Impact of chronic kidney disease on long-term clinical outcomes of everolimus-eluting stent implantation: A subanalysis of the Tokyo-MD PCI registry.

OBJECTIVE: The aim of the study was to investigate the impact of chronic kidney disease (CKD) on the 5-year clinical outcomes of everolimus-eluting stent (EES) implantation. BACKGROUND: Recent studies have demonstrated the safety and efficacy of EES. However, limited information exists on the long-term clinical outcomes associated with CKD. METHODS: The Tokyo-MD PCI study is a multi-center observational study designed to describe the clinical outcomes of unselected patients after EES implantation. In this subanalysis, patients on maintenance hemodialysis were excluded, and patients with (n = 316) or without (n = 1,424) CKD were evaluated for their 5-year incidence rates of major adverse cardiac events (MACEs), defined as death, non-fatal myocardial infarction, ischemia driven target lesion revascularization (ID-TLR), and stent thrombosis (ST). RESULTS: The mean and median follow-up duration were 1,391 ± 557 days and 1,769 days (interquartile range, 1,012-1,800 days), respectively. Although the incidence of ID-TLR and ST was similar between patients with and without CKD (4.9% vs. 3.7%, P = 0.26, 0.5% vs. 1.0%, P = 0.20, respectively), cardiac death and MACE were significantly higher in patients with CKD than in those without CKD (6.5% vs. 2.9%, P = 0.007, 26.9% vs. 14.0%, P < 0.001, respectively). In multivariate analysis, CKD was an independent predictor of MACE (hazard ratio 1.22 [95% confidence interval 1.04-1.43], P = 0.01). CONCLUSIONS: Patients with CKD had similar ID-TLR and ST rates as those without CKD at 5 years after EES implantation. The risk of long-term MACEs appeared to be associated with CKD.

Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study.

BACKGROUND: The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. PURPOSE: The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. METHODS: The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). RESULTS: The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1-5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P < 0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774-2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). CONCLUSION: This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD.

Treatment of In-Stent Restenosis by Excimer Laser Coronary Atherectomy and Drug-Coated Balloon: Serial Assessment with Optical Coherence Tomography.

OBJECTIVES: We aimed to compare the results of neointimal modification before drug-coated balloon (DCB) treatment with excimer laser coronary atherectomy (ELCA) plus scoring balloon predilation versus scoring balloon alone in patients presenting with in-stent restenosis (ISR). BACKGROUND: Treatment of ISR with ELCA typically results in superior acute gain by neointima debulking. However, the efficacy of combination therapy of ELCA and DCB remains unknown. METHODS: A total of 42 patients (44 ISR lesions) undergoing DCB treatment with ELCA plus scoring balloon (ELCA group, n = 18) or scoring balloon alone (non-ELCA group, n = 24) were evaluated via serial assessment by optical coherence tomography (OCT) performed before, after intervention, and at 6 months. RESULTS: Although there was significantly greater frequency of diffuse restenosis and percent diameter stenosis (%DS) after intervention in the ELCA group, comparable result was shown in %DS, late lumen loss, and binary angiographic restenosis at follow-up. On OCT analysis, a decreased tendency in the minimum lumen area and a significant decrease in the minimum stent area were observed in the ELCA group between 6-month follow-up and after intervention (-0.89 ± 1.36 mm2 vs. -0.09 ± 1.25 mm2, p = 0.05, -0.49 ± 1.48 mm2 vs. 0.28 ± 0.78 mm2, p = 0.03, respectively). The changes in the neointimal area were similar between the groups, and target lesion revascularization showed comparable rates at 1 year (11.1% vs. 11.4%, p = 0.85). CONCLUSIONS: Despite greater %DS after intervention, ELCA before DCB had possible benefit for late angiographic and clinical outcome.

Obesity paradox in the era of percutaneous coronary intervention with 2nd-generation drug-eluting stents: an analysis of a multicenter PCI registry.

