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This study aimed to report injury precipitating tissue loss and to provide updated information on the time from tissue loss occurrence to referral to a vascular center for patients who developed chronic limb-threatening ischemia (CLTI) in Japan.We examined 450 patients who developed CLTI with tissue loss and were registered in a multicenter prospective study between October 2017 and June 2020. They were referred to the participating vascular centers for revascularization. Information on the injury precipitating tissue loss and time to referral was collected at registration. The severity of tissue loss was evaluated using the Wound, Ischemia, and foot Infection classification.Injury precipitating tissue loss was absent in 52.0% (95% confidence interval, 47.3%-56.6%) of the patients. The absence was associated with lower albumin levels and preserved pressure sensation. Although the time to referral was significantly shorter in cases without a history of prereferral revascularization, 16.8% (12.8%-20.7%) of the patients were referred to the vascular centers more than 3 months after tissue loss occurrence. Time to referral, but not the lack of a clear precipitant for tissue loss, was significantly associated with the severity of tissue loss.A clear precipitant for tissue loss was often lacking, particularly in patients with low albumin levels and preserved pressure sensation. Delayed referral to a vascular center is still common.

More than 5-year clinical outcomes after femoropopliteal (FP) stenting with bare-nitinol stent (BNS) have not yet been unclear. We investigate the long-term patency and mortality following FP stenting with BNS.This study was a multicenter retrospective study of a prospectively maintained database. From April 2004 to December 2011, 1824 consecutive patients (2211 limbs) who underwent FP stenting with BNS for de novo lesions were selected and analyzed. Primary endpoint was primary patency which was defined as treated vessel without restenosis and reintervention and its associated factors.The prevalence of diabetes mellitus and dialysis was 60.5% and 23.8%, respectively. Chronic limb-threatening ischemia (CLTI) accounted for 30.8%. Chronic total occlusion (CTO) was found in 52.7%, and lesion length was more than 20 cm in 22.6%. During the median follow-up of 3.8 years (interquartile range, 1.4 to 7.4 years), 1049 cases lost patency, whereas 355 cases were dead without experiencing loss of patency. The primary patency (95% CI) was estimated to be 74.8%, 47.3% and 29.1% at 1-, 5- and 10-year. On multivariate analysis, female sex, age ≥ 80 years, diabetes, dialysis, CLTI, CTO, arterial calcification, long lesion (＞20 cm), and small vessel (≤ 4 mm) were the independent predictors of primary patency after FP stenting. In addition, the prognostic impact of age ≥ 80 years, CLTI, and arterial calcification was significantly attenuated afterwards (P＜0.05).Ten-year patency after BNS implantation for FP disease has been continuously reducing up to 10 years and the prognostic impact of risk factors was changed over time.

The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA).This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up.Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period.This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Elevated lipoprotein(a) (Lp[a]) levels are an independent risk factor for the development of atherosclerotic diseases, including peripheral artery disease (PAD). However, their prognostic impact in patients with PAD remains unknown.The aim of this study was to examine the prognostic impact of elevated Lp(a) levels in patients with PAD undergoing endovascular therapy (EVT).In total, 1,169 patients who underwent successful EVT for symptomatic PAD between September 2016 and August 2021 were included in this study. High Lp(a) levels were defined as30 mg/dL. The associations of high Lp(a) levels with incident major adverse cardiovascular events (MACE) (all-cause death, myocardial infarction, and stroke) and major adverse limb events (MALE) (repeat revascularization for target limb and major amputation) were analyzed.During a median follow-up period of 1.7 years (IQR: 0.6-3.0 years), 230 MACE (210 deaths, 15 myocardial infarctions, and 22 strokes) and 263 MALE (219 reinterventions and 36 major amputations) were observed. The cumulative incidence rate of MACE (48.1% vs 27.3%) and MALE (67.9% vs 27.2%) was significantly higher in patients with high Lp(a) levels (P 0.001 for both). The adjusted HR were 1.93 (95% CI: 1.44-2.59; P 0.001) for MACE and 4.15 (95% CI: 3.14-5.50; P 0.001) for MALE. These associations were not influenced by low-density lipoprotein cholesterol levels or statin administration (P for interaction0.05 for all).Elevated Lp(a) levels were independently associated with incident MACE and MALE in patients with PAD treated with revascularization irrespective of low-density lipoprotein cholesterol level and statin administration.

