Femoropopliteal Artery Disease Research Articles

Impact of the lower extremity arterial calcification score on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease

Abstract Background Severe calcification, assessed using the peripheral artery calcification scoring system (PACCS), is associated with poor clinical outcomes after endovascular treatment (EVT) for de novo femoropopliteal lesions. However, the PACCS classification is a qualitative assessment performed in the angiographic room, and there are no established indicators for the quantitative assessment of calcification prior to treatment. Purpose We aimed to investigate the impact of the lower extremity arterial calcification score (LEACS) calculated using non-contrast lower limb computed tomography on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Methods We retrospectively analyzed the clinical outcomes of 141 consecutive patients treated at our center for de novo femoropopliteal artery disease using a drug-coated balloon between April 2018 and December 2022. Patients who did not undergo lower limb computed tomography before EVT were excluded from the analyses. LEACS was determined based on the method used to calculate the Agatston score for the coronary arteries. Each patient’s score consisted of a sum of calcification scores from ostium of superficial artery to the popliteal artery at the knee joint of treated limb. The primary and secondary outcomes measured were primary patency and clinically-driven target vessel revascularization (CD-TVR) at 1 year. Cox proportional hazards analysis was used to explore independent predictors of clinical outcomes. The study population was divided into higher and lower LEACS groups based on the cut-off value (1750), which best discriminated patency, and the outcomes were compared between the two groups. Results In the higher and lower LEACS groups, the mean age was 75.1 ± 9.1 years and 75.5 ± 11.0 years (p = 0.87) and the mean lesion length was 170.3±102.8 mm and 157.7±112.1 mm (p = 0.64), respectively. The higher LEACS group showed significantly lower 1-year patency than the lower LEACS group (53.5% vs. 84.3%, log-rank, p = 0.041). In addition, freedom from 1-year CD-TVR was significantly lower in the higher LEACS group than in the lower LEACS group (66.8% vs. 93.7%, p = 0.047). The Cox proportional hazard analysis showed that the higher LEACS group was an independent predictor of 1-year restenosis (odds ratio: 2.80, 95% confidence interval: 1.24–8.84, p=0.037), along with a small (< 5 mm) reference vessel diameter (odds ratio: 3.55, 95% confidence interval: 1.44–9.53, p=0.028). Conclusion Higher LEACS scores were independently associated with clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Non-contrast lower limb computed tomography is an acceptable and feasible option for predicting the outcomes in patients with de novo femoropopliteal artery disease prior to treatment.

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study

AbstractThe JET-RANGER study (NCT03206762) was a multicenter (11 U.S. centers), randomized trial, core-lab adjudicated and designed to demonstrate the superiority of Jetstream + paclitaxel-coated balloon (JET + PCB) versus percutaneous transluminal angioplasty (PTA) + PCB in treating femoropopliteal arterial disease. The 1- and 2-year outcomes have been recently published. The 3-year outcome data are presented in this report. The JET-RANGER trial initially had 47 patients with 48 lesions. Thirty-one in the JET-PCB arm and 16 in the PTA + PCB arm (2:1 randomization). At 3-year follow-ups, there were 20 patients in the JET-PCB arm and 14 patients in the PTA + PCB arm. Kaplan–Meier survival analysis was performed to estimate the freedom from target lesion revascularization (TLR) at 3 years. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05. Freedom from TLR was statistically similar between the two groups at 3 years between JET + PCB and PTA + PCB (freedom from TLR was 88.0 vs. 67.8%, respectively, p = 0.1380). There was also no significant difference in the change of ankle-brachial index (ABI) between the PTA + PCB and JET + PCB from baseline at 6 months (p = 0.7890), 1 year (p = 0.4070), 2 years (p = 0.7410), and 3 years (p = 0.8010). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more categories from baseline to 3 years (p = 0.8949). There were no minor or major amputations for either arm throughout the 3-year follow-up. Five JET + PCB patients died before the 3-year specified window and none in the PTA + PCB arm (p = 0.137). Two of the deaths were due to cancer and three due to cardiac causes. None were deemed related to the device or procedure. JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 3-year follow-up with no difference in amputation or mortality between the 2 arms. A trend toward less TLR was seen in the JET + PCB arm.

