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BACKGROUND Limited data are available regarding the vascular response after fluoropolymer paclitaxel-eluting stent (FP-PES) implantation. This study sought to assess the vascular response at 6 and 12 months after FP-PES implantation for femoropopliteal artery lesions using serial optical coherence tomography (OCT) examination.Methods and Results:From the IMPERIAL trial, this study evaluated 10 de novo femoropopliteal lesions treated with FP-PES. The primary study endpoint was neointimal tissue coverage at a 6- and 12-month follow up, as assessed by serial OCT examination. The incidence of peri-strut low-intensity area (PLIA) and extra-stent lumen (ESL) was also assessed. A total of 203 matched cross-sectional images were evaluated at 6 and 12 months (5,615 and 5,763 struts, respectively). From 6 to 12 months, the mean neointimal thickness tended to increase from 198 µm to 233 µm, with a significant reduction in the incidence of malapposed struts (0.59% vs. 0.28%, P=0.039). Conversely, uncovered struts and PLIA were more frequently observed at 12 months (4.4% vs. 7.8%, P=0.01; 12.7% vs. 21.0%, P

BACKGROUND The aim of this study is to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with cancer.Methods and Results:Cancer screening was recommended before PCI in consecutive 1,303 patients who underwent their first PCI. By using cancer screening, cancer was diagnosed in 29 patients (2.2%). In total, 185 patients had present or a history of cancer. Patients with cancer more often suffered from non-cardiac death than those without (4.4% vs. 1.5%, P=0.006), and patients with cancer requiring ongoing therapy (n=18) more often suffered from major bleeding compared with those with recently (≤12 months) diagnosed cancer who do not have ongoing therapy (n=59) (16.7% vs. 3.4%, P=0.049). During the 1-year follow up, 25 patients (2.0%) were diagnosed as having cancer, in which 48.0% of bleeding events led to a cancer diagnosis. Patients with high bleeding risk according to the Academic Research Consortium for high bleeding risk (ARC-HBR) were associated with a greater 1-year major bleeding risk than those without high bleeding risk in patients with (7.9% vs. 0.0%, P=0.02) and without cancer (7.1% vs. 2.5%, P

BACKGROUND The aim of the current study was to identify the distribution of length and cost of hospital stay and their associated risk factors in poor-risk Japanese critical limb ischemia (CLI) patients undergoing revascularization. Methods and Results: We analyzed prospectively collected data from 507 CLI patients who required assistance in their daily lives due to disability in activities of daily living and/or cognitive function impairment and who underwent revascularization. The median length and cost of hospital stay were 23 days (IQR, 9-52 days) and ¥2.25m (IQR, ¥1.33m-3.58m), respectively. Reduced albumin, tissue loss, infection, surgical reconstruction, and bilateral revascularization were associated with prolonged hospital stay (P=0.012, 0.019

Several studies have reported a relationship between clinical outcomes and the ankle-brachial index (ABI) in different populations. However, the relationship in Japanese patients or in patients undergoing percutaneous coronary intervention (PCI) has not been examined well.Methods and Results:The subjects were 1,857 patients who underwent PCI from July 2007 to May 2010 and in whom the carotid and renal arteries and abdominal aorta were examined simultaneously by ultrasonography and ABI. We investigated the relationship between ABI and major adverse cardiovascular events (MACE: all-cause death, myocardial infarction, and stroke). The median follow-up was 1,322 days (interquartile range: 1,092-1,566 days). Patients with low (0.9), borderline (0.9-1.0) and high ABI (1.4) had significantly higher incidence of MACE at 4 years (31%, 15%, 10%, and 29% for the low, borderline, normal, and high groups, respectively; log-rank P0.0001) and all-cause mortality at 4 years (22%, 12%, 6.9%, and 29%, respectively; P0.0001) compared with the normal ABI group (1.0≤ABI≤1.4). The adjusted hazard ratios for MACE were 2.35 (1.72-3.20), 1.27 (0.89-1.80) and 1.87 (0.81-3.79) for low, borderline and high ABI, respectively.This study suggested that ABI provides additional information for cardiovascular disease risk stratification in Japanese patients undergoing PCI, even it is borderline ABI.

