OBJECTIVE:While drug-eluting treatment is a first-line therapy for femoropopliteal (FP) lesions, long-term comparative data between drug-eluting stents (DES) and drug-coated balloons (DCB) in real-world practice are scarce. We aimed to compare the 3-year outcomes of DES versus DCB for symptomatic FP disease. METHODS:We conducted a retrospective analysis of the CILANTRO study, a multicenter registry combining data from the CAPSICUM, POPCORN, and POPCORN Type R studies. Patients treated with either DES or DCB for symptomatic FP lesions were included. To minimize selection bias, we performed 1:1 propensity score matching. The primary outcome was clinically driven target lesion revascularization (TLR), while secondary outcomes included restenosis. RESULTS:A total of 2651 patients treated with DCB and 972 with DES were identified. Propensity score matching extracted 912 pairs with well-balanced baseline characteristics. The median follow-up period was 31.6 months. The 3-year rate of TLR was not significantly different between the DCB and DES groups (23.3% vs. 18.8%; hazard ratio, 1.19 [95% confidence interval, 0.93-1.53]; p = 0.16). Interaction analysis revealed that a more marked increased risk of TLR in the DCB group in patients with semi-compliant balloon use or without non-compliant balloon use (p = 0.017 and 0.018). The 3-year rate of restenosis was significantly higher in the DCB group than in the DES group (38.1% vs. 26.3%; hazard ratio, 1.77 [1.43-2.19]; p < 0.001). CONCLUSIONS:In this propensity score-matched analysis, the 3-year rate of TLR was not significantly different between DCB and DES, although DES demonstrated lower restenosis rate. Nevertheless, DCB remains a clinically viable option, and our sub-analysis suggests that balloon selection for pre-dilatation may influence its efficacy.

Background Chronic limb-threatening ischemia (CLTI) caused by infrapopliteal disease is a major therapeutic challenge, with percutaneous transluminal angioplasty (PTA) associated with high rates of restenosis and reintervention. The LIFE-BTK trial previously demonstrated superior efficacy of the Esprit (Abbott Vascular) BTK drug-eluting resorbable scaffold (DRS) over PTA at 1 year, with sustained benefits at 2 years, with comparable safety at both time points. This report presents the 3-year outcomes. Objectives We aimed to compare the 3-year safety and efficacy of DRS vs PTA in patients with CLTI and infrapopliteal artery disease. Methods In this randomized trial, 261 patients with CLTI were assigned 2:1 to DRS or PTA. The primary efficacy endpoint was freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion. The primary safety endpoint was freedom from major adverse limb events and perioperative death. Results A total of 57% of patients completed the 3-year follow-up. By Kaplan-Meier analysis, the 3-year primary efficacy endpoint was higher with DRS than PTA (59.5% vs 44.8%; P = 0.0025), binary restenosis occurred less frequently with DRS (38.0% vs 49.0%), and CD-TLR was numerically lower with DRS (10.2% vs 18.4%). Limb salvage remained high and comparable (93.8% vs 95.7%), as did the primary safety endpoint (90.8% vs 94.2%). In multivariable Cox regression at 3 years, treatment with DRS was associated with a lower hazard of CD-TLR compared with PTA (HR: 0.46 [95% CI: 0.22-0.97]), with previous minor amputation, greater preintervention stenosis, higher residual stenosis after predilatation, and use of postprocedure dual antiplatelet therapy being independent predictors of CD-TLR. Subgroup analyses showed that outcomes generally favored DRS for patency and reintervention across most patient and lesion characteristics. Conclusions At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile. These findings support the use of DRS in selected patients with CLTI and infrapopliteal disease. (Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee [LIFE-BTK]; NCT04227899)

Patients with chronic limb-threatening ischemia (CLTI) and Global Limb Anatomic Staging System (GLASS) stage IMP2 disease often lack suitable inframalleolar target arteries for distal bypass on conventional imaging, rendering them technically ungraftable. We adopted a staged revascularization strategy consisting of initial infrapopliteal/pedal endovascular therapy (EVT) to establish graftable pedal arteries, followed by distal bypass using autologous saphenous vein grafts before restenosis or reocclusion occurred. Two patients with Rutherford category 5 CLTI underwent this strategy after angiography and duplex ultrasonography failed to identify suitable bypass targets. Distal bypass was successfully performed several weeks and a few days after the initial EVT, respectively. Although restenosis of the graft and pedal arteries occurred during follow-up and required multiple additional EVT procedures, limb salvage was achieved in both patients until death from nonvascular causes at 6 and 12 months after bypass surgery. This staged strategy may represent a feasible treatment option for carefully selected patients with GLASS stage IMP2 CLTI who are initially considered unsuitable for distal bypass.

