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While primary percutaneous coronary intervention (PCI) has significantly contributed to improve the mortality in patients with ST segment elevation myocardial infarction even in cardiogenic shock, primary PCI is a standard of care in most of Japanese institutions. Whereas there are high numbers of available facilities providing primary PCI in Japan, there are no clear guidelines focusing on procedural aspect of the standardized care. Whilst updated guidelines for the management of acute myocardial infarction were recently published by European Society of Cardiology, the following major changes are indicated; (1) radial access and drug-eluting stent over bare metal stent were recommended as Class I indication, and (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. Although the primary PCI is consistently recommended in recent and previous guidelines, the device lag from Europe, the frequent usage of coronary imaging modalities in Japan, and the difference in available medical therapy or mechanical support may prevent direct application of European guidelines to Japanese population. The Task Force on Primary Percutaneous Coronary Intervention of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document for the management of acute myocardial infarction focusing on procedural aspect of primary PCI.

Some studies have suggested that radial access (RA) for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared to femoral access (FA). The purpose of this study was to investigate the routine use of hemostatic devices and bleeding complications among RA, brachial access (BA), and FA. Between January 2015 and December 2015, 298 patients treated for PCI with RA were compared with 158 patients using BA and 206 patients using FA. The radial sheath was routinely removed with ADAPTY, the brachial sheath with BLEED SAFE, and the femoral sheath with Perclose ProGlide. In-hospital bleeding complications were investigated. Cardiogenic shock was most frequent in patients in the femoral group (RA 1.3%, BA 2.5%, FA 9.2%, p < 0.0001). The rate of major bleeding was highest in the femoral group (RA 1.0%, BA 2.5%, FA 5.3%, p = 0.01). Blood transfusion rates were highest in the femoral group (RA 0.7%, BA 1.3%, FA 4.4%, p = 0.01). Retroperitoneal bleeding was observed in 1.9% of patients in the femoral group. Patients in the brachial group had large hematomas (RA 0.7%, BA 4.4%, FA 1.5%, p = 0.01). Pseudoaneurysm formation needing intervention occurred most frequently in the brachial group (RA 0%, BA 1.3%, FA 0%, p = 0.04). In conclusion, compared to the brachial and femoral approaches, the radial approach appears to be the safest technique to avoid local vascular bleeding complications. The brachial approach has the highest risk of large hematoma and pseudoaneurysm formation among the three groups.

Background: Clinical use of fractional flow reserve (FFR) has been rapidly increasing, but outcomes after FFR-based coronary intervention in Japanese daily clinical practice have not been well investigated.Methods and Results:The prospective multicenter cardiovascular intervention therapeutics registry (CVIT)-DEFER enrolled consecutive patients for whom FFR measurement was clinically indicated. This study comprised 3,857 vessels in 3,272 patients. Lesions were categorized into 4 groups according to FFR result and revascularization strategy: group 1: FFR >0.8, and deferral of PCI (n=1992); group 2: FFR >0.8, then PCI (n=230); group 3: FFR ≤0.8, and deferral of PCI (n=506); and group 4: FFR ≤0.8, then PCI (n=1,129). The event rate for deferred lesions was significantly low compared with that for PCI lesions (3.5% vs. 6.6%; P<0.05). Vessel-related events occurred in 62 (3.1%), 11 (4.8%), 25 (4.9%), and 79 (7.0%) patients in groups 1, 2, 3, and 4, respectively. PCI for lesions in which FFR was >0.8 (group 2) showed no improvement in the event rate compared with a defer-strategy. On the other hand, deferred lesions with lower FFR values had a higher risk of vessel-related events., Conclusions: A FFR-based revascularization strategy in daily clinical practice was safe with regard to vessel-related events.

This report describes a case of subacute stent thrombosis (SAT) after drug-coated balloon (DCB). A 79-year-old male was investigated for stable angina. An in-stent restenosis (ISR) lesion was detected by coronary angiography. A skin reaction related to the anti-platelet agent thienopyridine was also observed at this time. Therefore, DCB was used to treat the ISR lesion under single anti-platelet therapy (aspirin). However, 3 days after percutaneous coronary intervention, SAT occurred. OCT did not reveal the underlying cause of SAT. Further data are needed to clarify the optimal duration of dual anti-platelet therapy after DCB.

Objectives The fractional flow reserve (FFR) is an index of the severity of coronary stenosis that has been clinically validated in several studies. The instantaneous wave-free ratio (iFR) and the resting distal coronary artery pressure/aortic pressure (Pd/Pa) are nonhyperemic pressure-derived indices of the severity of stenosis. This study sought to examine the diagnostic accuracy of the iFR and resting Pd/Pa with respect to hyperemic FFR. Methods Following an intracoronary injection of papaverine, the iFR, resting Pd/Pa, and FFR were continuously measured in 123 lesions in 103 patients with stable coronary disease. Results The iFR and resting Pd/Pa values were strongly correlated with the FFR (R=0.794, p<0.001, R=0.832, p<0.0001, respectively). A receiver operator curve (ROC) analysis revealed that the optimal iFR cut-off value for predicting an FFR of <0.80 was 0.89 (AUC 0.901, sensitivity 84.1%, specificity 80.0%, positive predictive value 69.8%, negative predictive value 90.0%, diagnostic accuracy 81.3%), while the optimal resting Pd/Pa cut-off value was 0.92 (AUC 0.925, sensitivity 90.9%, specificity 78.5%, positive predictive value 70.2%, negative predictive value 93.9%, diagnostic accuracy 82.9%). The lesions with an iFR value of ≤0.89 and a Pd/Pa value of ≤0.92 were defined as double-positive lesions, while the lesions with an iFR value of >0.89 and a Pd/Pa value of >0.92 were defined as double-negative lesions. In these 109 lesions, the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were 92.3%, 82.9%, 75.0%, 95.1%, and 86.2%, respectively. Conclusion This analysis demonstrated that the iFR and resting Pd/Pa were strongly correlated with the FFR and that the diagnostic accuracy of the iFR was similar to that of the resting Pd/Pa. The diagnostic accuracy can be improved with the use of both the iFR and the resting Pd/Pa.

