Femoropopliteal Artery Research Articles

Comparison of angiography and ultrasound for femoropopliteal angioplasty: decision-making and 12-month outcomes.

This study aimed to investigate whether intravascular ultrasound (IVUS) combined with angiography during percutaneous transluminal angioplasty impacts treatment strategies and the 12-month patency of the femoropopliteal artery, compared to angiography alone. This retrospective, single-center study enrolled 137 patients who underwent a femoropopliteal endovascular intervention between February 2020 and May 2021. Among these interventions, 43 were guided by IVUS combined with angiography and the remaining 94 were guided by angiography only. Treatment strategies and 12-month patency were analyzed in both groups. Multivariable analysis was performed to clarify the predictors of restenosis within 12 months. Primary patency at 12 months was significantly higher in the IVUS group than in the angiography group (56.4% vs. 76.7%, P=0.047). The reference diameter on IVUS images was greater than that on angiography images. Therefore, the IVUS group presented a higher balloon-to-vessel ratio [1.0 (0.97, 1.01) vs. 1.06 (1.0.1.25)]. More adjunctive stents were required in the angiography group. However, more dissections were performed in the IVUS group, with no difference in flow-limiting dissections between groups. Target disease length (odds ratio 1.02, P=0.021) and balloon-to-vessel ratio (odds ratio 0.01, P=0.021) were independent predictors of restenosis. Compared with angiography guidance alone, IVUS guidance for femoropopliteal artery-related treatment can significantly increase primary patency. This finding may be explained by the selection of larger balloons in IVUS and the resulting sufficient plaque compression and elastic membrane stretch. Moreover, IVUS was shown to detect more non-flow-limiting dissections than angiography.

Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease

Despite increased use of intravascular ultrasound (IVUS) during peripheral artery interventions, evidence for reproducibility of IVUS measurements and its relation to angiography is lacking. Forty cross-sectional IVUS images of the femoropopliteal artery from 20 randomly selected patients enrolled in the XLPAD (Excellence in Peripheral Artery Disease) registry who underwent peripheral artery interventions and met criteria based on IVUS consensus guidelines were independently assessed by 2 blinded readers. IVUS images from 6 patients (40 images) were selected for angiographic correlation and met criteria for identifiable landmarks (e.g., stent edge and bifurcation). Lumen cross-sectional area (CSA), external elastic membrane (EEM) CSA, luminal diameter, and reference vessel diameter were repeatedly measured. The Lumen CSA and EEM CSA intra-observer agreement by Spearman rank-order correlation (ρ) was >0.993, intraclass correlation coefficient was >0.997, and repeatability coefficient was <1.34. For the interobserver measurement of luminal CSA and EEM CSA, the ρ=0.742 and 0.764; intraclass correlation coefficient=0.888 and 0.885; and repeatability coefficient=7.24 and 11.34, respectively. A Bland-Altman plot for lumen and EEM CSA showed good reproducibility. For angiographic comparison, the ρ for luminal diameter, luminal area, and vessel area were 0.419, 0.414, and 0.649, respectively. Femoropopliteal IVUS measurements showed strong intra-observer and interobserver agreement; IVUS and angiographic measurements did not demonstrate a similar strong agreement.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval

ABSTRACT Objectives Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. Methods Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). Results Fifty-two subjects were enrolled, 69% men, median age 69 (49–83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (−0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. Conclusion The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Management of In-Stent Restenosis in Femoro-Popliteal Arteries ;Drug Coated Balloon ,plain balloon,comparative study

Management of In-Stent Restenosis in Femoro-Popliteal Arteries ;Drug Coated Balloon ,plain balloon,comparative study

Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions.

The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01). The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.

Validation of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in patients undergoing peripheral endovascular interventions.

