Femoropopliteal Artery Disease Research Articles

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis.

The effect of drug-coated balloons (DCB) on hemodialysis (HD) in patients with femoropopliteal (FP) disease remains uncertain. This study aimed to investigate the outcomes of DCB therapy in patients with FP artery disease on HD. A total of 185 patients with FP lesions (140 HD patients) who underwent DCB treatment were included in the study. The incidence of restenosis and target lesion revascularization (TLR) at 12months were measured. Risk factors for TLR were also investigated. The mean age was 71.7years, and diabetes was observed in 82.3% of patients. The mean duration of receiving dialysis was 8.8years. The mean lesion length was 11.0cm, and approximately half of the lesions were severely calcified. Severe dissection after DCB therapy was observed in 19.5% of patients. During the follow-up period, 74 restenosis, 68 TLRs, 8 major amputations, and 28 deaths were observed. The freedom rates from restenosis and TLR at 12months were 63.8% and 71.3%, respectively. The freedom rates after low- and high-dose DCB at 12months were 61.9% and 70.6% for restenosis (P = 0.49) and 66.4% and 79.4% for TLR (P = 0.095), respectively. Independent risk factors for TLR at 12months of age were diabetes, chronic limb-threatening ischemia, and severe calcification. When patients were divided into four groups according to the number of these three risk factors, the rates of freedom from TLR at 12months were 100%, 94.8%, 76.7%, and 30.3% in the groups with no risk factors, any one risk factor, any two risk factors, and all risk factors, respectively (P < 0.0001). Clinical outcomes after endovascular therapy in HD patients with FP disease remain unsatisfactory, even if they are treated with DCB. In particular, patients on HD with diabetes, chronic limb-threatening ischemia, and severe calcification have poor outcomes.

C-75 | Comparison of the Cost of Care of Eluvia versus Zilver PTX in Treating Femoropopliteal Artery Disease

C-75 | Comparison of the Cost of Care of Eluvia versus Zilver PTX in Treating Femoropopliteal Artery Disease

Evaluation of the efficacy of combined device strategies for long femoropopliteal artery disease.

One of the major problems associated with bare nitinol stent implantation is stent fracture, particularly in the popliteal artery. The purpose of this study was to determine whether drug coated balloons (DCB), interwoven stents (IWS), or plain old balloon angioplasty (POBA) would be suitable for use in distal femoropopliteal (FP) long lesions when an Eluvia stent was implanted proximal to a lesion. This was a multi-center retrospective study enrolling patients undergoing concomitant use of Eluvia with DCB, IWS or POBA for symptomatic atherosclerotic femoropopliteal disease (lesion length > 15cm) [Rutherford category 2-6] between January 2018 and September 2021. 79 patients with 89 femoropopliteal lesions were enrolled in this study. The mean lesion length and the percentage of the popliteal artery involvement was 24.3 ± 6.4cm vs 24.0 ± 9.0cm vs 26.6 ± 6.2cm and 65.8% vs 89.4% vs 67.8% for the Eluvia + DCB, Eluvia + IWS, and Eluvia + POBA groups, respectively. The 1-year Kaplan-Meier estimates of primary patency and freedom from major adverse limb events (MALEs) were 53.3% vs 44.1% vs 24.2% and 62.4% vs 51.0% vs 28.1%, respectively. Eluvia + POBA was associated with a lower rate for 1-year primary patency (HR 2.49; 95% confidence interval (CI): 1.28-4.87; p = 0.007 and HR 2.38; 95% CI: 1.13-5.77; p = 0.04). In SFA long lesions with proximal Eluvia implantation, distal implantations of either a DCB or IWS were comparable, as opposed to POBA alone which generated worse results.

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 5years. 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 5years 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 3years of follow-up, mean time to reintervention was 5.5months longer (difference 166days, 95% CI: 51, 282days; 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 2years for patients treated with Eluvia at 737days versus 645days for the Zilver PTX group (difference 92days, 95% CI: -85, 269days; p=0.3099). Simulated savings considering reinterventions occurring over 1 and 5years 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.