BACKGROUND:Hemodynamic failure, defined as insufficient postprocedural improvement in limb perfusion, occurs frequently after endovascular therapy (EVT). However, the predictors of hemodynamic failure and its clinical course have not been adequately investigated. This study aimed to investigate the predictors and clinical course of chronic limb-threatening ischemia (CLTI) with hemodynamic failure after EVT. METHODS:This retrospective, multicenter analysis of the SAPLING database included 924 patients with CLTI and tissue loss who underwent EVT between April 2010 and March 2023, with skin perfusion pressure (SPP) measured pre- and postprocedure. Hemodynamic failure was defined as postprocedural SPP < 40 mmHg. Kaplan-Meier analysis evaluated cumulative wound healing, reintervention, and wound recurrence. Logistic regression and Cox proportional hazards models identified predictors of hemodynamic failure and wound healing. RESULTS:Hemodynamic failure occurred in 52.2% (482/924) of cases. Multivariable analysis identified lower preprocedural SPP and the absence of wound blush as independent predictors. Stratified analysis revealed the highest hemodynamic failure rate in patients with preprocedural SPP < 20 mmHg and absent wound blush (66.5%). Patients with hemodynamic failure showed significantly lower wound healing rates and higher rates of reintervention and wound recurrence (all p < 0.05). Factors independently associated with delayed wound healing included age ⩾ 75 years, nonambulatory status, hemodialysis, hemodynamic failure, Wound, Ischemia, and foot Infection (WIfI) stage 4, and the absence of wound blush. CONCLUSIONS:Hemodynamic failure after EVT was common and strongly associated with delayed wound healing, reintervention, and wound recurrence. Preprocedural SPP and wound blush assessment may be useful for identifying patients at high risk for hemodynamic failure.

PURPOSE:To provide recommendations for the most appropriate endovascular intervention of femoropopliteal (FP) arterial disease based on plaque characterization. MATERIALS AND METHODS:A panel of 22 physicians from multiple disciplines participated in a modified Delphi consensus, leveraging the RAND/UCLA Appropriateness Method. Panelists engaged in 2 rounds of voting, following a literature review, with an in-person discussion prior to the second round of voting. A rigorous statistical approach was used to analyze the points of agreement and disagreement. Consensus-based recommendations on the most appropriate endovascular approaches for treating patients with FP lesions, stratified by lesion morphology, were generated. RESULTS:Overall, 490 individual items were included in the voting, 458 (93%) of which achieved consensus and 32 (7%) were nonconsensus items, based on a priori criteria under the following categories: (a) recommendations on method for determining plaque morphology, (b) preferred endovascular devices for vessel preparation and definitive treatment stratified by (i) plaque morphology and (ii) Tosaka classification of in-stent restenosis, and (c) vessel preparation device safety-related considerations. CONCLUSIONS:This international, multidisciplinary consensus provides evidence- and expert-informed recommendations for vessel preparation and definitive treatment of FP arterial disease, tailored to plaque morphology. These consensus recommendations aim to support clinical decision making and promote best interventional practices by serving as an expert opinion supplement to existing guideline-based care pathways.

