Comparison of Subsequent Inframalleolar Bypass Surgery and Repeat Endovascular Therapy for Infrapopliteal Restenosis in Patients With Chronic Limb-Threatening Ischemia Undergoing Primary Endovascular Therapy.

PURPOSE: Although endovascular therapy (EVT) is considered a vital strategy for treating infrapopliteal lesions in chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT exceeds that after bypass surgery (BSX). The optimal approach for managing infrapopliteal lesion recurrence in patients with CLTI and unhealed ulcers remains uncertain. This study aimed to evaluate the clinical outcomes of repeat EVT and subsequent inframalleolar BSX for CLTI with infrapopliteal lesion recurrence. MATERIALS AND METHODS: We conducted a retrospective analysis of 140 patients with CLTI (mean age, 70±10 years; male, 71.4%; diabetes mellitus, 73.6%; dialysis, 74.3%; Rutherford 5, 79.3%; and Rutherford 6, 20.7%) who had an unhealed wound due to the recurrence of infrapopliteal lesions between January 2015 and May 2020. We compared the clinical outcomes of 40 patients who underwent the subsequent inframalleolar BSX with those of 100 patients who underwent repeat EVT. The outcome measures were amputation-free survival (AFS) and wound healing rate. Propensity score matching analysis was conducted to minimize differences in baseline characteristics. RESULTS: Propensity score matching extracted 38 pairs (38 patients in the subsequent BSX group and 83 patients in the repeat EVT group). AFS was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). No baseline characteristics had any significant interaction effect on the association between repeat EVT, subsequent BSX, and failure of AFS. CONCLUSION: This study using propensity score matching revealed that the clinical outcomes following repeat EVT were comparable with those following subsequent inframalleolar BSX, indicating that repeat EVT may be a viable treatment option for CLTI with infrapopliteal lesion recurrence. CLINICAL IMPACT: Although endovascular therapy (EVT) has expanded the treatment options for chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT is higher than that after bypass surgery (BSX). This retrospective study compared the clinical outcomes of repeat EVT with those of subsequent BSX for CLTI with infrapopliteal lesion recurrence. After propensity score matching, amputation-free survival (AFS) was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). There was no difference between the 2 revascularization strategies when treating infrapopliteal restenosis lesions.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

PURPOSE: Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. METHODS: This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. RESULTS: A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). CONCLUSIONS: This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. CLINICAL IMPACT: One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

BACKGROUND: Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. MATERIALS AND METHODS: Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. RESULTS: After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). CONCLUSION: In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). CLINICAL IMPACT: The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Impact of Infrapopliteal Revascularisation Establishing In Line Flow to the Wound in Patients with Chronic Limb Threatening Ischaemia.

OBJECTIVE: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow. METHODS: The Wound-directed Angiosome RevasculaRIzation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score. RESULTS: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher incidence of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association of IFW with wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51). CONCLUSION: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI.

Impact of intravascular ultrasound-guided endovascular therapy on periprocedural outcomes in patients with lower-extremity artery disease.

BACKGROUND: Although technological improvements in intravascular ultrasound (IVUS) may reduce technical failures in endovascular therapy (EVT), perioperative complications (POCs) associated with IVUS use may increase. AIMS: This study investigated the impact of IVUS on periprocedural outcomes in symptomatic lower-extremity artery disease (LEAD) patients undergoing EVT. METHODS: This study evaluated 28,088 symptomatic LEAD patients who underwent EVT between January 2021 and December 2021 using a prospective nationwide registry in Japan. Outcome measures included periprocedural outcomes, including technical failure and POCs. To compare outcomes with and without IVUS use, propensity score matching analysis was performed for overall and for each arterial region (aortoiliac [AI], femoropopliteal [FP], and infrapopliteal [IP] arteries) using a binary logistic regression model. RESULTS: IVUS was used in 75%, 72%, and 37% of AI, FP, and IP lesions, respectively. After propensity matching extraction, the IVUS group had a tendency of lower technical failure rate than the non-IVUS group, although not statistically different (3.9% vs. 5.4%, p = 0.054), without an increase in the POC rate (1.8% vs. 1.6%, p = 0.54). Regarding the per-regional analysis, the technical failure rate of FP-EVT was significantly lower in the IVUS group (3.1% vs. 4.2%, p = 0.006), whereas those of AI-EVT (2.2% vs. 3.1%, p = 0.12) and IP-EVT (6.8% vs. 6.1%, p = 0.37) were not significantly different between the two groups. Furthermore, IVUS did not increase the POC rate for any region (AI-EVT: 1.3% vs. 1.3%, p = 1.00; FP-EVT: 1.8% vs. 1.7%, p = 0.75; and IP-EVT: 2.0% vs. 1.7%, p = 0.56). CONCLUSION: The current study revealed that IVUS did not increase the POCs and technical failure for overall lesions but reduced the incidence of FP-EVT technical failure.

