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Background:  Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome., Methods and Results:  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, P<0.0001), the restenosis rate tended to be lower in women than in men (11.5% vs. 14.8%, P=0.11). Subsequently, the target lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05)., Conclusions:  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year.

Background: Intravascular ultrasound (IVUS) analysis software enables precise planimetry measurement and tissue characterization of coronary plaque. Recently, a new IVUS analysis software compatible with integrated backscatter-IVUS, VISIATLAS(TM), was developed. The validity and reliability of VISIATLAS(TM) were evaluated., Methods and Results: Forty patients who underwent IVUS-guided percutaneous coronary intervention were enrolled, and planimetry measurements were performed by 2 observers using VISIATLAS(TM) and echoPlaque(TM). IVUS analysis was performed in non-stent segments in 10 patients (non-target vessel, n=5; target vessel before stent implantation, n=5) at every 2.5mm for 20 slices in each patient. Stent segments were analyzed in the remaining 30 patients. With VISIATLAS(TM), the intraobserver and interobserver intraclass correlation coefficients (ICC) for the area of external elastic membrane (EEM), lumen, and plaque plus media (P+M) were 0.999 and 0.999, 0.996 and 0.993, and 0.993 and 0.991, respectively. The intersoftware ICC for EEM, lumen, and P+M area were 0.997, 0.993, and 0.985, respectively. The ICC of stent volume for intraobserver, interobserver and intersoftware comparisons were 0.997, 0.993, and 0.998, respectively. Bland-Altman plots showed small differences and narrow limits of agreement for all of the above parameters., Conclusions: VISIATLAS(TM) has high repeatability and reproducibility of measurement. This new IVUS analysis software is suitable for accurate measurement of coronary artery and stent structure in future IVUS studies.

Background: Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization., Methods and Results: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation., Conclusions: One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.

The long-term outcome and compliance of dual-antiplatelet therapy after implantation of drug-eluting stent in the "real world" setting in Japan has not been well investigated. The purpose of this study was to provide information on the introduction and outcomes including status and compliance of dual-antiplatelet therapy of sirolimus-eluting stent (SES). Five-year follow-up was achieved in 1937 of 2050 patients (94.5%). Off-label use was 87.3% in this study. The incidence of MACE was 23.2%, including death (13.4%), MI (3.4%), and target lesion revascularization (TLR, 9.6%). Multivariate analysis for TLR predicted dialysis [hazard ratio (HR) 3.5, 95% confidence interval (CI) 2.13-5.93], lesion length >30 mm (HR 1.89, 95% CI 1.24-2.84), vessel diameter <2.5 mm (HR 1.55, 95% CI 1.10-2.18), ostial lesion (HR 1.59, 95% CI 1.10-2.31), and previous PCI (HR 1.42, 95% CI 1.00-2.00). There were 25 events of definite/probable thrombosis. Very late thrombosis was identified in 17 cases, and the slope of the linear portion of the cumulative incidence curve of stent thrombosis was 0.28% per year. Seven of the 17 events (41.2%) occurred under dual anti-platelet therapy. Five-year outcomes after SES implantation in the "real world" in Japanese showed that dialysis, previous PCI, small vessel <2.5 mm, long lesion >30 mm, and ostial lesions were the predictors of TLR at 5-years. Stent thrombosis rate was lower than previous reports.

Background: Pivotal studies on drug-eluting stents have excluded hemodialysis (HD) patients. No quantitative coronary angiography (QCA) analysis has been reported., Methods and Results: The OUtcome of Cypher stent in Hemodialysis patients (OUCH) Study is a prospective non-randomized single-arm registry designed to assess the results of sirolimus-eluting stents in HD patients, with follow-up QCA in an independent core laboratory. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1 year. A total of 117 patients were enrolled. The TVF rate was 24.9% (2.6% cardiac death, 1.4% MI, 23.9% TVR), and stent thrombosis was documented in 1 patient (0.9%). Coronary calcification was a predictor of TVF. Late lumen loss (LLL) averaged 0.69±0.93mm. The histogram of LLL showed that a total of 76% of lesions were distributed the same normally as that in normal renal function (average LLL 0.20±0.29mm), but 24% of lesions were outliers (average LLL 2.07±0.62mm)., Conclusions: This report describes different clinical and QCA results in HD patients as higher TVF rate, different predictive factors, and different histogram of LLL compared with normal renal function. The different histogram of LLL was the existence of many outliers with the same average and the same deviation, suggesting the loss of sirolimus had an effect on a significant number of HD patients.

Background: We have noted abnormal angiographic findings--at the sites of drug-eluting stent implantation, suggesting contrast staining outside the stent struts--that do not fulfill the classic definition of coronary artery aneurysm. We propose a new term, peri-stent contrast staining (PSS), for these abnormal angiographic findings and assess their incidence, risk factors, and clinical sequelae., Methods and Results: Peri-stent contrast staining was defined as contrast staining outside the stent contour extending to ≥20% of the stent diameter. The study population consisted of 3081 lesions (1998 patients) that were treated exclusively with sirolimus-eluting stents and were evaluated by follow-up angiography within 12 months after sirolimus-eluting stent implantation in a single center. Late acquired PSS was observed in 58 lesions (1.9%) in 49 patients (2.5%). Independent risk factors of PSS included chronic total occlusion, whereas negative risk factors for PSS were left circumflex coronary artery lesion and in-stent restenosis lesion. Stent fracture was more frequently observed in lesions with PSS than in lesions without PSS (43.1% versus 5.4%, P<0.0001). Excluding 269 lesions with target-lesion revascularization within 12 months, the study population for long-term follow-up consisted of 51 lesions (42 patients) with PSS and 2761 lesions (1751 patients) without PSS. Cumulative incidence of target-lesion revascularization and definite very late stent thrombosis at 3 years in the PSS group was higher than that in the non-PSS group (15.0% versus 6.5%, and 8.2% versus 0.2%, respectively)., Conclusions: Peri-stent contrast staining found within 12 months after sirolimus-eluting stent implantation appeared to be associated with subsequent target-lesion revascularization and very late stent thrombosis.

Both severe calcified lesions and hemodialysis (HD) are predictors for high rates of restenosis, even in the drug-eluting stent era. We sought to investigate the angiographic and clinical outcome in a population of HD versus non-hemodialysis (non-HD) patients with severe calcified lesions requiring rotational atherectomy. One hundred consecutive lesions (28 lesions in the HD group, 72 in the non-HD group) from 82 patients (19 patients in the HD group, 63 in the non-HD group) requiring rotational atherectomy prior to sirolimus-eluting stent (SES) implantation were analyzed post-procedure and at 8 months. Clinical outcomes were assessed at 12 months. Inclusion criteria were calcified lesions with >270° of superficial calcification on the intravascular ultrasound (IVUS), lesions that the IVUS could not cross, or undilatable lesions. There were no differences in patient characteristics except for age. Although both baseline and post-procedure angiographic findings were similar between the two groups, late loss in stented segment was significantly greater in the HD group than in the non-HD group (HD vs. non-HD: 0.69 ± 0.74 mm vs. 0.34 ± 0.50; P = 0.030). Also, the HD group revealed significantly worse clinical outcomes. In conclusion, mid-term results of highly complex, severely calcified lesions requiring rotational atherectomy in non-HD patients were permissible as compared to on-label lesions. However, in HD patients, both angiographic and clinical outcomes were still suboptimal in this lesion subset, even using SES.

