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.

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.

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.

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 12 months were measured. Risk factors for TLR were also investigated. The mean age was 71.7 years, and diabetes was observed in 82.3% of patients. The mean duration of receiving dialysis was 8.8 years. The mean lesion length was 11.0 cm, 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 12 months were 63.8% and 71.3%, respectively. The freedom rates after low- and high-dose DCB at 12 months 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 12 months 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 12 months 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.

Trends and outcomes associated with intravascular ultrasound use during femoropopliteal revascularization in the Vascular Quality Initiative.

OBJECTIVE: Intravascular ultrasound (IVUS) use in lower extremity interventions is growing in popularity owing to its imaging in the axial plane, superior detail in imaging lesion characteristics, and its enhanced ability to delineate lesion severity and extent compared with catheter angiograms. However, there are conflicting data regarding whether IVUS affects outcomes. The purpose of this study was to assess the effect associated with IVUS implementation in femoropopliteal interventions. METHODS: This retrospective cohort study used Vascular Quality Initiative data. Patients undergoing an index endovascular femoropopliteal revascularization from 2016 to 2021 were included. Patients were differentiated by whether or not IVUS was used to assess the femoropopliteal segment during intervention (no IVUS, IVUS). Propensity score matching, based on preoperative demographics and measures of disease severity was used. Primary outcomes were major amputation-free survival (AFS), femoropopliteal reintervention-free survival (RFS), and primarily patent survival (PPS) at 12 months. RESULTS: IVUS use grew steadily throughout the study period, comprising 0.6% of interventions in 2016 and increasing to 8.2% of interventions by 2021; growth was most dramatic in ambulatory surgical center or office-based laboratory settings where IVUS use grew from 4.4% to 43% to 47% of interventions. In unmatched cohorts, patients receiving interventions using IVUS tended to have lower prevalence of multiple cardiovascular comorbidities (eg, congestive heart failure, hypertension, diabetes, and dialysis dependence) and presented more often with claudication and less often with chronic limb-threatening ischemia (CLTI). Intraoperatively, IVUS was used more often in complex femoropopliteal lesions (Transatlantic Intersociety grade D vs A), and more often in conjunction with stenting and/or atherectomy. IVUS use was associated with improved AFS, but similar RFS and PPS at 12 months. However, in multivariable analysis IVUS was not associated with any of the primary outcomes independently; rather, all outcomes were influenced primarily by CLTI, dialysis dependence, and prior major amputation status; technical outcomes (ie, RFS and PPS loss) were further driven by complexity of lesion (worse in Transatlantic Intersociety grade D vs A lesions) and treatment setting (ie, ambulatory surgical center or office-based laboratory setting associated with increased hazard for RFS and PPS loss). CONCLUSIONS: IVUS implementation in femoropopliteal interventions is growing, with rapid adoption among interventions in ambulatory surgical centers and office-based laboratories. IVUS was not associated with an effect on technical outcomes at 12 months; improvement in major AFS was observed; however, multivariable analysis suggests this finding may be an effect of confounding by multiple factors highly associated with IVUS use, namely, in patients with lower prevalence of CLTI, dialysis dependence, and prior major amputations, thus conveying baseline lower risk for major amputation and death.

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

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

Anemia as a risk factor for restenosis in femoropopliteal arterial disease after drug-coated balloon angioplasty.

OBJECTIVE: This study aimed to investigate the relationship between anemia and restenosis in patients with femoropopliteal arterial disease following drug-coated balloon (DCB) angioplasty. METHODS: 194 patients treated with DCB for femoropopliteal lesions were retrospectively analyzed for up to 12 months of follow-up between January 2017 and September 2020. Baseline clinical and procedural characteristics were compared between the anemia and non-anemia patients, and predictors of restenosis were identified using logistic regression. RESULTS: 32.5% of the patients undergoing DCB angioplasty had anemia. Patients with anemia were significantly older, with higher rates of hypertension, coronary artery disease, chronic renal insufficiency, and diabetes, and with lower rates of smoking and male gender. In the multivariate analysis, anemia was independently and significantly associated with a higher risk of restenosis (OR, 3.872; 95% CI, 1.556-9.638; P = 0.004). CONCLUSION: Anemia is independently associated with restenosis in patients treated with DCB for femoropopliteal arterial disease. Patients with lower baseline hemoglobin might have more chances to develop restenosis at follow-up.

Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.

OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.

Trends in Utilization and Outcomes of Orbital, Laser, and Excisional Atherectomy for Lower Extremity Revascularization.