Impact of Masticatory Performance and the Tongue-Lip Motor Function on Incident Adverse Health Events in Patients with Metabolic Disease.

AIM: The present study aimed to determine whether decreased masticatory performance and tongue-lip motor function are associated with an increased incidence of adverse health events in patients with metabolic disease. METHODS: One thousand patients with metabolic diseases including diabetes, dyslipidemia, hypertension, and hyperuricemia were recruited. Masticatory performance was assessed using a gummy jelly test, wherein glucose elution from chewed gummy jelly was measured. The tongue-lip motor function was measured using repeatedly pronounced syllables per second. Their association with the incidence of adverse health events (a composite of all-cause death, cardiovascular disease, bone fracture, malignant neoplasm, pneumonia, and dementia) was investigated using the generalized propensity score (GPS) method. RESULTS: During a median follow-up period of 36.6 (interquartile range, 35.0-37.7) months, adverse health events were observed in 191 patients. The GPS adjusted dose-response function demonstrated that masticatory performance was inversely associated with the incidence of adverse health events. The 3-year incidence rate was 22.8% (95% confidence interval, 19.0-26.4%) for the lower quartile versus 13.6% (10.5-16.7%) for the upper quartile (P＜0.001). Similarly, the tongue-lip motor function was inversely associated with the incidence of adverse health events, with a 3-year incidence rate of 23.6% (20.0-27.0%) for the lower quartile versus 13.2% (10.4-15.9%) for the upper quartile (P＜0.001). CONCLUSIONS: Decreased masticatory performance and tongue-lip motor function were associated with an increased incidence of adverse health events in patients with metabolic disease.

Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study.

BACKGROUND: Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. MATERIALS AND METHODS: This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. RESULTS: The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). CONCLUSIONS: The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.

Lower extremity arterial disease vs. coronary artery disease: mortality differences after revascularization.

BACKGROUND AND AIMS: Patients undergoing revascularization for lower extremity arterial disease (LEAD) may face a higher risk of mortality than those with coronary artery disease (CAD). This study aimed to characterize the difference in mortality risk between patients undergoing revascularization for LEAD and CAD and identify associated factors. METHODS: The 1-year database of 10 754 patients undergoing revascularization for CAD (n = 6349) and LEAD (n = 4405) was analysed. Poisson regression models were used to characterize interpopulation differences in mortality, adjusting for baseline clinical features, including age, sex, polyvascular disease, comorbidities, medications, and vulnerabilities. RESULTS: Individuals with LEAD were older, were more likely to have polyvascular disease, had more comorbidities, and received fewer cardioprotective drugs than those with CAD. Vulnerabilities remained more common in the LEAD group even after adjusting for these clinical features. The crude risk ratio of mortality incidence for LEAD vs. CAD was 2.91 (95% confidence interval, 2.54-3.34), attenuated to 2.14 (1.83-2.50) after controlling for age, sex, and polyvascular disease. The percentage attenuation in the excessive mortality associated with LEAD was 29%. The stepwise addition of comorbidities, medications, and vulnerabilities as adjusting factors attenuated the incidence risk ratio to 1.48 (1.26-1.72), 1.33 (1.12-1.58), and 1.17 (0.98-1.39), respectively, and increased the percentage attenuation to 64%, 73%, and 86%, respectively. CONCLUSIONS: Mortality risk was almost three-fold higher in patients undergoing revascularization for LEAD than in those with CAD. The excessive mortality was considerably attributable to inter-group differences in baseline characteristics, including potentially clinically or socially modifiable factors.