An 80-year-old woman with a history of rheumatoid arthritis and steroid diabetes had been given a diagnosis of multiple bilateral pulmonary cystic lesions 16 months previously, and these lesions were observed to gradually increase on follow-up. She presented with a fever of 38 degrees C, cough, and sputum for 2 weeks, and the pulmonary cystic lesions had enlarged, and therefore she was admitted. A chest X-ray film revealed multiple cystic lesions 4 cm in greatest dimension in both the left upper and middle lung fields, and chest computed tomography (CT) scans revealed that the lesions of the left S1+2 had niveau formation with a partially thickened wall. However, the lesions in the left S4 and S5 areas and the right S8 area had thin, smooth walls. Transbronchial lung biopsy of the left S4 lesion yielded granuloma formation and yeast-like fungus bodies within multinucleated giant cells, while bronchial lavage fluid culture showed cryptococcus neoformans. It is known that pulmonary cryptococcosis presents various images and histopathologic findings, according to the immune interactions between the fungus body and the host. We report a rare case that presented with multiple cryptococcal cystic lesions.

Enormous advance was obtained in the field of percutaneous coronary intervention, treatment for coronary artery disease. Drug eluting stent (DES) offers advantages over bare metal stent (BMS) such as reduction in restenosis rates. However, several concerns were proposed when compared with BMS. Currently, numerous technologies are under development to avert the complications of DES, such as stent thrombosis, or to challenge complex lesion, such as left main trunk/bifurcation. We summarized some of the development that is emerging on current management of coronary intervention.

Background: Long-term outcomes of patients with bifurcated lesions and the restenotic response of the side branches after sirolimus-eluting stent (SES) implantation, comparing 1-stent with 2-stent treatment, are still under discussion., Methods and Results: Japan Post-Marketing Surveillance Registry (J-PMS) is a prospective registry designed to evaluate the safety and efficacy of the SES in routine clinical practice. Angiograms of 1,063 patients with 1,250 lesions were analyzed at the independent core lab. Of these, 324 patients with bifurcation lesions were enrolled. Clinical endpoints were assessed at 3 years. Both main and side branches were evaluated by quantitative coronary angiography at post-procedure (n=349) and 8-month follow up (n=293). Two-stent treatment was performed in 12% of the cases. In-segment restenosis rates at 8 months were 25.6% in the side branch, but newly developed restenosis was seen in only 6.8%. Late loss at the carina of the side branch was -0.11mm in the 1-stent group. Major adverse cardiovascular events rate was 18.3% at 3 years. Target-lesion revascularization rate up to 3 years was 21.6% in the 2-stent group and 8.7% in the 1-stent group (P=0.037). Stent thrombosis occurred in 6 cases (2.0%) until 3 years. Of these, 4 cases were treated with 2-stent (10.81% vs. 0.76% in 1-stent, P=0.003, respectively)., Conclusions: In a real-world setting, treatment of coronary bifurcation lesions using SES demonstrated favorable long-term outcomes as long as the side branch was not stented.

A 54-year-old man with acute coronary syndrome underwent primary percutaneous coronary intervention (PCI) to implant a bare metal stent. Three weeks later, a subclinical in-stent thrombus was found at staged PCI despite dual antiplatelet therapy with aspirin and clopidogrel. Platelet function tests revealed high post-treatment platelet reactivity, indicating an inadequate response to clopidogrel. The patient's cytochrome P450 2C19 genotype was *2/*2. Cilostazol at 200 mg/day was initiated in addition. Three months later, platelet inhibition was enhanced, and no thrombus was detectable by coronary angiography. Our experience suggests that triple antiplatelet therapy with cilostazol as well as aspirin and clopidogrel could prevent stent thrombosis with improved clopidogrel responsiveness.

Background: The TAXUS Japan Postmarket Surveillance Study (TAXUS-PMS) enrolled patients receiving percutaneous coronary intervention in real-world clinical practice. This analysis focuses on outcomes in the overall patient population and in a subgroup of diabetic patients., Methods and Results: Between July 2007 and December 2008, 2,132 patients (with 2,504 lesions) were consecutively enrolled at 56 sites in Japan. One-year outcomes were analyzed. The prevalence of patients with diabetes was 44% (21% of diabetics were insulin-treated) and 5.5% of patients were receiving ongoing hemodialysis. The majority of patients received paclitaxel-eluting stents (PES) for `off-label' indications (68.2%). The rate of major adverse cardiovascular events (cardiac death, myocardial infarction, and target vessel revascularization (TVR)) at 1 year was 8.2%, driven mainly by TVR (6.9%). No differences in TVR, late loss or restenosis rates were found between diabetic and non-diabetic patients; outcomes in insulin- compared with oral hypoglycemic-treated diabetic patients, were similar. Multiple stent implantation and ostial lesion location were independent predictors for both major adverse cardiac events (MACE) and target lesion revascularization (TLR). Hemodialysis was an independent predictor for MACE but not TLR whereas in-stent restenosis was an independent predictor for TLR., Conclusions: TAXUS-PMS demonstrated a consistent, positive effect of PES in complex clinical cases. PES diminished the increased risk of clinical restenosis in diabetic patients, leading to a similar low risk of cardiac events in diabetic and non-diabetic patients.

We developed a new filter-type distal protection guide wire, Filtrap, that uses a polyurethane filter with 1834 100-μm micropores covering the distal half of a spindle-shaped spiral Ni-Ti basket. The basket is 5 mm in diameter, self-expandable, and is mounted at the distal end of the system. This study aimed to assess the usefulness and safety of Filtrap during percutaneous coronary intervention (PCI). Early angiographic and in-hospital outcomes were reviewed in 14 patients, including 9 acute coronary syndrome patients, treated with Filtrap during PCI. All lesions were located in native coronary arteries but one was located in a saphenous vein graft. The Filtrap was successfully delivered and deployed distal to the lesion in 13 of 14 patients (93%). All PCI procedures including stent implantation were successfully completed except for 2 AMI patients, who ended up with Thrombolysis in Myocardial Infarction (TIMI) 2 coronary flow. One of these 2 patients had a distal embolization which occurred after thrombectomy before Filtrap insertion. The mean time of device insertion was 9.4 ± 3.2 min. Five patients showed transient no-reflow that was completely restored immediately with removal of the device. Embolic debris was entrapped in 8 (62%) of these cases. All patients were free from in-hospital events except for one patient with a large anterior acute myocardial infarction who received an emergency surgery due to a free wall cardiac rupture. These results suggest that the Filtrap is a practical and safe device for embolic protection during PCI.