Objective Measuring the fractional flow reserve (FFR) requires the induction of coronary hyperemia, usually with adenosine, adenosine triphosphate (ATP), or papaverine. However, adenosine can induce rhythmic complications, and intracoronary boluses of papaverine that prolong the QT interval can cause ventricular tachycardia. Injection of contrast media, which is routinely performed to validate the FFR guidewire placement, also induces hyperemia and may be an alternative method of measuring the FFR. We evaluated the diagnostic accuracy of the FFR after contrast hyperemia (FFRcont) compared to FFR evaluated after intracoronary papaverine (FFRpp). Methods This study included 109 lesions in 93 patients (mean age 70.4±8.7 years) with stable coronary disease. The FFR was measured as follows: 1) baseline pressure value; 2) FFRcont after intracoronary contrast injection (iopamidol, 8 mL for left coronary artery [LCA] or 6 mL for right coronary artery [RCA]); 3) FFRpp after intracoronary injection of papaverine (12 mg for LCA or 8 mg for RCA). Results FFRcont values were strongly correlated with FFRpp (R=0.940, p<0.0001; FFRpp = FFRcont ×1.007-0.032). The best cut-off point in the receiver operator curve analysis for predicting a FFRpp <0.80 was 0.82 (area under the curve =0.980; sensitivity 95.1%, specificity 91.2%, positive predictive value 86.7%, negative predictive value 96.9%). Conclusion FFRcont is highly accurate for predicting FFRpp. An FFRcont threshold value of 0.82 provides excellent sensitivity and a negative predictive value. FFRcont is an alternative method of inducing hyperemia.

Objectives: To evaluate the safety and feasibility of virtual 3 Fr (V3), sheathless 5 Fr percutaneous coronary intervention (PCI)., Background: A small-diameter guiding catheter (GC) makes less-invasive PCI possible. The V3 is an extremely slender PCI system; however, the outcome of using this system has not yet been determined., Methods: The V3 registry is a prospective, multicenter, non-randomized study that enrolled patients who underwent elective V3-PCI. The primary endpoint was clinical success rate, and the secondary endpoints were PCI success rate in all cases, major adverse cardiac and cerebrovascular event (MACCE) at 30 days, and access-site complications., Results: A total of 260 patients with 321 lesions were enrolled. Of this group, 70% were male and the mean age was 70.8 ± 10.0 years. Type B2/C lesions comprised 50.7% of the total. The clinical success rate was 95.8%, and the PCI success rate was 99.2%. PCI failure was reported in 2 chronic total occlusion cases. No MACCE was reported. Although there was no major bleeding, hematoma occurred at the puncture site in 12.7% of cases. There was a single radial artery occlusion (0.4%) without symptoms., Conclusions: PCI with the V3 was safe and feasible. Radial artery occlusion and major bleeding complications were extremely low. However, access-site hematoma frequently complicated catheter exchange.

Background: Generally, newly progressed coronary lesions (NPCLs) are considered to be composed of lipid-rich plaques. In case of vulnerable plaque rupture, they may quickly become culprit lesions responsible for acute coronary syndromes., Methods: Between September 2011 and September 2015, 2034 patients underwent scheduled follow-up coronary angiography (CAG) after percutaneous coronary intervention (PCI) in Tsuchiya General Hospital. Patients with NPCLs found by CAG during the follow-up period were evaluated by optical coherence tomography (OCT). NPCLs were defined as the lesions with less than 50% diameter stenosis, which progressed to more than 75% diameter stenosis within 3years after the previous CAG. Patients with restenosis after PCI were excluded. We compared OCT findings of NPCLs between symptomatic and asymptomatic patients., Results: The follow-up CAG showed NPCLs in 64 patients (3.2%). OCT revealed fibrous plaque in 42 patients (65.6%) and thin-cap fibroatheroma in one patient. Thirteen patients had chest symptoms for one month before CAG and the remaining 51 patients were asymptomatic. The prevalence of fibrous plaque and intimal disruption or plaque rupture were not significantly different between symptomatic and asymptomatic patients (61.5% vs. 66.7%, p=0.752 and 30.8% vs. 11.8%, p=0.213, respectively). However, thrombi were more frequently observed in symptomatic patients (61.5% vs. 13.7%, p<0.001)., Conclusions: The majority of NPCLs found in asymptomatic patients at follow-up CAG were not vulnerable; however, those found in symptomatic patients might be vulnerable. In clinical practice, NPCLs found in asymptomatic patients should be evaluated for functional severity of stenosis in order to determine the need for coronary revascularization., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Electrocardiographic left ventricular hypertrophy (ECG-LVH) gradually regressed after aortic valve replacement (AVR) in patients with severe aortic stenosis. Sokolow-Lyon voltage (SV1 + RV5/6) is possibly the most widely used criterion for ECG-LVH. The aim of this study was to determine whether decrease in Sokolow-Lyon voltage reflects left ventricular reverse remodeling detected by echocardiography after AVR. Of 129 consecutive patients who underwent AVR for severe aortic stenosis, 38 patients with preoperative ECG-LVH, defined by SV1 + RV5/6 of ≥3.5 mV, were enrolled in this study. Electrocardiography and echocardiography were performed preoperatively and 1 year postoperatively. The patients were divided into ECG-LVH regression group (n = 19) and non-regression group (n = 19) according to the median value of the absolute regression in SV1 + RV5/6. Multivariate logistic regression analysis was performed to assess determinants of ECG-LVH regression among echocardiographic indices. ECG-LVH regression group showed significantly greater decrease in left ventricular mass index and left ventricular dimensions than Non-regression group. ECG-LVH regression was independently determined by decrease in the left ventricular mass index [odds ratio (OR) 1.28, 95 % confidence interval (CI) 1.03-1.69, p = 0.048], left ventricular end-diastolic dimension (OR 1.18, 95 % CI 1.03-1.41, p = 0.014), and left ventricular end-systolic dimension (OR 1.24, 95 % CI 1.06-1.52, p = 0.0047). ECG-LVH regression could be a marker of the effect of AVR on both reducing the left ventricular mass index and left ventricular dimensions. The effect of AVR on reverse remodeling can be estimated, at least in part, by regression of ECG-LVH.

Background: Three-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients., Methods: In the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES)., Results: There were no significant differences in baseline clinical characteristics aside from hypertension. Incidence of major adverse cardiac cerebrovascular events (MACCE) mainly due to higher target vessel failure (TVF) initially indicated a benefit in SES (MACCE rate at 1 year: SES 9.4%, PES 12.2%, p=0.08); however this had attenuated by the time of the 3-year follow-up (MACCE rate from 1 to 3 years: SES 8.4%, PES 6.1%, p=0.10). A similar pattern was observed in insulin-treated patients: MACCE rate from 1 to 3 years was 10.5% in SES and 6.4% in PES (p=0.25). Angiographic follow-up also resulted in higher major adverse cardiac event (MACE) rates at 1 year (presence 11.5%, absence 8.3%, p=0.04); however by 3 years rates were similar regardless of the presence of angiographic follow-up (MACE rate at 3 years: presence 16.0%, absence 14.5%, p=0.35)., Conclusions: The superiority of SES over PES in MACCE at 1 year had attenuated by 3-year follow-up. Eventually, the 3-year safety and efficacy profiles were similar regardless of insulin treatment., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan., Methods and results: We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years., Conclusions: Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan.