Being overweight has been identified as independent risk factors for coronary artery disease. However, overweight patients have been reported frequently to have better mortality outcomes, and there is little data showing they are at a disadvantage regarding secondary prevention of cardiovascular events. We analyzed the influence of being overweight (defined as body mass index > 25 kg/m2) on adverse events in patients who underwent everolimus-eluting stent (EES) implantation using a multicenter registry with a maximum follow-up of 3 years. Propensity score matching was done for adjusting baseline characteristics. We defined primary end points as major adverse cardiac and cerebrovascular events (MACCE: a composite of mortality from all causes, nonfatal myocardial infarction, and nonfatal stroke) and "MACCE excluding non-cardiac mortality". Other adverse events were analyzed as key secondary end points. Out of 1918 patients, 450 pairs were obtained through propensity score matching. Overweight patients were superior to non-overweight patients regarding MACCE (event rates: 8.2 vs. 13.8% in overweight vs. non-overweight, respectively; log-rank p = 0.009) and "MACCE excluding non-cardiac mortality" (5.9 vs. 10.1%, p = 0.03). On secondary end points, not only did overweight patients have significantly fewer major bleeding events (2.2 vs. 4.8%, p = 0.02), but they also had smaller adverse event rates for almost all such events; the differences were not statistically significant. Overweight patients had better outcomes for MACCE, even on excluding non-cardiac mortalities. No result was supportive of an evident advantage to non-overweight EES-implanted patients in terms of secondary prevention of cardiovascular events.

Incidence and predictors of early and late target lesion revascularization after everolimus-eluting stent implantation in unselected patients in japan.

OBJECTIVE: The objective of this study was to clarify the incidence and predictors of early and late target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in actual clinical practice. BACKGROUND: Several clinical studies have reported the incidence and predictors of TLR after EES implantation. However, detailed features of early and late TLR are unknown. METHODS: We analyzed the clinical data of patients who underwent EES implantation between January 2010 and December 2011 at 22 institutions in Japan (Tokyo-MD PCI study). Patients who underwent ischemia-driven TLR (ID-TLR) were grouped according to the number of years elapsed since stent placement, and incidence and correlations between clinical factors were analyzed. RESULTS: Statistical analysis was performed for 1,899 patients and 2,305 lesions. The mean age was 70.0 ± 9.9 years, and the median follow-up period was 1,281 days (IQR: 762-1,440 days). The incidence of ID-TLR was 2.7% at 1 year and 5.4% at 4 years. After 2 years, the ID-TLR rates plateaued. The independent predictors of ID-TLR occurring within 2 years were hemodialysis, triple vessel disease, restenotic lesion, and ostial lesions. The independent predictors of ID-TLR between 2 and 4 years were diabetes mellitus and peripheral artery disease. CONCLUSION: The ID-TLR rates leveled off after 2 years. Furthermore, the predictors of ID-TLR that occurred within 2 years of EES implantation differed from those that occurred later than 2 years. © 2017 Wiley Periodicals, Inc.

A Novel Methodology for Synthesis of 1,5,6-Trisubstituted 2(1H)-Pyrazinones of Biological Interest.

In this report, we describe a new method for the synthesis of densely functionalized 2(1H)-pyrazinones. Treatment of mesoionic 1,3-oxazolium-5-olates with carbanions derived from activated methylene isocyanides (p-toluenesulfonylmethyl isocyanide (TosMIC) and ethyl isocyanoacetate) causes a novel ring transformation affording 2(1H)-pyrazinones in moderate to high yields. The cytotoxicity and antibacterial activity of some of the obtained products were studied and some of the products exhibited tumor-specific cytotoxicity.

ß-Blockers Reduced the Target Lesion Revascularization After Percutaneous Coronary Intervention Using an Everolimus-eluting Stent.

BACKGROUND/AIM: The effect of ß-adrenergic blockers on everolimus-eluting stent (EES) implantation is unknown. We aimed to investigate how ß-blockers affect the outcomes of EES by using the Tokyo-MD PCI registry data and analyse real-world data in this drug-eluting stent era in Japan. PATIENTS AND METHODS: We selected 1,899 patients who underwent EES implantation. We compared patients with ß-blocker administration versus those without, at follow-up regarding the incidence rate of ischemia-driven target lesion revascularization (ID-TLR), all-cause death, cardiac death, acute myocardial infarction (AMI), and stent thrombosis (ST). RESULTS: Patients in the ß-blocker group had higher coronary risks than those in the non-ß-blocker group. Although no significant difference was observed in the five-year incidence of all-cause death, cardiac death, AMI, and ST between the two groups, the incidence of ID-TLR was significantly lower in the ß-blocker group (4.5% vs. 6.6%; p=0.04). ß-Blocker administration (hazard ratio=0.61; p=0.016) was negatively associated with ID-TLR via multivariate analysis. CONCLUSION: ß-Blocker administration reduced ID-TLR after percutaneous coronary intervention using an EES despite the greater comorbid risks and more severe disease lesions.