PURPOSE: The aim of this study is to analyze the utilization pattern of atherectomy modalities and compare their outcomes. MATERIALS AND METHODS: All patients undergoing atherectomy in the 2010-2016 Vascular Quality Initiative Database were identified. Utilization of orbital, laser, or excisional atherectomy was obtained. Characteristics and outcomes of patients treated for isolated femoropopliteal and isolated tibial disease by different modalities were compared. RESULTS: Atherectomy use increased from 10.3% to 18.3% of all peripheral interventions (n = 122 938). Orbital atherectomy was most commonly used and increased from 59.4% in 2010 to 63.2% of all atherectomies in 2016, while laser atherectomy decreased from 19.2% to 13.1%. Atherectomy was mostly used for treatment of isolated femoropopliteal disease (51.1%), followed by combined femoropopliteal and tibial disease (25.8%) and isolated tibial disease (11.7%). In isolated femoropopliteal revascularization, excisional atherectomy was associated with higher rate of perforation (1.2%) compared with laser (0.4%) and orbital atherectomy (0.5%). The technical success of orbital atherectomy (96.7%) was lower compared with excisional atherectomy (98.7%). Concomitant stenting was significantly higher with laser atherectomy (43.0%) compared with orbital (27.2%) and excisional (26.1%) atherectomy. Nevertheless, there was no difference in 1-year primary patency, reintervention, major amputation, improvement in ambulatory status, or mortality. Multivariable analysis also demonstrated no difference in 1-year primary patency and major ipsilateral amputation among the modalities. In isolated tibial revascularization, there were no differences in perioperative outcomes among the modalities. Excisional atherectomy was associated with the highest 1-year primary patency (88.1%). After adjusting for confounders, excisional atherectomy remained associated with superior 1-year primary patency compared with orbital atherectomy (odds ratio [OR] = 2.59, 95% confidence interval [CI] = [1.18-5.68]), and excisional atherectomy remained associated with a lower rate of 1-year major ipsilateral amputation compared with laser atherectomy (OR = 0.29, 95% CI = [0.09-0.95]). CONCLUSION: Atherectomy use has increased, driven primarily by orbital atherectomy. Despite significant variation in perioperative outcomes, there were no differences in 1-year outcomes among the different modalities when used for treating isolated femoropopliteal disease. In isolated tibial disease treatment, excisional atherectomy was associated with higher 1-year primary patency compared with orbital atherectomy and decreased major ipsilateral amputation rates compared with laser atherectomy. These differences warrant further investigation into the comparative effectiveness of atherectomy modalities in various vascular beds.

Network Meta-Analysis of All Available Regimens Based on Drug-Coated Balloon Angioplasty and Laser Atherectomy for Femoropopliteal In-Stent Restenosis.

PURPOSE: Drug-coated balloon (DCB) angioplasty and laser atherectomy (LA) have been frequently utilized to treat femoropopliteal in-stent restenosis (ISR); however, no studies have concurrently compared available regimens, including DCB, LA+DCB, and LA + plain balloon angioplasty (PB). Therefore, we conducted this network meta-analysis to determine whether there were significant differences in outcomes among these regimens. MATERIALS AND METHODS: A comprehensive search was conducted in PubMed, EMBASE, and the Cochrane library to identify all randomized controlled trials comparing DCB or LA-based regimes with POBA or each other for treating femoropopliteal in-stent restenosis (ISR) from their inception until March 2021. The primary outcome measure was binary restenosis, and secondary outcome measures were target lesion revascularization (TLR) and mortality, evaluated at 6 and 12 months, respectively. Statistical analysis was performed using Aggregate Data Drug Information System (ADDIS) 1.4 software, and all data were graphically summarized using Microsoft Excel software. RESULTS: The final analysis included 11 studies, of which 6 studies compared DCB with PB, 2 studies compared PB vs LA+PB, 2 studies compared DCB vs LA+DCB, and 1 study compared LA+DCB with LA+PB. DCB was better than PB in decreasing binary restenosis at 6 (odds ratio [OR]: 0.22, 95% credible interval [CrI]: 0.04-0.91) and 12 (OR: 0.26, 95% CrI: 0.12-0.50) months. DCB was associated with lower TLR than PB at 6 months (OR: 0.31, 95% CrI: 0.13-0.69). LA+DCB was also superior to PB in treating binary restenosis at 12 months (OR: 6.10, 95% CrI: 1.94-24.41) and TLR at 6 months (OR: 5.32, 95% CrI: 1.43-28.06). There was no statistical difference in mortality between PB, DCB, and LA+PB. DCB and LA+DCB were the first 2 options for reducing binary restenosis and TLR. CONCLUSION: The current network meta-analysis demonstrates that both DCB and LA+DCB are superior to PB alone, and that DCB and LA+DCB may be the preferred treatment options for reducing binary restenosis and TLR. CLINICAL IMPACT: The treatment for femoropopliteal in-stent restenosis (ISR) remains challenging clinical practice. One important reason is that no optimal treatment strategy was available. Drug-coated balloon angioplasty (DCB) and laser atherectomy (LA) have been extensively utilized to treat ISR; however, different combinations of these treatments further confused the clinicians' choices. This network meta-analysis systematically investigated the difference between the currently available treatments regarding therapeutic effects and safety, indicating that DCB and LA+DCB may be the optimal treatment for decreasing the risk of binary restenosis and target lesion revascularization. The results of the current network meta-analysis help to resolve the confusion of clinicians in making the decision.