Background: The influence of antiplatelet therapy discontinuation on the incidence of stent thrombosis, especially very late stent thrombosis, after drug-eluting stent implantation has not been yet fully addressed., Methods: Relationship between antiplatelet therapy discontinuation and stent thrombosis up to 5years was evaluated in 12,812 consecutive patients undergoing sirolimus-eluting stents (SES) implantation in the j-Cypher registry. Data on status of antiplatelet therapy during follow-up were collected prospectively., Results: Median follow-up interval was 1699days (interquartile range, 1184-1928days). Incidences of definite stent thrombosis were 0.34% at 30days, 0.55% at 1year, and 1.6% at 5years. Dual antiplatelet therapy was maintained in 97.4%, 63%, and 43.9% of patients at 30days, 1year, and 5years, respectively. The rates of stent thrombosis in patients who discontinued both thienopyridine and aspirin were significantly higher in the time intervals of 31-365days, 2-3years and 3-4years, and tended to be higher in the time intervals of 1-2years and 4-5years than those in patients who continued both (31-365days: 1.26% versus 0.2%, P<0.001; 1-2years: 0.59% versus 0.15%, P=0.06; 2-3years: 1.35% versus 0.2%, P=0.004; 3-4years: 1.09% versus 0.25%, P=0.0496; 4-5years: 1.35% versus 0.43%, P=0.17). Patients who discontinued either thienopyridine or aspirin only did not have an excess of stent thrombosis in any time intervals., Conclusions: In conclusion, discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine or aspirin only, was associated with an increased incidence of late and very late stent thrombosis up to 5years after SES implantation., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded., Methods and Results: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority<0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively)., Conclusions: Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640., (© 2015 American Heart Association, Inc.)

Background: Snow's work on the Broad Street map is widely known as a pioneering example of spatial epidemiology. It lacks, however, two significant attributes required in contemporary analyses of disease incidence: population at risk and the progression of the epidemic over time. Despite this has been repeatedly suggested in the literature, no systematic investigation of these two aspects was previously carried out. Using a series of historical documents, this study constructs own data to revisit Snow's study to examine the mortality rate at each street location and the space-time pattern of the cholera outbreak., Methods: This study brings together records from a series of historical documents, and prepares own data on the estimated number of residents at each house location as well as the space-time data of the victims, and these are processed in GIS to facilitate the spatial-temporal analysis. Mortality rates and the space-time pattern in the victims' records are explored using Kernel Density Estimation and network-based Scan Statistic, a recently developed method that detects significant concentrations of records such as the date and place of victims with respect to their distance from others along the street network. The results are visualised in a map form using a GIS platform., Results: Data on mortality rates and space-time distribution of the victims were collected from various sources and were successfully merged and digitised, thus allowing the production of new map outputs and new interpretation of the 1854 cholera outbreak in London, covering more cases than Snow's original report and also adding new insights into their space-time distribution. They confirmed that areas in the immediate vicinity of the Broad Street pump indeed suffered from excessively high mortality rates, which has been suspected for the past 160 years but remained unconfirmed. No distinctive pattern was found in the space-time distribution of victims' locations., Conclusions: The high mortality rates identified around the Broad Street pump are consistent with Snow's theory about cholera being transmitted through contaminated water. The absence of a clear space-time pattern also indicates the water-bourne, rather than the then popular belief of air bourne, nature of cholera. The GIS data constructed in this study has an academic value and would cater for further research on Snow's map.

Background: We previously reported that the incidence of 1-year major adverse cardiac events (MACE) in patients treated with paclitaxel-eluting stents (PES) was lower than that in the sirolimus-eluting stents in dialysis patients. However, it remains unclear whether there are differences in clinical outcomes between everolimus-eluting stents (EES) and PES., Methods: Between February 2010 and September 2013, 102 maintenance dialysis patients with 135 lesions treated with EES were compared to 107 maintenance dialysis patients with 147 lesions treated with PES. One-year clinical outcomes were investigated., Results: Diabetes mellitus was present in 64.7% in the EES group and 71.0% in the PES group (p = 0.33). Heavy calcification was in 27.4% vs. 34.0% (p = 0.23). Rotational atherectomy was undergone in 11.1% vs. 23.1% (p < 0.01). Total stented length was not significantly different (23.5 ± 14.6 mm vs. 24.4 ± 13.2 mm, p = 0.60). One patient in the EES group was lost to follow up. At 12 months, MACE occurred in 13.2% in the EES group and 17.4% in the PES group (p = 0.25). Target lesion revascularization (TLR) was observed in 9.5% vs. 10.4% respectively (p = 0.77). Mortality was 11.8% vs. 13.1% (p = 0.35). Cardiac death was 5.0% vs. 7.7% (p = 0.09). Definite stent thrombosis was observed in 2.0% vs. 0% (p = 0.14). Subgroup analysis in patients with diabetes mellitus revealed no significant differences in MACE (12.7% vs. 14.9%, p = 0.36), TLR (8.3% vs. 7.4%, p = 0.42), mortality (13.7% vs. 13.2%, p = 0.28), and cardiac death (6.3% vs. 8.0%, p = 0.15) between the two groups., Conclusions: One-year clinical outcomes following EES and PES implantations are similar in dialysis patients., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an "oculo-stenotic reflex" bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices.

Background: The significance of routine measurement of lactate level is unclear in patients with critical acute decompensated heart failure (ADHF)., Methods and Results: Consecutive 754 patients who were admitted to the intensive care unit (ICU) in our hospital from January 2007 to March 2012 and given a diagnosis of ADHF were eligible for retrospective entry into the registry. Lactate level was measured on admission from routine arterial blood sample and we investigated by comparing the lactate level and parameters of conventional in-hospital mortality predictors. Among the patients, 88 (12%) died during hospitalization. The lactate level had great power to predict in-hospital mortality, as suggested by the c-statistics of 0.71. The occurrence of in-hospital death was more pronounced in patients with high levels of lactate (>3.2mmol/l) and the tendency was observed in patients in both the acute coronary syndrome (ACS) group and non-ACS group. In multivariate analysis, elevated lactate levels remained an independent predictor of in-hospital death (odds ratio, 2.14; 95% confidence interval, 1.10-4.21; p=0.03)., Conclusions: Elevated levels of arterial lactate on admission were related to worse in-hospital mortality in patients with ADHF either with or without ACS, suggesting that the presence of high lactate in patients who enter the ICU with ADHF could help stratify the initial risk of early mortality., (Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

A 65-year-old man presented to our hospital due to intermittent claudication and swelling in his left leg. He had Leriche syndrome and deep vein thrombosis. We performed endovascular therapy (EVT) for Leriche syndrome, and a temporary filter was inserted in the inferior vena cava. He received anticoagulation therapy for deep vein thrombosis. The stenotic lesion in the terminal aorta was stented with an excellent postprocedural angiographic result and dramatic clinical improvement after EVT. This case suggests that EVT can be a treatment for Leriche syndrome.

