex, mode of HIV transmission, year of HIV diagnosis, HAV vaccine status, history of HAV infection, and history of other infectious diseases. A decision-tree algorithm was used to reveal the factors and profiles most relevant to the anti-HAV prevalence. RESULTS: Overall, 378 MSM patients living with HIV were examined for IgG-HA antibodies. After excluding 24 patients who had received a HAV vaccine, the data of 354 MSM were analyzed (median age 45 years, interquartile range 39-51 years). Of the 354 patients, 60 (16.9%) were positive for IgG-HA antibodies. The HA positivity rate increased with patients' age, and age (> 63.5 years) was extracted as the most important variable by classification of the decision-tree algorithm. CONCLUSIONS: Our study, conducted just before the HAV outbreak among MSM in Tokyo, showed that age was the most relevant factor in anti-HAV prevalences. An extensive HAV vaccination program for MSM patients living with HIV is urgently needed, particularly for younger people.

Prognostic Importance of Multiple Nutrition Screening Indexes for 1-Year Mortality in Hospitalized Acute Decompensated Heart Failure Patients.

Background: The purpose of the study was to evaluate the impact of nutritional status on 1-year mortality in hospitalized patients with acute decompensated heart failure (ADHF). Methods and Results: We enrolled 457 hospitalized ADHF patients. Previously established objective nutritional indexes (controlling nutritional status [CONUT], prognostic nutritional index [PNI], geriatric nutritional risk index [GNRI], and subjective global assessment [SGA]) were evaluated at hospital admission. Malnutrition was defined as CONUT score ≥5, PNI score <38, GNRI score <92, and SGA scores B and C. The frequencies of malnutrition based on CONUT, PNI, GNRI, and SGA were 31.5%, 21.4%, 44.9%, and 27.8%, respectively. All indexes were related to the occurrence of 1-year mortality on univariate Cox regression analysis (P<0.05). We constructed a reference model using age, body mass index, systolic blood pressure, sodium concentration, and renal function on multivariable Cox regression analysis. Adding SGA to the reference model significantly improved both net reclassification improvement (NRI) and integrated discrimination improvement (0.344, P=0.002; 0.012, P=0.049; respectively). Other indexes (CONUT, PNI, and GNRI scores) significantly improved NRI (0.254, P=0.019; 0.273, P=0.013; 0.306, P=0.006; respectively). Conclusions: Nutritional screening assessed at hospital admission was appropriate for the prediction of 1-year mortality in hospitalized patients with ADHF.

Hemorrhagic Pericardial Cyst Complicated with Constrictive Pericarditis.

Pericardial cysts are rare abnormalities and are usually asymptomatic. Although several case reports on their diagnosis and treatment have been published, those on hemorrhagic pericardial cysts remain limited. We herein report the case of a 70-year-old man with a hemorrhagic pericardial cyst complicated with constrictive pericarditis 2 years after the initial diagnosis.

Comparison of two dosing methods for immediate administration of tolvaptan in acute decompensated heart failure.

BACKGROUND: The clinical dosing method for tolvaptan in patients with acute heart failure (HF) is still unclear. We aimed to compare the differences in clinical effect between two dosing regimens: once-daily 7.5mg and twice-daily 3.75mg. METHODS: In this randomized trial, tolvaptan was administered within 12h from hospital admission. The primary outcome was the serial change in congestion scores measured every day from enrollment until dosing day 7. Outcomes including safety parameters were also evaluated. RESULTS: The subjects were assigned to either the once-daily 7.5mg dosing regimen (N=15) or the twice-daily 3.75mg dosing regimen (N=16). The time-course changes in body weight, serum sodium and creatinine levels, systolic blood pressure, daily urine output, and congestion scores were similar between the two groups. In the twice-daily 3.75mg dosing group, the serum sodium levels on days 3 and 4 were significantly (p<0.05) increased compared with those on day 1. The congestion scores significantly (p<0.05) decreased from day 2 to day 7 in both groups compared with those on day 1. However, the difference in the serial change in the congestion scores did not reach statistical significance. CONCLUSIONS: Our present results suggest that the early administration of tolvaptan within 12h after hospital admission significantly improved congestion from the first day after administration by either dosing regimen, i.e. once-daily 7.5mg or twice-daily 3.75mg in patients with acute HF.