Evaluating the Effectiveness and Clinical Outcomes of Endovascular Aneurysm Repair-First Approach for Ruptured Abdominal Aortic Aneurysm in Japan.

PURPOSE: To verify the validity of an endovascular aneurysm repair (EVAR)-first strategy for treating patients with ruptured abdominal aortic aneurysm (rAAA) in Japan. MATERIALS AND METHODS: This study was conducted on 2 groups of patients with rAAA who underwent surgical treatment at 3 hospitals in the Kanagawa Prefecture, Japan, between January 2007 and September 2016. The open surgical treatment group comprised patients with rAAA who underwent open surgical treatment before January 2012; their data were retrospectively collected from their medical records. The EVAR-first strategy group comprised patients with rAAA who underwent treatment based on the Shonan rAAA protocol (SRAP; the standard protocol-based EVAR-first strategy) in or after February 2012; their data were collected prospectively. The short- and long-term treatment outcomes of both groups were compared. In addition, a risk score-based sensitivity analysis (one-to-one matching) was conducted on both groups using a caliper with 0.2 standard deviations of the score. RESULTS: Of the 163 patients with rAAA, the open surgical and EVAR-first strategy groups comprised 53 and 110 patients, respectively (EVAR: 91.8%, open repair: 8.2%). The 30-day postoperative mortality rate differed significantly, being 42% for the open surgery group and 25% for the EVAR-first strategy group (odds ratio: 0.44, 95% confidence interval: 0.20-0.97). The postoperative survival rates at 6 months, 1 year, and 3 years were 66%, 48%, and 58% for the EVAR-first group, respectively, and 51%, 66%, and 48% for the open surgery group, respectively (p=0.072). In a matched cohort analysis (n=50), the 30-day postoperative mortality rate was 22% for the EVAR-first group and 44% for the open surgery group (odds ratio: 0.35, 95% confidence interval: 0.14-0.90). The postoperative survival rates at 6 months, 1 year, and 3 years were 76%, 76%, and 63% for the EVAR-first group, respectively, and 48%, 45%, and 45% for the open surgery group, respectively (p=0.003). CONCLUSION: The SRAP-based EVAR-first strategy for rAAA yielded significantly better treatment outcomes than the open surgical strategy. These findings suggest that EVAR should be considered the primary treatment option for rAAA, given its potential to reduce early mortality rates. CLINICAL IMPACT: Multicenter retrospective analysis of prospectively collected registry data was done to compare treatment outcomes of two groups of ruptured abdominal aortic aneurysm patients open surgery and endovascular-aneurysm-repair (EVAR)-first strategy (Shonan ruptured abdominal aortic aneurysm protocol). EVAR-first group showed better outcomes: lower 30-day mortality (25% vs. 42%), higher survival rates at 6 months, 1 year, and 3 years. Take home Message: The study supports the use of the EVAR-first strategy with the Shonan Protocol for treating ruptured abdominal aortic aneurysms in Japan, showing improved outcomes, reduced 30-day postoperative mortality, and better long-term survival rates compared to the conventional approach.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Impact of baseline yellow plaque assessed by coronary angioscopy on vascular response after stent implantation.

BACKGROUND: The relationship between baseline yellow plaque (YP) and vascular response after stent implantation has not been fully investigated. METHODS: This was a sub-analysis of the Collaboration-1 study (multicenter, retrospective, observational study). A total of 88 lesions from 80 patients with chronic coronary syndrome who underwent percutaneous coronary intervention were analyzed. Optical coherence tomography (OCT) and coronary angioscopy (CAS) were serially performed immediately and 11 months after stent implantation. YP was defined as the stented segment with yellow or intensive yellow color assessed by CAS. Neoatherosclerosis was defined as a lipid or calcified neointima assessed by OCT. OCT and CAS findings at 11 months were compared between lesions with baseline YP (YP group) and lesions without baseline YP (Non-YP group). RESULTS: Baseline YP was detected in 37 lesions (42 %). OCT findings at 11 months showed that the incidence of neoatherosclerosis was significantly higher in the YP group (11 % versus 0 %, p = 0.028) and mean neointimal thickness tended to be lower (104 ±â€¯43 µm versus 120 ±â€¯48 µm, p = 0.098). CAS findings at 11 months demonstrated that the dominant and minimum neointimal coverage grades were significantly lower (p = 0.049 and P = 0.026) and maximum yellow color grade was significantly higher (p < 0.001) in the YP group. CONCLUSIONS: Baseline YP affected the incidence of neoatherosclerosis as well as poor neointimal coverage at 11 months after stent implantation.

