Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

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

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Contemporary outcomes of surgical decompression for functional popliteal entrapment syndrome.

BACKGROUND: Functional popliteal entrapment syndrome (FPES) is an under-recognized source of leg pain caused by dynamic compression of the popliteal vessels by surrounding musculature in the absence of anatomic abnormality. Late recognition and difficulty capturing this entity across imaging modalities can lead to significant morbidity in an often young and active patient population. Surgical outcomes and optimal diagnostic strategies remain uncertain. METHODS: We performed a retrospective cohort study of all patients undergoing surgical decompression for FPES at an academic medical center between 2018 and 2022. Preoperative symptoms, patient characteristics, imaging, operative details, and follow-up were captured. The primary outcome was symptomatic improvement at last clinic visit. Secondary outcomes included symptomatic improvement at 6 months and postoperative complications. RESULTS: A total of 24 extremities (16 patients) were included. The mean ± standard deviation age was 23.3 ± 6.4 years and 75.0% of patients were female. The median symptom duration before decompression was 27 months (interquartile range, 10.7-74.6 months). Preoperative symptom severity in the affected extremity was as follows: 33.3% limited from peak exercise, 25% unable to exercise, and 41.7% with debilitating symptoms that affected activities of daily living. Preoperative imaging with provocative maneuvers included duplex ultrasound (87.5%), magnetic resonance angiography (100%), and digital subtraction angiography (100%). Using digital subtraction angiography as the gold standard, the sensitivity for detection of FPES was 85.7% for duplex examination and 58.3% for magnetic resonance angiography. The median follow-up was 451 days (interquartile range, 281-635 days). Most patients demonstrated durable improvement in the affected extremity, with 29.2% realizing complete resolution of symptoms and 37.5% reporting symptomatic improvement at last clinic visit for a total of 66.7%; 20.8% had initial improvement, but developed recurrent symptoms and were found to have elevated compartment pressures consistent with chronic exertional compartment syndrome and were treated with formal fasciotomy. Repeat decompression was required in one extremity (4.2%) owing to recurrent symptoms. Two patients (8.3%) had minimal or no improvement in their affected extremity and workup for the cause of continued discomfort was ongoing. CONCLUSIONS: Delays in diagnosis of FPES are common. Provocative maneuvers until replication of symptoms across multiple imaging modalities may be necessary to reliably identify the disease process. Surgical decompression improved or completely resolved symptoms in two-thirds of extremities. Treating physicians should maintain suspicion for comorbid chronic exertional compartment syndrome, especially if symptoms recur or persist after decompression.

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

OBJECTIVE: Percutaneous 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. METHODS: The 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. RESULTS: We 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. CONCLUSIONS: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Outcomes and predictors of amputation-free survival in patients undergoing below-knee popliteal-distal bypass.

OBJECTIVE: The infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). METHODS: The VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. RESULTS: A total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). CONCLUSIONS: Below-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.

Efficiency and safety of dual pathway inhibition for the prevention of femoropopliteal artery restenosis in repeated endovascular interventions.