Background: It is unclear whether there are differences in clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with moderate renal insufficiency (RI)., Methods: The Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) was a prospective, randomized multicenter trial which compared 1:1 coronary stenting between SES and PES patients. Patient with serious RI (serum creatinine value 2mg/dL or higher) were excluded. Patients were classified into 2 arms according to renal function: a non-RI arm of 2220 patients (SES 1094 and PES 1126 patients with estimated glomerular filtration rate (eGFR) ≥60 mL min(-1) 1.73 m(-2)) and an RI arm of 1206 patients (SES 613, PES 593 with 30≤eGFR <60 mL min(-1) 1.73 m(-2))., Results: At 12 months, the primary endpoint of target vessel failure in the non-RI arm occurred in 6.0% in the SES group and 8.7% in the PES group (p=0.02). In the RI arm, this occurred in 5.7% and 8.1% (p=0.10). Mortality rates were 0.8% vs 0.7% (p=0.78) in the non-RI arm, and 2.2% vs 2.1% (p=0.90) in the RI arm. Cardiac death was 0.4% vs 0.1% (p=0.17) in the non-RI arm, and 1.0% vs 1.0% (p=0.96) in the RI arm. Mortality was higher in patients with RI than those without RI (2.1% vs 0.8%; p<0.01). Cardiac death rates increased in the RI arm compared with those in the non-RI arm (1.0% vs 0.2%; p<0.01)., Conclusions: Regardless of the presence or absence of moderate RI, differences in outcomes between SES and PES change little except mortality and cardiac death., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: The optimal medication therapies are recommended in patients with coronary artery disease even after the coronary revascularization. However, the information of optimal medical therapy in dialysis population is scant. We assessed the efficacy of statin on the clinical outcomes after Sirolimus-eluting stent (SES) implantation in patients with and without dialysis., Methods and Results: We analyzed date from 843 consecutive patients who successfully treated with SES in our institution between August 2004 and November 2006. Among patients, 96 patients (11.4%) were undergoing dialysis. In non-dialysis patients, 405 patients (54%) were treated with statin at hospital discharge. In dialysis patients, only 16 patients (17%) were treated with statin. In non-dialysis patients, mortality rate was significantly lower in patients treated with statin than those without statin (4.4% vs. 13.9%, p<0.0001). While in dialysis patients, mortality rate was similar between patients treated with and without statin (56.3% vs. 57.6%, p=0.86). After adjusting for confounders, the hazard ratios for mortality were 0.39 (95% confidence interval (CI), 0.14-0.99; p=0.047) in non-dialysis patients and 1.79 (95% CI, 0.39-7.86; 0.45) for dialysis patients. The interaction probability between statin use and dialysis for mortality was 0.016., Conclusion: The use of statin may have beneficial effect on reducing mortality rate in patients after SES implantation in non-dialysis patients. However, such favorable effect was not observed in dialysis population.

Objective: Very late stent thrombosis (VLST) remains an unresolved problem, and recent reports have indicated that VLST onset can occur in patients treated with both drug-eluting stents (DES) and bare metal stents (BMS). We evaluated the causes of VLST using optical coherence tomography (OCT)., Methods: OCT was performed in 22 patients (12 DES-treated patients, 10 BMS-treated patients). Because two instances of VLST occurred simultaneously in one case in the DES group, the DES group comprised 13 lesions, while the BMS group comprised 10 lesions. All struts were counted in each frame, and the proportion of uncovered or malapposed struts was calculated based on the overall number of struts in the stent., Results: The interval from stent implantation to VLST onset was significantly longer in the BMS group. The proportion of uncovered struts and the ratio of malapposed struts were significantly higher in the DES group than in the BMS group. The OCT analysis demonstrated intimal hyperplasia or intimal disruption in all patients in the BMS group. However, in the DES group, severe hyperplasia and/or neoatherosclerosis was observed in only eight lesions (61.5%), while uncovered and malapposed struts were involved in the other lesions., Conclusion: In most BMS-treated lesions, it appeared that VLST was caused by the occurrence of neoatherosclerosis after stent implantation. The causes of VLST in DES-treated lesions are more various and complicated than those observed for BMS-treated lesions.

We report a case of a 56-year-old man with a cardiac tumor, which grew and spread rapidly in the right heart. Using transthoracic echocardiography (TTE) in the substernal window, a transvenous biopsy of the tumor was performed safely. The tissue diagnosis revealed a diffuse large B cell lymphoma. After undergoing chemotherapy, the tumor was completely cured and the patient continues to be in good health. A biopsy using TTE in the substernal window may be a useful method to diagnose right-sided extensive tumors.

Background: The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR)., Methods: This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up., Results: Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03)., Conclusions: This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB., (© 2013.)

Objectives: NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year., Background: Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited., Methods: The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618)., Results: At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation., Conclusions: One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study assessed 5-year outcomes after implantation of sirolimus-eluting stents (SES) for unprotected left main coronary artery (ULMCA) disease in comparison with that for non-left main disease., Background: More information on long-term outcomes after ULMCA stenting is needed., Methods: The j-Cypher is a multicenter prospective registry of consecutive patients undergoing SES implantation in Japan., Results: Among 12,812 patients enrolled in the j-Cypher registry, the unadjusted mortality rate at 5 years was significantly higher in patients with ULMCA stenting than in patients without ULMCA stenting (22.8% vs. 14.1%; p < 0.0001); however, the risk for death with ULMCA stenting was no longer significant after adjusting for confounders (hazard ratio: 1.18, 95% confidence interval: 0.95 to 1.46; p = 0.14). In the lesion-level comparison, the nonbifurcation ULMCA lesions treated exclusively with SES had a significantly lower rate of target lesion revascularization (TLR) than those in non-ULMCA nonbifurcation lesions (2.4% vs. 12.7%; p = 0.04). Among bifurcation lesions, those treated with a provisional 2-stent approach had similar rates of TLR (12.1% vs. 11.4%; p = 0.79) between the ULMCA and non-ULMCA groups. Lesions treated with an elective 2-stent approach had higher TLR rates in the ULMCA group as compared with the non-ULMCA group (33.5% vs. 19.7%; p = 0.002)., Conclusions: The safety of ULMCA stenting relative to non-LMCA stenting was maintained through 5 years follow-up. In terms of efficacy, SES implantation in nonbifurcation ULMCA lesions was associated with an extremely low cumulative incidence of TLR, whereas the elective 2-stent approach for ULMCA bifurcation lesions was associated with a markedly higher cumulative incidence of TLR as compared with that for non-ULMCA bifurcation lesions., (Copyright © 2013. Published by Elsevier Inc.)

