Clinical Outcomes of the Intraluminal Approach for Long Occlusive Femoropopliteal Lesions Assessed by Intravascular Ultrasound.

Aim: To investigate the relationship between intravascular ultrasound (IVUS) findings and restenosis after stent implantation for long occlusive femoropopliteal (FP) lesions using the intraluminal approach.

Methods: This was a single-center retrospective study of 45 patients (49 lesions) with de novo long occlusive FP lesions treated with bare metal stents implanted using the intraluminal approach under IVUS guidance from April 2007 to December 2014. All patients were followed up at least 12 months.

Independent predictors of retrograde failure in CTO-PCI after successful collateral channel crossing.

Objectives: To evaluate factors for predicting retrograde CTO-PCI failure after successful collateral channel crossing.

Background: Successful guidewire/catheter collateral channel crossing is important for the retrograde approach in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).

Methods: A total of 5984 CTO-PCI procedures performed in 45 centers in Japan from 2009 to 2012 were studied.

Ability of Fractional Flow Reserve to Predict Restenosis After Superficial Femoral Artery Stenting.

Purpose: To evaluate the clinical efficacy of poststenting fractional flow reserve (FFR) in terms of predicting restenosis in superficial femoral artery (SFA) disease.

Methods: This prospective, single-center, nonrandomized study enrolled 48 patients (mean age 76±9 years; 38 men) with 51 SFA lesions from July 2013 to June 2014. Mean FFR (distal mean pressure/proximal mean pressure) and systolic FFR (distal systolic pressure/proximal systolic pressure) were calculated, and the relationship between these FFR values and restenosis at 12 months was investigated using receiver operating characteristic (ROC) curve analysis.

A new scoring system (DAIGA) for predicting bleeding complications in atrial fibrillation patients after drug-eluting stent implantation with triple antithrombotic therapy.

Background: No scoring system for evaluating the bleeding risk of atrial fibrillation (AF) patients after drug-eluting stent (DES) implantation with triple antithrombotic therapy (TAT) is available. We aimed to develop a new scoring system for predicting bleeding complications in AF patients after DES implantation with TAT.

Methods And Results: Between April 2007 and April 2014, 227 AF patients undergoing DES implantation with TAT were enrolled.

Incidence and its characteristics of repetition of reintervention after drug-eluting stent implantation for femoropopliteal lesion.

Objective: Although clinical trials demonstrated the superiority of the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent (PTX), a recently developed drug-eluting stent (DES), to conventional therapy for femoropopliteal (FP) lesions, the incidence and risk factors of the repetition of reintervention after DES implantation in clinical practice remained unrevealed.

Methods: This was a subanalysis of the ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) study, enrolling FP lesions undergoing endovascular therapy (EVT) with DES implantation. The current study analyzed the 2-year database including 583 FP lesions in 495 patients undergoing preoperative intravascular ultrasound imaging before DES implantation.

Comparable 2-Year Restenosis Rates Following Subintimal and Intraluminal Drug-Eluting Stent Implantation for Femoropopliteal Chronic Total Occlusion.

Purpose: To report midterm outcomes after subintimal vs intraluminal drug-eluting stent (DES) implantation for femoropopliteal (FP) chronic total occlusion (CTO).

Methods: This subanalysis of the prospective, multicenter ZEPHYR study (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) included 176 patients (mean age 74±8 years; 130 men) with 192 de novo FP CTOs that were evaluated by intravascular ultrasound after successful guidewire crossing. The primary outcome was the 2-year restenosis rate after subintimal (n=73) or intraluminal (n=119) DES implantation.

Effect of Optimal Medical Therapy Before Procedures on Outcomes in Coronary Patients Treated With Drug-Eluting Stents.

It has not been established whether the achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent has a clinical benefit for patients with stable coronary artery disease (CAD). This study included 3,004 patients with CAD treated with drug-eluting stent from 123 Japanese participating centers. The achievement of OMT was defined as control of blood pressure <130/80 mm Hg, hemoglobin A1c <7.

Clinical impact and risk stratification of balloon angioplasty for femoropopliteal disease in nitinol stenting era: Retrospective multicenter study using propensity score matching analysis.

Objective: Nitinol stenting could bring the better outcome in endovascular therapy for femoropopliteal disease. However, it might be expected that recent marked advances in both device technology and operator technique had led to improved efficacy of balloon angioplasty even in this segment. The aims of this study were to evaluate the clinical impact of balloon angioplasty for femoropopliteal disease and make risk stratification clear by propensity score matching analysis.

Frequency and predictors of bleeding events after 2nd generation drug-eluting stent implantation differ depending on time after implantation.

Background: Antiplatelet therapy is required after drug-eluting stent (DES) implantation, but bleeding events occur unexpectedly. We aimed to assess whether bleeding event predictors after 2nd generation DES (2nd DES) implantation differed by time after implantation.

Methods: We studied 1912 consecutive patients who underwent successful 2nd DES implantation (70±10 years, 72% male).

Influence of Repeat Intervention on the Risk of Major Amputation After Infrapopliteal Angioplasty for Critical Limb Ischemia.

Purpose: To assess the influence of repeat intervention on the risk of major amputation after infrapopliteal angioplasty for patients with critical limb ischemia (CLI).

Methods: A multicenter database of Japanese CLI patients was interrogated to identify patients who underwent balloon angioplasty for isolated infrapopliteal lesions from April 2004 to December 2012. In that time frame, 1298 limbs of 1065 patients (mean age 72±10 years; 739 men) were eligible for this analysis.

Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Versus Without Active Cancer.

The aim of this study was to evaluate postprocedural and midterm outcomes of transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and active cancer. From October 2013 to August 2015, a total of 749 patients undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences, Irvine, California) were prospectively included in the OCEAN-TAVI registry from 8 Japanese centers. A total of 47 patients (44.

Impact of preparatory coronary protection in patients at high anatomical risk of acute coronary obstruction during transcatheter aortic valve implantation.

Background: This study aimed to assess the effectiveness of preparatory coronary protection (CP) in patients considered at high risk of acute coronary obstruction (ACO) after transcatheter aortic valve implantation (TAVI).

Methods: The Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry enrolled 666 consecutive patients. All patients were assessed by preprocedural multidetector computed tomography.

Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population.

Objectives: This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes.

Background: No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population.

Methods: The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries.

The Characteristics of In-Stent Restenosis After Drug-Eluting Stent Implantation in Femoropopliteal Lesions and 1-Year Prognosis After Repeat Endovascular Therapy for These Lesions.

Objectives: This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR.

Background: The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined.

Methods: This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study.

Drug-Eluting Stent vs Percutaneous Transluminal Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis: Results From a Retrospective 1-Year Multicenter Study.

Purpose: To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR).

Methods: A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion.

Comparison of Long-Term Clinical Outcomes of Lesions Exhibiting Focal and Segmental Peri-Stent Contrast Staining.

Background: Peri-stent contrast staining (PSS) after metallic drug-eluting stent deployment is associated with target lesion revascularization and very late stent thrombosis. However, the type of PSS that influences the clinical outcomes is unknown. Therefore, we aimed to reveal which PSS type was influencing clinical outcomes.

Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions.

Background: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions.

Methods: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups.

Comparison of first- and second-generation drug-eluting stent efficacies for treating left main and/or three-vessel disease: a propensity matched study.

The efficacy of second-generation drug-eluting stent (DES) for the treatment of left main disease (LM) and/or three vessel disease (3VD) remains unclear. We compared 2-year outcomes of second- versus first -generation DES implantation among patients with LM and/or 3VD and to assess the differential of risk by complexity of coronary artery disease using synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) scores. Between April 2007 and December 2012, 341 patients with LM and/or 3VD were treated by percutaneous coronary intervention; 154 with first-generation DES and 137 with second-generation DES.

Impact of Perioperative Complications After Endovascular Therapy in Diabetic Patients With Critical Limb Ischemia due to Isolated Infrapopliteal Lesions.

Purpose: To investigate the thus far poorly defined impact of perioperative complications (POCs) on clinical outcomes after endovascular therapy (EVT) of diabetic patients with critical limb ischemia (CLI) due to isolated infrapopliteal lesions.

Methods: A multicenter registry of CLI patients was interrogated to identify 780 consecutive diabetic patients (mean age 71 ± 10 years; 553 men) who successfully underwent balloon angioplasty for isolated infrapopliteal lesions. More than half of the population (487 patients) was on dialysis.

Three-year follow-up outcomes of SES and PES in a randomized controlled study stratified by the presence of diabetes mellitus: J-DEsSERT trial.

Background: Three-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients.

Methods: In the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES).

Risk Factors and Clinical Impacts of Peri-Stent Contrast Staining After Second-Generation Drug-Eluting Stent Implantation.

Background: Peri-stent contrast staining (PSS) after sirolimus-eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second-generation DES implantation remain unclear.

Methods And Results: This study comprised 2,090 patients with 2,883 lesions treated with second-generation DES from April 2009 to February 2013.

Mechanism of Residual Lumen Stenosis at the Side Branch Ostium After Final Kissing Balloon Inflation: A Volumetric Intracoronary Ultrasound Study of Coronary Bifurcation Lesions.

Objectives: To investigate the mechanisms of residual stenosis (RS) at side branch ostium (SBO) after final kissing balloon inflation (FKI) and clarify the impact of carina- and plaque-shifts on RS.

Background: Carina- and plaque-shift induce SBO compromise. FKI is an effective technique to treat this complication; however, RS often persist, and are associated with restenosis at SBO.

Clinical characteristics of patients with Rutherford category IV, compared with V and VI.

Objective: Patients categorized Rutherford category IV might have different characteristics compared with Rutherford category V and VI. Our study aims were to estimate the clinical differences between Rutherford category IV and Rutherford category V and VI, for those underwent endovascular therapy for isolated infrapopliteal disease, and also to find risk factors for endovascular therapy in Rutherford category IV.

Methods: Based on the Japanese multi-center registry data, 1091 patients with 1332 limbs (Rutherford category IV: 226 patients with 315 limbs, Rutherford category V and VI: 865 patients with 1017 limbs) were analyzed retrospectively.

Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry.

Objectives: This study was performed to evaluate the acute outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on operator experience.

Background: Despite developments in both technology and techniques, PCI procedures for CTO's remain challenging.

Methods: A total of 3,229 eligible subjects who underwent CTO-PCI were enrolled from 56 centers by a retrograde summit using a web registry system.

Mitral regurgitation prior to transcatheter aortic valve implantation influences survival but not symptoms.

Background: Current data about the impact of concomitant mitral regurgitation (MR) on outcome in patients who undergo transcatheter aortic valve implantation (TAVI) are conflicting. Our purpose was to analyze the clinical course of MR and to assess the influence of MR on survival and clinical status after TAVI.

Methods: We included 375 consecutive patients who underwent TAVI.