Background: Stent thrombosis (ST) after sirolimus-eluting stent implantation has not yet been adequately characterized, mainly because of its low incidence., Methods and Results: The Registry of Stent Thrombosis for Review and Reevaluation (RESTART) is a Japanese nationwide registry of sirolimus-eluting stent-associated ST comprising 611 patients with definite ST (early [within 30 days; EST], 322 patients; late [between 31 and 365 days; LST], 105 patients; and very late [>1 year; VLST], 184 patients). Baseline demographics, clinical presentation, and long-term outcome of sirolimus-eluting stent-associated ST were compared among patients with EST, LST, and VLST. Baseline demographics were significantly different according to the timing of ST. Characteristic demographic factors for LST/VLST versus EST identified by multivariable model were hemodialysis, end-stage renal disease not on hemodialysis, absence of circumflex target, target of chronic total occlusion, prior percutaneous coronary intervention, and age <65 years. For LST versus VLST, they were hemodialysis, heart failure, insulin-dependent diabetes mellitus, and low body mass index. Patients with LST had a significantly higher rate of Thrombolysis in Myocardial Infarction grade 2/3 flow (36%) at the time of ST than those with EST (13%) (P<0.0001) and VLST (17%; P<0.0001). Mortality rate at 1 year after ST was significantly lower in patients with VLST (10.5%) compared with those with EST (22.4%; P=0.003) or LST (23.5%; P=0.009)., Conclusions: ST timing-dependent differences in baseline demographic features, Thrombolysis in Myocardial Infarction flow grade, and mortality rate suggest possible differences in the predominant pathophysiological mechanisms of ST according to timing after sirolimus-eluting stent implantation.

The general restenosis rate after emergent coronary stent implantation for ST-elevation myocardial infarction (STEMI) patients in Japan has yet to be fully established. Totally 696 STEMI patients without left main disease were enrolled for either ASPARAGUS (22 centers) or VAMPIRE (23 centers) trial. Out of these, 202 lesions in 202 patients with baseline and 6-month follow-up quantitative coronary angiography (QCA) data after emergent bare metal stent (BMS) implantation without either aspiration or distal protection devices were enrolled for this study. QCA was performed at an independent core laboratory. Minimal lumen diameter (MLD), reference diameter (RD) and diameter stenosis (DS) were estimated at pre, post and follow-up phase. Left ventricular ejection fraction was evaluated by quantitative left ventriculography. Six-month binary restenosis (DS >50%) rate and target lesion revascularization (TLR) were investigated. Six-month binary restenosis and TLR was found in 39 (19.3%) and 32 (18.6%), respectively. In the patients with binary restenosis, smaller pre-RD (2.46 ± 0.54 vs. 2.68 ± 0.73 mm, p = 0.03), post-MLD (2.08 ± 0.54 vs. 2.34 ± 0.52 mm, p = 0.009), acute gain (1.90 ± 0.49 vs. 2.13 ± 0.61 mm, p = 0.001) and follow-up RD (2.44 ± 0.67 vs. 2.71 ± 0.63 mm, p = 0.03) were observed. When the lesions are divided into quartiles of pre-RD (≤2.16, 2.18-2.61, 2.62-3.11, ≥3.12 mm), the binary restenosis rates were 26, 25.5, 16 and 10%, and TLR rate were 19.5, 29.6, 13.6 and 12%, respectively. RD was smaller at pre and follow-up than post phase (pre: 2.64 ± 0.71 mm; post: 2.89 ± 0.57 mm; follow-up: 2.66 ± 0.64 mm; pre vs. post: p < 0.001; post vs. follow-up: p = 0.001; pre vs. follow-up: p = 1.00). In this study cohort, the binary restenosis and TLR rate were considerable in patients with BMS for STEMI. The decrement of RD at follow-up period was common and it indicates that vessel shrinkage post PCI for acute myocardial infarction may be a myth. TLR rate was more than the binary restenosis rate in two quartiles of pre-RD. Robust guideline regarding stent type and revascularization for STEMI patients should be established.

Hemodialysis ("HD") has been suggested as a risk factor for stent thrombosis. However, platelet function in HD patients after coronary stent implantation remains unclear. The aim of this study was to evaluate platelet function following coronary stent implantation in HD patients. A total of 10 HD and 31 non-HD patients who underwent a first coronary stent implantation were studied. All patients received 100 or 200 mg of asprin and thienopiridine (either ticlopidine 200 mg or clopidogel 75 mg) daily. Platelet function was assessed 2-6 weeks (21 ± 8 days) after stent implantation by: (1) platelet maximal aggregation, using light transmittance aggregometry; (2) platelet aggregation threshold index, which was defined as putative concentration of agonist giving 50% maximum aggregation using whole-blood aggregometry; and (3) platelet activation markers (PAC-1 and CD62p), using whole blood flow cytometry. There were no differences between the two groups in baseline and procedure characteristics, except for a greater prevalence of hypertension and calcification in the HD group. Early stent thrombosis and bleeding did not occur in either group. Although no differences in platelet maximal aggregation or whole-blood aggregation were observed, expression of PAC-1 (39.6 ± 9.1 vs 24.2 ± 13.2%) and CD62p (10.4 ± 5.5 vs 5.4 ± 2.3%) were significantly increased in the HD group compared with the non-HD group. HD patients exhibited enhanced platelet activation after coronary stent implantation, but suppression of platelet aggregation was achieved by the current dual antiplatelet therapy.

Aims: To investigate the consequences of inflating low-pressure balloon occlusion devices in native coronary arteries., Methods and Results: One hundred eighteen segments of 118 patients who were enrolled in the ASPARAGUS study were analysed post-procedure and at six months by means of quantitative coronary angiography. ASPARAGUS was a randomised study to assess the efficacy of the PercuSurge GuardWire system in acute myocardial infarction. Patients were divided into two groups; protection group (group P, n=53) and control group (group C, n=65). Matched 15 mm segments were selected for quantitative coronary angiographies using anatomical landmarks post-procedure and at six months. There were 118 matched QCA analysis (Group P 53, Group C 65). Baseline characteristics were similar between groups. The mean minimal lumen diameter (MLD) post procedure was 1.94+/-0.57 mm in group P and 1.92+/-0.57 mm in group C. The MLD at six months was 1.98+/-0.54 mm in group P and 1.92+/-0.54 mm in group C. There was virtually no late loss in both group (P: -0.04+/-0.38 mm, C: 0.00+/-0.38 mm, p=0.561)., Conclusions: The inflation of the low-pressure PercuSurge balloon in native coronary arteries was not associated with angiographic vascular response during the 6-month follow-up. This finding may suggest the safety of using similar technology such as the low-pressure balloon system in human native coronary arteries.