Distal embolism is a significant complication during endovascular therapy (EVT) for femoropopliteal (FP) lesions. This study describes a novel technique, the Flow-Controlled Anti-embolic Technique (FCAT), designed to prevent distal embolism during complex FP-EVT. The FCAT procedure involves three key steps. First, a balloon-guiding catheter is placed proximal to the target lesion to achieve antegrade flow arrest. Second, an external arteriovenous shunt is created between the femoral artery and vein, establishing continuous flow reversal through collateral pathways. Third, a blood filtration system incorporated within the shunt captures any liberated embolic debris. After establishing flow reversal, standard procedure is initiated. We prospectively evaluated this technique in 31 consecutive patients undergoing EVT for symptomatic FP disease. Technical success of the FCAT procedure was 100%. The primary outcome, angiographically evident distal embolism, did not occur in any patient. Macroscopic embolic debris was captured by the filtration system in all cases, confirming the technique's effectiveness in preventing particle embolization. No major procedure-related complications were observed. The FCAT is a safe and effective technique for preventing distal embolism during complex FP-EVT. By establishing flow reversal before and during intervention, it comprehensively protects the distal vascular bed from distal embolization during any FP-EVT.

To compare endovascular strategies for femoropopliteal lesions extending to the distal popliteal artery (PA). We retrospectively analyzed 275 femoropopliteal lesions extending to the distal PA (P2/P3) treated with drug-coated balloons (DCBs) and/or stents between July 2011 and October 2021. Outcomes were compared among three treatment strategies: full-cover stent (n = 90), full-cover DCB (n = 128), and hybrid therapy (n = 57) defined as stent implantation within P1 combined with DCB treatment in P2/P3. The primary outcomes were restenosis and major adverse limb events (MALE). Adjusted analyses using inverse probability of treatment weighing (IPTW) were performed to account for background differences. Predictors of restenosis were evaluated using Cox proportional hazards models. The 24-month restenosis rate was lowest with hybrid therapy compared to full-cover stent and full-cover DCB (26.7

In-stent occlusions (ISO) in femoropopliteal lesions increase the risk of repeat occlusion after revascularization for ISO and worsen limb prognosis. This study investigated the impact of dual-pathway inhibitor therapy (DPIT) on clinical outcomes after femoropopliteal ISO revascularization. We retrospectively analyzed 120 limbs in 113 symptomatic patients who underwent EVT for femoropopliteal ISO between August 2012 and October 2021. After ISO revascularization, antithrombotic therapy was switched to DPIT in 39 limbs, whereas dual antiplatelet therapy (DAPT) was continued in 81 limbs. The primary endpoint was repeat ISO. Safety endpoints were major bleeding defined as Bleeding Academic Research Consortium (BARC) grade 3 or 5 bleeding and International Society on Thrombosis and Haemostasis (ISTH) major bleeding. Cox proportional hazards models were used to identify prognostic factors. To adjust for baseline imbalances, inverse probability of treatment weighting (IPTW)-weighted Cox model were performed. One-year freedom from repeat ISO was higher with DPIT than with DAPT (74.7 ± 7.9

BACKGROUND:Medial artery calcification (MAC) is a hallmark of lower extremity artery disease, yet its precise distribution and relationship with intimal artery calcification (IAC) remain poorly understood because current clinical imaging modalities have limited ability to reliably distinguish between the 2. OBJECTIVES:The objectives of the study were to comprehensively characterize the histopathological distribution and morphology of MAC and to determine its spatial relationship with intimal atherosclerotic plaque. METHODS:We performed a systematic, section-by-section histopathological analysis of 3,566 cross-sections from 125 arterial segments in 58 patients with lower extremity artery disease. Calcification was quantified by circumferential arc, and plaque morphology was classified according to the modified American Heart Association criteria. RESULTS:MAC was highly prevalent (91.2% of segments) and significantly more extensive in below-the-knee than above-the-knee arteries, whereas IAC demonstrated the opposite distribution. Medial bone formation was identified in 16.0% of segments and was strongly associated with the greatest MAC burden, representing an advanced stage of the disease. In a section-level analysis (n = 3,003), the arcs of MAC and IAC were inversely correlated (r = -0.47; P < 0.0001) and showed minimal circumferential overlap, indicating distinct spatial segregation. Sections with extensive MAC were primarily associated with nonatherosclerotic intima, whereas advanced intimal plaques occurred predominantly in sections with minimal MAC. CONCLUSIONS:MAC and IAC represent spatially distinct calcific pathologies with an inverse quantitative relationship. Advanced MAC may be associated with reduced development of intimal atherosclerotic plaque and may partly explain the limited response of below-the-knee lesions to conventional endovascular therapies.