Background: The current development of serological biomarkers allows detection of smaller myocardial necrosis and early acute myocardial infarction (AMI). We evaluated the relevance of the heart-type fatty acid binding protein (H-FABP) assay, which has recently been approved in Japan, for early diagnosis of AMI as compared with the sensitive troponin assay., Methods: This is an observational study in a single center. From 2010 July to 2011 January, 114 patients who presented with symptoms suggestive of AMI were enrolled., Results: AMI was adjudicated in 45 patients (40%). The diagnostic accuracy of measurements obtained at presentation for AMI, as quantified by the area under the receiver-operating-characteristic curve (AUC), was significantly lower with H-FABP assay than the sensitive troponin assay [AUC for H-FABP, 0.59; 95% confidence interval (CI) 0.48-0.70; and for troponin I, 0.89; 95% CI, 0.83-0.94; P<.0001]. Among patients who presented within 2h after the onset of chest pain, the AUC for H-FABP was even low as compared with sensitive troponin (0.55; 0.39-0.72 vs. 0.89; 0.80-0.98, p<0.001). The clinical sensitivity for the diagnosis of AMI with the cutoff point of 99 th percentile was similar in both assays (81% and 81%, respectively), however, the specificity was extremely low in the H-FABP assay as compared with sensitive troponin assay (19% and 79%, respectively)., Conclusion: The measurement of H-FABP in 114 consecutive patients with chest pain suggestive of AMI showed no improvement of diagnosis for early AMI as compared with the current sensitive troponin assay because of its extremely low specificity., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: Excess alcohol consumption has serious adverse effects on health and violence-related harm. In the UK around 37% of men and 29% of women drink to excess and 20% and 13% report binge drinking. The potential impact on population health from a reduction in consumption is considerable. One proposed method to reduce consumption is to reduce availability through controls on alcohol outlet density. In this study we investigate the impact of a change in the density of alcohol outlets on alcohol consumption and alcohol-related harms to health in the community., Methods/design: A natural experiment of the effect of change in outlet density between 2005-09, in Wales, UK; population 2.4 million aged 16 years and over. Data on outlets are held by the 22 local authorities in Wales under The Licensing Act 2003. The study outcomes are change in (1) alcohol consumption using data from annual Welsh Health Surveys, (2) alcohol-related hospital admissions using the Patient Episode Database for Wales, (3) Accident & Emergency department attendances between midnight-6am, and (4) alcohol-related violent crime against the person, using Police data. The data will be anonymously record-linked within the Secure Anonymised Information Linkage Databank at individual and 2001 Census Lower Super Output Area levels. New methods of network analysis will be used to estimate outlet density. Longitudinal statistical analysis will use (1) multilevel ordinal models of consumption and logistic models of admissions and Accident & Emergency attendance as a function of change in individual outlet exposure, adjusting for confounding variables, and (2) spatial models of the change in counts/rates of each outcome measure and outlet density. We will assess the impact on health inequalities and will correct for population migration., Discussion: This inter-disciplinary study requires expertise in epidemiology and public health, health informatics, medical statistics, geographical information science, and research into alcohol-related violence. Information governance requirements for the use of record-linked data have been approved together with formal data access agreements for the use of the Welsh Health Survey and Police data. The dissemination strategy will include policy makers in national and local government. Public engagement will be through the Clinical Research Collaboration-Cymru "Involving People" network, which will provide input into the implementation of the research.

Aims: Lesion location might influence the efficacy of the bifurcation two-stent approach relative to the one-stent approach., Methods and Results: One-year outcomes after sirolimus-eluting stent (SES) implantation with the two-stent approach were compared to those with the one-stent approach in left main coronary artery (LMCA) bifurcation (945 lesions) and in left anterior descending coronary artery (LAD) bifurcation (1271 lesions). The two-stent approach was used more frequently in LMCA than in LAD. The target-lesion revascularisation (TLR) rate in the two-stent group was significantly higher than that in the one-stent group in LMCA (24.2% vs. 5.6%, p<0.0001), but not in LAD (9.0% vs. 5.4%, p=0.056). Adjusted odds ratio of two-stent versus one-stent for TLR was 4.93 (3.01-8.08, p<0.0001) in LMCA and 1.15 (0.64-2.07, p=0.63) in LAD, respectively (interaction p<0.0001). Angiographic restenosis rates in the main branch were significantly higher in the two-stent group in both LMCA and LAD (11.0% vs. 4.9%, p=0.02; and 13.2% vs. 6.8%, p=0.02). Restenosis rates in the side branch were significantly higher in the two-stent group in LMCA (35.3% vs. 14.5%, p<0.0001), but not in LAD (15.1% vs. 22.6%, p=0.07)., Conclusions: Risk of TLR after bifurcation stenting in lesions that needed the two-stent approach was significantly different between LMCA and LAD bifurcations.

A 46-year-old woman presented herself at the hospital with progressive effort dyspnea and lower limbs edema which she had had for 3 months. She had a history of surgical ligation of patent ductus arteriosus (PDA) at the age of 25-year-old. A transthoracic cardiac ultrasonography showed left ventricular dilatation, severe functional mitral regurgitation, and a recurrent shunt of PDA. Percutaneous coil closure of PDA was performed and 6 months after the procedure, resolution of functional mitral regurgitation and normalization of left atrial and ventricular sizes were achieved.

The sirolimus-eluting stent (SES) has dramatically reduced restenosis in patients with most types of coronary lesions, but bifurcation lesions remain a predictor of poor prognosis even in SES implantation. We aimed to determine the clinical outcomes of the left main trunk (LMT) side branches (SB) treated with a single SES strategy. SES implantation was successfully performed on 70 patients with LMT stenosis from August 2005 to August 2008. Of the 70 patients, 55 patients (59 SB) were treated with a single SES and a jailed SB. The 56 SB were divided into two groups according to percent diameter stenosis immediately following percutaneous coronary intervention (PCI) (Group 1: >50%; Group 2: <50%). Quantitative coronary angiography (QCA) data was evaluated. One year angiographic follow-up was performed on 23 patients (82.1%) in Group 1, and 21 patients (78.6%) in Group 2. Group 1 MLD was significantly larger at follow up than that post-PCI (0.9 ± 0.4 vs. 1.2 mm ± 0.6 mm, p < 0.01). In Group 2, MLD and percent diameter stenosis did not change significantly. SB revascularization was not performed on either group at follow-up. Clinical outcomes of moderate stenosis in LMT SB treated with a single SES were acceptable, and stenosis progression within 1 year was minimal. We concluded that patients who present moderate residual stenosis in LMT SB with no presentation of ischemic symptoms should be observed rather than re-stented.