Aim This study aimed to reveal the mortality risk by age in patients undergoing femoropopliteal endovascular therapy for intermittent claudication, in comparison to the national age-specific standard value. Methods We analyzed 2056 patients undergoing endovascular therapy for moderate to severe intermittent claudication between 2010 and 2018, performed at five cardiovascular centers in Japan. The 3-year mortality risk by age was compared with the data from year- and sex-matched Japanese citizens, which were obtained from Japan's national life table data. Clinical characteristics associated with age in the study patients were also explored. Results The mean age was 73±9 years. The 3-year mortality risk was increased with age in the patient population, from 6.4% for patients aged ＜65 years to 21.2% for those aged ≥ 85 years. On the contrary, its risk ratio relative to the matched citizens of the same age was decreased with age; the relative risk ratio was 3.08 for patients aged ＜65 years (P=0.001) and 0.60 for those aged ≥ 85 years (P=0.016). Current smoking, body mass index ≥ 25 kg/m2, hyperlipidemia, diabetes mellitus, and dialysis dependence were inversely associated with age (all P＜0.05). Conclusion Mortality risk increased with age, but the risk ratio relative to the matched citizens decreased with age. Younger patients had a higher mortality risk relative to the matched citizens, whereas patients aged ≥ 85 years had a lower mortality risk relative to the matched citizens. Younger patients were more likely to accumulate cardiovascular risk factors.

Aim This study aimed to demonstrate the clinical impact of various frailty-related aspects in poor-risk patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). Methods We analyzed a clinical database of a prospective multicenter observational study. A total of 562 CLTI patients who required assistance for their daily lives and were candidates for revascularization were included. We examined various measures of frailty severity, including activities of daily living (ADL)/mobility, physical performance, nutritional status, cognitive function, and cardiac function at baseline (before revascularization). Data on inflammatory markers at baseline and ADL/mobility before CLTI onset were also collected. Results The patients were aged 77±10 years, 65% were non-ambulatory, and 38% were categorized as mild dementia or severer. The correlation coefficients between the frailty measures ranged from 0.00 to 0.91. The random forest analysis for one-year mortality risk showed that these frailty-related measures, as well as age and inflammatory markers, had a relatively high variable importance compared with comorbidities and limb severity. Conclusion The correlations between measures of frailty severity were not always strong but rather widely varied in CLTI patients who required assistance for their daily lives and were candidates for revascularization. Measures of frailty severity, as well as age and inflammatory markers, had a relatively large predictive impact on one-year mortality risk compared with comorbidities and limb severity in the population.

The current study aimed to reveal clinical features and prognosis of asymptomatic contralateral limbs in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI).We analyzed a database of 520 CLTI patients registered in a prospective, multicenter registry in Japan. Severe ischemia in asymptomatic contralateral limbs was determined as the Wound, Ischemia, and foot Infection (WIfI) classification system Ischemia (I) grade 2/3.The prevalence of diabetes mellitus and dialysis-dependent renal failure was 74.2% and 53.5%, respectively. Asymptomatic limbs accounted for 65.0% [95% confidence interval (CI), 60.9-69.1%] of the overall population, and 55.0% (95% CI, 49.6-60.4%) of the asymptomatic contralateral limbs had WIfI I-2/3. The multivariate analysis identified age ≥65 years, dialysis-dependent renal failure, WIfI I-3 in the index limb, and loss of pressure sensation in the contralateral limb as independent risk factors for WIfI I-2/3 in asymptomatic contralateral limbs (all p 0.05). The 3-year cumulative incidence rate of major adverse limb events (MALE) in asymptomatic contralateral limbs was 19.3% (95% CI, 15.1-23.7%), whereas that of all-cause mortality was 46.9% (95% CI, 41.0-52.5%). The corresponding rate including a composite of mortality and MALE was 58.8% (95% CI, 52.9-64.6%). In asymptomatic contralateral limbs, the adjusted hazard ratio of WIfI I-2/3 versus I-0/1 was 1.53 (95% CI, 1.11-2.10) for a composite of mortality and MALE, 1.96 (95% CI, 1.14-3.36) for MALE, and 1.37 (95% CI, 0.95-1.96) for mortality (p = 0.009, 0.015, and 0.091, respectively).Two-thirds of CLTI patients had an asymptomatic contralateral limb, and approximately half of the asymptomatic contralateral limbs were exposed to severe ischemia. Older age, dialysis-dependent renal failure, WIfI I-3 in the index limb, and loss of pressure sensation in the contralateral limb were independently associated with severe ischemia in asymptomatic contralateral limbs. In addition to mortality, MALE commonly occurred in asymptomatic contralateral limbs, especially with WIfI I-2/3.

