Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study.

OBJECTIVE: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. MATERIALS AND METHODS: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. RESULTS: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. CONCLUSION: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Effects of additional exercise therapy after a successful vascular intervention for people with symptomatic peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) is characterised by obstruction or narrowing of the large arteries of the lower limbs, usually caused by atheromatous plaques. Most people with PAD who experience intermittent leg pain (intermittent claudication) are typically treated with secondary prevention strategies, including medical management and exercise therapy. Lower limb revascularisation may be suitable for people with significant disability and those who do not show satisfactory improvement after conservative treatment. Some studies have suggested that lower limb revascularisation for PAD may not confer significantly more benefits than supervised exercise alone for improved physical function and quality of life. It is proposed that supervised exercise therapy as adjunctive treatment after successful lower limb revascularisation may confer additional benefits, surpassing the effects conferred by either treatment alone. OBJECTIVES: To assess the effects of a supervised exercise programme versus standard care following successful lower limb revascularisation in people with PAD. SEARCH METHODS: We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers, most recently on 14 March 2023. SELECTION CRITERIA: We included randomised controlled trials which compared supervised exercise training following lower limb revascularisation with standard care following lower limb revascularisation in adults (18 years and older) with PAD. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were maximum walking distance or time (MWD/T) on the treadmill, six-minute walk test (6MWT) total distance, and pain-free walking distance or time (PFWD/T) on the treadmill. Our secondary outcomes were changes in the ankle-branchial index, all-cause mortality, changes in health-related quality-of-life scores, reintervention rates, and changes in subjective measures of physical function. We analysed continuous data by determining the mean difference (MD) and 95% confidence interval (CI), and dichotomous data by determining the odds ratio (OR) with corresponding 95% CI. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We identified seven studies involving 376 participants. All studies involved participants who received either additional supervised exercise or standard care after lower limb revascularisation. The studies' exercise programmes varied, and included supervised treadmill walking, combined exercise, and circuit training. The duration of exercise therapy ranged from six weeks to six months; follow-up time ranged from six weeks to five years. Standard care also varied between studies, including no treatment or advice to stop smoking, lifestyle modifications, or best medical treatment. We classified all studies as having some risk of bias concerns. The certainty of the evidence was very low due to the risk of bias, inconsistency, and imprecision. The meta-analysis included only a subset of studies due to concerns regarding data reporting, heterogeneity, and bias in most published research. The evidence was of very low certainty for all the review outcomes. Meta-analysis comparing changes in maximum walking distance from baseline to end of follow-up showed no improvement (MD 159.47 m, 95% CI -36.43 to 355.38; I2 = 0 %; 2 studies, 89 participants). In contrast, exercise may improve the absolute maximum walking distance at the end of follow-up compared to standard care (MD 301.89 m, 95% CI 138.13 to 465.65; I2 = 0 %; 2 studies, 108 participants). Moreover, we are very uncertain if there are differences in the changes in the six-minute walk test total distance from baseline to treatment end between exercise and standard care (MD 32.6 m, 95% CI -17.7 to 82.3; 1 study, 49 participants), and in the absolute values at the end of follow-up (MD 55.6 m, 95% CI -2.6 to 113.8; 1 study, 49 participants). Regarding pain-free walking distance, we are also very uncertain if there are differences in the mean changes in PFWD from baseline to treatment end between exercise and standard care (MD 167.41 m, 95% CI -11 to 345.83; I2 = 0%; 2 studies, 87 participants). We are very uncertain if there are differences in the absolute values of ankle-brachial index at the end of follow-up between the intervention and standard care (MD 0.01, 95% CI -0.11 to 0.12; I2 = 62%; 2 studies, 110 participants), in mortality rates at the end of follow-up (OR 0.92, 95% CI 0.42 to 2.00; I2 = 0%; 6 studies, 346 participants), health-related quality of life at the end of follow-up for the physical (MD 0.73, 95% CI -5.87 to 7.33; I2 = 64%; 2 studies, 105 participants) and mental component (MD 1.04, 95% CI -6.88 to 8.95; I2 = 70%; 2 studies, 105 participants) of the 36-item Short Form Health Survey. Finally, there may be little to no difference in reintervention rates at the end of follow-up between the intervention and standard care (OR 0.91, 95% CI 0.23 to 3.65; I2 = 65%; 5 studies, 252 participants). AUTHORS' CONCLUSIONS: There is very uncertain evidence that additional exercise therapy after successful lower limb revascularisation may improve absolute maximal walking distance at the end of follow-up compared to standard care. Evidence is also very uncertain about the effects of exercise on pain-free walking distance, six-minute walk test distance, quality of life, ankle-brachial index, mortality, and reintervention rates. Although it is not possible to confirm the effectiveness of supervised exercise compared to standard care for all outcomes, studies did not report any harm to participants from this intervention after lower limb revascularisation. Overall, the evidence incorporated into this review was very uncertain, and additional evidence is needed from large, well-designed, randomised controlled studies to more conclusively demonstrate the role additional exercise therapy has after lower limb revascularisation in people with PAD.