Objective: Several epidemiological investigations have reported that green tea reduces cardiovascular and cerebral vascular risks. Green tea catechins may improve peripheral endothelial dysfunction in smokers. The purpose of this study was to elucidate the beneficial effect of green tea catechins on the repair of endothelial dysfunction in smokers., Methods: Thirty healthy male smokers divided into three groups ingested a green tea beverage containing 0 mg (control group), 80 mg (middle dose group) or 580 mg (high dose group) of green tea catechins (GTC) daily for two weeks, and endothelial-dependent vasodilatation was investigated by measuring forearm blood flow (FBF) response to reactive hyperemia (RH) by venous occlusion strain-gauge plethysmography., Results: An acute effect was that the FBF response to RH significantly increased 2 hr after GTC intake in the high dose group. However, no increase was observed in the other groups. The chronic administration of GTC for one or two weeks ameliorated the FBF responses to RH in the high dose group. On the other hand, no significant increase was observed in the FBF responses to RH in the other groups. Moreover, the plasma concentration of 8-OHdG, IL-6, TNF-alpha, and soluble Fas decreased significantly for two weeks in the high dose group, however, the level of IL-1 beta remained unchanged over this period., Conclusion: Green tea consumption over short and long periods appears to ameliorate endothelial dysfunction by scavenging free radicals with anti-inflammatory and anti-apoptotic properties in healthy male smokers.

Background: Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan., Methods and Results: The CYPHER stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR., Conclusions: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.

Objectives: This study evaluated safety and efficacy of upfront thrombus aspiration during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI)., Background: Distal embolization during primary PCI results in reduced myocardial perfusion and poor clinical outcomes., Methods: The VAMPIRE (VAcuuM asPIration thrombus REmoval) study was a prospective, randomized, controlled multicenter trial conducted in 23 institutions. Patients (N = 355) presenting within 24 h of STEMI symptoms onset were randomized to primary PCI with (n = 180) or without (n = 175) upfront thrombus aspiration using Nipro's TransVascular Aspiration Catheter (Osaka, Japan)., Results: The TransVascular Aspiration Catheter reached the lesion in 100% of cases. It successfully crossed the target obstruction in 86% without any delay in procedure time or time to reperfusion; whereas macroscopic thrombi were removed in 75% of the cases. Procedure success was similar between groups (98.9% vs. 98.3%). There was a trend toward lower incidence of slow or no reflow (primary end point-defined as a Thrombolysis In Myocardial Infarction flow grade <3) in patients treated with aspiration versus conventional primary PCI (12.4% vs. 19.4%, p = 0.07). Rate of myocardial blush grade 3 was higher in the aspiration group (46.0% vs. 20.5%, p < 0.001). Aspiration was most effective in patients presenting after 6 h of symptoms onset (slow flow rate: 8.1% vs. 37.6%, p = 0.01)., Conclusions: This study suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI. The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.

Background: Final kissing balloon technique (KBT) is known to alter long-term clinical outcomes for treatment of bifurcated coronary lesions. However, determination of adequate diameters of the 2 balloons remains difficult because of lack of a working index., Methods and Results: Twenty-one cases of left main (LM)-related bifurcated lesions, treated with Cypher(TM) stents (single/crush stenting) and final KBT, were enrolled. The formula "R(2) = D(1)(2) + D(2)(2)" was used, adjusting balloon diameter (D(1), D(2)) to the downstream branches, to predict the theoretical mean hugging balloon diameter (R) within the main portion. The degree and pattern of stent expansion in the LM and main branch (MB) segments was compared by volumetric intravascular ultrasound assessment. Stents in the LM segments expanded to a greater extent and more asymmetrically than in MB segments (average stent area: 13.2+/-3.1 mm(2) vs 7.6+/-2.1 mm(2), p<0.0001, stent symmetry index: 0.77+/-0.08 vs 0.88+/-0.03, p<0.0001). The actual mean stent diameter significantly correlated with R (p=0.0003, r=0.76). The ratio of actual to theoretical stent expansion was highly consistent between the LM and MB (93.1% vs 93.4%, p=NS)., Conclusion: The proposed formula may be useful for predicting resultant stent expansion following KBT, despite a more elliptical dilation.

Objectives: The purpose of this research is to assess the patient's entrance skin dose (ESD) during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO), and discuss methods to reduce the maximum ESDs., Background: Only a few reports are available on the methods to reduce patients' maximum ESD during the procedures., Methods: This study included consecutive 30 patients who underwent PCI procedures for CTO in the three institutions. Pearson correlation test was employed to determine the relationship between total fluoroscopic time (TFT) and the maximum ESD, dose area product (DAP) value, and the maximum ESD in each institution., Results: There were significant correlations between the TFT and maximum ESD (Institution 1: P = 0.000410, Institution 2: P = 0.000525), and between the DAP and the maximum ESD (Institution 2: P < 0.0001). In Institution 1, TFT of 60 min was set as the upper limit, and the maximum ESDs were controlled within 7 Gy. In Institution 2, the angiographic unit was a biplane system, and two skin sites were exposed, corresponding to the angulation of each X-ray tube. In Institution 3, the interventionalist changed the beam angulations frequently by several degrees during the procedures, and the maximum ESD was controlled within 3 Gy even during procedures with a TFT of more than 1 hr., Conclusions: The TFT and DAP, the latter of which is preferable, are useful to estimate the maximum ESD. Limiting the TFT or DAP, or changing the beam angulations is important to control ESD during prolonged procedures., (2008 Wiley-Liss, Inc.)

Objective: To evaluate the performance of 40-detector row computed tomography (CT) in the detection of in-stent stenosis of coronary stents., Methods: Seven patent vascular models, 7 stenotic models, and 7 obstructed models were scanned with a 40-detector CT. We made the vascular models using 3 types of stent (Bx-Velocity, Express2, Driver) with an inner diameter of about 2.5, 3.0, or 3.5 mm. We measured the stent lumen diameter and evaluated the in-stent stenosis visually for the 21 vascular models. We evaluated attenuation values of the stent lumen of the 9 patent models of 2.5-mm diameter., Results: The inner diameters of the vascular models were underestimated by CT with mean measurement errors of -1.19 to -1.49 mm. The absolute mean overall measurement error decreased as the inner diameter increased. The direct visualization of in-stent stenosis was possible for the 3.0- and 3.5-mm diameter models, but impossible for the 2.5-mm diameter models. For patent vascular models of 2.5-mm diameter, the CT attenuation inside the stent was significantly higher than that of the unstented portion (P < 0.0001). For obstructed vascular models of 2.5-mm diameter, the CT attenuation inside the stent was significantly lower than that of the unstented portion (P < 0.0001). Also for stenotic vascular models of 2.5-mm diameter, the CT attenuation inside the stent was lower than that of the unstented portion., Conclusions: Visualization of stent lumen on CT is affected by the stent diameter. Measurement of stent lumen is useful for detection of in-stent stenosis, when the direct visualization of in-stent stenosis is impossible.