A Systematic Review and Meta-Analysis of Efficacy and Safety of Cilostazol Prescription in Patients With Femoropopliteal Peripheral Artery Disease After Endovascular Therapy.

The purpose of this study is to assess the efficacy and safety of cilostazol prescription in patients with femoropopliteal peripheral artery disease (PAD) after endovascular therapy (EVT). We conducted a systematic review and meta-analysis of all studies reporting the outcomes of cilostazol after femoropopliteal EVT of PAD up to September 2022. Clinical outcomes of interest included primary patency, in-stent restenosis (ISR), vessel re-occlusion, freedom from target lesion revascularization (TLR), repeat revascularization, all-cause mortality, amputation, major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs), and bleeding complication. A total of 4 randomized controlled trials (RCTs) and 8 observational studies containing a total of 4898 patients met the inclusion criteria and were included in this systematic review and meta-analysis. We found that the use of cilostazol was associated with higher primary patency after femoropopliteal artery EVT (odds ratio [OR]=1.67, 95% confidence interval [CI]=1.50-1.87, p<0.001, I2=33.2%), a lower risk of ISR (OR=0.43, 95% CI=0.29-0.63, p<0.001, I2=37.6%), repeat revascularization (OR=0.43, 95% CI=0.24-0.76, p<0.005, I2=27.4%), and vessel re-occlusion (OR=0.59, 95% CI=0.38-0.93, p<0.05, I2=0%). There was an increase in freedom from TLR rate (OR=2.19, 95% CI=1.58-3.05, p<0.001, I2=0%), as well as a reduction in the occurrence of MALEs (OR=0.50, 95% CI=0.29-0.85, p<0.05, I2=0%). However, there was no significant difference in amputation, MACEs, all-cause mortality, and major bleeding complications. Subgroup analysis showed that cilostazol treatment in patients with femoropopliteal drug-eluting stents (DES) implantation remained associated with higher primary patency and a lower risk of ISR. After EVT of femoropopliteal artery lesions, additional oral cilostazol enhances primary patency, reduces the occurrences of ISR and vessel re-occlusion, diminishes the risks associated with MALEs, lowers the need for repeat revascularization, and increases freedom from TLR rates. However, it does not impact amputation, MACEs, all-cause mortality, or major bleeding complications. These findings suggest cilostazol as a potentially safe and effective adjunct therapy in patients with femoropopliteal PAD after EVT. After undergoing endovascular therapy (EVT) for femoropopliteal artery lesions, the addition of cilostazol to antiplatelet therapy can significantly improve primary patency, reducing the incidence of in-stent restenosis, repeat revascularization, vessel re-occlusion, and major adverse limb events while increasing freedom from target lesion revascularization rate. The simultaneous use of drug-eluting stents in the femoropopliteal artery lesions, combined with cilostazol, potentially results in a synergistic anti-stenotic effect. This therapeutic approach does not appear to be associated with an increased risk of major bleeding events or all-cause mortality. These findings provide additional evidence supporting the treatment of anti-stenosis in patients with femoropopliteal artery lesions after EVT.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions

ObjectiveIn two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn, SECS) or drug-eluting stents (ZilverPTX, DES) are related to similar clinical outcomes at one-year follow-up. MethodsIn a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at one-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. ResultsA total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up there were no significant differences in primary patency (ITT 63.4% vs 71.1%: p=0.183 and PP 60.8% vs 71.1%; p=0.100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; p=0.054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS 85.6% versus DES 95.1%; p=0.038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%, p=0.481). No major amputations were performed in the SECS group and two in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after one-year follow-up (p=0.106). Based on diagnosis (IC versus CLTI) no differences between IC and CLTI patients were observed in primary, secondary patency and freedom from TLR. ConclusionsTreatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at one-year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

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.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study

To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

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

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.

