Perfusion increase in foot angiosomes: Comparison between direct and indirect revascularization of crural arteries.

BACKGROUND AND AIMS: In retrospective studies, wound healing and leg salvage have been better if revascularization is targeted to the crural artery supplying arterial flow to the wound angiosome. No data exist on how revascularization changes the blood flow in foot angiosomes. The aim of this study was to evaluate the change in perfusion after infrapopliteal artery revascularization in all foot angiosomes and to compare directly revascularized (DR) angiosomes to the indirectly revascularized (IR) angiosomes. METHODS: In this prospective study, foot perfusion was measured with indocyanine green fluorescence imaging (ICG-FI) before and after either surgical or endovascular below-knee revascularization. According to angiograms, we divided the foot angiosomes into DR and IR angiosomes. Furthermore, in a subanalysis, the IR angiosomes were graded as IR_Coll+ angiosomes if there were strong collaterals arising from the artery which was revascularized, and as IR_Coll- angiosomes if strong collaterals were not seen. RESULTS: A total of 72 feet (28 bypass, 44 endovascular revascularizations) and 282 angiosomes were analyzed. Surgical and endovascular revascularization increased perfusion significantly in both DR and IR angiosomes. After bypass surgery, the increase in DR angiosomes was 55 U and 53 U in IR angiosomes; there were no significant difference in the perfusion increase between IR and DR angiosomes. After endovascular revascularization, perfusion increased significantly more, 40 U, in DR angiosomes compared to 26 U in IR angiosomes (p < 0.05). In the subanalysis of IR angiosomes, perfusion increased significantly after surgical bypass regardless of whether strong collaterals were present or not. After endovascular revascularization, however, a significant perfusion increase was noted in the IR_Coll+ but not in the IR_Coll- subgroup. CONCLUSION: Open revascularization increased perfusion equally in DR and IR angiosomes, whereas endovascular revascularization increased perfusion significantly more in DR than in IR angiosomes. Strong collateral network may help increase perfusion in IR angiosomes.

Staged bilateral release of the popliteus muscle using a posterior surgical approach to the popliteal fossa to treat type 4 popliteal artery entrapment.

Popliteal artery entrapment syndrome (PAES) is a rare cause of intermittent claudication in the young. Aberrant embryological development results in entrapment of the popliteal artery by myofascial structures of the popliteal fossa. Type 4 PAES is due to aberrant development of the popliteus muscle superficial to the popliteal artery. We present a case of bilateral type 4 PAES, along with intraoperative photography highlighting the anatomical cause for this pathology. Both limbs in this patient were treated successfully with surgical release of the entrapping popliteus muscle via a posterior surgical approach to the popliteal fossa. This report emphasises the importance of determining popliteal artery integrity and entrapment subtype to guide the management of this condition.

The role of body mass index in high- and low-velocity trauma causing knee injury associated with popliteal artery lesions.

BACKGROUND: Among arterial traumas, osteoarticular traumas are particularly dangerous, and those involving the popliteal artery are associated with a high amputation rate. Despite representing a minority of arterial traumas, with an incidence that varies considerably by population and geographic location, traumatic lesions of the popliteal artery are challenging. This study aimed to verify the impact of body mass index (BMI) on arterial trauma damage and patient outcomes. METHODS: Data were retrospectively collected from the electronic medical reports of all patients with osteoarticular and vascular associated lesions treated in the emergency operating room at our institution between 1 January 2005 and 1 May 2022. Forty-one patients presented with lower limb arterial trauma (43.2%); popliteal artery lesions occurred in 11 of these patients (26.8%), who were eligible for inclusion in the study. The lesion mechanism was dislocation by high-velocity trauma in 9 patients and dislocation by low-velocity trauma in 3 patients. All 7 males (63.6%) experienced high-velocity trauma, and 2 of the 3 females experienced low-velocity trauma. Only one patient had an isolated popliteal artery lesion associated with fractures in the leg or the contralateral limb. Patients with low-velocity trauma were older than 54 years, while those with high-velocity trauma were aged 22 to 71 years. RESULTS: In 10/11 patients (90.9%), revascularization was performed after osteoarticular stabilization and reduction of the dislocation or fracture. Intraoperative angiography was selectively used. Two patients required above-the-knee amputation after the procedure: one due to infection of the surgical access point and the other due to severe soft tissue injury. One patient died during hospitalization due to trauma-related complications and comorbidities. CONCLUSIONS: High-velocity trauma and low-velocity trauma in patients with a body mass index > 35 kg/m2 and knee lesions are associated with popliteal artery lesions. Revascularization success is not associated with high- or low-velocity trauma.