Exercise Therapy for Peripheral Artery Disease.

PURPOSE OF REVIEW: To summarize evidence regarding exercise treatments for lower extremity peripheral artery disease (PAD). RECENT FINDINGS: Supervised walking exercise is recommended by practice guidelines for PAD. Supervised treadmill exercise improves treadmill walking distance by approximately 180 m and 6-min walk distance by 30-35 m, compared to control. The Centers for Medicaid and Medicare Services covers 12 weeks of supervised exercise, but most people with PAD do not participate. Home-based walking exercise may be more convenient and accessible than supervised exercise. In randomized clinical trials, home-based walking exercise interventions incorporating behavioral methods, such as accountability to a coach, goal-setting, and self-monitoring, improved 6-min walk distance by 40-54 m, compared to control. Arm and leg ergometry also improved walking endurance for people with PAD, but efficacy compared to walking exercise remains unclear. Walking exercise is first-line therapy for PAD-related walking impairment and can be effective in either a supervised or a structured home-based setting.

Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease.

BACKGROUND AND AIMS: Previous studies in percutaneous coronary intervention (PCI) patients showed a higher 3-year adverse event risk, including all-cause mortality, in those with concomitant peripheral arterial disease (PADs). Ten-year data of mortality and causes of death are scarce. This analysis assessed PCI patients, treated with contemporary drug-eluting stents, the impact of concomitant PADs on very long-term mortality, and causes of death. METHODS: We assessed PCI all-comers from our center who participated in the TWENTE and DUTCH PEERS trials (clinicaltrials.gov:NCT01066650, NCT01331707), comparing patients with versus without PADs. Life status was checked in the Dutch Personal Records Database; causes of death were obtained from medical records. RESULTS: Of 2705 study patients, 668 (24.7%) died during follow-up: 88/212 (41.5%) patients with PADs and 580/2493 (23.1%) without PADs. In PADs patients, the 10-year rate of all-cause mortality was about twice as high as in patients without PADs (41.5% vs.23.1%, HR: 2.05, 95%-CI: 1.64-2.57, p<0.001). For both groups, the rates of patients dying from various causes of death were: cardiac (14.1% vs.6.8%), vascular (2.8% vs. 1.1%), non-cardiovascular (17.4% vs. 9.8%), and unclear causes (7.1% vs. 5.3%), without a statistically significant between-group difference. When multivariate analysis was adjusted for between-group differences in cardiovascular risk profile, PADs remained predictor of all-cause mortality (adjusted HR: 1.38, 95%-CI: 1.08-1.75, p=0.01). CONCLUSIONS: The 10-year all-cause mortality rate in PCI patients with concomitant PADs was almost twice as high as in those without PADs. Age and other traditional cardiovascular risk factors were higher in patients with PADs, but after correction for these confounders PADs still accounted for almost 40% increase in mortality.

Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

A systematic review of the neutrophil to lymphocyte and platelet to lymphocyte ratios in patients with lower extremity arterial disease.

Lower extremity arterial disease (LEAD) is caused by atherosclerotic plaque in the arterial supply to the lower limbs. The neutrophil to lymphocyte and platelet to lymphocyte ratios (NLR, PLR) are established markers of systemic inflammation which are related to inferior outcomes in multiple clinical conditions, though remain poorly described in patients with LEAD. This review was carried out in accordance with PRISMA guidelines. The MEDLINE database was interrogated for relevant studies. Primary outcome was the prognostic effect of NLR and PLR on clinical outcomes following treatment, and secondary outcomes were the prognostic effect of NLR and PLR on disease severity and technical success following revascularisation. There were 34 studies included in the final review reporting outcomes on a total of 19870 patients. NLR was investigated in 21 studies, PLR was investigated in two studies, and both NLR & PLR were investigated in 11 studies. Relating to increased levels of systemic inflammation, 20 studies (100%) reported inferior clinical outcomes, 13 (92.9%) studies reported increased disease severity, and seven (87.5%) studies reported inferior technical results from revascularisation. The studies included in this review support the role of elevated NLR and PLR as key components influencing the clinical outcomes, severity, and success of treatment in patients with LEAD. The use of these easily accessible, cost effective and routinely available markers is supported by the present review.

Alginate-Encapsulated Mesenchymal Stromal Cells Improve Hind Limb Ischemia in a Translational Swine Model.