Purpose: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). Materials and Methods: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. Conclusion: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

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

Aim: The aim of the current study was to describe the clinical profile, frequency of in-hospital complications, and predictors of adverse events in patients undergoing endovascular therapy (EVT) for acute limb ischemia (ALI), and to compare them with those of patients undergoing EVT for chronic symptomatic peripheral artery disease (PAD). Methods: The current study compared 2,398 cases of EVT for ALI with 74,171 cases of EVT for chronic symptomatic PAD performed between January 2015 and December 2018 in Japan. We first compared the clinical profiles of ALI patients with those of PAD patients. We then evaluated the proportion of in-hospital complications and investigated their risk factors in the ALI patients. The association of clinical characteristics with the risk of in-hospital complications was analyzed via logistic regression modeling. Results: Patients with ALI were older and had a higher prevalence of female sex, impaired mobility, and history of cerebrovascular disease, but a lower prevalence of cardiovascular risk factors and history of coronary artery disease. The proportion of in-hospital EVT-related complications in ALI was 6.1% and was significantly higher compared with those in chronic symptomatic PAD patients (2.0%, P ＜0.001). Bedridden status (adjusted odds ratio [aOR], 1.74 [1.14 to 2.66]; P =0.010), history of coronary artery disease (aOR, 1.80 [1.21 to 2.68]; P =0.004), and a suprapopliteal lesion (aOR, 1.70 [1.05 to 2.74]; P =0.030) were identified as independent risk factors for in-hospital complications. Conclusion: The current study demonstrated that ALI patients with significant comorbidities show a higher proportion of in-hospital complications after EVT.

Aim Originally developed for predicting the risk of stroke in patients with atrial fibrillation (AF), the CHA2DS2-VASc score also has the potential to predict the risk of other cardiovascular disease. This study aimed to investigate the prognostic value of the CHA2DS2-VASc score in patients with peripheral artery disease (PAD) requiring Femoral popliteal (FP) endovascular therapy (EVT). Methods This multicenter, retrospective study analyzed the clinical database of 2190 patients who underwent FP EVT for symptomatic PAD (Rutherford categories 2-4) between January 2010 and December 2018. We calculated the CHA2DS2-VASc score and then investigated the association between the score, as well as AF, and their prognosis. Outcome measures were major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs). Results During a median follow-up of 3.0 years (interquartile range, 1.5-5.0 years), 532 MACEs and 562 MALEs occurred. The CHA2DS2-VASc score and AF were independently associated with an increased risk of MACEs; their adjusted hazard ratios [95% confidence intervals] were 1.28 [1.20-1.36] (P＜0.001) per 1-point increase and 1.49 [1.06-2.09] (P=0.022), respectively. The CHA2DS2-VASc score was almost linearly associated with MACEs, without any clear threshold point. On the other hand, these variables were not associated with MALEs risk (P=0.32 and 0.48). Conclusion The CHA2DS2-VASc score and AF were independently associated with the increased risk of MACEs but not of MALEs in patients with symptomatic PAD who underwent FP EVT. The score might be useful in stratifying the MACEs risk in this type of patients.