Five-Year Impacts of Antithrombotic Therapy Based on 10-Year Clinical Outcomes of Cypher™ Stent Implantation.

INTRODUCTION: Few researchers have investigated the optimal long-term antithrombotic therapy regimen, especially after first-generation drug-eluting stent (DES) use. This study aimed to evaluate the impact of mid-term antithrombotic therapy on long-term outcomes in patients treated with the first sirolimus-eluting coronary stent (Cypher™). METHODS: Between 2004 and 2009, 1021 patients underwent Cypher™ implantation at our institute; among them, 567 patients had available data on antithrombotic therapy at year 5. We assessed patients' antithrombotic therapy at year 5 post Cypher™ implantation and examined their association with adverse events from year 5 to year 10 post Cypher™ implantation. RESULTS: Patients with dual-antiplatelet therapy (DAPT) at year 5 had significantly lower risk of stent thrombosis (ST) than those with single-antiplatelet therapy (SAPT) (hazard ratio [HR] 0.24, p = 0.034). The HR of major bleeding in DAPT, compared to SAPT, was high, but the difference was not significant (HR 1.72, p = 0.26). Risk of major bleeding was significantly higher in patients on oral anticoagulants (OAC) than in those in other groups (OAC/SAPT; HR 5.31, p = 0.0048, OAC/DAPT; HR 3.08, p = 0.022), without significant reduction in the risk of cardiovascular events. CONCLUSIONS: The incidence of ST after Cypher™ implantation in patients with DAPT at year 5 was significantly lower than that in SAPT. However, the risk of bleeding was higher with DAPT than with SAPT. Moreover, the risk of major bleeding was significantly higher in patients on anticoagulant therapy than in other patients. New options for the use of antithrombotic drugs after percutaneous coronary intervention warrant further studies on the optimal antithrombotic therapy for first-generation DES.

Fragmented QRS on far-field intracardiac electrograms as a predictor of arrhythmic events.

BACKGROUND: Studies suggest that fragmented QRS (fQRS) can predict arrhythmic events in various cardiac diseases. However, the association between fQRS recordings on intracardiac electrogram (EGM) and ventricular arrhythmic events remains unknown. METHODS: We enrolled 51 patients (age, 62 ± 12 years; 40 men) with an implantable cardioverter-defibrillator (ICD) and structural heart disease and evaluated surface electrocardiogram (ECG) and EGM measurement of fQRS and the association between fQRS and arrhythmic events. RESULTS: fQRS was detected on surface ECG and ICD-EGM in 12 (23.5%) and 15 (29.4%) patients, respectively. fQRS was detected more frequently on ICD-EGM in patients with fQRS on surface ECG than in patients without fQRS (7/12 [58.3%] vs 8/39 patients [20.5%], P = .01). Appropriate ICD therapies were documented in 16 patients. Among these patients, fQRS was detected more frequently on surface ECG and ICD-EGM in patients with appropriate ICD therapies (8/16, 50.0%; P = .001 and 11/16, 68.9%; P < .001). Nonsustained ventricular tachycardia was significantly more frequent in patients with appropriate ICD therapies (15/16, 93.8%; P = .04). Multiple logistic regression analysis showed that fQRS on ICD-EGM was a predictor of arrhythmic events (P = .03). Kaplan-Meier survival analysis revealed that ICD therapies were significantly more frequent among patients with fQRS on both surface ECG and ICD-EGM than among those without fQRS (66.7% vs 6.6%, P < .001). CONCLUSION: The presence of fQRS on ICD-EGM can be a predictor of arrhythmic events in ICD patients. Surface ECG and ICD-EGM measurement may help predict ventricular arrhythmic events.

Incidence of outflow tract ventricular tachycardia long after surgical aortic valve replacement.

