Femoropopliteal Lesions Research Articles

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

ObjectivePercutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. MethodsThe DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. ResultsWe enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. ConclusionsThe DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

The Impact of Balloon Pre-dilatation Techniques on Drug-Coated Balloon Therapy for Femoropopliteal Artery Disease: Six-Month Results From the CIVILIAN Registry.

The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions. This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months. During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83-7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07-3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00-2.69, p=0.048). By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons. The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.

Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.

Predicting residual pressure gradients after balloon angioplasty in patients with femoropopliteal artery lesions.

In endovascular therapy (EVT) for femoropopliteal artery (FPA) lesions, studies examining the relationship between lesion morphology and hemodynamic status are limited. The purpose of this study was to investigate FPA lesion characteristics, including imaging findings and their cutoff values that can predict hemodynamic significance after balloon angioplasty. This single-center retrospective study enrolled 50 de novo FPA lesions from 43 patients treated under intravascular ultrasound (IVUS) usage between June 2022 and March 2023. As a physiological parameter, the pressure gradient was measured, and the cutoff value of the residual pressure gradient (RPG) was defined as a systolic pressure > 10mmHg through the lesions after balloon angioplasty. The pressure gradients were measured using a 0.014-inch wire-guided, rapid exchange-type microcatheter, Navvus II (Acist, Eden Prairie, Minnesota, USA). Predictive risk factors for RPG were analyzed using the random forest (RF) method. The relationship between the variables, RPG, and the cutoff points of each predictor was assessed using the partial dependence plot (PDP) method. RPG was observed in 20% of the lesions after balloon angioplasty. The RF model revealed that the percent diameter stenosis (%DS) and minimum lumen area (MLA) on IVUS assessment were strong predictive factors for RPG after balloon angioplasty. The PDP model revealed that a higher %DS (cutoff 30%) and smaller MLA (cutoff 10 mm2) could predict RPG after balloon angioplasty. Conventional lesion parameters such as %DS and MLA can predict hemodynamic significance during EVT for FPA lesions.

Using Isolated Femoral Bifurcation Endarterectomy or Combined with Bypass Surgery for Patients with Chronic Limb-Threatening Ischemia.

Background and Objectives: The aim of this study was to evaluate the clinical outcomes of patients suffering from chronic limb-threatening ischemia (CLTI) and tissue loss treated with primary isolated femoral bifurcation endarterectomy (FBE) or with FBE combined with bypass surgery. Materials and Methods: This retrospective study was performed in a tertiary university-based care centre. Between January 2008 and December 2019, a prospectively collected database of patients suffering from CLTI and tissue loss and undergoing either primary FBE (group A) or FBE in combination with bypass surgery (group B) was analysed. Study endpoints were ulcer healing, primary and secondary patency rate, limb salvage, and survival. Results: In total, FBE was performed in 73 patients and FBE with bypass in 60 patients. Between both groups, there were no significant differences regarding demographic data or the Global Limb Anatomic Staging System (GLASS) grade III and IV of femoropopliteal lesions. After 3 years, ulcer healing could be achieved in 72% of FBE and in 75% of FBE with bypass patients. The primary patency rate was 95% and 91% for FBE and 83% and 80% for FBE with bypass after one and three years, respectively. The 3-year limb-salvage rate was 78% for FBE and 84% for FBE with bypass. The secondary patency rate after one and three years was 99% and 97% for FBE and 93% and 88% for FBE with bypass. Conclusions: FBE and FBE with bypass are equally effective for ulcer healing in cases of combined CFA and superficial femoral artery lesions. There was no significant difference between both groups regarding primary and secondary patency rates, limb salvage rates and ulcer healing. Isolated FBE could be an alternative strategy in patients with higher operative risk.

Comparing Endovascular Approaches in Lower Extremity Artery Disease: Insights from a Network Meta-Analysis.