Background: A paucity of data exists with respect to changes in whole saphenous vein grafts (SVGs) despite accelerated atherosclerosis within grafted saphenous vein conduits. In the present study, we evaluated the one-year change in SVGs by means of quantitative coronary analysis., Methods: This study enrolled consecutive 52 patients with 109 SVGs, who underwent coronary artery bypass graft surgery successfully. A follow-up study was performed in 33 patients with 65 SVGs after one year because 16 SVGs were obstructed (baseline, 8; follow-up period, 8), and 15 patients with 28 SVGs dropped out within one year., Results: Both minimal and mean lumen diameters decreased significantly (3.17 +/- 0.64 mm vs 2.41 +/- 0.57 mm, p < 0.001; 3.70 +/- 0.69 mm vs 2.92 +/- 0.70 mm, p < 0.001; respectively). Graft length also decreased significantly (107.1 +/- 25.8 vs 100.6 +/- 25.2 mm, p < 0.001). The graft shortening rate (graft shortening length/baseline graft length x 100) was greater than 5% in 33 vessels (51%) and greater than 10% in 23 vessels (35%). Coronary risk factors (smoking, diabetes mellitus, hypertension, dyslipidemia) did not reveal significant relationship with late loss of minimal and mean lumen diameters., Conclusions: The present study showed a considerable and uniform lumen loss of SVGs after one year, irrespective of coronary risk factors. Graft length shortening was seen more than elongation.

Objectives: The purpose of this research is to assess the patient's entrance skin dose (ESD) during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in six institutions., Background: Only a few reports are available on the patients' exposure during the procedures., Methods: This study was approved by all of the six institutional review boards, and all patients gave informed consent. This study included consecutive 72 patients who underwent PCI procedures for CTO in the six institutions. They wore jackets that had 100 radiosensitive indicators adhered to the back during the PCI procedures. The patients' ESDs were calculated from the color difference of the indicators. The total fluoroscopic time, total number of cine frames, and maximal ESD were compared among institutions. To check for effects on the skin, clinical follow-up was performed at 1-2 days, 2 weeks, and 3 months after the PCI procedure., Results: The total fluoroscopic time was 45.0 +/- 24.5 min (range: 10.3-113.0 min) and the total number of cine frames was 4,558 +/- 3,440 (range: 855-22,950). The maximum ESD for each patient was 3.2 +/- 2.1 Gy (range: 0.5-10.2 Gy, median: 2.7 Gy). The average maximum ESDs were significantly different among institutions (P = 0.0006), and they were 1.6-5.3 Gy. Radiation skin injuries were observed in 2 patients., Conclusions: The maximum ESDs during PCI for CTO exceed the thresholds for radiation skin injuries in many cases, although there are differences in the average maximum ESDs among institutions., (Copyright 2008 Wiley-Liss, Inc.)

Objectives: To assess the myocardium-reperfusing effect of a distal protection device, GuardWire Plus (GuardWire Plus), in patients with acute myocardial infarction (AMI)., Background: Distal embolization may result in reduced myocardial perfusion, increasing the risk of non-Q-wave myocardial infarction and death. Distal protection devices may protect the microcirculation from embolic debris, improving short- and long-term clinical outcomes., Methods: From February 2002 to July 2003, a total of 341 AMI patients at 22 institutions in Japan were enrolled in the present, multicenter, prospective, randomized trial. Patients experiencing AMI within 12 hr of symptom onset, who were considered treatable by stenting and who met the inclusion criteria, were eligible for randomization. Stenting with and without GuardWire Plus was conducted to examine whether the device provides faster and more complete ST-segment resolution, smaller infarct size, and improved myocardial blush score., Results: The rates of slow flow and no-reflow immediately after PCI were 5.3 and 11.4% in the GuardWire Plus and control groups, respectively (P = 0.05). Blush score 3 acquisition rates immediately after PCI were 25.2 and 20.3% in the GuardWire Plus and control groups, respectively (P = 0.26), and the rates at 30 days after PCI were 42.9 and 30.4%, respectively (P = 0.035)., Conclusions: A significant difference was found between the GuardWire Plus and control groups with respect to the total incidence of distal embolization, indicating that GuardWire Plus angiographically improved myocardial perfusion without demonstrating the preventive effect of myocardial damage., ((c) 2007 Wiley-Liss, Inc.)

Objective: To evaluate the performance of 40-detector row computed tomography (CT) in the assessment of coronary stents in comparison with 16-detector row CT., Methods: A total of 6 vascular models (3 models without stenosis and 3 with stenosis) using 3 types of stent (Bx-Velocity, Express2, and Driver) with an approximately 3.5-mm inner diameter filled with contrast material (450 Hounsfield units) were scanned with 2 computed tomographic scanners (collimation, 16 x 0.75 and 40 x 0.625 mm). We evaluated the in-stent stenosis visually for the 6 vascular models in 4 orientations (0, 30, 60, and 90 degrees) to the z-axis of the scanner. We evaluated attenuation values of the stent lumen of the 3 patent models in the 4 orientations. The average and standard deviation of the luminal attenuation values were assessed to evaluate the degree of blooming and streak artifacts., Results: The visualization of the stent lumen of the vascular models at 90 degrees was improved using 40-detector row CT. For all the 3 stents, the average luminal attenuations values using 40-detector row CT were significantly lower than those using 16-detector row CT in all orientations. For all the 3 stents, the standard deviations of the luminal computed tomographic attenuation using 40-detector row CT were significantly smaller than those using 16-detector row CT in the 4 orientations to the z-axis except for Express 2 at 0 degrees., Conclusions: The visualization of coronary stents is improved by the use of 40-detector row CT with reduced blooming and streak artifacts.