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Background: In previous studies, the minimal luminal diameter (MLD) of lesions treated with a bare metal stent (BMS) was shown to improve from 6 months to 3 years. However, the long-term response to a sirolimus-eluting stent (SES) implantation remains unclear., Methods and Results: To evaluate 6-month, 12-month and 3-year outcomes, clinical and angiographic follow-up data were analyzed for 367 consecutive patients (506 de novo lesions) who underwent successful SES implantation compared to follow-up data for 617 consecutive patients (802 de novo lesions) who underwent BMS implantation. Clinical follow-up information was obtained for 363 SES-treated patients (98.9%) and 581 BMS-treated patients (94.2%) at 1 year, and 334 SES-treated patients (91.0%) and 566 BMS-treated patients (91.7%) at 3 years. At 3 years, there were no significant differences in the cumulative cardiac death and myocardial infarction. Target lesion revascularization (TLR) rates were significantly higher in BMS-treated patients than in SES-treated patients. In BMS-treated patients, most TLR was performed within 450 days, however, after 450 days, the TLR rate was significantly lower than that for the SES-treated patients. In quantitative coronary angiographic data, among lesions that required no revascularization at the initial 12-month follow up, MLD increased significantly from the 12-month to the 3-year follow-up angiography in BMS-treated lesions. However, MLD decreased significantly in SES-treated lesions., Conclusions: From a 12-month follow-up to a 3-year follow-up, stenosis in BMS-treated lesions regressed, but stenosis in SES-treated lesions progressed. And late TLR was more frequently required in the SES-treated patients.

Restenosis still occurs, even with the sirolimus-eluting stent (SES), and the precise mechanisms have not yet been elucidated. In the present case, focal in-stent stenosis was discovered on angiography 16 months after SES implantation. Intravascular ultrasound revealed an echolucent homogeneous zone, which has been termed "black hole". A sample of stenotic tissue retrieved by aspiration revealed neointimal hyperplasia, composed of proteoglycans and smooth muscle cells with scanty cellularity. Furthermore, infiltration of many macrophages and T lymphocytes coexisted in the restenotic tissue. These findings suggest that delayed healing is 1 of the mechanisms of SES restenosis.

Background: The influences of antiplatelet therapy discontinuation on the risk of stent thrombosis and long-term clinical outcomes after drug-eluting stent implantation have not yet been addressed adequately., Methods and Results: In an observational study in Japan, 2-year outcomes were assessed in 10 778 patients undergoing sirolimus-eluting stent implantation. Data on status of antiplatelet therapy during follow-up were collected prospectively. Incidences of definite stent thrombosis were 0.34% at 30 days, 0.54% at 1 year, and 0.77% at 2 years. Thienopyridine use was maintained in 97%, 62%, and 50% of patients at 30 days, 1 year, and 2 years, respectively. Patients who discontinued both thienopyridine and aspirin had a significantly higher rate of stent thrombosis than those who continued both in the intervals of 31 to 180 days, 181 to 365 days, and 366 to 548 days after stent implantation (1.76% versus 0.1%, P<0.001; 0.72% versus 0.07%, P=0.02; and 2.1% versus 0.14%, P=0.004, respectively). When discontinuation of aspirin was taken into account, patients who discontinued thienopyridine only did not have an excess of stent thrombosis in any of the time intervals studied. Adjusted rates of death or myocardial infarction at 24 months were 4.1% for patients taking thienopyridine and 4.1% for patients not taking thienopyridine (P=0.99) in the 6-month landmark analysis., Conclusions: Discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy only, was associated with an increased risk of stent thrombosis. Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after sirolimus-eluting stent implantation.

Background: The sirolimus-eluting stent (SES) has dramatically reduced the rate of restenosis in comparison to that with the bare-metal stent (BMS). In previous studies, the minimal luminal diameter (MLD) of lesions treated with a BMS was shown to improve from 6 months to 1 year., Methods: To evaluate 6-month and 1-year outcomes, angiographic follow-up data were analyzed for 285 patients (451 lesions) who underwent successful SES implantation compared to follow-up data for 2,561 patients (3,367 lesions) who underwent BMS implantation., Results: Angiographic follow-up was performed at 6 months for 396 SES-treated lesions and 2,628 BMS-treated lesions and at 1 year for 322 SES-treated lesions and 1,540 BMS-treated lesions. The 6-month angiographic restenosis rate was significantly lower for SES-treated lesions than for BMS-treated lesions (4.8% vs. 23.4%, p<0.01). From immediately after stent implantation to 6 months, quantitative coronary angiography revealed a significantly larger decrease in MLD of BMS-treated lesions than in MLD of SES-treated lesions (p<0.01). In BMS-treated lesions in which repeat revascularization was not performed at 6 months, MLD increased significantly from 2.08+/-0.63 mm at 6 months to 2.11+/-0.61 mm at 1 year (p<0.01). In SES-treated lesions, however, MLD decreased significantly from 2.55+/-0.56 mm at 6 months to 2.44+/-0.61 mm at 1 year (p<0.05)., Conclusions: From 6 months to 1 year, stenosis of BMS-treated lesions regressed, but stenosis of SES-treated lesions progressed.

Objective: In patients with acute myocardial infarction (AMI), angiographic slow/no-flow during percutaneous coronary intervention (PCI) may lead to unfavorable outcomes. The aim of our study was to investigate the predictors and long-term prognosis of AMI patients with angiographic slow/no-flow., Methods: We evaluated 228 consecutive AMI patients with either normal flow (Thrombolysis in Myocardial Infarction [TIMI] flow grade 3)(n=192) or slow/no-flow (< or =TIMI-2)(n=36) based on cineangiograms performed during PCI., Results: Multivariable analysis demonstrated that a long lesion (> or =10 mm)(odds ratio [OR], 3.514; 95% confidence interval [CI], 1.505-8.206; p=0.004) and acute hyperglycemia (> or =180 mg/dl)(OR, 3.011; 95% CI, 1.211-7.485; p=0.018) were significant and independent predictors of angiographic slow/no-flow. Further, we found that there was a high correlation (89%) for predicting angiographic slow/no-flow when the optimal cut-off values of lesion length (10.45 mm) and blood glucose levels on admission (187.5 mg/dl) were combined as identified by analysis of the receiver operating characteristic curves. One-year mortality and incidence of major adverse cardiac and cerebrovascular events (MACCE) were significantly higher in the slow/no-flow group than that in the normal flow group. Angiographic slow/no-flow was independently predictive of MACCE (hazard ratio [HR], 3.642; 95% CI, 1.208-10.980; p=0.022) and cardiac death (HR, 5.287; 95% CI, 1.155-24.204; p=0.032)., Conclusions: Lesion length and blood glucose level on admission can be used to stratify AMI patients into a lower or higher risk for angiographic slow/no-flow before optimal coronary intervention. In addition, angiographic slow/no-flow predicts an adverse outcome in AMI patients.