It remains unclear whether the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria could apply to peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT). We sought to evaluate the application of the ARC-HBR criteria to PAD patients undergoing EVT with contemporary drug-coated devices (DCD) for femoropopliteal artery lesions. Between May 2012 and December 2019, 542 consecutive patients undergoing EVT with DCD for femoropopliteal artery lesions were retrospectively analysed. The primary study endpoint was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5. Of 542 patients, 435 (80.3%) were stratified into the HBR group. The cumulative 5-year incidence of major bleeding events was significantly higher in the HBR group than in the non-HBR group (31.9% vs 2.3%; p<0.001). The 5-year major bleeding event rate gradually increased with the number of ARC-HBR criteria (≥2 major criteria: 48.6%, 1 major: 33.1%, ≥2 minor: 12.9%, and non-HBR: 2.3%; p<0.001). Major bleeding events were associated with a 5.4-fold increased risk of mortality (adjusted hazard ratio: 5.42, 95% confidence interval: 2.91-10.1; p<0.001). Severe chronic kidney disease, heart failure, and severe anaemia were predictors of major bleeding events. 80.3% of PAD patients undergoing EVT for femoropopliteal artery lesions with contemporary drug-coated devices met the ARC-HBR criteria. Given that major bleeding events remarkably increased the risk of mortality after EVT, the ARC-HBR criteria might be helpful for the risk stratification of PAD patients who undergo EVT with contemporary DCD.

Novel Self-Expanding Interwoven Nitinol Stent for Treating Femoropopliteal Artery Disease: 12-Month Results of Single-Center First-in-Man Study

Purpose: To evaluate the safety and efficacy of Innospring® stent, a novel self-expanding interwoven nitinol stent, in treating femoropopliteal atherosclerotic lesions. Methods: A prospective, single-center, single-arm, first-in-human study enrolled 15 patients (mean age 73.1 years; 13 men) to evaluate the safety and efficacy of the Innospring® stent monitored by core laboratories. The inclusion criteria were claudication or ischemic rest pain, de novo lesions or nonstented restenosis, >70% stenosis, lesion length <20 cm, and a reference vessel diameter of 4–7 mm. The primary safety endpoint was 30-day major adverse events. The primary efficacy end point was stent patency at 12 months. Follow-up evaluations were conducted at 30 days, 6 months, and 12 months. Results: The lesion length was 6.1 ± 3.5 mm. Fourteen (93.3%) patients had lesions of the superficial femoral artery and 3 (20.0%) patients had lesions of the popliteal artery. Nine (60.0%) patients had moderate-to-severe calcified lesion. Technical and procedural success was 100%. No patients experienced major adverse events in the first 30 days. The Rutherford category showed significant and sustained improvement at 6 and 12 months. The 12-month follow-up radiographs obtained in 13 patients confirmed the absence of stent fractures in 100% of examinations. The cumulative primary stent patency rate at 6 and 12 months were 93.3% and 84.6%, respectively. Conclusion: Stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide superior stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress. Clinical Impact Endovascular recanalization is a widely accepted and recommended treatment for symptomatic peripheral artery diseases. The Innospring® stent is a novel self-expanding interwoven stent containing eight nitinol wires with additional radial force, fracture-resistance, and visibility under fluoroscopy. This first-in-human study using the Innospring® stent in patients with femoropopliteal occlusive disease reported that stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide an impressive stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.

Predictors of recurrence after paclitaxel drug-coated balloon use for treating femoropopliteal in-stent restenosis.