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease.

Background: Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. Methods: A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon. Clinical events included target lesion revascularization (TLR), amputation, and death. Transition probabilities and utility values were derived from published literature. Healthcare costs were based on German Diagnosis Related Groups (DRG) codes. Costs and outcomes were discounted at a rate of 3% per year. The incremental cost-effectiveness ratio (ICER) was calculated, and sensitivity analyses were performed to assess the robustness of the results. Results: In the one-year horizon, IVUS-guided PTA resulted in incremental quality-adjusted life-years (QALY) and costs of 0.02 and €919 per patient respectively, with a corresponding ICER of €45,195/QALY gained versus angiography-guided PTA. In the lifetime horizon, IVUS-guided PTA outperforms angiography-guided PTA; it was associated with a cost saving of €46 per patient and incremental QALY of 0.22. Utility value for post-TLR, as well as probabilities of death and TLR had the greatest impact on the one-year ICER, while cost of TLR and probabilities of TLR and amputation influenced the lifetime ICER most. The probability of IVUS-guided PTA being cost-effective at a willingness-to-pay (WTP) threshold of €50,000/QALY was 50.4% in the one-year horizon and increased to 85.9% in the lifetime horizon. Conclusions: In this analysis IVUS-guided PTA among patients with symptomatic FP atherosclerosis was cost-saving in a lifetime horizon from the German healthcare payer perspective.

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.

Midterm Results of Drug-Coated Balloon and Bare Metal Stent in the Treatment of TASCII C/D Femoropopliteal Artery Occlusive Disease: A Retrospective Multicenter Study.

This study aimed to compare midterm efficacy between drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of TASCII C/D femoropopliteal artery lesions. The clinical data of patients with TASCII C/D femoropopliteal artery disease admitted to 3 vascular surgery centers from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into DCB group and BMS group. The DCB group was further subdivided into DCB alone subgroup and DCB+BMS subgroup. Study primary outcomes were freedom from clinical-driven target lesion reintervention (FCD-TLR) at 24 months postprocedure. Secondary outcomes included ankle brachial index (ABI), Rutherford classification, major amputation rate, and mortality. A total of 410 consecutive patients were enrolled. At 24 months follow-up, in DCB group (114 patients) relative to BMS group (296 patients), FCD-TLR (86.00% vs 71.91%, p=0.039), and ABI (0.53±0.11 vs 0.47±0.19, p=0.007) were higher; mean Rutherford class was lower (1.57±0.68 vs 3.31±1.39, p=0.000); and major amputation rate (0.87% vs 4.05%, p>0.05) and all-cause mortality (8.92% vs 6.41%, p>0.05) were statistically similar. In DCB alone, subgroup relative to DCB+BMS subgroup, FCD-TLR (90.00% vs 85.00%, p>0.05), major amputation rate (0 vs 1.08%, p>0.05), and all-cause mortality rate (9.09% vs 8.69%, p>0.05) were statistically similar, while FCD-TLR was higher in the DCB+BMS subgroup (90.00% vs 71.91%, p=0.045). At midterm follow-up of patients treated for TASCII C/D femoropopliteal artery disease, use of DCB or of DCB combined with rescue BMS appeared similarly efficacious, and yielded more favorable outcomes than use of BMS. The efficacy of drug-coated balloons relative to that of bare metal stents for the treatment of complex femoropopliteal artery lesions, particularly TASCII grade D lesions, remains uncertain. There is a scarcity of multicenter comparative studies, and in this multicenter retrospective study with up to 24-month follow-up, use of drug-coated balloon alone or combined with rescue bare metal stent appeared similarly efficacious while yielding more favorable outcomes than use of bare metal stent alone in the treatment of TASCII grade C/D femoropopliteal artery lesions. Randomized studies are warranted.