Objective: We sought to determine the effect of impaired renal function (IRF) and diabetes on the long-term outcome in patients undergoing primary angioplasty for acute coronary syndrome (ACS). Background Diabetes and IRF occur frequently in patients presenting with ACS. However, the prognostic importance of IRF in comparison with diabetes after primary angioplasty has not been specifically studied., Methods: A total of 742 patients with ACS treated by primary angioplasty were evaluated. Study endpoints were major adverse cardiac events (MACE), a composite of all-cause mortality, ACS, and target vessel revascularization (TVR)., Results: During an average follow-up period of 6.8 years, we documented 13 cardiovascular deaths, 27 non-cardiovascular deaths, 12 incidents of ACS, and 165 incidences of TVR. Six-year rates of MACE were significantly higher in diabetics with IRF (47.6%), nondiabetics with IRF (36.4%), and diabetics without IRF (36.0%) than in nondiabetics without IRF (28.4%, Log-rank test: p=0.0057). Nondiabetics with IRF, diabetics without IRF, and diabetics with IRF had a relative hazard ratio for MACE of 1.63 (95% confidence interval (CI) 1.04 to 2.54, p=0.033), 1.47 (95% CI, 1.03 to 2.11; p=0.036), and 1.97 (95% CI, 1.12 to 3.48; p=0.019), respectively, compared with nondiabetics without IRF., Conclusions: IRF has an important association with MACE after primary angioplasty in patients with ACS and may be nearly as predictive of long-term outcome as is diabetes.

Objectives: We sought to determine the incidence of acute coronary events after coronary stenting in comparison to that after plain old balloon angioplasty (POBA)., Background: Although coronary stenting is proven to be effective in reducing the incidence of restenosis, the long-term outcome in terms of acute coronary events has not been clarified., Methods: Study subjects were 1,507 patients with 2,780 native coronary artery lesions treated by POBA (n=1,400) or stenting (n=1,380). Lesion stabilization, which was defined as freedom from restenosis confirmed by follow-up angiography 3 months after POBA and 6 months after stenting, was achieved in all subjects. All patients were clinically monitored for symptoms for at least 1 year after angioplasty, and the incidence of angiographically confirmed acute coronary event was compared between groups., Results: The clinical follow-up period was significantly longer in the POBA group than in the stent group (8.4 +/- 5.0 years vs. 5.9 +/- 3.0 years, p<0.0001). Acute coronary events occurred in association with 32 lesions (1.2% overall); the incidence was 1.1% (15 of 1,400) after POBA and 1.2% (17 of 1,380) after stenting. Freedom from acute coronary events related to the treated lesions was similar between the two groups. (p=0.0518 by log-rank test)., Conclusion: In terms of acute coronary events, the long-term clinical outcome of stenting is equivalent to that of POBA.

We studied the clinical features and factors of successful catheter ablation for common and uncommon atrioventricular nodal reentrant tachycardia(AVNRT). The study population consisted of 41 consecutive patients, 33 with common type AVNRT (16 males mean age of 57.8 years), and 8 patients with uncommon type AVNRT (4 males, mean age of 57.1 years). In all patients with common type AVNRT, the earliest atrial activation during tachycardia was recorded at the His bundle region. The effective ablation sites were located in the medial septal area and all cases were successfully ablated without complication. In patients with uncommon type AVNRT, dual pathway was observed in 5 patients(63%) and triple pathway in 3 patients(38%). The earliest atrial activation during tachycardias was recorded at the ostium of the coronary sinus. Radiofrequency ablation therapy was performed during sinus rhythm in 5 patients, and during tachycardia in 3 others. The effective ablation sites were located at the posterior septal area around the coronary sinus ostium. All cases were successfully ablated without any major complication, but one case had second-grade atrioventricular block after ablation. There were no significant differences between the common and uncommon type AVNRT cases with regard to the therapeutic success rate, the mean application number or the total energy applied. However, the successful ablation sites were different between the two groups. We concluded that radiofrequency catheter ablation would be effective in patients with both common and uncommon types AVNRT. Selective ablation at the site of the retrograde slow pathway exit was the most important factor for successful catheter ablation for uncommon type AVNRT. However, it should be performed only after careful analysis, taking into account the complex mechanism of uncommon type AVNRT.

Few studies have investigated the long-term angiographic outcome of successful coronary balloon angioplasty (CBA) among diabetic and nondiabetic dilated lesions. The purpose of this study was to evaluate and compare the long-term (>5 years) outcomes of diabetic and nondiabetic CBA lesions which had remained patent 3-12 months after intervention. Twenty-five patients (45 lesions) with diabetes mellitus and 79 patients (138 lesions) without diabetes mellitus were enrolled as subjects. All patients who underwent CBA without restenosis within 3-12 months of the initial CBA based on follow-up angiographic evaluation were included. Quantitative coronary angiograms performed before, immediately after CBA, during the 3-12-month period (mean 4.1 +/- 1.0 months), and at or after 5 years (mean 6.4 +/- 2.0 years) were compared. There was no significant difference in the reference diameter between nondiabetic and diabetic lesions at any of the four time points studied. The minimum lumen diameter before and immediately after the procedure and at the 3-12-month follow-up did not differ significantly between the two groups. At >5-year follow-up. the minimum lumen diameter was significantly (P = 0.005) decreased in diabetic lesions. Total occlusion occurred in 9% (4/45) of the diabetic lesions compared to only 1%, (1/138) in the nondiabetic lesions (P = 0.007). Diabetic lesions showed significant (P = 0.049) narrowing between the 3-12 month period and >5-year follow-up. Fifty-one percent (18/35) of the nondiseased vessels in the diabetic patients at the time of enrollment had new stenosis during the follow-up periods. In conclusion, compared to nondiabetic lesions, patients with diabetic lesions who underwent CBA were more predisposed to have stenotic progression and total occlusion.

We performed electrophysiological study and catheter ablation on a 62-year-old patient with supraventricular tachycardia(SVT). This SVT was reproducibly initiated and terminated by atrial stimulation during the electrophysiological testing. The P-wave morphology and atrial activation sequence of intracardiac electrograms were identical to those in normal sinus rhythm. SVT was terminated with carotid sinus massage that increased vagal tone, and for this reason, the reentry circuit of SVT could be localized in sinus node. On the basis of these findings, the SVT was diagnosed as sinus node re-entrant tachycardia and was successfully eliminated by radiofrequency catheter ablation. Radiofrequency catheter ablation would be effective in patients with sinus node reentrant tachycardia refractory to anti-arrhythmic drugs. It should, however, be performed with careful consideration to the influence of the sinus node.

Object: In hypercholesterolemic patients, acetylcholine- and substance P-mediated endothelium-dependent dilation of the coronary resistance vessels is impaired due to decreased nitric oxide production. However, it is not clear if bradykinin-induced coronary vasodilation is impaired in these patients. We investigated whether the endothelium-dependent dilation of coronary resistance vessels mediated by bradykinin is impaired in patients with hypercholesterolemia and, if so, whether this impairment is caused by a decreased production of nitric oxide., Methods: We examined the coronary vascular responses to acetylcholine and bradykinin. The vascular responses to bradykinin were also assessed after N(G)-monomethyl-L-arginine was infused to inhibit nitric oxide production. Drugs were infused into the left coronary ostium and coronary blood flow (CBF) and coronary vascular resistance were evaluated by quantitative angiography and Doppler flow velocity measurements., Patients: Twelve hypercholesterolemic patients and 11 control patients with angiographically normal coronary arteries were studied., Results: The vasodilator responses to acetylcholine and bradykinin were reduced in hypercholesterolemic patients compared with control patients (p<0.005 and p<0.04, respectively, by two-way analysis of variance (ANOVA)). The CBF responses to acetylcholine and bradykinin were significantly correlated (r=0.56; p<0.01). Bradykinin-induced dilation was similar in hypercholesterolemic patients and control patients after inhibition of nitric oxide., Conclusion: These results suggest that the bradykinin-mediated endothelium-dependent dilation of coronary resistance vessels may be impaired due to depressed nitric oxide production in patients with hypercholesterolemia.