BACKGROUND:In patients with chronic limb-threatening ischemia (CLTI), a subset of patients are beneficiaries of welfare assistance. We sought to investigate the clinical features and prognosis of patients with CLTI receiving welfare compared to those not receiving welfare in the Japanese population. METHODS:This is a subanalysis of the multicenter, prospective Wound-directed Angiosome RevasculaRIzation apprOach to patients with cRitical limb iSchemia (WARRIORS) registry. We evaluated 440 patients with CLTI accompanied by tissue loss undergoing infrapopliteal revascularization. The outcome measures included a 24-month wound-healing rate, and overall survival and follow-up continuity. We compared the outcomes between the welfare and nonwelfare groups (n = 48 and 392, respectively) using the Kaplan-Meier method and log-rank tests. RESULTS:Frequencies of nonambulatory status, diabetes mellitus, hemodialysis, and wound severity stratified by Wound, Ischemia, and foot Infection classification showed no significant inter-group differences. The number of patients treated with bypass surgery was lower in the welfare group than in the nonwelfare group. The 24-month wound healing and follow-up continuity rates were significantly lower in the welfare group compared to the nonwelfare group (37.3% vs 59.6%, p = 0.005 and 47.9% vs 58.0%, p = 0.048, respectively). In contrast, the 24-month overall survival rate did not differ significantly between the groups (63.1% vs 71.7%, p = 0.27). CONCLUSIONS:Patients receiving welfare had significantly worse wound-healing rates and a higher loss to follow up even within the framework of the Japanese universal health insurance system.

This study aimed to compare the association of statin treatment with incident major adverse cardiovascular event (MACE) between patients undergoing revascularization for symptomatic lower extremity artery disease (LEAD) and those for coronary artery disease (CAD). We enrolled 10,658 patients undergoing revascularization for either symptomatic LEAD or CAD between September 2019 and June 2021. Of them, the present study analysed the 4,861 patients (2,061 and 2,818 patients undergoing revascularization for LEAD and CAD, respectively) who did not receive a statin before revascularization. Of the 4,861 patients, 2,557 patients (408 with LEAD and 2,149 with CAD)initiated statin treatment at revascularization (the statin group), whereas the remaining 2,304 patients (1,635 with LEAD and 669 with CAD) did not (the non-statin group). The median follow-up period was 35.1 (interquartile range, 13.6–38.6) months. The primary outcome measure was the incident of major adverse cardiovascular event (MACE), defined as a composite of non-fatal myocardial infarction, stroke, and cardiovascular death. The propensity score matching extracted 378 pairs in the population with LEAD and 585 pairs in the population with CAD. The hazard ratio of statin treatment for incident MACE was 0.63 (95

ABSTRACT Background Conventional cross‐spline bipolar electrograms (CSBEs) with the pentaspline pulsed field ablation (PFA) catheter suffer from far‐field interference. Intra‐spline bipolar electrograms (ISBEs) can provide more localized data. We evaluated ISBE efficacy in enhancing mapping precision. Methods In 20 AF patients post‐PVI, left atrial maps were constructed. We compared 13 533 CSBEs and 8097 ISBEs for voltage and peak frequency, excluding noise/scar potentials. Results ISBEs yielded significantly higher peak frequencies (median: 236 vs. 185 Hz, p < 0.01) and lower potential voltages (0.47 vs. 0.48 mV, p < 0.01) than CSBEs. Conclusions ISBEs enhance mapping precision by reducing far‐field interference and providing localized electrophysiological data during pentaspline PFA.