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis

Abstract Background Hemodialysis (HD) patients, who are at high risk for atherosclerosis including peripheral artery disease, are associated with poor clinical outcomes after endovascular therapy. Although recent clinical trials have reported favorable outcomes after drug-coated balloon (DCB) treatment for femoropopliteal lesions, its usefulness and risk factors in HD patients have not been well elucidated. Purpose This study aimed to investigate clinical outcomes and the associated risk factors after DCB treatment in HD patients with femoropopliteal lesions. Methods This study included 140 HD patients with their 185 femoropopliteal lesions that underwent DCB treatment between September 2018 and January 2022. Non-HD patients and cases of acute limb ischemia were excluded. The endpoints were 1-year freedom from restenosis and clinically driven target lesion revascularization (CD-TLR). The risk factors were also evaluated. Result Duration of maintenance hemodialysis in all patients was 8.6 years. Mean lesion length was 11.0±6.9 cm, and rates of chronic total occlusion and severe calcification were 17.3% and 45.4%, respectively. Types of DCB were IN.PACT Admiral (22.9%), Lutonix (50.8%) and Ranger (24.3%). Bail-out stenting was performed in 1.1% of all lesions. The Kaplan-Meier estimate of freedom from restenosis and CD-TLR were 63.8% and 71.3% at 12 months, respectively. The freedom rates from CD-TLR after high-dose and low-dose DCB therapy were 79.4% and 66.4%, respectively (p=0.095). Risk factors independently associated with 1-year CD-TLR were diabetes [hazard ratio (HR) 2.30, 95% confidence interval (CI) 1.03-5.15, p=0.043], chronic limb-threatening ischemia (HR 1.93, 95%CI 1.05-3.53, p=0.035) and sever calcification (HR 2.42, 95%CI 1.39-4.21, p=0.0019). When patients were divided into groups according to number of these three risk factors, the rates of freedom from CD-TLR at 12 months were 100%, 94.8%, 76.7% and 30.3% among groups with no risk factor, any 1 risk factor, any 2 risk factors and all risk factors, respectively (p&amp;lt;0.0001). Conclusion The 1-year clinical outcomes after DCB treatment in HD patients with femoropopliteal lesions were unsatisfactory. Independent risk factors for 1-year CD-TLR were diabetes, chronic limb-threatening ischemia and severe calcification.

Abstract 18246: Determining the Most Important Factors for 1-year Health Status Using a Machine-Learning Algorithm in Patients With Peripheral Artery Disease Undergoing Revascularization for Claudication

Introduction: Over time, patients with peripheral artery disease (PAD) are at high risk of poor cardiovascular outcomes, but most immediately, their health status is impacted due to lifestyle-limiting symptoms. To improve functioning, peripheral vascular intervention (PVI) may be offered. We aimed to understand which factors predict subsequent health status outcomes following PVI. Methods: We used data from the international ILLUMENATE examining the safety of peripheral angioplasty with vs. without Stellarex drug-coated balloon for femoropopliteal artery disease in randomized trial between 2013 and 2019. Treatment arms were combined for this analysis. EQ-5D 3L Index and Visual Analog Scale (VAS) were assessed at baseline and 1 year. Random forest regression, a base-trees machine-learning algorithm, was built in the training sample (80% of the cohort) and evaluated in the validation sample (20% of the cohort). The importance of 58 included pre-procedural variables was ranked. The most important variables were defined based on visual inspection of the relative importance plots to evaluate the information gained value of each included variable. Results: In the 473 included patients, the mean age was 68.2 ± 9.2 years, 32.1% were female and 4.2% were Black. For the 1-year 3L Index, the most important pre-procedural variables were liver disease and the 3L Index (54.1%). For the 1-year VAS, the most important variables were angioplasty/drug eluting stent following by chronic lung disease (94.9%), mechanical thrombectomy (81.0%), anticoagulant (80.1%) and congestive heart failure (76.5%). (Figure) Conclusions: As part of an effort to develop an individualized health status profile with machine learning, a predictable ranking of pre-procedural variables can inform 1-year health status outcomes in patients with PAD undergoing PVI for claudication. These approaches can inform clinical decision-making and pre-habilitation efforts to maximize treatment success.