Unfractionated Heparin during the Interruption of Antiplatelet Therapy for Non-cardiac Surgery after Drug-eluting Stent Implantation.

OBJECTIVE: Heparin is not recommended to be administered during the interruption of antiplatelet therapy for non-cardiac surgery. However, there are insufficient data to determine the value. The purpose of the present study was to evaluate the clinical results of the administration of unfractionated heparin during the interruption of antiplatelet therapy in non-cardiac surgery patients who had previously undergone drug-eluting stent (DES) implantation. METHODS: We retrospectively identified 210 elective non-cardiac surgical procedures that were performed with the administration of unfractionated heparin during interruption of all antiplatelet therapies in patients who had previously undergone DES implantation. Heparin was administered during the perioperative period in accordance with the local practice guideline at out institution. We examined the clinical outcomes within 30 days of surgery. RESULTS: The mean number of implanted DESs was 2.1±1.3. No major adverse cardiac events (including cardiac death, definite stent thrombosis, and non-fatal myocardial infarction) occurred in any of the 210 cases within 30 days of surgery. Four of the 210 cases (1.9%) required reoperation for bleeding within 30 days of surgery. CONCLUSION: Our data showed the potential for the perioperative management with unfractionated heparin administration in Japanese patients who had previously undergone DES implantation who required non-cardiac surgery with the interruption of all antiplatelet therapies.

Progression from stenosis to occlusion in the proximal native coronary artery after coronary artery bypass grafting.

Coronary artery bypass grafting (CABG) is an established treatment for multivessel coronary artery disease. However, problematic situations are occasionally encountered after CABG, such as disease progression in the native coronary artery with graft occlusion, which causes difficulty in revascularization. The purpose of this study was to evaluate changes in the native coronary artery after CABG. Between 2009 and 2012 in our institution, 351 patients underwent CABG, and 768 bypass grafts were anastomosed to non-occluded coronary arteries. Of these, 489 bypass grafts had available early postoperative angiographic results (≤6 months) suitable for assessment in this study. We defined malignant graft failure after CABG to be bypass graft occlusion and de novo complete occlusion of the target native coronary artery proximal to the graft anastomosis site. In the early angiographic results, 17 grafts were occluded (17/489; 3.5 %). Two of the grafts displayed malignant graft failure (a saphenous vein graft to the right coronary artery and a saphenous vein graft to the diagonal branch) (2 of 17 occluded grafts, and 2 of 489 studied grafts). Of the patent bypass grafts, 24 involved progression to occlusion in the proximal native coronary artery (19 saphenous vein grafts, 4 left internal thoracic artery grafts, and 1 right internal thoracic artery graft). Malignant graft failure was uncommon during short-term follow-up after CABG. At the same time, disease progression in the proximal native coronary artery from stenosis to occlusion following patent bypass grafting was relatively common, especially for vein grafts.

Impact of the statin escape phenomenon on long-term clinical outcomes in patients with acute myocardial infarction: Subgroup analysis of the Nagoya Acute Myocardial Infarction Study (NAMIS).

BACKGROUND: Statins are reportedly effective in the primary and secondary prevention of cardiovascular disease, mainly due to their ability to aggressively reduce low-density lipoprotein cholesterol (LDL-C) levels. However, patients sometimes exhibit the so-called "statin escape" phenomenon. The purpose of our study was to investigate the impact of the statin escape phenomenon on long-term clinical outcomes in patients with acute myocardial infarction (AMI). METHOD: This was a subgroup analysis of 1144 patients from the Nagoya Acute Myocardial Infarction Study (NAMIS) treated between January 2004 and December 2012. We analyzed 660 patients who initiated statin treatment after AMI. Statin escape phenomenon was defined as an increase in the LDL-C levels during the 9-month treatment period by >10% of the initial values after 4 weeks of initiating statin treatment. Patients were divided into two groups depending on whether they exhibited the statin escape phenomenon, with 474 patients in the non-escape group and 186 patients in the escape group. RESULT: Compared to the non-escape group, the escape group showed significantly lower LDL-C levels at 4 weeks after treatment initiation (81.3 ± 20.1 mg/dL vs. 101.1 ± 25.4 mg/dL, P < 0.01). By contrast, the escape group showed significantly higher LDL-C levels at 9 months after treatment initiation (105.8 ± 28.3 mg/dL vs. 90.3 ± 22.6 mg/dL, P < 0.01). Major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause death, MI, and stroke) were more frequent in the escape group than in the non-escape group (10.8% vs. 6.1%, P = 0.03). Multivariate analysis showed that statin escape phenomenon was an independent predictor of MACCE (hazard ratio: 2.02, 95% confidence interval: 1.11-3.66, P = 0.02). CONCLUSION: Statin escape phenomenon may be an independent predictor of long-term clinical outcomes in AMI patients.