Although recent advances in endovascular devices have markedly improved clinical outcomes of femoropopliteal endovascular therapy, lesions located in the popliteal artery are still a major challenge. This study aimed to determine the association of cardiovascular risk factors, including smoking, diabetes mellitus, and dialysis-dependent renal failure, with the location of atherosclerotic lesions in femoropopliteal artery disease.We used a multicenter prospective study database registering patients with symptomatic femoropopliteal artery disease undergoing drug-coated balloon treatment. The analysis included 1912 patients with de novo femoropopliteal lesions. The association of clinical characteristics with popliteal lesions was investigated using the logistic regression model. In addition, the femoropopliteal artery was divided into six segments (the proximal, middle, and distal portions of the superficial femoral artery and P1, P2, and P3 segments of the popliteal artery), and the association of clinical characteristics with the presence of atherosclerotic lesions in the respective arterial segments was investigated.Smoking and dialysis-dependent renal failure showed a statistically significant inverse and positive association with the presence of popliteal lesions, respectively (adjusted odds ratio, 0.66 [95% confidence interval, 0.51-0.85] and 2.01 [1.62-2.49]; P=0.001 and P＜0.001), whereas diabetes mellitus did not (P=0.17). The subsequent per-segment analysis presented similar results.Smoking was inversely associated with popliteal lesions, whereas renal failure on dialysis was positively associated in patients with symptomatic femoropopliteal artery disease who underwent drug-coated balloon treatment. Diabetes mellitus was not significantly associated.

It remains unclear whether the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria could apply to peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT).We sought to evaluate the application of the ARC-HBR criteria to PAD patients undergoing EVT with contemporary drug-coated devices (DCD) for femoropopliteal artery lesions.Between May 2012 and December 2019, 542 consecutive patients undergoing EVT with DCD for femoropopliteal artery lesions were retrospectively analysed. The primary study endpoint was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5.Of 542 patients, 435 (80.3%) were stratified into the HBR group. The cumulative 5-year incidence of major bleeding events was significantly higher in the HBR group than in the no-HBR group (31.9% vs 2.3%; p0.001). The 5-year major bleeding event rate gradually increased with the number of ARC-HBR criteria (≥2 major criteria: 48.6%, 1 major: 33.1%, ≥2 minor: 12.9%, and non-HBR: 2.3%; p0.001). Major bleeding events were associated with a 5.4-fold increased risk of mortality (adjusted hazard ratio: 5.42, 95% confidence interval: 2.91-10.1; p0.001). Severe chronic kidney disease, heart failure, and severe anaemia were predictors of major bleeding events.80.3% of PAD patients undergoing EVT for femoropopliteal artery lesions with contemporary drug-coated devices met the ARC-HBR criteria. Given that major bleeding events remarkably increased the risk of mortality after EVT, the ARC-HBR criteria might be helpful for the risk stratification of PAD patients who undergo EVT with contemporary DCD.

To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1–6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events. Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined. The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

Background: The objective of the RANGER II SFA long lesion cohort analysis was to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) in patients with lesion lengths greater than 100 mm. Methods: Patients from the RANGER II SFA randomized controlled trial and long balloon sub-study were included in the long lesion cohort if their baseline lesion measurement was > 100 mm and if they had been treated with a RANGER DCB. Patients had symptomatic lower limb peripheral artery disease and Rutherford classification 2–4 symptomatology. The endpoints of interest included the 12-month target lesion primary patency and freedom from major adverse events (MAEs).Additional patient outcomes including changes in Rutherford classification were also evaluated. Results: A total of 129 patients met the inclusion criteria and were included in the long lesion cohort. Mean lesion length was 144.5 ± 31.7 mm. Seventy-five lesions had Peripheral Arterial Calcium Scoring System (PACSS) grades 3 (33.3%, 43/129) and 4 (24.8%, 32/129). The Kaplan–Meier estimate of the primary patency rate at 12 months was 88.0%. The rate of freedom from MAEs at 12 months was 95.1% (117/123; 95% CI: 89.7%, 98.2%); all MAEs were clinically driven target lesion revascularization (4.9%, 6/123). The 12-month mortality rate was 2.4% (3/125). Conclusions: Patients with lesions > 100 mm treated with Ranger DCBs demonstrated excellent 1-year safety and efficacy results, comparable to those of the overall RANGER II SFA randomized clinical trial. This suggests that the Ranger DCB can provide consistent results regardless of lesion length. (ClinicalTrials.gov Identifier: NCT03064126)

Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Purpose: Revascularization of both endovascular therapy (EVT) and surgical reconstruction improve clinical outcomes of patients with critical limb ischemia (CLI); however, treatment of dialysis-dependent patients with CLI is still challenging. This study aimed to investigate the impact of dialysis-related parameters on the risk of mortality in dialysis-dependent patients undergoing revascularization for CLI. Materials and Methods: We retrospectively identified 274 dialysis-dependent patients with CLI (196 males; mean age 71 years), who underwent revascularization, from the clinical database of the surgical reconstruction vs peripheral intervention in patients with critical limb ischemia (SPINACH) study, which was a prospective, multicenter, observational study. Of these patients, 175 patients underwent EVT and 99 patients received surgical reconstruction. The current study evaluated the impact of dialysis vintage and renal biomarkers on the mortality rate of dialysis-dependent patients with CLI undergoing revascularization. Results: During a mean follow-up period of 1.7 ± 1.1 years, 147 deaths were observed. The 3-year overall survival rate and its standard error were estimated to be 40.5% ± 8.1% using the Kaplan-Meier method. A Cox proportional hazard analysis revealed that dialysis vintage ≥4 years, serum creatinine levels 2/dL2 were independent risk factors for mortality after adjustment for the detailed mortality risk score developed in the SPINACH study. Adding these parameters to the original mortality risk score slightly, but not significantly, increased the area under the time-dependent receiver operating characteristics curve from 0.74 (95% CI, 0.67 to 0.81) to 0.77 (0.71 to 0.84) (p=0.084), whereas continuous net reclassification improvement reached 0.75 (0.12 to 0.90) (p=0.027). Conclusion: We found that long dialysis vintage, low serum creatinine, high serum urea nitrogen, and high calcium-phosphate product were independently associated with the increased risk of mortality in dialysis-dependent patients with CLI undergoing revascularization.

The current study aimed to reveal the clinical impact of plasma homocysteine levels in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization. This was a sub-analysis of a prospective multicenter registry of CLTI patients, named the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH) study. The current analysis included 192 non-dialysis-dependent CLTI patients who underwent revascularization for CLTI, and whose plasma homocysteine levels at baseline were available. The association of clinical characteristics with homocysteine levels was evaluated with the linear regression model. The association of homocysteine levels with the mortality risk was investigated using the Cox proportional hazards regression model. Cystatin C-based estimated glomerular filtration rate (eGFR) was independently associated with log-transformed homocysteine levels; the adjusted standardized regression coefficient (95% confidence interval) was − 0.432 (− 0.657 to − 0.253; P P = 0.017); the unadjusted hazard ratio was 1.71 (1.13–2.50) per twofold increase. The association was significantly attenuated when adjusted for cystatin C-based eGFR (P P = 0.29). An apparent association of homocysteine levels with an increased risk of mortality could be explained by renal dysfunction. Future studies will be needed to validate the current findings.

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

Aim: To investigate the associations between preoperative characteristics and the risk of reintervention in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) in a contemporary real-world setting. Methods: We retrospectively analyzed data from a clinical database formed by the Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study, which was a multicenter, prospective, observational study. The study population was composed of 520 CLTI patients with the wound, ischemia, and foot infection (WIfI) classes I-3 with resting pain or classes I-2/3 with ulcers/gangrene. Of the 520 patients, 192 had surgical reconstruction planned, whereas 328 had endovascular therapy (EVT) alone planned at the time of registration. The current analysis was conducted to explore the associations between preoperative characteristics and the risk of reintervention. Results: A total of 452 participants (87%) completed the 3-year follow-up regarding reintervention. The competing risk analysis estimated that the three-year cumulative incidence rates for reintervention and reintervention-free deaths were 44.0% and 28.7%, respectively. No preoperative characteristics had a significant interaction effect with EVT versus surgical reconstruction. The risk analysis identified the following independent risk factors for reintervention: 1) EVT instead of bypass reconstruction, 2) renal dysfunction, 3) history of revascularization after CLTI onset (i.e., requirement of redo revascularization for CLTI), and 4) bilateral CLTI. Patients with more than one of these risk factors had an increased risk of reintervention. Conclusions: The current study identified preoperative characteristics associated with an increased risk of reintervention. No preoperative characteristics had any significant interactions with EVT or surgical reconstruction.

To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT). IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30–140 mm, Rutherford category 2–4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow. At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan–Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings. Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events. Clinical trial Registration: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015. Level of evidence: Level 1; randomized controlled trial.