Investigation of Optimal Needle Position for Radiofrequency Ablation-Based Blockade of Interspace between the Popliteal Artery and the Posterior Capsule of the Knee: A Cadaveric Study.

Background and Objectives: The interspace between the popliteal artery and the posterior capsule of the knee (iPACK) block has been widely used in perioperative settings to control posterior knee pain and can additionally be used for chronic knee pain. In this cadaveric study, we aimed to investigate the needle tip position and its proximity to the articular branch of the tibial nerve (ABTN) during an iPACK-targeted radiofrequency procedure. Materials and Methods: An ultrasound-guided iPACK block was performed on 20 knees of 10 cadavers. We injected 0.1 mL each of blue and green gelatinous dye near the tibial artery (point A) and posterior knee capsule (point B), respectively, and evaluated the spread of both around the ABTN. For a hypothetical conventional radiofrequency ablation (RFA) lesion (diameter, 2.95 mm) and cooled RFA lesion (diameter, 4.9 mm), we counted the number of specimens in which the ABTNs would be captured. Results: The percentage of specimens in which the ABTN would be captured by a cooled RFA lesion was 64.71% at point A and 43.75% at point B (p = 0.334). Meanwhile, the percentage of specimens in which the ABTN would be captured by a conventional RFA lesion was 58.82% from point A and 25% from point B (p = 0.065). Conclusions: When performing an RFA-based iPACK block, the needle tip may be positioned either lateral to the tibial artery or in the space between the posterior knee capsule and the tibial artery. However, more studies with larger samples are needed to verify these results before the clinical use of this procedure can be recommended.

Endovascular Transvenous versus Open Femoropopliteal Bypass.

Background and Objectives: Lower extremity arterial disease is one of the most prevalent manifestations of atherosclerosis. The results from numerous studies regarding the best revascularization method of an occluded superficial femoral artery have been conflicting. The aim of this study was to compare the patency of transvenous endovascular with open femoropopliteal bypass, both with vein and prosthetic grafts. To our knowledge, a direct patency comparison between transvenous endovascular and open femoropopliteal bypass has not been published. This could help elucidate which method is preferable and in which cases. Materials and Methods: Patients with complex TASC-C and D SFA lesions were offered endovascular transvenous or open bypass. A total of 384 consecutive patients with PAD requiring surgical treatment were evaluated for inclusion in this study. Three-year follow-up data were collected for 52 endovascular procedures, 80 prosthetic grafts, and 44 venous bypass surgeries. Bypass patency was investigated by Duplex US every 6 months. Kaplan-Meier plots were used to analyze primary, primary-assisted, and secondary patency for endovascular transvenous, autovenous, and prosthetic bypasses. Results: Primary, primary-assisted, and secondary patency in venous group at 3 years was 70.5%, 77.3%, and 77.3%, respectively. In the endovascular transvenous group, primary, primary-assisted, and secondary patency at 3 years was 46.2%, 69.2%, and 76.9%, respectively. The lowest patency rates at 3 years were noted in the prosthetic graft group with 22.5% primary, 26.6% primary-assisted, and 28.2% secondary patency. Conclusions: The saphenous vein is the best graft to perform in above-the-knee femoropopliteal bypass. Transvenous endovascular bypass is a viable option with comparable primary-assisted and secondary patency. Primary patency is substantially lower for endovascular transvenous compared to venous bypass. Patients treated with endovascular transvenous bypass will require a significant number of secondary procedures to provide optimal patency. Prosthetic grafts should only be used if no other option for bypass is available.