Impact of airflow limitation on carotid atherosclerosis in coronary artery disease patients.

BACKGROUND: Both airflow limitation and smoking are established cardiovascular risk factors. However, their interaction as risk factors for the development of atherosclerosis in coronary artery disease patients remains unclear. OBJECTIVES: To evaluate the effect of the interaction between airflow limitation and smoking status on the severity of carotid atherosclerosis. METHODS: We categorized the 234 enrolled patients with coronary artery disease into four groups: never-smokers with normal pulmonary function (group A), never-smokers with airflow limitation (group B), ever-smokers with normal pulmonary function (group C), and ever-smokers with airflow limitation (group D). RESULTS: The prevalence of airflow limitation in the enrolled patients was 23.1% (ever-smokers: 15.8%, never-smokers: 7.3%). The prevalence of severe carotid atherosclerosis was 28.2, 29.4, 41.3, and 45.9%, respectively, in the four groups (group D vs. group A, p = 0.035). Even after multivariate adjusting for confounding factors, ever-smokers with airflow limitation were independently associated with severe carotid atherosclerosis (odds ratio 2.89, 95% confidence interval, 1.19-7.00, p = 0.019). CONCLUSIONS: Ever-smokers with airflow limitation were significantly associated with severe carotid atherosclerosis among patients with coronary artery disease. These findings also provide additional insight into the correlation between airflow limitation and poor cardiovascular clinical outcomes.

Relation between paradoxical decrease in high-density lipoprotein cholesterol levels after statin therapy and adverse cardiovascular events in patients with acute myocardial infarction.

Statin therapy moderately increases high-density lipoprotein cholesterol (HDL-C) levels. Contrary to this expectation, a paradoxical decrease in HDL-C levels after statin therapy is seen in some patients. We evaluated 724 patients who newly started treatment with statins after acute myocardial infarction (AMI). These patients were divided into 2 groups according to change in HDL-C levels between baseline and 6 to 9 months after initial AMI (ΔHDL). In total, 620 patients had increased HDL-C levels and 104 patients had decreased HDL-C levels. Both groups achieved follow-up low-density lipoprotein cholesterol levels <100 mg/dl. Adverse cardiovascular events (a composite of all-cause death, myocardial infarction, and stroke) have more frequently occurred in the decreased HDL group compared with the increased HDL group (15.4% vs 7.1%, p = 0.01). Multivariate analysis showed that decreased HDL, onset to balloon time, and multivessel disease were the independent predictors of adverse cardiovascular events (hazard ratio [HR] 1.95, 95% confidence interval [CI] 1.08 to 3.52; HR 1.05, 95% CI 1.01 to 1.09; and HR 2.08, 95% CI 1.22 to 3.56, respectively). In conclusion, a paradoxical decrease in serum HDL-C levels after statin therapy might be an independent predictor of long-term adverse cardiovascular events in patients with AMI.

Impact of albuminuria on the incidence of periprocedural myocardial injury in patients undergoing elective coronary stent implantation.