Three-year clinical course after fluoropolymer-based drug-eluting stent implantation for femoropopliteal lesions.

BACKGROUND: Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions. METHODS: This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration. RESULTS: The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively (p < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased (p < 0.001 and p = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years (p = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years (p = 0.69 and 0.20, respectively). CONCLUSIONS: This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration.

Association between infant birth weight and gestational weight gain in Japanese women with diabetes mellitus.

AIMS/INTRODUCTION: In 2021, the guidelines on gestational weight gain (GWG) were revised and increased by 2-3 kg in Japan. This study aimed to investigate whether the revised guidelines would increase the incidence of babies with excessive birth weight in mothers with diabetes. MATERIALS AND METHODS: This retrospective study included 369 deliveries of women with diabetes whose pre-pregnancy body mass index was below 30 kg/m2 between 1982 and 2021. The primary outcome measure was large for gestational age (LGA). We compared the incidence of LGA between women who gained weight within the previous guidelines and women who gained weight within the revised guidelines. We also compared the incidence of macrosomia, preeclampsia, small for gestational age (SGA), and low birth weight. RESULTS: The incidence of LGA was not significantly different between women who gained weight within the revised guidelines and those within the previous guidelines (34.6% [95% confidence interval 25.6-44.6%] for the revised guidelines vs 28.9% [21.6-37.1%] for the previous guidelines; P = 0.246). Neither was the incidence of macrosomia or preeclampsia significantly different (8.7% [4.0-15.8%] vs 5.6% [2.5-10.8%] and 5.8% [2.1-12.1%] vs 6.3% [2.9-11.7%]; P = 0.264 and 0.824, respectively), while women who gained weight within the revised guidelines had a lower incidence of SGA (1.9% [0.2-6.8%] vs 10.6% [6.0-16.8%]; P = 0.001) and low birth weight (1.0% [0.02-5.2%] vs 7.0% [3.4-12.6%]; P = 0.023). CONCLUSIONS: The revised GWG guidelines could be beneficial in women with diabetes in terms of delivering babies with appropriate birth weight.

Effect of sodium-glucose cotransporter 2 inhibitors on serum low-density lipoprotein cholesterol in Japanese patients with type 2 diabetes mellitus.

AIMS/INTRODUCTION: We aimed to evaluate factors that influence changes in blood low-density lipoprotein cholesterol (LDL-C) levels after treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: We retrospectively analyzed clinical data of outpatients newly initiated on SGLT2 inhibitors (n = 176) and other oral antidiabetic drugs (n = 227). The patients were classified into four subgroups according to statin administration and baseline LDL-C levels (<120 or ≥120 mg/dL). Clinical characteristics were compared among the subgroups. Multivariate analysis was carried out to identify factors contributing to changes in LDL-C. RESULTS: The median follow-up period was 13.0 weeks (range 11.9-14.1 weeks, min 8 weeks, maximum 16 weeks) in the SGLT2i group, and 12.0 weeks (range 10.0-14.0 weeks, min 8 weeks, maximum 16 weeks) in the control group. Both groups showed a significant decrease in LDL-C (SGLT2i group -3.8 ± 24.7 mg/dL, control group -3.4 ± 15.0 mg/dL). Multivariate regression analyses showed that in both groups, the change in LDL-C depended on statin use and baseline LDL-C levels. Stratified analyses showed that LDL-C level was significantly decreased in statin users with baseline LDL-C ≥120 mg/dL (from 148.9 ± 33.5 to 109.3 ± 17.9 mg/dL, P = 0.002), and significantly increased in statin non-users with baseline LDL-C <120 mg/dL (from 96.3 ± 27.3 to 104.7 ± 24.8 mg/dL, P = 0.002). These changes were more characteristic for SGLT2 inhibitors than for other oral antidiabetic drugs (P for interaction = 0.010 and <0.001, respectively). CONCLUSIONS: LDL-C levels and statin medication at baseline influence changes in LDL-C after SGLT2 inhibitors treatment in Japanese patients with type 2 diabetes.

Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.

Multicenter Registry of Common Femoral Artery Disease Treated With Endovascular Revascularization Using Interwoven Nitinol Stents: An Observational Retrospective Study.

PURPOSE: Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice. MATERIALS AND METHODS: This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT. RESULTS: This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08-0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56-10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00-9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73-0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04-30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02-6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion. CONCLUSIONS: Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization. CLINICAL IMPACT: This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.

Impact of Procedural Techniques on Midterm Patency of Fluoropolymer-Based Drug-Eluting Stent Placed in the Femoropopliteal Artery.

PURPOSE: To investigate the impact of compliance with recommended procedural techniques on the midterm patency of a fluoropolymer-based drug-eluting stent (FP-DES) in the femoropopliteal artery. MATERIALS AND METHODS: This retrospective study included 200 femoropopliteal lesions (chronic limb-threatening ischemia, 59%; chronic total occlusion, 41%) in 173 patients (male, 66%; diabetes mellitus, 62%; hemodialysis, 40%) with lower extremity arterial disease who underwent intravascular ultrasound (IVUS)-guided endovascular therapy with FP-DES between January 2016 and July 2021. The primary outcome measure was restenosis, defined as a peak systolic velocity ratio of >2.4 based on the duplex US findings. The association between procedural techniques and incidence of restenosis was investigated using Cox proportional hazards regression models. RESULTS: The 2-year cumulative incidence of restenosis was 19.5% (SD ± 3.3). Multivariate analysis revealed that noncompliance with recommended procedural techniques, such as plaque burden at the stent edge of <50%, a minimum stent area (MSA) of >12 mm2, and stent placement within the P1 segment, was independently associated with an increased risk of restenosis (hazard ratios [HRs], 3.22, 4.71, and 4.67 and P = .004, P < .001, and P < .001, respectively). The 2-year restenosis risk for procedures performed in compliance with all 3-technical criteria was 8.4% (SD ± 3.4), whereas the risks for those in compliance with 2-technical criteria or 0- or 1-technical criteria were 25.0% (SD ± 6.2) and 48.6% (SD ± 10.4), respectively. HRs relative to 3-technical criteria compliance were 3.79 (P = .007) and 11.85 (P < .001), respectively. CONCLUSIONS: Noncompliance with recommended procedural techniques, including plaque burden at the stent edge of <50%, MSA of >12 mm2, and stent placement within the P1 segment, was significantly associated with an increased risk of 2-year restenosis after FP-DES implantation in the femoropopliteal artery.

Evaluation of changes in glycemic control and diabetic complications over time and factors associated with the progression of diabetic complications in Japanese patients with juvenile-onset type 1 diabetes mellitus.

BACKGROUND: This study aimed to evaluate the changes in glycemic control and diabetic complications over time in Japanese patients with juvenile-onset type 1 diabetes mellitus and to clarify the factors associated with the progression of diabetic complications. METHODS: We tracked 129 patients with type 1 diabetes mellitus (21.8 ± 4.1 years old [mean ± SD] with a diabetes duration of 12.6 ± 5.7 years) for up to 19 years and analyzed data on glycated hemoglobin (HbA1c) and indicators related to the severity of diabetic complications (estimated glomerular filtration rate [eGFR], urinary albumin excretion rate [UAE], carotid intima-media thickness [CIMT], and brachial-ankle pulse wave velocity [baPWV]) using linear mixed model and decision tree analysis. RESULTS: Although the HbA1c and UAE levels improved over time, the eGFR, CIMT, and baPWV worsened. Decision tree analysis showed that HbA1c and the glycoalbumin/HbA1c ratio for eGFR; HbA1c and systolic blood pressure for UAE; low-density lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, glycoalbumin/HbA1c ratio, and body mass index (BMI) for CIMT; and HbA1c for baPWV were associated factors. CONCLUSIONS: In this retrospective observational study, glycemic control and albuminuria improved; however, renal function and arteriosclerosis worsened over time. HbA1c levels, glycemic excursion, and blood pressure are associated with nephropathy progression. HbA1c levels, glycemic excursion, lipid levels, and BMI are associated with the progression of atherosclerosis.