Abstract 19047: Comparison of Drug-Eluting Stent With Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis

Introduction: Trials comparing drug eluting stent (DES) versus bare metal stents (BMS) in patients undergoing endovascular therapy for femoropopliteal artery disease (FPAD) have shown variable results. Data indicating clear patency benefit of DES has not been definitively demonstrated. Methods: Medline, Embase, &amp; Cochrane Central databases were searched to identify previous studies comparing efficacy of drug eluting stent versus bare metal stents in treatment of FPAD. The primary outcome of interest was risk of restenosis. Secondary outcomes included all-cause mortality, stent fracture, target vessel revascularization and primary patency. Odds ratios (OR) were pooled using a random-effect model while heterogeneity among studies was assessed using the Higgins I 2 value. Results: A total of 7 studies (5 RCTs and 2 retrospective cohorts) with 1786 patients were included in our analyses. The risk of target vessel revascularization was significantly reduced with the use of DES (OR: 0.69, 95% CI: 0.49-0.98, I 2 = 0) as compared with BMS. However, there was no significant difference observed in risk of restenosis (OR: 0.83, 95% CI 0.59-1.16), primary patency (OR: 1.09, 95% CI 0.91-1.29), stent fracture (OR: 0.84, 95% CI 0.27-2.67) and all-cause mortality (OR: 1.65, 95% CI 0.71-3.85). Conclusion: The risk of target vessel revascularization was significantly reduced with the use of DES implantation in patients with FPAD. However, DES does not seem to provide much benefit in terms of clinical outcomes. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.

Safety and Efficacy of Excimer Laser Atherectomy Combined with a Drug-Coated Balloon in de Novo Femoral Popliteal Artery Disease: A Retrospective Study

ObjectivesThe effectiveness of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) for de novo femoropopliteal artery disease (FPAD) is currently unknown. This case series evaluated the clinical outcomes of ELA combined with DCB in de novo FPAD from a real-world clinical perspective. MethodsWe conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate, secondary endpoints included target lesion revascularization without clinically driven target-lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications. ResultsThe mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23±8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication and 13 patients had critical limb threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n=27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month and 48-month primary patency rates of ELA + DCB group were 75%, 66.1%, 58.9% and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36 and 48 months was 83.9%, 80.3%, 76.8% and 57.1%, respectively. ConclusionIn real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.

A New Drug-Coated Balloon for the Treatment of Superficial Femoropopliteal Artery Disease: 12-Month Results from the IN-DEPT SFA Trial

PurposeTo report the outcomes of the IN-DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon (DCB) product for peripheral artery disease (PAD) in Chinese patients. Materials and MethodsThis is a prospective, multicenter, single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) and/or proximal popliteal artery lesions were treated with a new paclitaxel-coated DCB. The preliminary effectiveness end point was 12-month primary patency. The primary safety end point was freedom from device- and procedure-related mortality over 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization (CD-TLR) within 12 months after the index procedure. ResultsIn total, 160 patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with 1 DCB, whereas the other 23 lesions (14.2%) were treated with 2 devices. The device success rate was 100%. A total of 135 subjects reached the preliminary effectiveness end point, with a 12-month primary patency rate of 84.4%. There was no 30-day device- or procedure-related death or unplanned major target limb amputation at 12 months. Five CD-TLRs (3.1%) occurred during the 12-month follow-up period. ConclusionsResults from the IN-DEPT SFA trial showed satisfactory feasibility and safety of the new DCB over 12 months in Chinese patients with PAD and femoropopliteal de novo lesions, including both stenoses and total occlusions.