Albuminuria has traditionally been associated with an elevated risk of cardiovascular events. However, few studies have examined the potential relation between albuminuria and periprocedural risk in percutaneous coronary intervention (PCI). The aim of this study was to evaluate the impact of albuminuria on the incidence of periprocedural myocardial injury (PMI) in patients who underwent PCI. The study included 252 consecutive patients who underwent PCI. The incidence of PMI was significantly higher in patients with albuminuria than in those with normoalbuminuria (31.9% vs 43.3%, respectively, p = 0.014). Even after adjustment for confounders, the presence of albuminuria predicted PMI (odds ratio 2.07, 95% confidence interval 1.08 to 3.97, p = 0.029). Furthermore, patients with albuminuria and preserved estimated glomerular filtration rate had a 4.2-fold higher risk for PMI than did patients with normoalbuminuria and preserved estimated glomerular filtration rate. In conclusion, albuminuria was a strong predictor of PMI in patients who underwent PCI.

Long-term clinical outcome after surgical or percutaneous coronary revascularization in hemodialysis patients.

BACKGROUND: Although revascularization via coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) has been widely performed, there are limited data on which procedure is best in hemodialysis (HD) patients. METHODS AND RESULTS: This 10-year follow-up study consisted of 997 HD patients electively undergoing coronary revascularization (CABG, n=210; PCI, n=787). With an adjustment for propensity scores with all baseline covariates, the incidence of major adverse cardiac events (MACE) was evaluated as a composite endpoint including all-cause death, non-fatal myocardial infarction (MI) and any revascularization. During the follow-up period, 465 MACE (death, n=325; non-fatal MI, n=45; revascularization, n=274) occurred. The 10-year freedom from MACE was higher in the CABG group compared to the PCI group (51.0% vs. 34.8%, adjusted hazard ratio [HR], 0.64; 95% confidence interval [CI]: 0.49-0.82, P=0.0003). On landmark analysis, adjusted HR of death was higher during the first 6 months after CABG compared to PCI (1.72; 95% CI: 1.04-2.79, P=0.036), but lower from 6 months onward (0.69; 95% CI: 0.48-0.97, P=0.033). When compared to patients treated with drug-eluting stent alone (n=345) in the PCI group, the CABG group still had an advantage for any revascularization (adjusted HR, 0.38; 95% CI: 0.22-0.62, P<0.0001), but not for MACE (adjusted HR, 0.86; 95% CI: 0.64-1.15, P=0.33). CONCLUSIONS: CABG was totally clinically advantageous compared to PCI in HD patients.

CCDC3 is specifically upregulated in omental adipose tissue in subjects with abdominal obesity.

OBJECTIVE: The aim of this study was to search for novel markers of visceral adiposity. METHODS: Visceral (omental) and subcutaneous adipose tissues were obtained from 43 Japanese men. Microarray analysis using total RNA from visceral and subcutaneous adipose tissues obtained from five men with abdominal obesity and five nonobese men was first conducted. Then the expression pattern of candidate genes identified in the human study in mouse models of adiposity was examined. RESULTS: Among 30,500 genes evaluated, the mRNA expression of CCDC3 (encoding coiled-coil domain-containing protein 3) was upregulated in omental adipose tissues from abdominally obese subjects (3.07-fold) but not in subcutaneous adipose tissues (0.89-fold). Similar expression patterns were found in two distinct mouse models of obesity. In the analysis of all 43 men, CCDC3 mRNA levels in omental, but not in subcutaneous adipose tissue, were positively correlated with waist circumference and body mass index. CCDC3 was predicted to be a secretory protein, which was confirmed by western blotting, as overexpressed CCDC3 was secreted into the culture media. CONCLUSIONS: The expression of CCDC3 is specifically increased in visceral adipose tissues in abdominally obese subjects. These results suggest that CCDC3 is a potential biomarker for estimating visceral adiposity.

Sirolimus- vs. paclitaxel-eluting stent to coronary intervention in dialysis patients.