BACKGROUND: The peri-outflow tract region could be the origin of ventricular tachycardia (VT) after aortic valve replacement (AVR). However, the clinical characteristics of outflow tract ventricular tachycardias (OTVTs) after AVR are yet to be clarified. This study investigated the incidence, risk factors, and clinical characteristics of patients with OTVTs after AVR. METHODS: We retrospectively analyzed the clinical course of 120 patients who had undergone surgical AVR (SAVR) between April 1980 and October 2018. The patients had no ischemic or diagnosed cardiomyopathies other than primary aortic valve diseases. RESULTS: Six patients (5.0%) developed OTVTs after SAVR. The average onset was at 10.8 ± 5.7 years after SAVR. All cases of VT arose from the inferior axis and included left and right bundle branch block configuration. Two patients who underwent cardiac magnetic resonance imaging (MRI) had late gadolinium enhancement (LGE) in the midlayer of the left ventricle basal anteroseptal wall. Patients with periaortic VTs had significantly larger left ventricular (LV) diameter at systole, lower LV ejection fraction, higher positive rates of signal-averaged electrocardiogram (SAECG), and nonsustained VTs on Holter monitoring. On ablation, local fragmented potentials with low voltage zones were observed in accordance with the LGE distribution. Multiple VTs originating from the periaortic region were provoked in the sessions. CONCLUSIONS: Acute OTVT was found in 5% of patients after SAVR. Arrhythmia risk stratification by SAECG, Holter ECG, and cardiac MRI should be considered for a long period in patients after SAVR.

Feasibility and safety of uninterrupted apixaban in patients undergoing radiofrequency ablation for atrial fibrillation.

BACKGROUND: An optimal periprocedural anticoagulation strategy is essential for minimizing bleeding and thromboembolic complications during atrial fibrillation (AF) ablation. Limited data are available on the uninterrupted use of apixaban in patients with AF undergoing catheter ablation. This study aimed to evaluate the safety and efficacy of uninterrupted apixaban in patients undergoing radiofrequency ablation for AF. In particular, we evaluated silent cerebral infarction (CI) during radiofrequency catheter ablation of AF. METHODS: This was a prospective and nonrandomized cohort study. A total of 259 consecutive patients who underwent AF ablation were evaluated; 157 patients received apixaban (Api group), and 102 patients received dose-adjusted (PT-INR 2.0-3.0) warfarin (Wf group). All oral anticoagulants were continued throughout the periprocedural period, including the morning of the procedure. Intravenous heparin was administered during the procedure and neutralized by protamine at the end of the procedure. Sixty-one patients underwent magnetic resonance imaging (MRI) after the procedure to evaluate for silent CI. RESULTS: Mean age was 66 ± 11 years; there were 91 men (73.7%) and 148 cases of paroxysmal AF (57.1%). No symptomatic CI was observed. Silent CI occurred in 6/61 patients (9.8%). No significant difference was observed between the Api group (4/30 patients, 13.3%) and the Wf group (2/31 patients, 6.5%). There was no significant difference regarding major bleeding events between the Api group (1/157 patients, 0.6%) and the Wf group (2/102 patients, 2.0%). CONCLUSIONS: The safety and efficacy of uninterrupted apixaban for patients undergoing AF ablation were equivalent to warfarin for preventing bleeding and thromboembolic complications.

Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study).

BACKGROUND: Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy. METHODS: Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR). RESULTS: Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9-3.6) years. The mean age of the patients was 72.3 ±â€¯8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74-155.5; p = 0.01, HR, 9.01; 95% CI, 1.34-62.5; p = 0.02). CONCLUSIONS: PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.

The Hypercholesterolemia Paradox in Percutaneous Coronary Intervention: An Analysis of a Multicenter PCI Registry.

Objective The aim of this study was to assess the relationship between hypercholesterolemia (HC) and clinical events through a percutaneous coronary intervention (PCI) registry. HC is a well-known independent risk factor for long-term cardiovascular events after PCI. However, it has been reported to be associated with a lower risk of adverse events in patients with cancer or acute coronary syndrome. Methods We analyzed the relationship between HC and adverse events in patients treated with everolimus-eluting stents (EESs) through the Tokyo-MD PCI study (an all-comer, multicenter, observational registry). The propensity score method was applied to select two groups with similar baseline characteristics. Results The unadjusted population included 1,536 HC patients and 330 non-HC patients. Propensity score matching yielded 314 matched pairs. After baseline adjustment, the outcomes of HC patients were significantly better than those of the non-HC patients with respect to the primary endpoint, which was a combination of mortality from all causes, nonfatal myocardial infarction (MI), nonfatal neurological events, and major bleeding [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.39-0.81; p=0.002], and the secondary endpoints, which included a combination of mortality from all causes, nonfatal MI, and nonfatal neurological events (HR 0.59, 95% CI 0.39-0.88; p=0.01), and major bleeding (HR 0.42, 95% CI 0.20-0.88; p=0.02). A subgroup analysis showed age as an interaction factor for the primary endpoint (interaction p=0.035). Conclusion HC was associated with better outcomes in patients who underwent EES implantation, even after baseline adjustment.