A Single-Center Study on the Outcomes of Target Limb Revascularization in Femoropopliteal Lesions Treated With Drug Coated Balloons and Bare Metal Stents.

PURPOSE: Multiple randomized controlled trials have shown that both drug coated balloons (DCBs) and bare metal stents (BMSs) significantly reduce restenosis in femoropopliteal lesions compared with plain balloon angioplasty. However, few studies have directly compared DCB and BMS treatments. Therefore, the goal of our study was to determine if the rate of target lesion revascularization (TLR) differs between DCB and BMS treatment at our center. MATERIALS AND METHODS: We performed a retrospective chart review of femoropopliteal interventions at a single center from 2009 to 2017. The intervention, patient and lesion characteristics, and TLR events were recorded. Exclusion criteria were loss of follow-up, death, bail-out stenting, and amputation within 60 days of treatment. Freedom from TLR was analyzed over a 3 year period with Kaplan-Meier survival curves. Cox hazard ratios were calculated to account for patient and lesion characteristics. RESULTS: A total of 322 lesions (234 patients) treated with DCBs and 225 lesions (194 patients) treated with BMSs were included in this study. There were significant differences in baseline patient and lesion characteristics between groups-a greater proportion of women, patients with dyslipidemia, and lesions with popliteal involvement were treated with DCBs. There was no difference in the freedom from TLR between DCBs and BMSs. Accounting for patient and lesion characteristics, there was still no difference between DCBs and BMSs on the hazard of TLR. While our analysis did not detect a difference in the rate of TLR, there was a significant difference in the type of TLR. Compared with DCBs, a greater proportion of lesions initially treated with BMSs were retreated via surgical bypass rather than endovascular intervention, suggesting that lesions treated with DCBs may be more amenable to future endovascular intervention. CONCLUSION: Our retrospective analysis showed no difference in the rate of TLR between lesions treated with DCBs and BMSs. However, DCBs were more often used in complicated lesions involving popliteal arteries and may also allow for easier endovascular reintervention.

Real-World Clinical Outcomes of IN.PACT Admiral Drug-Coated Balloon for Femoropopliteal Artery Disease　- 12-Month Results From Japan Post-Market Surveillance Study.

BACKGROUND: To confirm the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) based on the indication approved by the Pharmaceuticals and Medical Devices Agency Japan in real-world patients with femoropopliteal artery disease.Methods and Results:IN.PACT PMS Japan was a prospective, multicenter, single-arm, post-market surveillance (PMS) study conducted in Japan that enrolled 304 participants (mean age 75.3±7.9 years). The primary endpoint was primary patency at 6 months following the index procedure, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤2.4 (assessed by the independent DUS core laboratory). Secondary endpoints included acute outcomes, primary patency at 12 months post-index procedure, freedom from CD-TLR, and major adverse events at 12 months. The mean lesion length was 97.81±58.97 mm. The primary endpoint, 6-month primary patency, was 91.3% (240/263). Kaplan-Meier estimates of primary patency and freedom from CD-TLR through 12 months were 91.5% and 94.1%, respectively. The CD-TLR rate was 5.8% (14/240) with low rates of thrombosis (0.8%) and target limb amputation (0.4%) at 12 months. CONCLUSIONS: The results of this real-world PMS study were consistent with outcomes from previous IN.PACT DCB studies, confirming the safety and efficacy of the IN.PACT Admiral DCB for broader use in patients seen in everyday practice.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Rapid increase in hybrid surgery for the treatment of peripheral artery disease in the Vascular Quality Initiative database.