Background The internal endoconduit technique may facilitate transfemoral transcatheter aortic valve replacement (TAVR) in complex vascular anatomies. Case Summary A 71-year-old woman with symptomatic severe aortic stenosis and diffusely narrowed iliac and femoral arteries was considered unsuitable for transfemoral access. A staged, internal endoconduit-assisted transfemoral TAVR was performed. First, overlapping VIABAHN covered stent grafts were deployed to create an arterial conduit in iliofemoral arteries. Two weeks later, a 26-mm Evolut FX valve was successfully implanted. Hemostasis was successfully achieved using Perclose ProStyle sutures and an additional stent graft. Discussion The internal endoconduit technique in TAVR has not been previously described in detail. A preprocedural ex vivo simulation was performed to devise an optimal strategy, enabling the safe execution. Take-Home Message The internal endoconduit technique represents a viable alternative for overcoming hostile vascular anatomy during transfemoral TAVR; nonetheless, important considerations remain, such as the interval before TAVR, the graft puncture site, and sheath selection.

OBJECTIVE:Acute limb ischemia may impair functional status and hinder return home after hospitalization, even in patients who survive to discharge. However, the associations among discharge destination, clinical characteristics, and outcomes have not been fully evaluated. METHODS:Using a multicenter registry, we analyzed 769 patients with acute limb ischemia who underwent revascularization between July 2011 and March 2025 and survived to discharge. Nonhome discharge was defined as transfer to another hospital or nursing facility. Multivariable logistic regression incorporating baseline and procedural variables was performed to identify determinants of non-home discharge. One-year mortality after discharge was compared between the home and nonhome discharge groups. RESULTS:Nonhome discharge occurred in 287 patients (37.3%). Multivariable analysis demonstrated that advanced age, nonambulatory status, frailty, prior cerebrovascular disease, hypoalbuminemia, and receipt of public assistance were independently associated with nonhome discharge, as was severe ischemia (Rutherford category IIb/III). Procedural factors, including the need for surgical revascularization and inadequate distal perfusion (final Tibial Infrapopliteal Perfusion Index grade 0-1) were also associated with nonhome discharge. When stratified by cumulative risk burden (0-2, 3-5, ≥6 factors), the incidence of nonhome discharge increased stepwise (18%, 50%, and 92%, respectively; P < .001). One-year mortality was significantly higher among patients with nonhome discharge than among those discharged home (21.2% vs 7.6%; log-rank P < .001). CONCLUSIONS:More than one-third of patients with acute limb ischemia were unable to return home after revascularization. Discharge destination was independently associated with baseline vulnerability, disease severity, and procedural factors, and was linked to increased 1-year mortality.

Background The long-term vascular response to paclitaxel-eluting stents (PESs) in infrapopliteal (IP) lesions remains histologically uncharacterized.Case summary A 78-year-old woman with chronic limb-threatening ischaemia underwent implantation of two overlapping paclitaxel-eluting stents from the tibioperoneal trunk to the peroneal artery for an ischaemic ulcer. Multimodality follow-up imaging was obtained at both 3 and 5 years, including optical frequency domain imaging (OFDI) and angioscopy performed immediately before amputation. At 3 years, OFDI and angioscopy demonstrated uncovered struts with adherent thrombus. At 5 years, OFDI and angioscopy showed mature neointima over the proximal and distal segments but persistent fibrin-coated, uncovered struts within the 40-mm overlap. Progressive ischaemia culminated in below-the-knee amputation, permitting stent explantation. Histopathology confirmed proteoglycan-rich neointima at the non-overlapped segments and delayed healing with fibrin deposition and uncovered struts confined to the overlap.Conclusion The 5-year histological evaluation of the PES revealed paclitaxel-related impaired endothelialization in IP lesions.

Severe calcification in femoropopliteal lesions remains a clinical challenge to achieve both the technical and long-term success in endovascular therapy. Although atherectomy is an effective treatment for calcified lesions, it is associated with the risk of distal embolization, even with the use of embolic protection devices (EPDs), and currently, no definitive strategy has been established to prevent this complication. We present a case successfully treated with atherectomy under EPDs and Parodi Anti-Embolism System (PAES). We report the case of a 77-year-old man with intermittent claudication in the left leg due to a severely calcified lesion in the superficial femoral artery. To mitigate the risk of distal embolization during atherectomy, proximal protection was achieved using Optimo catheter and distal protection was provided by Filtrap device. Additionally, arteriovenous circulation was established via a venous sheath and an external filter chamber, facilitating continuous flow reversal from the artery to the vein and effectively capturing debris within the external chamber. Atherectomy was performed under this double protection system, followed by drug-coated balloon angioplasty. Completion angiography confirmed the absence of distal embolization. Multiple calcified embolic debris were successfully captured by the aspiration system, filter, and filter chamber. This case demonstrates that combining double protection with arteriovenous circulation can establish a reliable flow reversal circuit during atherectomy, effectively preventing distal embolization. This strategy may offer an enhanced protection method for the atherectomy treatment of severely calcified femoropopliteal lesions.