OBJECTIVE: There is a lack of consensus regarding the optimal strategy for evaluating the efficiency and safety of dual-pathway inhibition (DPI) in preventing femoropopliteal restenosis in patients undergoing repeated endovascular interventions. Despite several therapeutic interventions available for preventing femoropopliteal restenosis post repeated endovascular interventions, the ideal strategy, particularly evaluating the efficacy and safety of DPI, remains a matter of debate. METHODS: From January 2015 to September 2021, patients who underwent repeated endovascular interventions for femoropopliteal restenosis were compared with those who underwent DPI or dual antiplatelet therapy (DAPT) after surgery using a propensity score-matched analysis. The primary outcome was clinically driven target lesion revascularization (CD-TLR). The principal safety outcome was a composite of major bleeding and clinically relevant non-major (CRNM) bleeding. To further enhance the rigor, Kaplan-Meier plots, Cox proportional hazards modeling, and sensitivity analyses, as well as subgroup analyses were employed, reducing potential confounders. RESULTS: A total of 441 patients were included in our study, of whom 294 (66.7%) received DAPT and 147 (33.1%) received DPI, with 114 matched pairs (mean age, 72.21 years; 84.2% male). Cumulative probability of CD-TLR at 36 months in the DPI group (17%) trended lower than that in the DAPT group (32%) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.26-0.78; P =.004). The cumulative probability of freedom from CD-TLR at 36 months in the DPI group was 83%. No significant difference was observed in the composite outcome of major or CRNM bleeding between the DPI and DAPT groups (HR, 1.26; 95% CI, 0.34 to 4.69; P = .730). The DPI group was associated with significantly lower rates of CD-TLR in the main subgroup analyses of diabetes (P = .001), previous smoking history (P = .008), longer lesion length (>10 cm) (P = .003), and treatment with debulking strategy (P = .003). CONCLUSIONS: In our investigation focused on CD-TLR, we found that DPI exhibited a significant reduction in the risk of reintervention compared with other treatment modalities. This underscores the potential of DPI as a viable therapeutic strategy in preventing reinterventions. Moreover, our assessment of safety outcomes revealed that the bleeding risks associated with DPI were on par with DAPT, thereby not compromising patient safety. These findings pave the way for potential broader clinical implications, emphasizing the effectiveness and safety of DPI in the context of reducing reintervention risks.

Outcomes of endovascular intervention for atherosclerotic lesions confined to the popliteal artery.

OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.

Clinical implications of diverse calcification patterns in endovascular therapy for femoral-popliteal arterial occlusive disease.

OBJECTIVE: The aim of this study was to investigate whether intimal arterial calcification (IAC) and medial arterial calcification (MAC) are correlated with the various clinical outcomes following endovascular therapy (EVT) for peripheral arterial disease (PAD). METHODS: This single-center retrospective study comprised 154 consecutively hospitalized individuals with PAD who underwent EVT for de novo femoral-popliteal calcific lesions from January 2016 to July 2021. The predominant calcification patterns of IAC and MAC were assessed using a semi-quantitative computed tomography scoring system. The Kaplan-Meier method and Cox regression were conducted to evaluate the correlations between calcification patterns and medium- to long-term outcomes. RESULTS: The distribution of calcification patterns was as follows: IAC in 111 patients (72%) and MAC in 43 patients (28%). No remarkable variation was noted between the IAC and MAC groups regarding age (P = .84) and gender (P = .23). The MAC group indicated lower rates of 4-year primary patency, assisted primary patency, secondary patency, and amputation-free survival (AFS) compared with the IAC group (24% ± 7% vs 40% ± 6%; P = .003; 30% ± 8% vs 51% ± 6%; P = .001; 51% ± 8% vs 65% ± 5%; P = .004; and 43% ± 9% vs 76% ± 5%; P < .001, respectively). There was no significant difference in the rate of freedom from clinically driven target lesion revascularization between the MAC and IAC groups (63% ± 10% vs 73% ± 5%; P = .26). Stepwise multivariable Cox regression analysis demonstrated that MAC was associated with poor patency (hazard ratio, 1.81; 95% confidence interval, 1.12-2.93; P = .016) and AFS (hazard ratio, 2.80; 95% confidence interval, 1.52-5.16; P = .001). CONCLUSIONS: Compared with IAC, MAC is independently associated with lower medium- to long-term patency and AFS after EVT for de novo femoral-popliteal occlusive lesions.

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

OBJECTIVE: We 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. METHODS: We 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. RESULTS: In 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. CONCLUSIONS: The 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.

Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

The effect of cilostazol on late outcomes after endovascular treatment for occlusive femoropopliteal disease.