Clinical outcomes following invasive treatment of femoropopliteal artery disease: a retrospective single-center cohort study

To identify predictors of clinical success in invasive treatment for femoropopliteal disease aiding clinical decision-making. A retrospective analysis was performed on 676 consecutive patients who underwent a first episode of invasive treatment for femoropopliteal disease, either endovasular therapy (EVT) or femoropopliteal bypass (FPB), between 2004 and 2015. Primary endpoints were primary and secondary clinical patency and amputation rate. Kaplan-Meier curves were used to evaluate clinical patency. A Cox proportional hazard model explored predictors of primary endpoints. Most patients (58%) underwent EVT as primary intervention, while 42% underwent FPB. Median follow-up was 43 months. The only independent predictor for loss of primary clinical patency was critical limb-threatening ischemia (CLTI) (P=0.008, HR 1.25; 95% CI 1.07 to 1.47). Secondary clinical patency was positively associated with FPB surgery (P=0.037, HR 0.66; 95% CI 0.44 to 0.97), a higher pre-interventional ankle-brachial index (ABI) (P=0.029, HR 0.43; 95% CI 0.20 to 0.92), more distal runoff vessels (P=0.036, HR 0.77; 95% CI 0.60 to 0.98) and the absence of ischemic heart disease (P=0.006, HR 1.69; 95% CI 1.16 to 2.47). In CLTI patients, chronic renal failure predicted loss of primary and secondary clinical patency and increased amputation risk. In this cohort, CLTI was independently associated with decreased primary clinical patency in invasive treatment for femoropopliteal disease. Secondary clinical patency was positively associated with FPB, higher ABI, more runoff vessels and the absence of ischemic heart disease.

Trends in the utilization of drug-eluting stents to treat femoropopliteal peripheral artery disease

ObjectiveThere is a paucity of data exploring the real-world use of the two drug-eluting stents approved for use in the United States for the treatment of femoropopliteal peripheral artery disease. This study examined the use trends of Eluvia drug-eluting vascular stent and Zilver PTX drug-eluting peripheral stent between 2016 and 2022 using medical claims. MethodsUsing the Truveta data platform, patients aged ≥18 years with peripheral artery disease who underwent lower extremity femoropopliteal peripheral artery endovascular revascularization with either Eluvia paclitaxel-eluting stents (introduced in 2018) or Zilver PTX paclitaxel-coated stents were identified between January 1, 2016, and December 31, 2022. The annual use overall by setting (inpatient vs outpatient) and within clinical subgroups were explored. ResultsOverall, 710 patients who received paclitaxel-eluting stents and 620 who received paclitaxel-coated stents were identified. The paclitaxel-eluting stent was released during the study period; by the end of the study period, paclitaxel-eluting stents accounted for 82% of the index femoropopliteal peripheral artery procedures. The use of paclitaxel-coated stents decreased from 100% to 18% over the same period. This change occurred among patients with diabetes, chronic limb-threatening ischemia, and chronic kidney disease. There were significant differences in stent use by race and geographic region. ConclusionsThe use of paclitaxel-eluting stent for the treatment of femoropopliteal peripheral artery disease in the United States has increased steadily since its introduction in 2018; by 2022, it was used in 82% of femoropopliteal peripheral artery procedures in medical centers using the Truveta platform.

Innovative nomogram for predicting 1-year clinically driven revascularization outcomes in endovascular femoropopliteal disease.

Femoropopliteal artery disease (FPAD) is a common vascular disease that usually requires surgical treatment. The aim of this study was to apply predictive modeling to develop predictive models for predicting clinically driven target revascularization (CD-TLR) events 1 year after intervention in patients with FPAD. In this study, clinical data were collected from a total of 484 patients who underwent FPAD endovascular intervention from 2014 to 2019. According to the inclusion and exclusion criteria, 400 patients will be finally included and assigned to the training cohort and test cohort in the ratio of 7:3. By analyzing these data through statistical methods, we will explore the effects of different factors on target revascularization events 1 year after intervention in FPAD patients, and build the corresponding prediction model of the column line graph. The final nomogram model consisted of 5 independent predictors: history of cerebrovascular disease, lesion length >15 cm, no atherectomy device used, no medicated balloon used and procedure time. The C-index of the model was 0.766 and 0.726 for the training cohort and validation cohort, respectively. The calibration curves also showed that the model had satisfactory agreement in both cohorts. The newly developed prediction model can accurately predict clinically driven target revascularization events at 1 year in patients with FPAD, providing valuable information for the development of individualized treatment plans.

Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

Shockwave Intravascular Lithotripsy Use in the Femoro-Popliteal Segment: Considerations From an Expert Pan-European Panel Regarding Best-Care Practice.