Background: Previous studies have demonstrated that atheroembolism during percutaneous coronary intervention is associated with myocardial damage. The purpose of this study is to investigate the clinical and angiographic characteristics related to removable plaque elements in patients undergoing thrombectomy for myocardial infarction., Methods: Eighty consecutive lesions in 80 patients (M/F=58/22, age 65.5+/-11.6 years) with myocardial infarction who underwent thrombectomy (TVAC system, Nipro, Osaka, Japan) prior to mechanical dilatation (balloon angioplasty and/or stent implantation) were investigated. Visible debris was collected and plaque elements (cholesterol clefts and/or foamy cells) were investigated pathologically. Baseline angiographic characteristics [baseline thrombolysis in myocardial infarction (TIMI) grade, culprit lesion, haziness, lesion length, ostium, bifurcation, calcification, eccentricity, thrombus, and multivessel] were analyzed, and predictive angiographic and clinical factors for plaque elements were investigated., Results: There were no complications related to thrombectomy. Final TIMI grade 3 and blush grade 2 or 3 were achieved in 75 (94%) and 66 (83%) patients, respectively. Visible debris specimens were obtained in 49 (61%) patients. Histological plaque elements (cholesterol clefts and/or foamy cells) were observed in 27 out of 49 patients with debris specimens. There was no significant difference in the clinical characteristics between the groups of patients with (group P) and without (group NP) plaque elements. Aspirated plaque elements were more frequently observed in discrete and eccentric lesions (group P vs. group NP: discreteness, 52% vs. 28%, P<.05; eccentricity, 67% vs. 36%, P<.05)., Conclusions: This study demonstrated the clinical characteristics associated with removable plaque components in patients with myocardial infarction undergoing thrombectomy by means of the TVAC system. Discreteness and eccentricity were more frequently observed in lesions with removable plaque elements.

Objective: To assess the effect of tube voltage on the in-stent visibility of coronary stents in vitro on computed tomography (CT) angiography., Methods: A total of 6 vascular models (3 models without stenosis and 3 with stenosis) using 3 kinds of stent (Bx Velocity, Express2, and Driver) with an inner diameter of approximately 3.5 mm and filled with contrast material (CT attenuation, 450 Hounsfield units) were scanned by means of a 16-detector row CT. We assessed the visual stenosis evaluation and inhomogeneity of stent lumen in 4 orientations (0-, 30-, 60-, and 90-degree angles) relative to the z-axis of the scanner using 3 imaging techniques (120-kV tube voltage using a medium convolution kernel, 120-kV tube voltage using a convolution kernel for bone, and 140-kV tube voltage using a convolution kernel for bone). Statistical analysis involved F test with a statistical significance of P < 0.05., Results: The convolution kernel for bone made it easier to evaluate the stenosis inside the stents, although it increased the luminal inhomogeneity significantly (Bx Velocity and Express2, P < 0.005; Driver, P < 0.05). The luminal inhomogeneity tended to increase as the strut diameter and the weight per unit length increased. Using 120-kV tube voltage, the luminal inhomogeneity inside the stents was at the minimum in the angle of 0 degree relative to the z-axis, and at the maximum in the angle of 90 degrees, except for Driver. The 140-kV tube voltage was effective for the improvement of luminal inhomogeneity and visibility of in-stent stenosis compared with the 120-kV tube voltage., Conclusions: The in-stent visibility of coronary stents on CT angiography can be improved by the use of 140-kV tube voltage with the convolution kernel for bone.

Background: The aim of this study was to measure the patient entrance skin dose (ESD) during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO), and assess the factors that affect it., Methods and Results: Radiosensitive indicators were used to measure ESDs during 23 procedures. Multiple regression analysis identified the strength of the linear relationship of the dependent variable (the natural logarithm of the maximum ESD) with the set of multiple independent variables (the natural logarithm of both the patient and angiographic data). The methods for estimating the maximum ESD and the estimated ESDs were compared with the actual ESDs. The average maximum ESD for all the patients was 2.7+/-1.5 Gy (median: 2.6 Gy). The natural logarithm of the maximum ESD correlated well with the natural logarithm of body mass index (BMI; p=0.0112), total fluoroscopic time (TFT; p=0.0002), and Frame Fixation Rate (p=0.0014). For the higher Frame Fixation Rate group, there were significant correlations between the BMI2 x TFT value and maximum ESD (r=0.972, p<0.0001), and the TFT and maximum ESD (r=0.968, p<0.0001). There were no significant correlations for the lower Frame Fixation Rate group., Conclusions: In PCI for CTO, the BMI2 x TFT value or TFT is a good predictor of radiation skin injury risk, when the beam angulation is not changed frequently. It is important to change the beam angulation to control ESD during a prolonged procedure.

The main reason for failure of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) is because the calcified plaque prevents the guide wire crossing the occlusion. We aimed to identify the route, and characterize plaque components within CTO, using 16-slice computed tomography (MSCT). Twenty three angiographic CTO in 22 patients (mean age 69 +/- 5 years, 17 males) were included. All patients had undergone MSCT prior to PCI. Images were analyzed for lesion visibility and plaque characteristics of CTO. The presence and location of calcified plaque within the CTO were systematically assessed. Each lesion was classified as a noncalcified, moderately calcified, or exclusively calcified plaque. Procedural failure was defined as the inability to cross a guide wire through the occlusion. All coronary routes of CTO segment were visualized. MSCT revealed three markedly bent CTO segments (13.0%), which could not be identified by coronary angiography only. Calcified plaques were detected in 30 lesions of 19 CTO segments (82.6%), but were not detected in the other four. The majority of calcified plaque was located in the proximal lesion, or both proximal and distal lesions. Fifteen out of 30 calcified lesions (50.0%) were exclusively calcified plaques. Overall procedural success was obtained in 21 CTOs (91.3%). MSCT can accurately identify the route of the CTO segment and evaluate both distribution and amount of the calcified plaque within it. Even with the complicated and/or calcified lesions, PCI success rate was excellent under MSCT guidance. MSCT should become a useful tool in PCI of CTO., (Copyright 2006 Wiley-Liss, Inc.)

Institutional review board approval and informed patient consent were obtained. The purpose of the study was to prospectively evaluate the use of radiosensitive indicators to estimate patient entrance skin dose (ESD). Forty-six patients wore a jacket with 48 or 52 indicators adhered to the back during percutaneous coronary interventions; they had eight additional indicators on their upper arms. The patients' ESDs were calculated according to the change in color of the indicators. There were good correlations between the ESDs estimated by using color measurements performed with an optical instrument and those estimated at visual observation (P < .001) and between the ESDs estimated by using a thermoluminescent dosimeter and those estimated by using color measurements (P < .001). The radiosensitive indicator method seems to be useful for estimating ESDs and their distribution during percutaneous coronary intervention; however, visual observation is reliable for estimating doses of up to 5 Gy only. (c) RSNA, 2006., ((c) RSNA, 2006.)