OBJECTIVE: Restenosis and late occlusion remain a significant problem for endovascular treatment of peripheral artery disease. This meta-analysis aims to evaluate the effect of cilostazol on late outcomes after endovascular repair of occlusive femoropopliteal disease. METHODS: A systematic literature review was conducted conforming to established criteria to identify articles published up to September 2023 evaluating late outcomes after endovascular treatment for atherosclerotic femoropopliteal disease. Eligible studies should compare outcomes between patients treated with cilostazol and patients not treated with cilostazol. Both prospective and retrospective studies were eligible. Late outcomes included primary patency (PP), restenosis, target lesion revascularization (TLR), and major amputation during follow-up. RESULTS: Overall, 10 clinical studies were identified for analysis including 4721 patients (1831 with cilostazol vs 2890 without cilostazol) that were treated for 5703 lesions (2235 with cilostazol vs 3468 without cilostazol). All studies were performed in Japan. Mean follow-up was 24.1 ± 12.5 months. Cilostazol was associated with a lower risk for restenosis (pooled odds ratio [OR], 0.503; 95% confidence interval [CI], 0.383-0.660; P < .0001). However, no association was found between cilostazol and TLR (pooled OR, 0.918; 95% CI, 0.300-2.812; P = .881) as well as major amputation (pooled OR, 1.512; 95% CI, 0.734-3.116; P = .263). Regarding primary patency, cilostazol was associated with a higher 12-month PP (OR, 3.047; 95% CI, 1.168-7.946; P = .023), and a higher 36-month PP (OR, 1.616; 95% CI, 1.412-1.850; P < .0001). No association was found between cilostazol and mortality during follow-up (pooled OR, .755; 95% CI, 0.293-1.946; P = .561). CONCLUSIONS: Cilostazol seems to have a positive effect on 1- to 3-year PP and restenosis rates among patients treated endovascularly for atherosclerotic femoropopliteal disease. A positive effect on TLR and amputation risk was not verified in this review.

Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

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

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

Three-year outcomes of contemporary endovascular treatment in over 25-cm femoropopliteal artery disease from a retrospective multicenter registry: A retrospective observational study.

BACKGROUND: Endovascular therapy (EVT) is often performed for diffuse femoropopliteal lesions. This study investigated 3-year patency and clinical outcomes in patients with EVT-treated femoropopliteal lesions >25 cm. METHODS: This retrospective multicenter registry analyzed patients who presented with lower extremity artery disease having femoropopliteal lesions >25 cm who underwent EVT between 2017 and 2021. The primary outcome was restenosis 3 years after EVT. RESULTS: Overall, 504 patients with 614 lesions undergoing EVT for diffuse femoropopliteal lesions were enrolled. The prevalence of restenosis was 184.3 per 1000 lesion-years. Kaplan-Meier estimate of freedom from restenosis was 58.6% at 3 years. In the multivariate Poisson regression model, female sex (adjusted incidence risk ratio: 1.54; p = 0.003), cilostazol use (0.44; p < 0.001), revascularization history (1.87; p = 0.001), P3 involvement (2.09; p < 0.001), and reference vessel diameter <5 mm (1.88; p < 0.001) were associated independently with restenosis risk. The accumulation of these factors was associated with a lower rate of freedom from restenosis; the Kaplan-Meier estimates of the rates were 49.3% and 22.4% in the subgroups with two and more risk factors, respectively, while they were 81.1% in patients without any risk factors and 70.3% in those with one risk factor. CONCLUSIONS: Female sex, nonuse of cilostazol, revascularization history, P3 involvement, and small vessels were associated with high restenosis risk after EVT for diffuse femoropopliteal lesions. Although patients with multiple risk factors have a low patency rate, EVT offers an acceptable patency rate for those with fewer risk factors.

Outcomes of non-flow-limiting spiral dissection after drug-coated balloon angioplasty for de novo femoropopliteal lesions.