BACKGROUND: Patients on maintenance hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) even if treated with a sirolimus-eluting stent (SES). The aim of this study was to compare the effects of SES and paclitaxel-eluting stent (PES) in preventing restenosis in HD patients with coronary artery disease. METHODS: A total of 100 consecutive patients on HD who underwent PCI were enrolled into the study. They were randomly assigned to receive either SES or PES. We compared follow-up angiographic outcomes between the SES and PES groups at 8-month follow-up. RESULTS: The angiographical restenosis rate, defined as % diameter stenosis>50% at 8-month follow-up, was 19.7% in the SES group and 20.0% in the PES group (p=0.97). Late loss was also similar between the two groups (0.49±0.70 mm vs. 0.48±0.91 mm, P=0.94). There were no significant differences in the rates of all-cause death, non-fatal myocardial infarction, or TLR due to stent restenosis-induced ischemia between the two groups (2.0% vs. 4.0%, p=0.56, 2.0% vs. 4.0%, p=0.56, and 16.0% vs. 12.0%, p=0.57, respectively). CONCLUSIONS: There was no significant difference in angiographical outcome at 8-month follow-up between HD patients treated with SES and PES. Even if treated with DES including SES and PES, patients on HD are at high risk of restenosis after PCI.

Algorithm to determine the outcome of patients with acute liver failure: a data-mining analysis using decision trees.

BACKGROUND: We established algorithms to predict the prognosis of acute liver failure (ALF) patients through a data-mining analysis, in order to improve the indication criteria for liver transplantation. METHODS: The subjects were 1,022 ALF patients seen between 1998 and 2007 and enrolled in a nationwide survey. Patients older than 65 years, and those who had undergone liver transplantation and received blood products before the onset of hepatic encephalopathy were excluded. Two data sets were used: patients seen between 1998 and 2003 (n=698), whose data were used for the formation of the algorithm, and those seen between 2004 and 2007 (n=324), whose data were used for the validation of the algorithm. Data on a total of 73 items, at the onset of encephalopathy and 5 days later, were collected from 371 of the 698 patients seen between 1998 and 2003, and their outcome was analyzed to establish decision trees. The obtained algorithm was validated using the data of 160 of the 324 patients seen between 2004 and 2007. RESULTS: The outcome of the patients at the onset of encephalopathy was predicted through 5 items, and the patients were classified into 6 categories with mortality rates between 23% and89%. When the prognosis of the patients in the categories with mortality rates greater than 50% was predicted as "death", the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the algorithm were 79, 78, 81, 83, and 75%, respectively. Similar high values were obtained when the algorithm was employed in the patients for validation. The outcome of the patients 5 days after the onset of encephalopathy was predicted through 7 items, and a similar high accuracy was found for both sets of patients. CONCLUSIONS: Novel algorithms for predicting the outcome of ALF patients may be useful to determine the indication for liver transplantation.

Using decision tree learning to predict the responsiveness of hepatitis C patients to drug treatment.

The recommended treatment for patients with chronic hepatitis C, pegylated interferon α (PEG-IFN-α) plus rebavirin (RBV), does not provide a sustained virologic response in all patients, especially those with hepatitis C virus (HCV) genotype 1. It is therefore important to predict whether or not a new patient with HCV genotype 1 will be cured by the recommended treatment. We propose a prediction method for a new patient using a decision tree learning model based on SNPs evaluated in a genome-wide association study. By the decision tree learning for 142 Japanese patients with HCV genotype 1 (78 with null virologic response and 64 with virologic response), we can predict with high probability (93%) whether or not a new patient with HCV will be helped by the recommended treatment.

Sirolimus-eluting stent vs. everolimus-eluting stent for coronary intervention in patients on chronic hemodialysis.

BACKGROUND: Even in the drug-eluting stent era, adverse cardiac events, including restenosis after percutaneous coronary intervention (PCI), have been more frequently seen in patients on hemodialysis (HD) than in non-HD patients. The objective of this study was to compare the sirolimus-eluting stent (SES) and everolimus-eluting stent (EES) for prevention of adverse cardiac events, including restenosis, in HD patients. METHODS AND RESULTS: A total of 100 consecutive patients on HD who underwent PCI were enrolled and randomly assigned to receive SES or EES. Although there was no difference between the 2 groups in baseline patient and lesion characteristics, the angiographic restenosis rate at 8-month follow-up was 21.2% in the SES group and 8.7% in the EES group (P = 0.041). Significant differences were also seen in % diameter stenosis (%DS), minimal lumen diameter, and late lumen loss at 8-month follow-up (P = 0.0024, P = 0.0040, and P = 0.033, respectively). During the 1-year follow-up, major adverse cardiac events occurred in 11 (22.0%) patients in the SES group and in 5 (10.0%) patients in the EES group (P = 0.10). CONCLUSIONS: The use of EES was as safe as that of SES. Moreover, EES significantly prevented restenosis in patients on maintenance HD compared with SES.