BACKGROUND The mechanism and time course of in-stent restenosis (ISR) after implantation of second-generation DES have not yet been fully elucidated. We sought to evaluate the differences in tissue characteristics between the different phases of ISR after second-generation DES implantation using optical coherence tomography (OCT).Methods and Results:From June 2010 to December 2015, 324 consecutive patients with 337 ISR lesions underwent OCT. Of these, we analyzed 53 lesions in 53 patients who had their first ISR after second-generation DES implantation and underwent OCT before any procedures. According to the timing of ISR, the patients were divided into the early group (within 1 year: E-ISR, n=30) and late group (beyond 1 year: L-ISR, n=23). Quantitative parameters and qualitative characteristics of the neointima were evaluated. In the minimum lumen area site analysis, the E-ISR group had more frequently homogeneous intima than the L-ISR group (26.7% vs. 4.4%, P=0.02). The frequencies of neointima with lipid-laden, thin-cap fibroatheroma, neovascularization and macrophage infiltration were significantly higher in the L-ISR group than in the E-ISR group (30.0% vs. 69.6%, P

BACKGROUND Bypass surgery (BSX) as first-line therapy for Trans-Atlantic Inter-Society Consensus-II (TASCII) C/D femoropopliteal (FP) lesions is recommended. Recent reports have shown that a drug-eluting stent (DES) provides good durability up to the mid-term. We investigated clinical outcomes after BSX vs. DES for TASCII C/D FP lesions. METHODS AND RESULTS As treatment of de novo TASCII C/D FP lesions, 274 patients who underwent DES implantation and 201 patients who had BSX were identified and analyzed. Each group had at least 1 year of follow-up data. The primary endpoint was binary restenosis. Secondary endpoints were major amputation, reintervention, reocclusion and major adverse limb event (MALE; including major amputation or any reintervention and restenosis). Before matching, the binary restenosis rate was significantly higher in the DES group than in the BSX group (42% vs. 18%, P

Background:Atherosclerotic renal artery stenosis (ARAS) causes renovascular hypertension (HTN) and impairs renal function, leading to chronic kidney disease (CKD). The J-RAS study was a prospective, multicenter study to assess the clinical outcome of renal artery stenting for up to 1 year in Japanese patients with ARAS.Methods and Results:One hundred and forty-nine patients were enrolled between November 2010 and January 2013. The patients were classified into an HTN (n=121) group and a CKD (n=108) group in the primary analysis. The primary efficacy endpoints were change in blood pressure for the HTN group and change in estimated glomerular filtration rate (eGFR) for the CKD group at 1 months. The primary safety endpoint was freedom from major cardiovascular or renal events at 12 months. In the HTN group, the mean systolic blood pressure (SBP) significantly decreased from 161.6±21 mmHg at baseline to 137.0±21 mmHg (P

BACKGROUND The efficacy and safety of ultrasound-guided thrombin injection (UGTI) for the treatment of post-catheterization femoral and brachial artery pseudoaneurysms (PSA) is unclear in Japan. METHODS AND RESULTS A retrospective study of 32 consecutive patients undergoing percutaneous UGTI of post-catheterization PSA between February 2011 and February 2014 was performed. There were 23 femoral PSA and 9 brachial PSA treated with UGTI. The prevalence of CAD and smoking history were higher in the brachial PSA patients, but there were no statistically significant differences in other patient demographic factors or in the preprocedural antiplatelet therapy between the femoral and brachial PSA patients. The median dose of thrombin injected was 200 U (range, 100-600 U). The initial success rate, early recurrence rate and surgical conversion rate were 91%, 0% and 4% in the femoral PSA, and 89%, 11% and 11% in the brachial PSA, respectively. There were 2 cases of medial nerve compression in the brachial PSA group, but there were no complications in the femoral PSA group (P=0.0198). On outpatient clinical follow-up in the successfully treated patients, there were no recurrences after an average follow-up of 16 months. CONCLUSIONS UGTI is a feasible, safe and effective less-invasive treatment for post-catheterization PSA. Brachial PSA, however, might require additional attention because of their tendency toward higher recurrence and complications.

Background: Although endovascular therapy (EVT) has advanced, few reports have compared EVT and bypass surgery in claudication patients with femoropopliteal disease. The present study used data from a multicenter registry in Japan to analyze outcomes of EVT and bypass surgery for claudication patients with Trans-Atlantic Inter-Society Consensus (TASC)-II C and D femoropopliteal lesions. Methods and Results: Of 1,156 patients who underwent revascularization, 696 patients were treated for intermittent claudication. A total of 263 patients with femoropopliteal lesion were classified into TASC-II C and D. The primary and secondary patency rates of the EVT and bypass surgery groups were analyzed. The overall complication rate was 14.4% in the bypass surgery group and 3.5% in the EVT group (P

Background: The goal of this study was to evaluate the prevalence and outcomes of polyvascular disease (polyVD; defined as lower extremity artery disease, carotid artery disease, renal artery disease, or abdominal aortic aneurysm) in patients undergoing percutaneous coronary intervention (PCI). Methods and Results: The subjects were 1,597 patients who underwent PCI and who were prospectively enrolled in the study. The carotid, renal and peripheral arteries and abdominal aorta were simultaneously evaluated using duplex ultrasound and ankle-brachial index to evaluate the presence of polyVD. The primary endpoint was major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction [MI], and stroke). PolyVD was found in 446 of 1,597 patients (27.9%). MACE were significantly higher in the polyVD group compared to those with coronary artery disease (CAD) alone (n=1,151; 12.1% vs. 3.8%, P