BACKGROUND: Whether drug-coated balloon (DCB) angioplasty would be effective in spiral dissection (SD) lesions with no flow impairment has been thoroughly investigated. AIMS: The present study sought to assess the clinical outcomes of non-flow-limiting SD after DCB angioplasty for de novo femoropopliteal lesions in patients with symptomatic lower extremity artery disease. METHOD: This single-center retrospective study enrolled 497 patients with non-flow-limiting SD (n = 92) or non-SD (n = 405) without bailout stenting. The primary endpoint was 1-year primary patency, with the secondary endpoints including freedom from target lesion revascularization (TLR), major adverse limb event (MALE), all-cause death, and 30-day restenosis. RESULTS: The 1-year primary patency and freedom from TLR were significantly lower in the SD group than in the non-SD group (69.8% vs. 83.3%, p = 0.004; 78.7% vs. 93.0%, p = 0.007, respectively). The SD group had a higher incidence of MALE and 30-day restenosis than the non-SD group (24.6% vs. 11.9%, p = 0.001; 4.3% vs. 0.5%, p = 0.002, respectively). All-cause death was comparable. One-year restenosis after SD was associated with chronic limb-threatening ischemia (CLTI) (hazard ratio, 3.36 [95% confidence interval, 1.21-9.36]; p = 0.020), TASC Ⅱ D (hazard ratio, 3.97 [95% confidence interval, 1.02-15.52]; p = 0.047), and residual stenosis ≥50% (hazard ratio, 4.92 [95% confidence interval, 1.01-23.94]; p = 0.048). The incidence of restenosis after SD increased with the number of these risk factors. CONCLUSIONS: Despite normal antegrade flow, the 1-year primary patency rate after DCB angioplasty for de novo femoropopliteal lesions was significantly lower in lesions with SD than those without SD. CLTI, TASC II D, and residual stenosis ≥50% were risk factors associated with 1-year restenosis after DCB angioplasty for non-flow-limiting SD lesions.

Effects of atherectomy on major adverse limb events for femoropopliteal interventions: Vascular Quality Initiative registry.

BACKGROUND: Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. AIMS: We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. METHODS: Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. RESULTS: Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. CONCLUSIONS: In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.

Position- and posture-dependent vascular imaging-a scoping review.

OBJECTIVES: Position- and posture-dependent deformation of the vascular system is a relatively unexplored field. The goal of this scoping review was to create an overview of existing vascular imaging modalities in different body positions and postures and address the subsequent changes in vascular anatomy. METHODS: Scopus, Medline, and Cochrane were searched for literature published between January 1, 2000, and June 30, 2022, incorporating the following categories: image modality, anatomy, orientation, and outcomes. RESULTS: Out of 2446 screened articles, we included 108. The majority of papers used ultrasound (US, n = 74) in different body positions and postures with diameter and cross-sectional area (CSA) as outcome measures. Magnetic resonance imaging (n = 22) and computed tomography (n = 8) were less frequently used but allowed for investigation of other geometrical measures such as vessel curvature and length. The venous system proved more sensitive to postural changes than the arterial system, which was seen as increasing diameters of veins below the level of the heart when going from supine to prone to standing positions, and vice versa. CONCLUSIONS: The influence of body positions and postures on vasculature was predominantly explored with US for vessel diameter and CSA. Posture-induced deformation and additional geometrical features that may be of interest for the (endovascular) treatment of vascular pathologies have been limitedly reported, such as length and curvature of an atherosclerotic popliteal artery during bending of the knee after stent placement. The most important clinical implications of positional changes are found in diagnosis, surgical planning, and follow-up after stent placement. CLINICAL RELEVANCE STATEMENT: This scoping review presents the current state and opportunities of position- and posture-dependent imaging of vascular structures using various imaging modalities that are relevant in the fields of clinical diagnosis, surgical planning, and follow-up after stent placement. KEY POINTS: • The influence of body positions and postures on the vasculature was predominantly investigated with US for vessel diameter and cross-sectional area. • Research into geometrical deformation, such as vessel length and curvature adaptation, that may be of interest for the (endovascular) treatment of vascular pathologies is limited in different positions and postures. • The most important clinical implications of postural changes are found in diagnosis, surgical planning, and follow-up after stent placement.