OBJECTIVE:This study aims to analyze available data on patients the latest-generation heparin-bonded Viabahn endoprosthesis in the femoropopliteal artery. DESIGN:This study is an individual patient data (IPD) meta-analysis. METHODS:This study incorporated all available cases from databases that reported outcomes of patients treated with the heparin-bonded Viabahn endoprosthesis in the femoropopliteal artery. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 IPD Guidelines were followed. All eligible centers were invited to contribute. Authors were asked to provide anonymized patient information: patient characteristics at baseline, lesion, procedural, and hospitalization details, and data of all follow-up visits. RESULTS:A total of 977 patients were included (1023 treated limbs). One-year primary, primary-assisted, and secondary patency rates were 80.6%, 89.1%, and 95.7%, respectively, and 5-year rates were 54.8%, 68.9%, and 85.3%, respectively. Freedom from target lesion revascularization was 85.3%, 77.2%, and 63.0% at 1-, 2-, and 5-year follow-up, respectively. Major amputations were performed in 15/1023 limbs (1.5%); 12 presented with chronic limb-threatening ischemia at baseline. Freedom from major adverse limb events was 82.4%, 72.5%, and 56.6% through 1-, 2-, and 5-year follow-up, respectively. Sustained clinical benefit was observed by improved ankle-brachial index and Rutherford classification throughout follow-up. Younger age (hazard ratio [HR] 0.947, P < .001) and female sex (HR 1.752, P = .002) were predictors for loss of 1-year primary patency. Occlusive lesions failed more often in 1-year primary (HR 1.615, P = .017), primary-assisted (HR 2.141, P = .013), and secondary patency (HR 2.240, P = .028) compared with stenotic lesions. One-year primary patency was significantly lower in smaller (5-6 mm) compared with larger endoprosthesis (7-8 mm); 78.8% versus 90.0% (P < .001), although not an independent predictor of failing patency (HR 1.921, P = .096). No differences were observed in loss of primary patency in subgroups based on Rutherford classification, the number of run-off vessels, lesion length, Trans-Atlantic Inter-Society Consensus II (TASC II) II classification, and degree of calcification. CONCLUSION:The heparin-bonded Viabahn endoprosthesis demonstrates a good safety profile and acceptable patency rates through 2 years. Longer follow-up data is needed to draw robust conclusions through 5 years. Independent predictors of patency loss include younger age, female sex, and occlusive lesions, highlighting the importance of tailoring follow-up strategies to individual patient and lesion characteristics.Clinical ImpactWhat does this study/review add to the existing literature and how will it influence future clinical practice?This Individual-Patient-Data meta-analysis includes 977 patients with 1023 treated limbs, representing, to our knowledge, the largest cohort reported in the literature. It provides a comprehensive assessment of the performance of the latest generation Viabahn endoprosthesis in the treatment of complex femoropopliteal lesions. By identifying key predictors of patency and analyzing relevant subgroups, this study offers valuable insights into which patients benefit most from this treatment.

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018 and updated in 2022 (Ozaki et al. in Cardiovasc Interv Ther 33:178–203, 2018), (Ozaki et al. in Cardiovasc Interv Ther 37:1–34, 2022). Following the publication of the 2023 European Society of Cardiology (ESC) Guidelines for the management of acute coronary syndromes, the CVIT Task Force released another revised version in 2024 (Ozaki et al. in Cardiovasc Interv Ther 39:335–375, 2024). In light of new clinical evidence and technological advances that have emerged since then, the Task Force now proposes an updated expert consensus document for the management of ACS focusing on procedural aspects of primary PCI in 2026 version.