Endovascular therapy offers an alternative for treating femoropopliteal (FP) and infrapopliteal (IP) lesions related to occlusive lower extremity artery disease. Despite numerous trials, the effectiveness of restenosis prevention using local drug delivery devices remains a topic of debate. An updated systematic review and network meta-analysis was conducted. Our overall aim was to summarize the most recent clinical evidence regarding endovascular approaches for FP and IP atherosclerotic lesions. We conducted a search for randomized trials in the MEDLINE database, and extracted data related to clinical endpoints. Our primary focus was on the rate of major adverse events (MAEs), including mortality, amputation, and target lesion revascularization (TLR). A multiple treatment network meta-analysis supplemented with component network analyses was performed to examine the impact of combined treatment. Our search yielded 33 randomized controlled trials encompassing 5766 patients. This included 19 studies focused on femoropopliteal and 14 on IP lesions, accounting for 3565 and 2201 patients, respectively. Drug-coated balloons (DCBs) and drug-eluting stents (DESs) displayed a reduced MAE risk in comparison to plain old balloon angioplasty (POBA)-RR for DCB: 0.64 (95% CI: 0.52-0.77) and for DES: 0.71 (95% CI: 0.51-0.99). The bare-metal stent (BMS) group manifested the most substantial MAE risk, being 59% higher relative to the DCB cohort (BMS vs. DCB RR: 1.59; 95% CI: 1.03-2.47). For FP lesions, DES was the standout performer, curtailing MAE risk by 55% relative to POBA. Within IP lesions, DES mitigated the MAE risk by 25% versus POBA. DCB did not exhibit any notable MAE reduction when pitted against POBA. In FP arteries, both DESs and DCBs yielded significantly diminished MAEs, thus outpacing other techniques. Regarding IP arteries, only DESs resulted in significantly fewer MAEs. In alignment with contemporary research, our findings revealed no signs of elevated mortality in patients undergoing treatment with drug-eluting apparatuses.

Plaque Morphological Changes in Femoropopliteal Arterial Lesions Caused by Balloon Angioplasty: Analysis Through Integrated Backscatter Intravascular Ultrasound

Plaque Morphological Changes in Femoropopliteal Arterial Lesions Caused by Balloon Angioplasty: Analysis Through Integrated Backscatter Intravascular Ultrasound

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

Impact of Platelet Reactivity on 1-Year Clinical Outcomes After Endovascular Therapy for Femoropopliteal Lesions

Impact of Platelet Reactivity on 1-Year Clinical Outcomes After Endovascular Therapy for Femoropopliteal Lesions

Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon

PurposeTo investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the ‘halo’ phenomenon. Long-term data of DES is scarce. A focal reaction (‘halo’) following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear.MethodsThis prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates.ResultsThe primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the ‘halo’ sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19–5.16, P = .015).ConclusionsThe presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort.Level of Evidence IIINon-randomized controlled cohort/follow-up study.Graphical

Comparison between intermittent claudication versus chronic limb-threatening ischemia in peripheral arterial disease: a retrospective multicenter cohort study.

The anatomical distribution, characteristics of lesions, and treatment modalities for peripheral artery disease (PAD) are diverse. Endovascular intervention is popular for symptomatic PAD, for both intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI). We aimed to investigate the endovascular devices used by comparing patients with PAD referred for endovascular revascularization with IC and CLTI. We identified 736 patients with PAD enrolled in the multicenter PAD registry in South Korea from 2019 to 2022. Of these patients, 636 received endovascular treatment at the time of this study. After excluding missing data, we analyzed 506 patients with IC or CLTI. Patients' characteristics, target lesions, and endovascular device data such as type, length, balloon diameter, and stent, were examined. Procedure outcomes of the aortoiliac, femoropopliteal, and below-the-knee lesions were analyzed. Patients with CLTI were more likely to have diabetes mellitus, below-the-knee interventions, and multilevel PAD than the IC group. Patients with IC had more aortoiliac artery lesions and underwent atherectomies than the CLTI group (63.3% and 61.1% vs. 39.7% and 40.6%, respectively; P < 0.001). In patients with femoropopliteal lesions, those with CLTI were more revascularized with stents than the patients with IC, without significant differences (35.3% vs. 29.1%, P = 0.161). Compared to the IC group, the CLTI patients showed significantly worse rates of primary patency, amputation, and mortality (P = 0.029, P < 0.001, and P < 0.001, respectively). Among Korean patients with PAD, there is a significant difference in baseline and lesion characteristics, endovascular strategies, and short-term follow-up outcomes among those with IC and CLTI.

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry.