Infrapopliteal Bypass In Patients On Dialysis: Patency And Survival.

INTRODUCTION: Portugal has one of the highest prevalence of patients on a regular dialysis program. This population has a higher incidence of peripheral arterial disease with higher rates of postoperative morbidity and mortality. Our goal was to compare outcomes between dialysis and non-dialysis patients with chronic limb threatening ischemia (CLTI) submitted to infrapopliteal bypass. MATERIALS AND METHODS: A retrospective single-center study of infrapopliteal bypass for CLTI was performed between 2012 and 2019. Patients were divided in two groups based on dialysis status (group 1 incorporated patients on dialysis). Primary end point was 1-year freedom from CLTI. Secondary end points were limb-salvage, survival and primary (PP) and tertiary patency (TP) rates at 3 years of follow-up. RESULTS: A total of 352 infrapopliteal bypasses were performed in 310 patients with CLTI. Fourteen percent of the revascularizations were performed on dialysis patients (48/352). Median age was 73 years (interquartile range - IQR 15) and 74% (259/352) were male. Median follow-up was 26 months (IQR 42). Overall, 92% (325/352) had tissue loss and 44% (154/352) had some degree of infection. The majority of revascularization procedures were performed with vein grafts (61%, 214/352). The 30-day mortality was 4% (11/310), with no difference between groups (p = 0.627). Kaplan-Meier analysis showed no difference between groups regarding freedom from CLTI (76% vs. 79%; HR 0.96, CI 0.65-1.44, p=0.857), limb-salvage (70% vs. 82%; HR 1.40, CI 0.71-2.78, p=0.327) and survival (62% vs. 64%; HR 1.08, CI 0.60-1.94, p=0.799). PP rates were 39% in group 1 and 64% in group 2 (HR 1.71, CI 1.05-2.79, p=0.030). TP rates were not different between groups (57% and 78%; HR 1.79, CI 0.92-3.47, p=0.082). CONCLUSION: Infrapopliteal bypass for CLTI, on dialysis patients, resulted in lower PP rates. No differences were observed in freedom from CLTI, TP, limb salvage and survival.

A rare case of epithelioid angiosarcoma.

Epithelioid angiosarcoma is a rare high-grade vascular neoplasm with a poor prognosis. We present an anticoagulated 77-year-old man, with a history of popliteal/soleal vein thrombosis in the previous month, complaining of ipsilateral persistent lower limb pain and claudication. Absent popliteal/distal pulses prompted an arterial doppler ultrasound (DUS), revealing thrombosis of the distal superficial femoral artery and a popliteal mass. As the arterial wall's integrity could not be appropriately evaluated by DUS, adventitial cystic disease of the popliteal artery was suspected. Computed tomography angiography and magnetic resonance imaging findings were also suggestive. Due to refractory pain, he was submitted to a popliteal mass excision along with a femoral-posterior tibial bypass. Pathology revealed an epithelioid angiosarcoma. He was referred to a Sarcoma Center, requiring hospitalization for agitation and fever. A positron emission tomography (PET) scan revealed extensive lower limb disease persistence and distant metastases. He died on the 56th day after surgery. To our knowledge, there are only 15 cases of angiosarcoma of the popliteal artery described in the literature. Ours stands out as the first one unrelated to a popliteal aneurysm. Being a highly-aggressive tumor, an early diagnosis is challenging but essential to a successful treatment, warranting the need for suspicion of this neoplasm. An early core biopsy or surgical sample may expedite the diagnosis.