Novel 16-membered macrolides modified at C-12 and C-13 positions of midecamycin A1 and miokamycin. Part 1: Synthesis and evaluation of 12,13-carbamate and 12-arylalkylamino-13-hydroxy analogues.

Design and synthesis of 16-membered macrolides modified at the C-12 and 13 positions are described. The compounds we report here have an arylalkylamino group attached to the C-12 position of the macrolactone. Both types of derivatives, 12,13-cyclic carbamates and non-carbamate analogues, were synthesized via 12-amino-13-hydroxy intermediates derived from 12,13-epoxide that was prepared by selective epoxidation at the C-12 and C-13 positions. 4'-Hydroxyl analogues were also prepared by acidic hydrolysis of a neutral sugar. These compounds were evaluated for in vitro antibacterial activity against respiratory tract pathogens. Some of these analogues exhibited an improved activity compared with the corresponding parent compound.

Design and synthesis of novel leucomycin analogues modified at the C-3 position. Part II: 3-O-(3-Aryl-2-propenyl)leucomycin analogues.

The design and synthesis of 16-membered macrolides modified at the C-3 position are described. Starting from fully protected intermediate (5), appropriate modifications including Heck reaction were performed to furnish 3-O-(3-aryl-2-propenyl)leucomycin A(7) analogues (9a-9m). These leucomycin A(7) derivatives showed improved in vitro antibacterial activities against clinically important pathogens including erythromycin-resistant Streptococcus pneumoniae (ERSP). SAR analysis of derivatives modified at the C-3 and C-3'' positions suggested that single modification at C-3 or C-3'' was effective for in vitro antibacterial activity.

Effect of over-2-year dual antiplatelet therapy on the rate of major adverse cardiac and cerebral events for everolimus-eluting stent implantation: The landmark analysis from Tokyo-MD PCI registry.

BACKGROUND: Long-term dual antiplatelet therapy (DAPT) for patients treated with coronary stents has been reported to be effective. However the effectiveness of long-term DAPT for everolimus-eluting stent (EES) implanted patients has been controversial. We assessed the major adverse cardiac and cerebral events (MACCE: a composite of death, myocardial infarction, or cerebral arterial disease) in patients free from MACCE during the first 2 years after EES implantation. METHODS AND RESULTS: A total of 1918 patients who underwent successful percutaneous coronary intervention (PCI) with EES at 22 centers in Japan in 2010-2011 were enrolled, and 742 patients were free from MACCE for 2 years. We divided these MACCE-free patients into two groups: those who received DAPT for >2 years (Over-2-Year DAPT: n=591), and those who received DAPT for ≤2 years (Under-2-Year DAPT: n=151). We performed the landmark analysis that began at 2 years and evaluated at 3 years after PCI about the occurrence of MACCE, major bleeding, stent thrombosis, and restenosis between these groups, both with and without baseline adjustment by propensity score matching (n=145 in both groups). RESULTS: Fifty MACCE cases were reported (Over-2-Year DAPT, 38; Under-2-Year DAPT, 12), with no significant differences between the 2 groups (log-rank test, p=0.19). Even after baseline adjustment, there were no differences in MACCE occurrence (Over-2-Year DAPT, 8; Under-2-Year DAPT, 11, p=0.19); 15 cases of major bleeding, 5 of restenosis, and 2 of stent thrombosis were observed after 2-years' follow-up, with no statistical differences between the groups, although the event numbers were too low for comparison. CONCLUSION: Continuing DAPT for >2 years did not prevent MACCE in patients free from MACCE during initial 2 years after EES implantation. Few events of major bleeding, stent thrombosis, and restenosis were observed, with no statistical differences.

Comparison of outcomes after everolimus-eluting stent implantation in diabetic versus non-diabetic patients in the Tokyo-MD PCI study.