The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients. Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08-11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16-0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Outcome of Endovascular Procedure in Chronic Limb Ischemia Femoropopliteal Lesion: A Literature Review

Introduction. Angioplasty and stenting are the two main endovascular treatments for femoropopliteal lesions associated with chronic limb ischemia. To summarize the research in this area, this article examines the state of these treatments today, diving into clinical subtleties and new trends. The objectives was to thoroughly analyze the body of research, combining knowledge about the results of endovascular angioplasty and stenting. Methods: Literature was searched in some databases (Cochrane, PubMed, and EBSCO) from June to July 2021. Results: Five articles that met the inclusion and exclusion criteria were identified. There were two randomized control trials and three cohort studies. There was no difference in primary patency of balloon angioplasty and nitinol stenting on follow-up for five years. Amputation-free survival rates in the coated balloon and plain balloon groups were not different. Revascularization was also not significantly different in both groups. There was no complication reported in either group. Mortality rates in both groups were also not different after follow-up in 30 days. Conclusions: There were no notable variations in the results of endovascular angioplasty and stenting for femoropopliteal lesions associated with chronic limb ischemia.

Stand-Alone Rotational Atherectomy Versus Combination With Drug-Coated Balloon Angioplasty for the Endovascular Treatment of Heavily-Calcified Femoropopliteal and Popliteal Lesions.

Despite major technical advances in the endovascular treatment for peripheral artery disease (PAD), heavy calcification still represents a major obstacle to overcome both due to the high number of periprocedural complications (dissections, embolization, etc) and the limited long-term durability. A promising tool to overcome these obstacles is debulking calcified lesions with atherectomy. Since vessel preparation with atherectomy might even improve the diffusion of antiproliferative substances, we wanted to evaluate the impact of atherectomy±DCB in lower extremity PAD. To explore the safety, efficacy, and long-term durability on treatment of rotational atherectomy in heavily-calcified complex femoropopliteal and isolated popliteal lesions. In addition, we wanted to investigate whether advanced debulking strategies where atherectomy is followed by a drug-coated angioplasty bear an additional advantage over atherectomy and standard percutaneous angioplasty alone in terms of clinical success and freedom from target lesion revascularization. In total, 218 femoropopliteal and 46 popliteal predominantly heavily-calcified lesions have been investigated. Of 264 cases, in a total of 53 cases, atherectomy treatment was followed by a drug-eluting balloon (DEB) angioplasty (43 in the femoropopliteal and 10 in the popliteal lesions). The lesions were characterized by a significant length (17.3±12.1 cm) and complexity (TASC C in 48.4% and TASC D in 19.7%). During a mean follow-up of 19 (±11) months, a total of 12 patients (4.5%) died. Clinically-driven target lesion revascularization (CD-TLR) was performed in 32 (14.7%) femoropopliteal and 11 isolated popliteal (23.9%) lesions and did not differ significantly between stand-alone atherectomy and atherectomy followed by a DEB. Mean ABI was improved from 0.57±0.22 immediately before intervention to 0.86±0.23 on intervention and remained stable: 0.83±0.16 at follow-up. During follow-up, a mean Rutherford category was reduced from 3.64±1.0 to 2.38±0.98. Our real-life study provides evidence that atherectomy in combination with DEB is safe and effective but did not have a significant impact on the freedom from target lesion revascularization in our population. Additional large-scale randomized trials are needed to verify these findings. This study investigates the efficacy and safety of combining rotational atherectomy with drug-coated balloon (DCB) angioplasty for treating heavily calcified femoropopliteal and isolated popliteal lesions in peripheral artery disease (PAD). The retrospective analysis of 264 patients highlights the potential of this combination in improving procedural success and reducing periinterventional complications. While demonstrating an excellent procedural and clinical success rate over an average 19-month follow-up, the study finds no significant long-term benefit in freedom from target lesion revascularization (TLR) compared to atherectomy alone. These findings suggest the need for further research to optimize treatment strategies for complex PAD cases, particularly in evaluating the long-term clinical benefits of such combined interventions.

Endovascular Treatment of TASC C and D Femoropopliteal Arterial Disease With Heparin-Bonded Covered Stents: The Impact of Distal Run-Off Vessels.