Novel classification of acute liver failure through clustering using a self-organizing map: usefulness for prediction of the outcome.

BACKGROUND: Patients with acute liver failure are classified according to the interval between the onset of hepatitis symptoms and the development of hepatic encephalopathy. We examined the validity of such classifications. METHODS: The subjects were 1,022 patients enrolled in a nationwide survey in Japan. The intervals between the onset of the hepatitis symptoms and the development of encephalopathy were 10 days or less in 472 patients (group-A), between 11 and 56 days in 468 patients (group-B), and longer than 56 days in 82 patients (group-C). Data on a total of 104 items collected from the patients were subjected to clustering using a self-organizing map. RESULTS: The patients were classified into three clusters. The first cluster consisted of 411 patients (group-A: 57%, group-B: 39%, group-C: 4%). Their incidence of complications was low; 34% underwent liver transplantation (LT), and their survival rate was 90%, while 94% of those treated without transplant were rescued. The second cluster consisted of 320 patients (21, 65, and 14% groups A, B, and C, respectively), who showed a high incidence of complications; the survival rate was 7% in the patients treated conservatively without LT. Sixteen percent underwent LT and survival rate of these patients was 52%. There was a third cluster, of 291 patients (59, 34, and 7% groups A, B, and C, respectively). Without LT, 81% of the patients died. Seven percent were treated by LT and their survival rate was 60%. CONCLUSIONS: Clustering revealed that patients with acute liver failure could be classified into three clusters independent of the interval between the onset of disease symptoms and the development of encephalopathy. This technique may be useful, since the outcomes of the patients differed markedly among the clusters.

Submucosal electrocoagulation for prolapsed hemorrhoids:a new operative approach to hemorrhoidal varices.

The results of submucosal electrocoagulation (SEC), a new radical operation for prolapsed hemorrhoids, in 403 patients with third- or fourth-degree hemorrhoids are reported. After resecting the anal skin tags that coexisted with prolapsed hemorrhoids, the hemorrhoidal varices could be resected and electrically coagulated through the wound without cutting the anal canal epithelium by using a fine needle-type electric knife. The results of this series indicated that SEC could dramatically reduce the incidence of the postoperative complications that sometimes occur after conventional hemorrhoidectomy, such as severe anal pain, massive anal bleeding and anal stenosis. Moreover, SEC could ensure that operated patients make an early return to social activities and have a satisfactory quality of life. Relapse of prolapsed hemorrhoids after SEC was rare.