BACKGROUND Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality. OBJECTIVES To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. METHODS The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. RESULTS The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p

Purpose:To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.Materials and Methods:The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.Results:Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.Conclusion:The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

Purpose: To investigate the incidence and clinical predictors, including institutional annual case volume, of critical in-hospital complications after endovascular therapy (EVT) for peripheral artery disease (PAD). Materials and Methods: The data were extracted from the nationwide registry of peripheral interventions in Japan [Japanese EVT (J-EVT)] between 2012 and 2017. A total of 92,224 EVT cases either for chronic limb-threatening ischemia (CLTI) or intermittent claudication were included in the analysis. The primary outcome measure was critical in-hospital complications, which were defined as a composite of urgent surgery and in-hospital death within 30 days after EVT. The institutional volume was classified into quartiles. The association of institutional volume, as well as baseline characteristics, with the critical in-hospital complications was explored using a multivariable logistic regression model with multiple imputation for missing data. Results are presented as the adjusted odds ratio (OR) with the 95% confidence intervals (CI). Results: The estimated prevalence of critical in-hospital complications was 0.3% (95% CI 0.3% to 0.4%). The following 10 patient- and limb-related characteristics were identified as independent risk factors for critical in-hospital complications: (1) female sex (OR 1.75, 95% CI 1.36 to 2.25), (2) age ≥75 years (OR 1.60, 95% CI 1.06 to 2.40), (3) CLTI (OR 2.12, 95% CI 1.47 to 3.05), (4) nonambulatory status (OR 1.66, 95% CI 1.23 to 2.24), (5) regular dialysis (OR 1.35, 95% CI 1.02 to 1.77), (6) cerebrovascular disease (OR 1.76, 95% CI 1.33 to 2.33), (7) urgent revascularization (OR 5.10, 95% CI 3.64 to 7.13), (8) aortoiliac TASC II D lesion (OR 3.65, 95% CI 2.51 to 5.33), (9) femoropopliteal TASC II D lesion (OR 1.77, 95% CI 1.24 to 2.52), and (10) infrapopliteal TASC D lesion (OR 1.52, 95% CI 1.08 to 2.13). In addition, the 4th quartile of the institutional volume (≥158 cases/year), but not the 2nd or 3rd quartile, had a significantly and independently lower risk of critical in-hospital complications than the 1st quartile (OR 0.13, 95% CI 0.07 to 0.23). Conclusion: After EVT for symptomatic PAD, 0.3% of the population encountered critical in-hospital complications. A higher institutional volume was significantly associated with a lower risk of critical in-hospital complications.

Purpose: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT). Materials and Methods: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI). Results: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%). Conclusion: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group.

Aim: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX. Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year. Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P = 0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p = 0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P = 0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P = 0.08). Stent thrombosis was not observed in either group. Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Treatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined.This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease.As a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed.A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044).The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.

Endovascular repair for brachiocephalic artery aneurysms (BAAs) and subclavian artery aneurysms (SAAs) is often unclear. We treated 2 such cases percutaneously with covered stents. It may be an alternative to surgical repair for patients with isolated BAA or SAA. (

Background: The scope of clinical guidelines for the management of chronic limb-threatening ischemia (CLTI) is limited to atherosclerotic disease of the lower-extremity arteries. This study aimed to reveal the clinical features and prognoses of CLTI due to inflammatory nonatherosclerotic etiologies undergoing revascularization. Methods: DECOPON (DatabasE of ChrOnic limb-threatening ischemia Presenting ischemic ulcer and gangrene due to nON-atherosclerotic disease) is a multicenter retrospective study that evaluated 465 limbs of 414 patients with CLTI undergoing revascularization for ischemic tissue loss with inflammatory nonatherosclerotic etiologies between 2010 and 2020. Clinical features and prognoses were compared with 930 limbs of 809 patients with atherosclerotic CLTI during the same period. Results: The frequency of conventional atherosclerotic risk factors was significantly lower in the inflammatory nonatherosclerotic group. The inflammatory nonatherosclerotic group had more severe WIfI (wound, ischemia, and foot infection) W and fI grades, and more frequent infrapopliteal and inframalleolar artery diseases with a rarer presence of arterial calcification (all p < 0.05). Adjunctive therapy was more frequently performed in the inflammatory nonatherosclerotic group ( p < 0.05). The inflammatory nonatherosclerotic group had a lower incidence rate of wound healing (0.64-fold, p < 0.001) and a higher incidence rate of major reintervention (2.30-fold, p = 0.006), whereas the risk ratio of all-cause mortality was 0.83-fold ( p = 0.067). The association of inflammatory nonatherosclerotic disease with the delayed wound healing and the susceptibility to major reintervention remained significant even after adjustment for covariates (both p < 0.001). Conclusions: Patient, limb, and lesion characteristics of inflammatory nonatherosclerotic CLTI were considerably different from those of atherosclerotic CLTI. Inflammatory nonatherosclerotic CLTI was less likely to heal than atherosclerotic CLTI.