Paclitaxel drug-coated balloon (PDCB) angioplasty has been shown to be an effective treatment of in-stent restenosis (ISR) at the femoropopliteal (FP) arteries. Long-term studies, however, have shown a progressive decrease in the patency rates following PDCB. The aim of this study was to determine the predictors of stenosis recurrence after PDCB treatment of FP-ISR, and its immediate and mid-term outcomes. This prospective, non-randomized study included all chronic lower extremity ischemia patients of Rutherford class 3-6 who underwent PDCB angioplasty to treat >50% FP-ISR between June 2017 and December 2019. The primary endpoint was primary patency, defined as freedom from binary restenosis and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints included 12-months freedom from CD-TLR and major adverse events (MAEs). A total of 73 symptomatic chronic limb ischemia patients (73 limbs including 63 with limb threatening ischemia) underwent PDCB angioplasty of FP-ISR lesions (13.7% Tosaka class I, 54.8% class II, and 31.5% class III). The mean ISR lesion length was 121.8 ± 52.7mm. Technical success was achieved in 70 (95.9%) patients. Kaplan-Meier estimate of the 12-months rates of primary patency and freedom from CD-TLR was 76.1% and 87.4%, respectively. At one year, MAEs occurred in eight patients (11.0%) including two deaths (2.7%), one major amputation (1.4%), and six (8.2%) surgical revascularizations. Multivariable analysis showed that Tosaka class III ISR (HR 4.51, CI: 1.31-15.53, p < 0.001) and reference vessel diameter (HR 0.38, 95% CI: 0.18-080, p = 0.01) were independently associated with recurrent ISR. PDCB is safe and effective treatment of FP-ISR lesions. Occlusive ISR lesions and reference vessel diameter were independently associated with recurrent ISR stenosis after PDCB treatment.

Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement

ObjectiveTo compare the results of endovascular treatment with drug-eluting stents (DES) and drug-coated balloons (DCB) in atherosclerotic lesions in the femoropopliteal artery, as well as to assess restenotic patterns. MethodsClinical data from 617 cases treated with DES or DCB for femoropopliteal diseases were analyzed in this multicenter, retrospective cohort study. From these, 290 DES and 145 DCB cases were extracted by propensity score matching. Outcomes investigated were 1- and 2-year primary patency, reintervention, and restenotic pattern and its impact on symptoms in each group. ResultsThe primary patency rates at 1 and 2 years in the DES group were superior to those in the DCB group (84.8% and 71.1% vs 81.3% and 66.6%, P = .043), whereas there was no significant difference in freedom from target lesion revascularization (91.6% and 82.6% vs 88.3% and 78.8%, P = .13). Compared with what was measured before the index procedures, exacerbated symptoms, rate of occlusion, and an increase in the occluded length at loss of patency were more frequent in the DES group than in the DCB group. The odds ratios were 3.53 (95% confidence interval, 1.31-9.49; P = .012), 3.61 (1.09-11.9; P = .036), and 3.82 (1.15-12.7; P = .029), respectively. On the other hand, the frequency of an increase in lesion length and requirement of target lesion revascularization were similar between the two groups. ConclusionsPrimary patency was significantly higher at 1 and 2 years in the DES than in the DCB group. However, DES were associated with exacerbated clinical symptoms and complicated lesion characteristics at the point of loss of patency.

A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention

Optimal antiplatelet therapy after endovascular therapy (EVT) for peripheral artery disease is controversial. This trial aimed to evaluate whether sarpogrelate plus aspirin was non-inferior for preventing early restenosis after femoropopliteal (FP) EVT compared to clopidogrel plus aspirin. In this open-label, prospective randomized trial, 272 patients were enrolled after successful EVT for FP lesions. Patients in each group received aspirin 100 mg and clopidogrel 75 mg or sarpogrelate 300 mg orally once per day for 6 months. The primary outcome was target lesion restenosis at 6 months, tested for noninferiority. Patient characteristics and EVT patterns were similar, except for increased inflow procedures in the sarpogrelate group and increased outflow procedures in the clopidogrel group. The sarpogrelate group showed a tendency of less restenosis at 6 months than the clopidogrel group (13.0% vs. 19.1%, difference 6.1 percentage points, 95% CI for noninferiority − 0.047 to 0.169). Secondary endpoints related to safety outcomes were rare in both groups. Risks of target lesion restenosis of the two intervention arm were uniform across most major subgroups except for those with coronary artery disease. In conclusion, Sarpogrelate plus aspirin is non-inferior to clopidogrel plus aspirin in preventing early restenosis after FP EVT. Larger multi-ethnic trials are required to generalize these findings. Trial registration: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02959606; 09/11/2016).

Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease

PurposeTo compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions. Materials and MethodsIn this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1–3, 66.0%; 4–6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model. ResultsThe propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05). ConclusionsThe 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.

Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia

ObjectiveData regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. MethodsWe retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. ResultsDemographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). ConclusionsFPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.

CRT-300.01 Five-Year Results From the IMPERIAL Randomized Study of Eluvia and Zilver PTX Drug-Eluting Stents and the Long Lesion Sub-Study for Femoropopliteal Artery Disease

CRT-300.01 Five-Year Results From the IMPERIAL Randomized Study of Eluvia and Zilver PTX Drug-Eluting Stents and the Long Lesion Sub-Study for Femoropopliteal Artery Disease

Target Balloon-Assisted Antegrade and Retrograde Use of Re-Entry Catheters in Complex Chronic Total Occlusions.

We report data from a retrospective multicenter registry. Eligibility criteria included either antegrade or retrograde use of the OutbackTM or GoBackTM re-entry catheter in combination with a balloon as a target to accomplish wire passage, when conventional antegrade and retrograde recanalization attempts had been unsuccessful. Procedural outcomes included technical success (defined as wire passage though the occlusion and delivery of adjunctive therapy with <30% residual stenosis at final angiogram), safety (periprocedural complications, e.g., bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from target lesion revascularization after 12-months follow-up). Thirty-six consecutive patients underwent target balloon-assisted recanalization attempts. Fourteen (39 %) patients had a history of open vascular surgery in the index limb. Fifteen patients were claudications (Rutherford Class 2 or 3, 21 presented with chronic limb threatening limb ischemia (Rutherford Class 4 to 6). The locations of the occlusive lesions were as follows: iliac arteries in 3 cases, femoropopliteal artery in 39 cases, and in below-the-knee arteries in 12 cases. In 15 cases, recanalization was attempted in multilevel occlusions. Retrograde access was attempted in 1 case in the common femoral artery, in the femoropopliteal segment in 10 cases, in below-the-knee arteries in 23 cases, and finally in 2 patients via the brachial artery. In 10 cases, the re-entry devices were inserted via the retrograde access site. Technical success was achieved in 34 (94 %) patients. There were 3 periprocedural complications, none directly related to the target balloon-assisted re-entry maneuver. Amputation-free survival was 87.8 % and freedom from clinically driven target lesion revascularization was 86.6 % after 12-months follow-up. Target balloon-assisted use of re-entry devices in chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

Popliteal access for endovascular procedures in femoropopliteal artery occlusive disease.

Even though it has been reported that femoropopliteal artery endovascular revascularization is often performed with antegrade femoral artery interventions, which are technically relatively challenging, having the advantage of better control, it has also been reported that recanalization failure may occur in approximately 20% of patients and some materials have been developed for this reason. To evaluate the safety of retrograde popliteal artery intervention and our procedural success rate for symptomatic femoropopliteal artery occlusive disease. A total of 95 endovascular revascularization procedures were performed for treating symptomatic occlusive peripheral artery disease in the study period. Inclusion criteria were defined as patients who underwent endovascular revascularization procedures for symptomatic femoropopliteal artery occlusive disease. Patients who underwent a percutaneous endovascular procedure for iliac artery or below-knee arterial occlusive disease in the same session and patients who had previously undergone peripheral arterial bypass grafting or endovascular treatment for existing femoropopliteal artery disease were excluded. We evaluated 45 peripheral endovascular procedures performed on 39 patients with a mean age of 62.49 ±11.38 years in our hospital for chronic femoropopliteal artery occlusive disease. Twelve (26.7%) of the endovascular treatment procedures were performed with retrograde access through the popliteal artery (Group 2). In neither group were any complications of arterial rupture, distal embolism, early thrombosis, or pseudoaneurysms observed. We are of the opinion that the retrograde popliteal artery technique is an effective and safe intervention option in endovascular revascularization, particularly in the revascularization of the long segment and complex femoropopliteal artery occlusions.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease

BackgroundNo adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. ObjectivesThis study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. MethodsPrincipal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. ResultsA total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). ConclusionsThese findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

Retrospective multicenter registry for endovascular treatment with newer devices in over 25-cm femoropopliteal artery disease: A retrospective observational study.