Mortality, Safety, and Effectiveness of Paclitaxel-Containing Balloons and Stents in the Femoropopliteal Artery: Systematic Review and Meta-Analysis of Randomized Controlled Trials since 2018.

PURPOSE: To provide an updated systematic review and meta-analysis of safety and effectiveness outcomes with paclitaxel-containing devices. MATERIALS AND METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) investigating paclitaxel-containing balloons or stents in the treatment of femoropopliteal disease was performed. Pooled risk ratio (RR) was calculated using the inverse-variance, random-effects model in the assessment of primary patency, all-cause mortality, target limb major amputation, target lesion revascularization (TLR), and thrombosis. RESULTS: In total, 19 RCTs were included comprising 4,284 participants. All-cause mortality rates did not differ significantly between the 2 arms at 12 months (RR, 1.06; 95% confidence interval [CI], 0.66-1.72; P = .80), 24 months (RR, 0.92; 95% CI, 0.56-1.50; P = .73), 36 months (RR, 1.21; 95% CI, 0.65-2.25; P = .55), or 48-60 months (RR, 0.95; 95% CI, 0.66-1.39; P = .81) after intervention. Primary patency was significantly higher at 12 months in the paclitaxel-containing arm: 80.92% (1,438/1,777) versus 57.48% (607/1,056) in the control arm (RR, 1.44; 95% CI, 1.30-1.59; P < .00001). CONCLUSIONS: The present study demonstrates no statistically significant difference in all-cause mortality, target limb major amputation, or thrombosis with paclitaxel drug-eluting therapy to the femoropopliteal region. Additionally, improved and durable patency rates with a statistically significantly lower risk of clinically driven TLR with paclitaxel drug-eluting therapy have been demonstrated.

Impact of Procedural Techniques on Midterm Patency of Fluoropolymer-Based Drug-Eluting Stent Placed in the Femoropopliteal Artery.

PURPOSE: To investigate the impact of compliance with recommended procedural techniques on the midterm patency of a fluoropolymer-based drug-eluting stent (FP-DES) in the femoropopliteal artery. MATERIALS AND METHODS: This retrospective study included 200 femoropopliteal lesions (chronic limb-threatening ischemia, 59%; chronic total occlusion, 41%) in 173 patients (male, 66%; diabetes mellitus, 62%; hemodialysis, 40%) with lower extremity arterial disease who underwent intravascular ultrasound (IVUS)-guided endovascular therapy with FP-DES between January 2016 and July 2021. The primary outcome measure was restenosis, defined as a peak systolic velocity ratio of >2.4 based on the duplex US findings. The association between procedural techniques and incidence of restenosis was investigated using Cox proportional hazards regression models. RESULTS: The 2-year cumulative incidence of restenosis was 19.5% (SD ± 3.3). Multivariate analysis revealed that noncompliance with recommended procedural techniques, such as plaque burden at the stent edge of <50%, a minimum stent area (MSA) of >12 mm2, and stent placement within the P1 segment, was independently associated with an increased risk of restenosis (hazard ratios [HRs], 3.22, 4.71, and 4.67 and P = .004, P < .001, and P < .001, respectively). The 2-year restenosis risk for procedures performed in compliance with all 3-technical criteria was 8.4% (SD ± 3.4), whereas the risks for those in compliance with 2-technical criteria or 0- or 1-technical criteria were 25.0% (SD ± 6.2) and 48.6% (SD ± 10.4), respectively. HRs relative to 3-technical criteria compliance were 3.79 (P = .007) and 11.85 (P < .001), respectively. CONCLUSIONS: Noncompliance with recommended procedural techniques, including plaque burden at the stent edge of <50%, MSA of >12 mm2, and stent placement within the P1 segment, was significantly associated with an increased risk of 2-year restenosis after FP-DES implantation in the femoropopliteal artery.