Effects of oral cilostazol 100 mg BID on long-term patency after percutaneous transluminal angioplasty in patients with femoropopliteal disease undergoing hemodialysis: a retrospective chart review in Japanese patients.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) for femoropopliteal lesions in peripheral artery disease has been performed in patients undergoing hemodialysis as well as in the general population. Cilostazol, a selective inhibitor of phosphodiesterase 3, has been reported to reduce target lesion revascularization after PTA for femoropopliteal lesions in the general population. OBJECTIVE: This study investigated the effects of cilostazol use on long-term patency after PTA in patients with femoropopliteal disease undergoing hemodialysis. METHODS: In this retrospective study, data from patients undergoing hemodialysis who underwent successful PTA for femoropopliteal disease, defined as a final luminal diameter stenosis <30% without angiographically visual arterial dissection and no in-hospital complications, were included. One study group received long-term treatment with oral cilostazol 100 mg BID after PTA; the control group did not. The duration of follow-up was 50% of the vessel diameter in femoropopliteal lesions. Data on baseline characteristics, patency, and covariates (diabetes, hypertension, hyperlipidemia, smoking, coronary artery disease, critical limb ischemia, TransAtlantic Inter-Society Consensus classification, and stenting) were obtained from electronic medical records and telephone interviews with patients. To minimize the effects of selection bias for cilostazol administration, a propensity-matched analysis using Cox univariate and multivariate models including the previously mentioned covariates was conducted. The propensity scores of the 2 groups were matched 1:1 (AUC = 0.69 [receiving operating characteristics analysis]). Data were obtained from electronic medical records and telephone interviews with patients by trained personnel who were blinded to treatment assignment. RESULTS: A total of 358 consecutive lesions of 174 patients undergoing hemodialysis were included (103 men, 71 women; mean [SD] age, 66 [11] years; cilostazol group, 61 patients, 121 lesions; control group, 113 patients, 237 lesions). The mean duration of follow-up was 37 (27) months. The 6-year event-free rate of restenosis of >50% of the vessel diameter was significantly higher in the cilostazol group than in the control group (72/121 [59.5%] vs 120/237 [50.6%]; P = 0.005 [logrank test]; hazard ratio [HR] = 0.63; 95% CI, 0.45-0.88; P = 0.008 [Cox univariate analysis]). Also, event-free rates of target lesion revascularization and limb amputation were significantly higher in the cilostazol group than in the control group (40/61 [65.6%] vs 57/113 [50.4%]; P = 0.013 [log-rank test] and 54/61 [88.5%] vs 90/113 [79.6%]; P = 0.047 [logrank test], respectively). On propensity score matching (105 lesions), the baseline characteristics were comparable between the 2 groups. The 6-year eventfree rate of restenosis was significantly higher in the cilostazol group than in the control group (66/105 [62.9%] vs 52/105 [49.5%]; HR = 0.58; 95% CI, 0.38-0.88; P = 0.012 [Cox univariate analysis]). On propensity-matched (Cox multivariate) analysis, cilostazol (HR = 0.51; 95% CI, 0.27-0.84; P = 0.008), age (HR = 1.01; 95% CI, 1.01-1.04; P = 0.031), and critical limb ischemia (HR = 2.21; 95% CI, 1.39-3.53; P = 0.001) were independent predictors of restenosis. None of the patients in the cilostazol group discontinued cilostazol treatment during the follow-up period. Four patients (6.6%) experienced mild headache. CONCLUSION: This study found that in these patients with femoropopliteal lesions in peripheral artery disease who were undergoing hemodialysis, those treated with cilostazol 100 mg BID after PTA had a higher mean rate of cumulative patency after PTA than those in the control group.

Prognostic values of C-reactive protein levels on clinical outcome after implantation of sirolimus-eluting stents in patients on hemodialysis.

BACKGROUND: Percutaneous coronary intervention (PCI) using drug-eluting stents significantly reduces the risk of restenosis in the general population. However, in patients on hemodialysis, adverse cardiac events are frequently seen even if treated with drug-eluting stents. Recent studies suggest that C-reactive protein (CRP) reflects vascular wall inflammation and can predict adverse cardiac events. We evaluated possible prognostic values of CRP on outcomes in patients on hemodialysis undergoing PCI with drug-eluting stents. METHODS AND RESULTS: A total of 167 patients undergoing PCI with sirolimus-eluting stents for stable angina (322 lesions) were enrolled. They were divided into tertiles according to serum CRP levels. We analyzed the incidence of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction, and target lesion revascularization after PCI as well as quantitative coronary angiographic data. The mean follow-up was 31 months (SD, 14). Major adverse cardiac events occurred in 11 patients (19.6%) of the lowest tertile, in 22 patients (39.3%) of the middle tertile, and in 28 patients (50.9%) of the highest tertile during follow-up period (P=0.0009). There was a progressive increase in neointimal growth after sirolimus-eluting stent implantation during follow-up because preprocedural CRP levels were higher, despite similar angiographic data just after PCI. Angiographic restenosis at 6 to 8 months after PCI was seen in 10.6% in the lowest tertile, 17.9% in the middle tertile, and 32.0% in the highest tertile (P=0.0007). CONCLUSIONS: Increased preprocedural serum CRP levels would predict higher major adverse cardiac events and restenosis rates after sirolimus-eluting stents implantation in patients on hemodialysis.