Endovascular therapy (EVT) is recommended in femoropopliteal (FP) lesions shorter than 25 cm by current guidelines; however, diffuse FP lesions remains challenging for EVT. The aim of this study was to investigate the efficacy of EVT with the latest devices for FP lesions longer than 25 cm. This retrospective multicenter registry analyzed patients presented peripheral artery disease (PAD) having FP lesions longer than 25 cm who underwent EVT using the latest devices between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. The present study enrolled a total of 504 PAD patients with 614 lesions undergoing EVT for diffuse FP lesions. The Kaplan-Meier analysis showed that the rates of freedom from restenosis and clinically-driven target lesion revascularization were 79.3% and 82.4% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that clinical features associated independently with restenosis risk were cilostazol use (adjusted hazard ratio, 0.49 [0.32-0.74]; p = 0.001), reference vessel diameter (RVD) (0.72 [0.58-0.89] per 1-mm increase; p = 0.002), and P3 segment involvement (2.08 [1.33-3.26]; p = 0.001). The Kaplan-Meier analysis was conducted to compare the primary patency between cases with and without a small RVD, P3 involvement, and/or lack of cilostazol; any risk factors were related to a worse primary patency rate, compared with cases without risk factors. In the current EVT era, the primary patency at 1 year was acceptable at 79.3% in patients with FP lesions longer than 25 cm. A small vessel and P3 segment involvement might be associated with a poor 1-year patency rate after EVT, whereas cilostazol administration might contribute to reducing restenosis.

Midterm Results of Drug-Coated Balloon Alone or Combined with Rotarex Thrombectomy Device for Treatment of Subacute Femoropopliteal Artery Thrombotic Occlusion

This retrospective multicenter study aimed to compare the midterm results of the Rotarex rotational thrombectomy device combined with drug-coated balloon (DCB) and DCB-alone for the treatment of subacute femoropopliteal artery thrombotic occlusion. All patients (74, aged 70.1±9.3years) were nonrandomized and divided into 2 groups based on treatment strategy between 2018 and 2020. Intraoperative technical success (defined as <30% residual stenosis), dissection types and bailout-stenting rates were assessed. Ankle-brachial index (ABI), primary patency (PP, restenosis <50%) and freedom from clinically driven target lesion reintervention (CD-TLR) were documented at follow-up. Among them, 35 patients were treated with the Rotarex catheter combined with DCB while 39 patients underwent DCB-alone. The-overall technical success rate was 100%. Patients in the Rotarex+DCB group showed lower rate of bailout stenting than those in the DCB alone group (22.9% vs. 59.0%; P=0.01). ABI at discharge was significantly higher in both groups. Mean follow-up time was 18.5±3.4months; 62 patients completed Doppler ultrasound investigation while 12 patients were censored. According to Kaplan-Meier analysis, the estimated PP was 82.0±6.7% in the Rotarex+DCB group, whereas a significantly lower rate in the DCB alone group (60.9±8.3%, P=0.04). In addition, the freedom from CD-TLR rate was 82.9±6.4% in the Rotarex+DCB group and 61.5±7.8% in the DCB-alone group (P=0.04). These initial data indicate that the Rotarex thrombectomy device combined with DCB is an effective choice for the treatment of subacute femoropopliteal artery thrombotic occlusion compared to DCB-alone. The combined procedure had superior midterm results.

Association of Clinical Setting With Sociodemographics and Outcomes Following Endovascular Femoropopliteal Artery Revascularization in the United States.