Popliteal-to-Distal Extreme Bypass in Endovascular Era.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is characterized by rest pain and tissue loss, with an annual mortality rate of 20% and amputation rate of 40%, if not treated. Open bypass surgery is recommended in CLTI, depending on the availability of good quality venous material, outflow artery patency, and surgical expertise. The aim of the study is to analyze primary patency, limb salvage, and survival rate in patients undergoing popliteal-to-distal bypass. METHODS: All consecutive patients who underwent popliteal-to-distal bypass surgery between January 2016 and December 2021 were enrolled in the study. Primary outcomes were primary patency, limb salvage, and overall survival. Secondary outcomes included amputation-free survival and secondary patency. RESULTS: Forty-nine patients were included during the study. Technical success was achieved in 100% of cases. Target outflow artery was in 27% (n. 13) of cases the anterior tibial artery, in 27% (n. 13) the dorsalis pedis, in 2% (n. 1) the peroneal artery, in 30% (n. 15) the retromalleolar tibial artery, in 10% (n. 5) the medial plantar artery, and in 4% (n. 2) the tarsal artery. Two-year primary patency was 85% ± 5. Secondary patency rates were 86% ± 3 at 2 years. The overall survival was 81% ± 6 at 2 years, the amputation-free survival was 70% ± 9, and the limb salvage rate was 81% ± 6. CONCLUSIONS: Popliteal-to-distal bypass requires high technical expertise to be performed. When a good autologous vein and adequate outflow artery are present, they can be feasible with good patency rates and overall survival.

Two-year outcomes of endovascular therapy for femoropopliteal arterial lesions for patients with high bleeding risk.

The Academic Research Consortium (ARC) recently published a definition of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. However, the prevalence of the ARC-HBR criteria in patients undergoing endovascular therapy (EVT) for femoropopliteal arterial lesions has not been thoroughly investigated. The study population comprised 165 patients undergoing initial EVT for femoropopliteal lesions between June 2018 and June 2020. They were divided into two groups according to the ARC-HBR criteria. The primary end point was a composite of all-cause death, Bleeding Academic Research Consortium type 3 or 5 bleeding, and target lesion revascularization (TLR) within 2 years of EVT. The 165 patients were divided into two groups: 125 (75.8%) patients at HBR (HBR group) and 40 (24.2%) patients at no HBR (non-HBR group). The cumulative incidence of the primary endpoint was significantly higher in the HBR group than in the non-HBR group (40.6% vs. 0%, log-rank p < 0.001). The HBR group had a significantly higher risk of all-cause death, major bleeding, and TLR than the non-HBR group (25.2% vs. 0%, log-rank p = 0.004, 13.9% vs. 0%, log-rank p = 0.047, 16.8% vs. 0%, log-rank p = 0.035). Most patients with peripheral artery disease were classified as HBR patients, and HBR patients were at higher risk of death, major bleeding, and TLR than non-HBR patients.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

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 > 15 cm) [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 ± 6.4 cm vs 24.0 ± 9.0 cm vs 26.6 ± 6.2 cm 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 5 years. 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 5 years 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 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; 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 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years 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.

Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery.

BACKGROUND: The treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. METHODS: From June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications, and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class. RESULTS: A total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions, while 41 (67.2%) patients had chronic total occlusions. The mean length of these lesions was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. CONCLUSIONS: ELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.

Outcomes of Endovascular and Open Surgical Therapy for Popliteal Artery Injury.

BACKGROUND: Popliteal arterial injury carries an appreciable risk of limb loss and, despite advances in stent and stent-graft technology, endovascular therapy for popliteal arterial trauma is infrequently used when compared with traditional open repair. Thus, this study aims to assess outcomes of endovascular management (EM) with open surgery (OS) as a historical reference. METHODS: An electronic search was performed (from January 2010 until June 2023) using multiple databases. Initial records were screened against eligibility criteria. Next, the full-text manuscript of articles that passed the title and abstract assessment was reviewed for relevancy of data points. Data from articles passing the inclusion criteria were extracted and tabulated. Comparative analysis was completed by performing chi-square tests and 2-sampled t-tests (Welch's). RESULTS: The 24 selected studies described 864 patients (96 EM; 768 OS). In the endovascular group, patients underwent procedures primarily for blunt trauma using covered, self-expanding stents, resulting in universal technical success and patency. Patients had an average length of stay of 7.99 ± 7.5 days and follow-up time of 33.0 ± 7.0 months, with 21% undergoing fasciotomies, 6% undergoing amputation, and 4% having pseudoaneurysms. Patients in the OS group were evenly divided between blunt and penetrating trauma, chiefly undergoing vein graft interposition and exhibiting fasciotomy and amputation rates of 66% and 24%, respectively. Patients had an average length of stay of 5.66 ± 4.6 days and a 96% survival rate at discharge. CONCLUSIONS: The current evidence sheds light on the nature of treatment offered by EM and OS treatment and suggests EM is associated with several important positive outcomes. Although it is difficult to directly compare endovascular and open surgical techniques, the data with respect to open surgical management of popliteal artery trauma can still provide a powerful frame of reference for the outcomes of EM to date. However, this claim is weak due to the little published data for EM of popliteal trauma, publication bias accompanying the published studies, and general, selection bias. Additional prospective data are necessary to define patients who specifically benefit from endovascular repair.