Produce expert recommendations regarding the optimal use of Shockwave intravascular lithotripsy (IVL) when treating femoro-popliteal steno-occlusive peripheral artery disease (PAD), guiding operators to use Shockwave IVL. A modified 3-step Delphi process was used to gain consensus surrounding preoperative/intraoperative/postoperative considerations when using Shockwave IVL for femoro-popliteal PAD. This included a structured survey, focus-group (with qualitative thematic analysis of views expressed), and final confirmatory round; participants were recruited across Europe including the United Kingdom/Switzerland. Following a review to inform an online survey, 25 experts took part in a survey (5 European countries, 2023), followed by a focus-group (15 participants), 9 interviews, and final confirmatory round. A list of recommendations was prepared where at least moderate-level or high-level agreement was reached (≥70% participants agreeing). The recommendations relate to the optimal preoperative imaging, preoperative preparation(s), intraoperative imaging and use of adjuncts, as well as postoperative course, when using Shockwave IVL. A list of expert recommendations is provided guiding the optimal use of Shockwave IVL in femoro-popliteal PAD. This will help operators achieve better clinical outcomes. This pan-European panel of experts using intravascular lithotripsy in routine peripheral arterial disease endovascular practice has provided important insights into best care practices before, during, and after such procedures. Several recommendations have been produced based on a structured consensus process to guide clinicians globally. This will improve and standardise the use of this technology in the femoro-popliteal arterial segment.

Safety and efficacy of drug-eluting stents versus heparin-bonded stents in treatment of femoropopliteal peripheral artery disease: study protocol for a multicentre, prospective randomised controlled trial in China (ELITE trial)

IntroductionEndovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered...

Intravascular Ultrasound Assessment of Arterial Dissections Following Rotarex Atherectomy: Results of the iDissection Rotarex Study

BackgroundThere are limited data on the mechanism of the Rotarex Rotational Excisional Atherectomy System in treating femoropopliteal arterial disease. The Rotarex iDissection study is a prospective, single center study evaluating the extent of excision and dissection in de novo and restenotic (not in-stent) lesions of the femoropopliteal arteries in symptomatic peripheral arterial disease patients. MethodsConsecutive patients with symptomatic peripheral arterial disease were prospectively enrolled in the Rotarex iDissection study at a single US center after obtaining informed consent. The study was approved by a central ethics committee. Quantitative vascular angiography and intravascular ultrasound images were analyzed by an independent core laboratory. The Eagle Eye Platinum ST intravascular ultrasound (Phillips) was used to identify the depth (A, B, C for intima, media, and adventitia, respectively) and arc of dissections (1 and 2 for <180° and ≥180°, respectively) using the iDissection classification. Statistical significance was determined by a P value <.05. ResultsA total of 19 patients (20 procedures) were enrolled by 1 endovascular specialist. There were 57.9% men with mean age of 71.1 ± 9.6 years. Of the patients, 31.6% had diabetes mellitus, and 84.2% were current or past smokers. Thirty percent of treated vessels were chronic total occlusions. A total of 10 patients received stents (2 covered stents due to perforation, 6 due to National Heart, Lung, and Blood Institute Type C dissections, and 2 were primary stenting). Two distal embolizations occurred; one was attributed to the Rotarex, and both were treated with no adverse consequences. Angiographic baseline stenosis was 74.7% ± 25.6%; after Rotarex, 48.7% ± 14.8%; and after percutaneous transluminal angioplasty (PTA), 16.0% ± 6.2%. Baseline minimal lumen diameter was 1.0 ± 1.0 mm; after Rotarex, 2.4 ± 1.1 mm; and after PTA, 4.4 ± 1.0 mm. Angiographically, there was 1 type A dissection at baseline; 1 A, 1 B, and 2 C after Rotarex, and 3 A and 5 C after final adjunctive PTA. Intravascular ultrasound revealed a reference diameter of 6.2 ± 1.0 mm; 70% of patients had adventitial dissections. The mean arc of calcium was 221° ± 39.4° (moderate to severe calcium). ConclusionsThe Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of adventitial dissections is seen with the Rotarex. The long-term outcomes of this finding need to be further studied.

Practice patterns in utilization of atherectomy and embolic protection devices in inpatient and outpatient treatment settings

ObjectiveThe frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings. MethodsWe conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting. Results2849 matched pairs were inlcuded in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention. ConclusionsUse of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared to procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting.

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 1-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 1-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 = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, 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 1 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.