After the Centers for Medicare and Medicaid Services modified reimbursement rates for outpatient peripheral vascular intervention in 2008 with the intent of improving access to care, providers began to increasingly perform peripheral vascular interventions in privately owned office-based clinics. Little is known about the characteristics of patients treated in this setting and their long-term outcomes as compared with those treated in hospital-based centers. In this retrospective cohort study, Medicare beneficiaries ≥66 years undergoing outpatient femoropopliteal peripheral vascular interventions in office-based clinics and hospital-based centers from 2015 to 2017 were identified. Sociodemographics, comorbidities, and institutional characteristics were compared across sites. Multivariable Cox proportional hazards models were used to estimate the adjusted associations between practice site location and outcomes. The primary outcome was the composite of major amputation or death analyzed through the end of follow-up. Among 134 869 patients, 29.9% were treated in office-based clinics and 70.1% in hospital-based centers. Patients treated in office-based clinics were more often Black (16.9% versus 11.9%), dually enrolled in Medicaid (26.3% versus 19.6%), and residents of lower-resourced regions (32.6% versus 25.6%). Over a median follow-up time of 800 days (interquartile range, 531-1119 days), patients treated in office-based clinics had reduced risks of major amputation or death compared with outpatients treated in hospital-based centers (hazard ratio, 0.92 [95% CI, 0.89-0.95]). They also had lower adjusted all-cause mortality (hazard ratio, 0.93 [95% CI, 0.90-0.96]), major lower extremity amputation (hazard ratio, 0.84 [95% CI, 0.79-0.89]), and all-cause hospitalization (hazard ratio, 0.86 [95% CI, 0.84-0.88]). These findings persisted after stratification by critical limb ischemia, race, dual enrollment, and regional socioeconomic status, as well as among operators treating patients in both clinical settings. In this large nationwide analysis of Medicare beneficiaries, office-based clinics treated a more socioeconomically disadvantaged population compared with hospital-based centers. Long-term outcomes were comparable between locations. As such, these clinics appear to be selecting lower-risk patients for outpatient peripheral vascular interventions, although there remains the possibility of unmeasured confounding.

Accuracy and Reliability of Peripheral Artery Calcium Scoring Systems Using an Intravascular Ultrasound Reference Standard

Peripheral artery calcium scoring systems are commonly used in clinical trials to categorize calcium severity but there are little data on their accuracy and reliability. The purpose of this study was to investigate the accuracy and reliability of these systems. Angiographic, computed tomography angiography, and intravascular ultrasound (IVUS) imaging were obtained from 47 consecutive cases sourced from a prospectively collected database of patients undergoing femoropopliteal artery endovascular intervention. Two independent blinded readers graded calcium severity using the Peripheral Arterial Calcium Scoring System, Peripheral Academic Research Consortium, and Fanelli calcium scoring systems. IVUS maximum arc of calcium and calcium length were compared between severity grades for each scoring system. The diagnostic accuracy of each scoring system for identifying severe calcium was calculated using the reference standard of an IVUS maximum calcium arc ≥180°. Agreement testing was performed between scoring systems and between and within observers for each system. IVUS identified calcium in 85% (42/47) of cases, compared to 68% (32/47) of cases with angiography. There were no differences in IVUS calcium parameters between grades of calcium for any of the scoring systems. Severe calcium was detected by IVUS in 30 cases, in 23 cases by Peripheral Arterial Calcium Scoring System (sensitivity: 73%, specificity: 33%, positive predictive value [PPV]: 83%, negative predictive value [NPV]: 22%), in 12 cases by Peripheral Academic Research Consortium (sensitivity: 42%, specificity: 83%, PPV: 92%, NPV: 25%), and in 10 cases by Fanelli (sensitivity: 39%, specificity: 100%, PPV: 100%, NPV: 27%). Agreement between scoring systems was weak to moderate (range: k=0.55-0.74). Interobserver agreement was weak (k=0.41-0.54) and intraobserver agreement was highly variable ranging from k=0.41 to k=0.92. The poor diagnostic accuracy and weak-to-moderate reliability of calcium scoring systems raise doubts about the use of current calcium scoring systems for use in clinical trials.