Comparison of the popliteal artery and the capsule of the posterior knee (IPACK) block and the genicular nerve block in primary total knee arthroplasty: A prospective randomized trial.

OBJECTIVES: To compare the efficacy of genicular block and interspace between the popliteal artery and the posterior capsule (IPACK) block in the reduction of postoperative pain, the need for rescue analgesics, and the effects on a range of motion (ROM) in patients with TKA. METHODS: This prospective randomized controlled study was carried out between February and May 2023. Based on the block method, 60 participants were divided into three equal groups. These groups included the IPACK block group (n=20), the genicular block group (n=20), and control group (n=20). Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Society score (KSS) and Oxford Knee score (OKS) were used for clinical evaluation in the postoperative period. RESULTS: The KSS and OKS scores of the IPACK and GNB were significantly lower than the control group (p<0.001, p<0.001). The timed up and go (TUG) values of the IPACK and GNB groups at 12th and 24th hour were significantly lower than the control group (p<0.001, p<0.001). The Tramadol rescue values of the IPACK block and control groups were significantly higher than the GNB group (p=0.028, p=0.001, respectively). The ROM values of the IPACK and GNB groups were significantly higher than the control group (p<0.001, p<0.001). CONCLUSION: Both GNB and IPACK blocks had a significant positive impact on postoperative pain scores within the initial 24 hours following total knee arthroplasty (TKA). In comparison with IPACK, GNB had lower opioid consumption in the early postoperative period while also promoting better mobilization.

Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease.

BACKGROUND: According to a meta-analysis of randomized clinical trials, paclitaxel-coated devices (PCDs) for lower limb endovascular revascularization may be associated with increased risk of late mortality. OBJECTIVES: The purpose of this study was to determine whether PCDs are associated with all-cause mortality in a real-world setting. METHODS: DETECT is a nationwide, exhaustive retrospective cohort study using medico-administrative data from the French National Healthcare System representing >99% of the population. The main selection criterion was the first procedure of interest: endovascular revascularization for lower limb peripheral artery disease involving ≥1 balloon and/or stent performed between October 1, 2011, and December 31, 2019. Patients with or without PCDs were compared for all-cause mortality until December 31, 2021. RESULTS: A total of 259,137 patients were analyzed, with 20,083 (7.7%) treated with ≥1 PCD. After a median follow-up of 4.1 years (Q1-Q3: 2.3-6.4 years), a total of 5,385 deaths/73,923 person-years (PY) (7.3/100 PY) and 109,844 deaths/1,060,513 PY (10.4/100 PY) were observed in the PCD and control groups, respectively. After adjustment for confounding factors, PCD treatment was associated with a lower risk of mortality in multivariable Cox analyses (HR: 0.86; 95% CI: 0.84-0.89; P < 0.001). Similar results were observed using propensity score matching approaches based on either nearest-neighbor or exact matching. CONCLUSIONS: In a nationwide analysis based on large-scale real-world data, exposure to PCDs was not associated with a higher risk of mortality in patients undergoing endovascular revascularization for lower limb peripheral artery disease. (The DETECT Project; NCT05254106).

Comparison of the Pre-Established and Finally Selected Treatment Strategies for Endovascular Treatment in Femoropopliteal Artery Lesions.

This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.