Background: The relationship between major adverse cardiac events (MACE) and serum polyunsaturated fatty acid (PUFA) parameters has not been well documented in patients who have undergone percutaneous coronary intervention (PCI). The aim of the present study was to investigate this relationship. Methods and Results: A total of 284 consecutive patients who underwent elective PCI were enrolled and stratified according to median serum levels of n-6 PUFAs (arachidonic acid [AA]), n-3 PUFAs (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), and serum EPA/AA and DHA/AA ratios. The relationship between these PUFA parameters and the incidence of MACE including cardiac death, acute coronary syndrome, PCI for de novo lesions, and coronary artery bypass grafting, was analyzed. Multivariate analysis showed that among the PUFA parameters, only a high serum EPA/AA ratio was significantly associated with a low incidence of MACE in all the models tested (model A, without adjusted variables: hazard ratio [HR], 0.52; 95% confidence interval [CI]: 0.27-0.99, P=0.048; model B, adjusted for age and diabetes: HR, 0.51; 95%CI: 0.26-0.98, P=0.043; model C, adjusted for age, sex, diabetes, hypertension, smoking, and low-density lipoprotein cholesterol: HR, 0.49; 95%CI: 0.25-0.94, P=0.033). Conclusions: The incidence of MACE in patients who have undergone PCI is significantly associated with serum EPA/AA ratio. (Circ J 2012; 76: 423-429)

Background: The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different nitinol stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done. Methods and Results: A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with nitinol stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx stent (P=0.10). Conclusions: Despite a different stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx stents for up to 5 years. (Circ J 2011; 75: 421-427)

Background: Exercise training (ET) after coronary stenting is considered to have a risk of stent thrombosis (ST). The present study investigated whether ET increases the incidence of ST in patients undergoing coronary stenting. Methods and Results: The current study was a prospective observational study. We enrolled 3,672 patients who underwent successful coronary stenting. Patients decided whether to participate in exercise and were divided into an ET group (n=1,592) and a control group (n=2,080). The primary endpoint was the incidence of ST. Secondary endpoints were major adverse cardiovascular events (MACE: death, myocardial infarction, and stroke) and unscheduled hospital visits for angina. The incidence of ST and MACE were similar in both groups (1.8% vs. 2.0%, P=0.73, 14.9% vs. 15.0%, P=0.97, respectively). Unscheduled hospital visits were significantly lower in the ET group (20.2% vs. 27.2%, P

Background: The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done. Methods and Results: A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. ControlTM stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P

Background Optimal target vein selection for the pacing lead results in a better outcome, but left ventricular (LV) variability limits this selection. The aim of the present study was to investigate the efficacy of coronary venoplasty for insertion of a LV lead. Methods and Results Transvenous LV lead placement was attempted in 208 consecutive patients from November 2002 to January 2007, with success in 206 patients (99%). Retrospective analysis of the cardiac resynchronization therapy system implantation showed that 4 of the 206 patients (1.9%) required coronary venoplasty for insertion of the pacing lead implant. Using coronary balloon angioplasty catheters of 2.5 mm (2 patients), 3.0 mm (1 patient) and 4.0 mm (1 patient), each target vein was dilated. Of 4 patients, stenoses in 3 were dilated by balloon angioplasty only. However, focal stenosis of 1 patient was not able to be dilated due to severe stenosis. Therefore, part of the lesion was sharpened by rotational atherectomy and the stenosis was successfully dilated. The LV pacing lead could then be inserted and no complications occurred. Conclusion Venoplasty for stenosis was effective in allowing deployment of a LV lead into a target vein in some patients. The safety and complications of the procedure remain unclear. (Circ J 2007; 71: 1442 - 1445)

Endovascular procedure is frequently used as an alternative to surgical bypass in aortic atherosclerotic lesions. Two rare cases of chronic mesenteric ischemia treated with a stent implantation are reported. The patients were a 72-year-old woman and a 57-year-old woman. They presented with severe abdominal pain after meals, repeatedly. Angiography revealed severe stenosis and occlusion of the super mesenteric artery (SMA). Endovascular treatment was initially and technically successful in both patients. A Palmaz® stent was deployed in the ostium lesion of the SMA for both cases. Completion angiography showed successful recanalization of the SMA without any complication and with satisfactory distal flow. The patients' symptoms were alleviated. They remained asymptomatic after stent implantation. Primary stenting may be considered a viable alternative to conventional surgery in carefully selected patients with chronic mesenteric ischemia due to SMA stenosis. (Circ J 2008; 72: 1198 - 1200)