Object: This study was performed to compare the coronary microvascular response to adenosine 5'-triphosphate (ATP) with the response to adenosine in humans., Methods: Coronary blood flow velocity was determined using a Doppler flow wire. After intracoronary nitroglycerin infusion, intracoronary bolus injections of adenosine (20 microg) and ATP (20 microg) were performed to induce reactive hyperemia., Patients: Twenty-nine patients (23 men and 6 women, mean age: 63+/-9 years) with coronary artery disease and risk factors for coronary atherosclerosis were studied., Results: Coronary flow reserve in response to ATP was similar to that for adenosine (2.7+/-0.7 vs. 2.7+/-0.7). However, the duration of ATP-induced vasodilation was longer than that of adenosine-induced dilation (39+/-25 seconds vs. 26+/-12 seconds, p<0.0001). The coronary flow reserve obtained with either ATP or adenosine was significantly reduced in the interventioned arteries compared with non-stenosed arteries. The coronary flow reserve obtained with ATP was similar to that obtained with adenosine in both artery groups. The duration of the vasodilator effect of ATP was significantly greater than that of adenosine in both artery groups., Conclusion: These results suggest that ATP induces maximal dilation of coronary microvessels, most likely through an endothelium-independent mechanism. The degradation of ATP to adenosine 5'-monophosphate (AMP) and adenosine, as well as the direct action of ATP on A2-adenosine receptors may be responsible for the dilation. We conclude that coronary flow reserve can be determined safely with intracoronary ATP administration.

We investigated in humans the effects of adenosine triphosphate (ATP), administered by intracoronary bolus (4-16 microg) or intravenous infusion (25-200 microg/kg/min), on coronary and systemic hemodynamics and electrocardiogram (ECG) variables. All patients had normal epicardial coronary arteries. The maximal coronary blood flow velocity (CBFV) was determined with intracoronary bolus of papaverine. A 12 microg bolus of ATP (n=12) caused maximal coronary hyperemia similar to that caused by papaverine. Intracoronary boluses caused a small brief decrease in arterial pressure but no significant changes in HR or ECG variables. Intravenous infusion of ATP at 150 microg/kg/min (n=15) caused a decrease in the coronary resistance index similar to that caused by papaverine, but the rate of increase in CBFV by ATP was smaller than that caused by papaverine. No patients had a significant change in ECG variables, but some patients (40%) had a serious decrease in arterial pressure. These studies suggest that maximal coronary vasodilation can be achieved safely with intracoronary ATP administration and that intravenous infusions at 150 microg/kg/min cause near-maximal coronary hyperemia in most patients.

This study was designed to test the hypothesis that the cellular metabolism of Ca2+ and Mg2+, which is important in platelet function, is abnormal in the platelets of patients with vasospastic angina. Cytosolic free Mg2+ concentration ([Mg2+]i) and Ca2+ handling were determined in the platelets of 24 patients with vasospastic angina and 24 control subjects by use of mag-fura 2 and fura 2. Platelet aggregation was also examined. Basal [Mg2+]i and cytosolic free Ca2+ concentration ([Ca2+]i) in platelets were significantly higher in patients with vasospastic angina than in control subjects. The amplitude of the [Ca2+]i transient induced by thrombin (0.03-1.0 U/ml) was significantly increased in the presence, but not in the absence, of extracellular Ca2+ in patients with vasospastic angina, as compared with controls. Therefore, the influx of Ca2+ across the plasma membrane may be accelerated in vasospastic angina. Thrombin (0.1-1.0 U/ml)-induced maximum aggregation response was significantly greater in patients with vasospastic angina than in controls. Results suggest that increased [Mg2+]i and altered Ca2+ handling by platelets may be associated with coronary vasospasm.

This study was designed to elucidate the nature of coronary endothelial dysfunction in patients with hypertension and/or hypercholesterolemia and normal smooth coronary arteries by evaluating the coronary vascular responses to acetylcholine and bradykinin. The study included 19 patients (10 men; age [mean +/- SD] 61 +/- 9 years) with angiographically normal smooth coronary arteries and either hypertension (n = 7) and/or hypercholesterolemia (n = 13). Patients received acetylcholine (3 or 30 microg/min) infusions followed by bradykinin (0.5, 1.5, 2.5 microg/min) and nitroglycerin (200 microg/min) infusions into the left coronary ostium. Epicardial coronary artery diameters were measured by quantitative angiography. Angiography detected both vasoconstricted and dilated segments following acetylcholine infusion. Bradykinin significantly dilated both types of segments (p <0.001, respectively). However, bradykinin-induced dilation was significantly greater in segments exhibiting acetylcholine-induced vasodilation than in those exhibiting vasoconstriction (p <0.01 in the proximal portion and p <0.02 in the distal portion). Nitroglycerin-induced dilation was similar in all segments. These results suggest that coronary endothelial dysfunction may be a heterogeneous process in patients with coronary risk factors. Moreover, the mechanism underlying diminished endothelium-dependent dilation involves not only the muscarinic receptor, but also B2-kinin receptor.

NG-monomethyl-L-arginine (L-NMMA), a specific inhibitor of nitric oxide (NO) synthesis, was used to investigate the effects of inhibition of NO synthesis on the coronary conductance and resistance vessels in hypercholesterolemic patients. Acetylcholine (3 and 30 micrograms/min) was administered to 10 hypercholesterolemic and 10 control patients before and after L-NMMA (25 micromol/min) infusion. Epicardial coronary diameter was measured by quantitative angiography, and coronary blood flow (CBF) was derived from Doppler flow-velocity and coronary diameter measurements. In hypercholesterolemic patients, acetylcholine-induced dilation of epicardial arteries was attenuated, and the percentage increase in CBF caused by acetylcholine was smaller than that in control patients. L-NMMA attenuated acetylcholine-induced dilation of epicardial arteries in control patients. L-NMMA had no effect on CBF responses to acetylcholine in both patient groups. L-NMMA significantly decreased the baseline coronary diameter and CBF in both groups. These results indicated that hypercholesterolemia impaired the acetylcholine-induced dilation of the conductance and resistance coronary vessels. This impairment in the conductance vessels was dependent on NO production; that of resistance vessels was not. The basal release of NO in conductance and resistance vessels was preserved in hypercholesterolemic patients.