BACKGROUND: Cellular therapies have been investigated to improve blood flow and prevent amputation in peripheral artery disease with limited efficacy in clinical trials. Alginate-encapsulated mesenchymal stromal cells (eMSCs) demonstrated improved retention and survival and promoted vascular generation in murine hind limb ischemia through their secretome, but large animal evaluation is necessary for human applicability. We sought to determine the efficacy of eMSCs for peripheral artery disease-induced limb ischemia through assessment in our durable swine hind limb ischemia model. METHODS AND RESULTS: Autologous bone marrow eMSCs or empty alginate capsules were intramuscularly injected 2 weeks post-hind limb ischemia establishment (N=4/group). Improvements were quantified for 4 weeks through walkway gait analysis, contrast angiography, blood pressures, fluorescent microsphere perfusion, and muscle morphology and histology. Capsules remained intact with mesenchymal stromal cells retained for 4 weeks. Adenosine-induced perfusion deficits and muscle atrophy in ischemic limbs were significantly improved by eMSCs versus empty capsules (mean±SD, 1.07±0.19 versus 0.41±0.16, P=0.002 for perfusion ratios and 2.79±0.12 versus 1.90±0.62 g/kg, P=0.029 for ischemic muscle mass). Force- and temporal-associated walkway parameters normalized (ratio, 0.63±0.35 at week 3 versus 1.02±0.19 preligation; P=0.17), and compensatory footfall patterning was diminished in eMSC-administered swine (12.58±8.46% versus 34.85±15.26%; P=0.043). Delivery of eMSCs was associated with trending benefits in collateralization, local neovascularization, and muscle fibrosis. Hypoxia-cultured porcine mesenchymal stromal cells secreted vascular endothelial growth factor and tissue inhibitor of metalloproteinase 2. CONCLUSIONS: This study demonstrates the promise of the mesenchymal stromal cell secretome at improving peripheral artery disease outcomes and the potential for this novel swine model to serve as a component of the preclinical pipeline for advanced therapies.

Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Association between diabetes mellitus and primary restenosis following endovascular treatment: a comprehensive meta-analysis of randomized controlled trials.

IMPORTANCE: Diabetes mellitus (DM) is thought to be closely related to arterial stenotic or occlusive disease caused by atherosclerosis. However, there is still no definitive clinical evidence to confirm that patients with diabetes have a higher risk of restenosis. OBJECTIVE: This meta-analysis was conducted to determine the effect of DM on restenosis among patients undergoing endovascular treatment, such as percutaneous transluminal angioplasty (PTA) or stenting. DATA SOURCES AND STUDY SELECTION: The PubMed/Medline, EMBASE and Cochrane Library electronic databases were searched from 01/1990 to 12/2022, without language restrictions. Trials were included if they satisfied the following eligibility criteria: (1) RCTs of patients with or without DM; (2) lesions confined to the coronary arteries or femoral popliteal artery; (3) endovascular treatment via PTA or stenting; and (4) an outcome of restenosis at the target lesion site. The exclusion criteria included the following: (1) greater than 20% of patients lost to follow-up and (2) a secondary restenosis operation. DATA EXTRACTION AND SYNTHESIS: Two researchers independently screened the titles and abstracts for relevance, obtained full texts of potentially eligible studies, and assessed suitability based on inclusion and exclusion criteria.. Disagreements were resolved through consultation with a third researcher. Treatment effects were measured by relative ratios (RRs) with 95% confidence intervals (CIs) using random effects models. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. MAIN OUTCOMES AND MEASURES: The main observation endpoint was restenosis, including > 50% stenosis at angiography, or TLR of the primary operation lesion during the follow-up period. RESULTS: A total of 31,066 patients from 20 RCTs were included. Patients with DM had a higher risk of primary restenosis after endovascular treatment (RR = 1.43, 95% CI: 1.25-1.62; p = 0.001). CONCLUSIONS AND RELEVANCE: This meta-analysis of all currently available RCTs showed that patients with DM are more prone to primary restenosis after endovascular treatment.

Effect of EDTA with porous balloon on calcified lesion: An atherosclerotic cadaver study.

BACKGROUND: Ethylene diamine tetra-acetic acid (EDTA) is a chelating agent used to dissolve calcium deposits but evidence in decalcifying atherosclerotic lesions is limited. AIMS: We assessed the feasibility and efficacy of EDTA delivered via porous balloon to target calcified lesions in cadaveric below-the-knee (BTK) arteries. METHODS: Using porcine carotid arteries, EDTA concentration was measured in the arterial wall and outside the artery at the 0-, 0.5-, 4-, and 24-h circulation after the injection through a porous balloon. In cadaver BTK samples, the proximal and distal anterior tibial artery (ATA) and distal posterior tibial artery (PTA) were studied. EDTA-2Na/H2O or EDTA-3Na/H2O were administrated using a porous balloon, then circulated for 6 h for EDTA-3Na/H2O and 24 h for EDTA-2Na/H2O and EDTA-3Na/H2O. Micro-CT imaging of the artery segments before and after the circulation and cross-sectional analyses were performed to evaluate calcium burden. RESULTS: In the porcine carotid study, EDTA was delivered through a porous balloon present in the arterial wall and was retained there for 24 h. In BTK arteries, cross-sectional analyses of micro-CT revealed a significant decrease in the calcium area in the distal ATA segment under 24-h circulation with EDTA-2Na/H2O and in the distal ATA segment under 24-h circulation with EDTA-3Na/H2O. The proximal ATA segment under 6-h circulation with EDTA-3Na/H2O showed no significant change in any parameters of calcium CONCLUSION: EDTA-3Na/H2O or EDTA-2Na/H2O with longer circulation times resulted in greater calcium reduction in atherosclerotic lesion. EDTA may have a potential therapeutic option for the treatment of atherosclerotic calcified lesions.

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.