BACKGROUND: Diabetes mellitus (DM), especially in those requiring insulin for treatment, is known to be a risk factor for adverse events after percutaneous coronary intervention using first-generation drug-eluting stents. However, the role of DM in patients treated with everolimus-eluting stents (EES) is less known. The purpose of the present analysis was to evaluate the outcomes of treatment with EES for DM patients both requiring and not requiring insulin, and to compare them with non-DM patients. METHODS: Of patients treated with EES in the Tokyo-MD PCI study, an all-comer, multicenter, observational cohort study, we identified 199 insulin-requiring diabetics (IRDM), 575 non-insulin requiring diabetics (NIRDM), and 1092 non-diabetics (non-DM). The main outcomes were major adverse cardiovascular events (MACE) defined as a composite of all-cause death, myocardial infarction, and stroke, and target lesion revascularization (TLR). RESULTS: The cumulative incidence of MACE and TLR was significantly greater in patients with IRDM than non-DM [MACE: hazard ratio 1.97, 95% confidence interval (CI) 1.31-2.90, p<0.01; TLR: hazard ratio 3.43, 2.07-5.55, p<0.0001] according to univariate Cox proportional hazards model. After adjusting for confounders using the multivariate Cox proportional hazard model, the risk of IRDM versus non-DM for TLR remained significant (hazard ratio 1.92, 1.10-3.29, p=0.02). The incidence of TLR in NIRDM was slightly greater than that in non-DM according to univariate analysis (hazard ratio 1.65, 1.07-2.54, p=0.02). However, the risk was not statistically different in the multivariate analysis (hazard ratio 1.52, 0.97-2.35, p=0.06). CONCLUSIONS: In this all-comer, observational study, the risk of TLR was greater in IRDM compared with non-DM after EES implantation, while the increased risk for TLR from NIRDM did not reach statistical significance.

Mother-child technique using a novel 4 Fr inner catheter.

AIMS: The aim of this study was to assess the efficacy of the mother and child technique using a 4 Fr inner catheter in coronary angioplasty following the failure of conventional techniques. METHODS AND RESULTS: We identified cases in which a 4 Fr inner catheter had been used to facilitate stent delivery following the failure of conventional techniques. Stent delivery using a 4 Fr inner catheter was performed in 30 cases and was successful in 29 cases. Nineteen cases for RCA, six cases for LAD and five cases for LCx were examined. Direct engagement of a 4 Fr inner catheter was accomplished in eight cases. In the remaining patients, deep engagement of a 4 Fr inner catheter was accomplished with the anchor technique and/or distal balloon deflation technique. Proximal stent delivery followed by distal stent deployment was performed in seven cases by using the distal balloon deflation technique in multiple stent deployment. There were no complications related to deep intubation of a 4 Fr inner catheter. CONCLUSIONS: The use of a 4 Fr inner catheter is safe and highly effective for aiding stent delivery. The anchor technique and/or distal balloon deflation technique could be required for deep engagement of a 4 Fr inner catheter.

Popliteal Retrograde Approach is Effective and Safe for Superficial Femoral Artery Chronic Total Occlusion.

OBJECTIVE: Endovascular treatment (EVT) using a popliteal approach is effective for superficial femoral artery (SFA) chronic total occlusion (CTO); however, its effectiveness, safety, and consequent complications are unclear. MATERIALS AND METHODS: We studied 324 consecutive EVTs (in 187 patients) performed at three centers between April 2008 and March 2013, and selected all EVTs that included SFA CTO regions. A total of 91 EVTs (in 65 patients) were included and divided into two groups; "with popliteal approach" (WPA) and "without popliteal approach" (WOPA). RESULTS: Despite higher rates of hypertension (WPA, 88.9% vs. WOPA, 69.1%; p = 0.04) and CTO length >200 mm (55.6% vs. 28.3%, respectively; p <0.01), the primary success rate was better in the WPA group (97.2% vs. 78.2%, respectively; p <0.01); however, both total complication rate and major complication rate were not significantly different. We compared popliteal puncture using a sheath and using a microcatheter alone. There were no significant differences between sheath and microcatheter use in terms of primary success rates (95.5% vs. 100%, respectively; p = 0.61) and puncture site complications (22.7% vs. 14.2%, respectively; p = 0.53). CONCLUSION: A popliteal approach improved the primary success rate of EVT for SFA CTO.