In the last 2 decades, several studies in the literature evaluated the possible role of covered stents in the treatment of TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions but, despite the encouraging results, the employment of these devices was never included in clinical guidelines. The aim of this study is to evaluate the role of the technical aspects in patients with TASC C or D lesions that were treated with the GORE VIABAHN endoprosthesis and to elaborate a computerized method to objectively estimate the post-stent run-off and predict stent-graft failure. In this monocentric retrospective study, we collected the patients who were treated in our department from December 2014 to May 2021. Inclusion criteria comprised: (1) patients who underwent endovascular treatment of a TASC C or D femoropopliteal lesions using one or more heparin-bonded covered stent(s) and (2) clinical follow-up >2 years. Exclusion criteria were clinical follow-up <2 years or missing. An in-house computerized analysis to estimate the post-stent run-off, CEVERO (Computerized Estimation of VEssel Run-Off), was elaborated. Sixty-six patients were enrolled in the study. Eleven patients had a TASC type C lesion, and 55 patients presented a type D lesion. The median follow-up time was 2.6 years. Twenty-nine patients (43.9%) experienced a major adverse limb event. Primary patency after 6, 12 and 24 months was 74.2%, 60.6%, and 57.6%; primary-assisted patency was 78.8%, 65.2%, and 59.1%. The presence of <2 run-off vessels (p<0.001) was correlated with stent-graft failure. The CEVERO analysis demonstrated an accuracy of 90.0% in predicting stent-graft failure. The treatment of TASC C and D femoropopliteal lesions remains technically challenging. Our study supported the hypothesis that run-off is the most critical factor in determining the outcome of the procedure and that concomitant angioplasty of the tibial vessels might improve the patency of the covered stent. The CEVERO analysis could permit a real-time, objective estimation of the distal run-off using conventional angiographic images, and it might be employed as a tool in the intraprocedural decision-making process, but its clinical applicability should be evaluated on external validation cohorts. The endovascular treatment of TASC C and D femoropopliteal lesions is technically challenging and run-off seems to be the most critical factor in determining the outcome. Concurrent angioplasty of the tibial vessels can create adequate run-off to avoid stent failure. The CEVERO analysis is a computerized estimation of run-off that might be a useful tool in the decision-making process.

Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease

ObjectiveWe evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. MethodsWe conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. ResultsIn a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. ConclusionsThe use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry

Purpose: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. Materials and Methods: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. Results: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. Conclusion: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. Clinical Impact In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias. We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types. Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines. This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.

Technical Success, Midterm Primary Patency, and Factors Affecting Primary Patency of Subintimal Angioplasty Followed by Vasculomimetic Stenting for Trans-Atlantic Intersociety Consensus II C and D Femoropopliteal Arterial Disease—A Prospective Study

Abstract Background The best option among the endovascular options in long, complex femoropopliteal (FP) lesions, and factors affecting the patency have yet to be well described. There are few studies describing the mid- and long-term patency of endovascular stents in long-segment FP occlusions. Aim This study aimed to determine the technical success and mid-term patency of subintimal angioplasty with vasculomimetic stenting in Trans-Atlantic Inter-Society Consensus II (TASC) C and D FP disease. The patient and imaging factors that affect primary patency were also analyzed. Methods and Materials A single-center prospective study was performed on 52 consecutive patients undergoing endovascular treatment for TASC C and D FP disease from 2017 to 2021. Angioplasty with stenting was performed in all patients and followed up for 36 months. Endpoints were primary patency rates and amputation-free survival of the limb. Kaplan–Meier curves were used to see patency rates and amputation-free survival rates. Results A total of 52 patients underwent stenting with a technical success rate of 100% if the sub-intimal arterial flossing with antegrade-retrograde intervention (SAFARI) technique was used. Primary stent patency at 6, 12, 18, 24, and 36 months was 89.8, 81.4, 76.2, 71.4, and 62.5%, respectively. Amputation-free survival was 98, 95.6, 91.8, and 85.7% at 12, 24, 30, and 36 months, respectively. Cox proportional regression analysis showed smoking and vessel wall calcium score more than 270 degrees as independent predictors of loss of primary patency (hazard ratio 0.35 confidence interval [CI]: 0.003–0.448) and 0.102 (CI: 0.022–0.47), respectively. Conclusion Subintimal angioplasty with vasculomimetic stent has good midterm patency in and amputation-free survival in long-segment FP occlusions. Smoking and severe vessel wall calcification adversely affect patency.