Background: Radiation skin injuries have been reported as a result of various procedures, so in the present study the patients' entrance skin dose (ESD) during percutaneous coronary intervention (PCI) was evaluated., Methods and Results: ESDs were assessed during 97 procedures (13 for chronic total occlusion (CTO), 14 for multivessel stenoses, 22 for single-vessel multiple stenoses, and 48 for single stenosis). The patients wore jackets that had 48 or 52 radiosensitive indicators placed on the back during the PCI procedures, with 8 other indicators placed on both upper arms. After the procedure, the color of the indicators was analyzed with a color measuring instrument, and the patients' ESDs were calculated from the color difference of the indicators. The average maximum ESDs of the patients were 4.5 +/- 2.8 Gy (median: 4.6 Gy) for CTO, 2.3 +/- 0.7 Gy (median: 2.4 Gy) for multivessel stenoses, 1.8 +/- 1.0 Gy (median: 1.5 Gy) for single-vessel multiple stenoses, and 1.4 +/- 0.9 Gy (median: 1.2 Gy) for single stenosis., Conclusions: Skin injury can occur during PCI, especially for CTO, so it is important to estimate each patient's ESD and attempt to reduce it.

Background: A pharmacokinetic (PK) study was conducted to evaluate sirolimus-eluting stents (SES) in Japanese people, representing the first clinical trial of the use of drug-eluting stents in Japan., Methods and Results: The PK study was conducted in 20 patients with 30 lesions treated with sirolimus-coated BX Velocity stents. All lesions were treated with a single SES (3 x 18 mm). Angiographic follow-up was performed at 8 months after SES implantation, and the clinical outcomes were evaluated at 1 year in all cases. All procedures were successful, and all patients were discharged without any adverse cardiac events. The total restenosis rate was 10% (3 lesions) and target vessel revascularization was performed in those 3 cases (15%). Restenoses occurred at the proximal and distal stent margins. Intravascular ultrasound examination of restenosis cases revealed abundant plaque burden at the stent edges even though the luminal area was preserved., Conclusions: The sirolimus-eluting BX Velocity stent is safe and useful for Japanese patients with coronary artery disease. However, restenosis at proximal stent edge seems to be a problem.

The aim of this study was to evaluate the pharmacokinetics of the sirolimus-eluting stent (SES) implanted in 20 Japanese patients with angina pectoris and compare it with that in US study. Bx VELOCITY stent loaded with a total sirolimus dose of 150 mug was used in this study. Ten patients were treated by single-SES (group 1) and 10 patients were treated by double-SES (group 2). Sirolimus levels in whole blood were serially measured in the 2 groups after the SES implantation and compared with the pharmacokinetics in US study. We also evaluated the side effect of sirolimus, major adverse clinical events, and binary angiographic restenosis at 8 months after the SES implantation. Peak concentrations were observed approximately 4 hours after the SES implantation, and sirolimus half-lives were approximately 120 hours in each group. Mean peak sirolimus levels were 0.86 and 2.00 ng/mL for the group 1 and group 2, respectively. The peak concentrations of sirolimus in this study were twice higher in Japanese than in Americans, but they were much lower than effective concentration of sirolimus when orally administrated as an immunosuppressive agent. There were no side effects of sirolimus and no binary angiographic restenosis in any patients. One patient had target vessel revascularization at 8 months after the SES implantation. Although blood concentrations of sirolimus in Japanese patients after SES implantation are somewhat higher than those in American patients, its level is extremely low compared with the systemic administration, indicating the same clinical benefits by the SES could be safely expected in Japanese patients.

A water-soluble green coffee bean extract (GCE) has been shown to be effective against hypertension in both spontaneously hypertensive rats and humans. This multicenter, randomized, double-blind, placebo-controlled, parallel group study evaluated the dose-response relationship of GCE in 117 male volunteers with mild hypertension. Subjects were randomized into four groups: a placebo and three drug groups that received 46 mg, 93 mg, or 185 mg of GCE once a day. After 28 days, systolic blood pressure (SBP) in the placebo, 46 mg, 93 mg, and 185 mg groups was reduced by -1.3+/-3.0 mmHg, -3.2+/-4.6 mmHg, -4.7+/-4.5 mmHg, and -5.6+/-4.2 mmHg from the baseline, respectively. The decreases in SBP in the 93 mg group (p<0.05) and the 185 mg group (p<0.01) were statistically significant compared with the placebo group. Diastolic blood pressure (DBP) in the placebo, 46 mg, 93 mg, and 185 mg groups was reduced by -0.8+/-3.1 mmHg, -2.9+/-2.9 mmHg, -3.2+/-3.2 mmHg, and -3.9+/-2.8 mmHg from the baseline, respectively, and significant effects were observed in the 93 mg group (p<0.05) and the 185 mg group (p<0.01) compared with the placebo group. Both blood pressures were significantly reduced in a dose-related manner by GCE (p<0.001). Adverse effects caused by GCE were not observed. The results suggested that daily use of GCE has a blood pressure-lowering effect in patients with mild hypertension.

A 75-year-old woman was admitted to the emergency room because of hypotension and loss of consciousness induced by cardiac tamponade. Electrocardiography revealed ST elevation and laboratory data showed elevation of serum creatine kinase and troponin I. The patient was referred to the cardiology department 5 days later. Cardiac catheterization revealed ventricular aneurysm in the anterior wall, significant stenosis (75%) in the left anterior descending coronary artery and subtotal stenosis (99%) in the diagonal branch. Cardiac multislice computed tomography suggested that the ventricular pseudoaneurysm was probably due to cardiac rupture caused by myocardial infarction in the diagonal area. Subsequently, aneurysmectomy and coronary artery bypass graft surgery were performed. Cardiac multislice computed tomography is useful for evaluating coronary artery and cardiac rupture.

Background: The radial artery has become a popular conduit for coronary artery bypass surgery. However, limited information has been provided regarding the atherosclerotic nature of this artery, which may affect both the immediate intraoperative difficulties and long-term graft patency., Methods: We examined intravascular ultrasound (IVUS) images of the radial artery in patients with coronary artery diseases. Cross sections of the radial artery were assessed using the following factors: lumen diameter, lumen area, vessel diameter, vessel area, plaque area, percent plaque area, and extent of calcium deposition., Results: The IVUS images were obtained from radial arteries of 58 patients (47 men, average 67 +/- 9 years) during transradial procedures; ie, transradial coronary angiography and/or transradial coronary intervention. Mean luminal diameter was 3.28 +/- 0.69 mm and 3.00 +/- 0.70 mm at the proximal and distal segments, respectively, and 2.58 +/- 0.73 mm at the minimal lumen cross section. A percent plaque area greater than 50% was seen in five radial arteries (8.6%) whose average plaque length was 26.4 +/- 30.8 mm. Of these, one showed a plaque length greater than 50 mm, and another showed vessel caliber less than 2.0 mm. Five of 58 radial arteries (8.6%) showed calcium deposition, two of which showed diffuse calcification (> 50 mm). Thus, among 58 radial arteries, four (6.9%: one with diffuse arteriosclerosis, one small radial artery, two with diffuse calcification) were considered unsuitable for bypass conduit., Conclusions: Preoperative evaluation of the radial artery is recommended in order to prevent unnecessary exploration of the forearm and to improve graft patency.