Purpose: Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear. Materials and Methods: Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect. Results: The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (Conclusion: In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. Clinical Impact EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

Although symptomatic peripheral arterial disease (PAD) is common in patients with hemodialysis (HD), few studies have evaluated the long-term clinical outcomes of revascularization in this population. The aim of the current study was to investigate the 10-year clinical outcomes of HD patients with PAD undergoing endovascular therapy (EVT). We retrospectively analyzed 750 limbs from 578 HD patients with symptomatic PAD due to infrainguinal lesions, treated with EVT, between May 2004 and November 2011. The primary outcome was 10-year mortality and the secondary outcome was 10-year freedom from major adverse limb events (MALEs). Predictors for each outcome were evaluated by Cox proportional-hazards model. The 10-year rate of survival and freedom from MALEs was 23.6 ± 3.1% and 76.4 ± 2.9%, respectively. In the multivariate analysis, patients with over 80 years [hazard ratio (HR) 2.10; 95% confidence interval (CI) 1.58-2.80; p 0.001], non-ambulatory status (HR 1.55; 95% CI 1.19-2.03; p = 0.001), absence of hypertension (HR 1.59; 95% CI 1.19-2.08; p = 0.001), heart failure (HR 1.36; 95% CI 1.02-1.80; p = 0.03), and tissue loss (HR 1.65; 95% CI 1.28-2.12; p 0.001) were at an increased risk of 10-year mortality. Cerebrovascular diseases (HR 1.60; 95% CI 1.03-2.49; p = 0.038), no cilostazol use (HR 1.69; 95% CI 1.09-2.70; p = 0.021), tissue loss (HR 3.87; 95% CI 2.37-6.34; p 0.001), and poor below-the-knee (BTK) run-off (HR 1.68; 95% CI 1.04-2.71; p = 0.035) were significantly associated with MALEs. After risk stratification analysis based on risk score assignment according to number of predictors, 10-year survival and freedom from MALE were lower in the higher score groups (10-year survival rates according to number of risk factors: 0, 35.1%; 1, 20.3%; 2-5, 10.8%; respectively, p 0.001, 10-year freedom from MALE rates in patients with greater number of risk factors: 0-1, 90.2%; 2-3, 65.5%; 4-5, 61.6%; respectively, p 0.001). The 10-year clinical outcomes after EVT for HD patients with PAD due to infrainguinal disease were clinically suboptimal. Risk stratification based on these predictors before EVT would be useful in estimating future adverse outcome.

This study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice.Although clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated.This multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9 cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration.The 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration.This study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted.

Background To confirm the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) based on the indication approved by the Pharmaceuticals and Medical Devices Agency Japan in real-world patients with femoropopliteal artery disease.Methods and Results:IN.PACT PMS Japan was a prospective, multicenter, single-arm, post-market surveillance (PMS) study conducted in Japan that enrolled 304 participants (mean age 75.3±7.9 years). The primary endpoint was primary patency at 6 months following the index procedure, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤2.4 (assessed by the independent DUS core laboratory). Secondary endpoints included acute outcomes, primary patency at 12 months post-index procedure, freedom from CD-TLR, and major adverse events at 12 months. The mean lesion length was 97.81±58.97 mm. The primary endpoint, 6-month primary patency, was 91.3% (240/263). Kaplan-Meier estimates of primary patency and freedom from CD-TLR through 12 months were 91.5% and 94.1%, respectively. The CD-TLR rate was 5.8% (14/240) with low rates of thrombosis (0.8%) and target limb amputation (0.4%) at 12 months. Conclusions The results of this real-world PMS study were consistent with outcomes from previous IN.PACT DCB studies, confirming the safety and efficacy of the IN.PACT Admiral DCB for broader use in patients seen in everyday practice.