Background: After treatment with intracoronary brachytherapy, enlargement of lumen (negative late loss) at follow-up has been demonstrated. The aim of the study is to analyze the sensitivity and specificity of quantitative coronary angiography (QCA) parameters to detect a positive vessel remodeling after intracoronary -radiation as compared to intravascular ultrasound (IVUS)., Methods: Twenty-seven patients (27 vessels) treated with balloon angioplasty followed by catheter-based intracoronary -radiation with a (90)Strontium/(90)Yttrium source were assessed by both QCA and three-dimensional IVUS with electrocardiogram-gated pullback. Irradiated segments were analyzed over the total treatment length and in subsegment lengths of 5 mm., Results: Change in minimum luminal diameter (MLD) was not a predictor for the positive remodeling in either total irradiated segments or 5 mm subsegments, with a 54.3% ROC curve area [95% confidence interval (CI), 30-79%], sensitivity of 39% and specificity of 44% (p = not significant) in the total irradiated segments and a 55.9% ROC curve area (95% CI, 46-66%), sensitivity of 55% and specificity of 54% (p = not significant) in the 5 mm subsegments. Changes in mean and maximal lumen diameter were not significant parameters to detect positive vessel remodeling. When only central subsegments were analyzed, change in MLD was a significant predictor, with a 63.3% ROC curve area (95% CI, 52-75%), sensitivity of 55% and specificity of 64% (p = 0.029)., Conclusion: Lumen enlargement detected by QCA does not reliably indicate a positive vessel remodeling after intracoronary radiation. IVUS analysis may be necessary to investigate the mechanism of restenosis after balloon angioplasty followed by catheter-based radiation.

Doxorubicin (DXR) is one of the most effective antineoplastic agents, but its use is limited by its myocardial toxicity. Myocardial injury reduces the cyclic variation of integrated backscatter (CV-IBS) and so the present study was designed to investigate whether CV-IBS can be used to detect the early phase of myocardial damage in patients receiving DXR. Thirty-four subjects constituted the study population, none of whom showed clinically evident heart failure. CV-IBS was obtained for both the interventricular septum and the left ventricular posterior wall in the parasternal short-axis view. Standard echographic measures of left ventricular function were also made. Subjects without DXR exposure or evident cardiac diseases served as controls. The total dose of DXR administered per patient was 339+/-164 mg/m2 (range: 95-680 mg/m2). Conventional echographic parameters, including left ventricular wall thickness, dimensions, fractional shortening, and ejection fraction, showed no significant differences between the 2 groups. In contrast, CV-IBS was significantly decreased in the DXR group compared with the control group (septum: 4.7+/-1.7 vs 7.2+/-1.9 dB, p<0.0001; posterior wall: 6.7 +/-2.2 vs 8.0+/-1.6 dB, p<0.05). CV-IBS can be used as an early indicator of DXR-induced myocardial damage in patients demonstrating normal left ventricular systolic function.

Aims: Recent trials in humans have given us insight into some of the consequences of intracoronary radiation. The authors describe a new observation noted on intravascular ultrasound: that of intraluminal echolucent tissue, dubbed the 'black hole', noted at six-month follow-up., Methods and Results: One hundred and twenty-eight consecutive patients enrolled in brachytherapy protocols were analyzed. The control group (C) consisted of individuals who underwent percutaneous transluminal coronary angioplasty with (n = 48) and without (n = 22) stent implantation. Radiation groups included those who underwent low activity (LA) (n = 18), high activity (HA) (n = 26) and cold-end (CE) (n = 18) radioactive stenting. The Novoste Betacath (n = 39) and Guidant (n = 27) catheter-based radiation systems were also employed. At six-month follow-up echolucent tissue was identified in a total of 28 cases (22%). Angiographic restenosis occurred in 17 cases (61%). No echolucent tissue was seen in the control group or in the LA group. HA and CE radioactive stents were most commonly associated with echolucent tissue. Echolucent tissue was seen in all groups treated with catheter-based radiation with and without stenting. Pathology after atherectomy demonstrated smooth muscle cells scattered in extracellular matrix containing abundant proteoglycans and an absence of elastin and mature collagen., Conclusions: Echolucent tissue is common after radioactive stenting. It is composed of tissue rich in proteoglycans while poor in mature collagen and elastin.

Introduction: Quantitative angiographic assessment after balloon angioplasty is a poor predictor of immediate and long-term outcome. However, the measurement of blood flow velocity during angioplasty has been proved clinically useful., Aims: To analyse the value of the maximal stenotic flow velocity and the presence of stenotic flow velocity acceleration (aSV) for the long-term outcome after balloon angioplasty., Methods and Results: Patients undergoing single lesion angioplasty within the DEBATE trial were included. aSV was defined as acceleration in the stenotic coronary flow velocity >50% baseline velocity assessed at a reference site of the target vessel. After balloon angioplasty diameter stenosis, minimal lumen diameter (MLD) and coronary flow velocity reserve were similar between the aSV (n=54) and non-aSV group (n=125). At follow-up, the aSV group had a higher restenosis rate (52% vs 30%, P=0.006) The presence of aSV was the strongest independent predictor of restenosis (OR 3.08, 95% CI 1.35 to 7.05, P=0.008). The best predictive cut-off value of SV was 101cm.s(-1) (sensitivity of 46%, specificity of 81%, positive predictive value of 85% and a negative predictive value of 58%)., Conclusion: Following angioplasty, SV appears to be exquisitely sensitive to the changes experienced at the treated area without depending on the status of the microcirculation., (Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd.)

Aims: Intracoronary radiation is a promising therapy potentially reducing restenosis following catheter-based interventions. Currently, only limited data on this treatment are available. The feasibility and outcome in daily routine practice, however, is unknown., Methods and Results: In 100 consecutive patients, intracoronary beta-radiation was performed with a (90)Strontium system (Novoste Beta-Cathtrade mark) following angioplasty. Predominantly complex (73% type B2 and C) and long lesions (length 24.3+/-15.3 mm) were included (37% de novo, 19% restenotic and 44% in-stent restenotic lesions). Radiation success was 100%. Mean prescribed dose was 19.8+/-2.5 Gy. A pullback procedure was performed in 19% lesions. Geographic miss occurred in 8% lesions. Periprocedural thrombus formation occurred in four lesions, dissection in nine lesions. During hospital stay, no death, acute myocardial infarction, or repeat revascularization was observed. Major adverse cardiac events occurred predominantly between 6 and 12 months after the index procedure with major adverse cardiac event-free survival of 66% at 12 months (one death, 10 Q-wave myocardial infarctions, 23 target vessel revascularizations; ranked for worst event)., Conclusion: Routine catheter-based intracoronary beta-radiation therapy after angioplasty is safe and feasible with a high acute procedural success. The clinical 1-year follow-up showed delayed occurrence of major adverse cardiac events between 6 and 12 months after the index procedure., (Copyright 2001 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.)