OBJECTIVE: Advances in technology have increased the use of endovascular therapy for lower extremity revascularization (LER), but the impact on hybrid surgery has not been studied. This study aims to (1) investigate the contemporary national trends in frequency of hybrid LER and (2) compare the outcomes of open bypass (BYP) and hybrid surgery for isolated femoropopliteal revascularization. METHODS: Using the national Vascular Quality Initiative database from 2010 to 2017, all patients receiving bypass or hybrid LER for PAD were identified. A trend of all hybrid LER compared with open LER was obtained. Next, only patients who underwent hybrid or open isolated femoropopliteal LER were identified. Patients treated with hybrid surgery underwent femoral endarterectomy and antegrade endovascular intervention of the femoropopliteal vessels (HYB), whereas patients treated with BYP underwent femoral endarterectomy and femoropopliteal bypass. These two groups of patients were matched based on age, gender, race, indication, ambulatory status, emergency status, diabetes, hypertension, coronary artery disease, chronic obstructive pulmonary disease, and hemodialysis. Patient characteristics and the perioperative and 1-year outcomes of the two groups were compared. RESULTS: The overall rate of hybrid LER procedures increased from 6.1% in 2010 to 32% in 2017 (P = .03). Hybrid LER was significantly more commonly used in patients with claudication (47%) and BYP surgery was used in patients with tissue loss (38.5%; P = .019). There were 456 HYB and 2665 BYP for isolated femoropopliteal revascularization. After propensity matching, the cohort comprised 425 patients in each group. HYB was associated with lower rate of myocardial infarction (1.9% vs 5.7%; P = .005) and renal complications (2.1% vs 6.7%; P = .003), length of stay (4.7 vs 6.1 days; P = .001), and higher rate of discharge to home (90.8% vs 81.4%; P < .001) compared with BYP. There was no significant difference in 30-day mortality (HYB 1.5% vs BYP, 2.5%; P = .44). The 1-year outcomes comparison suggested that patients in the BYP group had a higher likelihood of improvement in ambulatory status compared with patients in HYB group (16.7% vs 7.7%; P = .044). However, Kaplan-Meier analysis showed no difference in overall survival (P = .13) or amputation-free survival (P = .057) between the two groups. There was no statistical difference in graft patency, limb loss, or secondary interventions. CONCLUSIONS: Hybrid LER for PAD has been increasingly used and accounts for up to one-third of open LER in the Vascular Quality Initiative. Hybrid femoropopliteal revascularization improves perioperative outcomes compared with femoropopliteal bypass. However, the 1-year outcomes between the two procedures are comparable, suggesting that hybrid femoropopliteal revascularization should be favored in high-risk patients because of its perioperative advantages.

Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes.

BACKGROUND: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. METHODS: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. RESULTS: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34-0.9, p = .027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. CONCLUSIONS: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.

Platelet to lymphocyte ratio predicting 6-month primary patency of drug-coated balloon for femoropopliteal disease.

BACKGROUND: Inflammatory reaction is an essential factor in the occurrence, development and prognosis of femoropopliteal disease (FPD). The ratio of platelets to lymphocytes (PLR) is a new indicator reflecting platelet aggregation and burden of systemic inflammation. Our study is to explore the association between preoperative platelet-to-lymphocyte ratio (pre-PLR) and 6-month primary patency (PP) after drug-coated balloon (DCB) in FPD. METHODS: There were 70 patients who underwent DCB for FPD contained in the study. According to 6-month PP, patients were divided into group A (PP ≥6 months, n = 54) and group B (PP < 6 months, n = 16). Logistic regression analysis was used to identify potential predictors for 6-month PP after DCB in FPD. A receiver operating characteristic (ROC) curve analysis was used to identify the cut-off value of pre-PLR to predict 6-month PP. RESULTS: Logistic regression analysis showed that pre-PLR (OR: 1.008, 95% CI: 1.001-1.016, P = 0.031) and lesion length > 10 cm (OR: 4.305, 95% CI: 1.061-17.465, P = 0.041) were independently predictive for 6-month PP. The cutoff value of pre-PLR obtained from the ROC analysis was 127.35 to determine 6-month PP with the area of 0.839. Subgroup analysis was conducted based on the cutoff value of pre-PLR. The 6-month PP in the group of pre-PLR < 127.35 was higher than that of pre-PLR ≥ 127.35 group (p < 0.001). CONCLUSIONS: The present study indicated that an elevated pre-PLR was an effective additional indicator for predicting early PP in FPD after DCB.

Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta-analysis of randomized controlled trials.

BACKGROUND: Drug-coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta-analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). METHODS: Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web-of-Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q-statistics. Random effects model was used. RESULTS: Twenty-two RCTs, including five trials of in-stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow-up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow-up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40-0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37-0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. CONCLUSIONS: Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta-analysis. Extended follow-up of the available RCT data will be essential to analyze long-term device-related mortality.

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.

PURPOSE: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. RESULTS: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. CONCLUSION: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

Hybrid femoropopliteal procedures are associated with improved perioperative outcomes compared with bypass.

OBJECTIVE: Hybrid procedures have gained momentum as less invasive operations that can potentially improve outcomes for patients. However, there is a paucity of data comparing hybrid procedures with traditional bypass. This study compares the perioperative outcomes of hybrid and bypass surgery for femoropopliteal (FP) revascularization. METHODS: The American College of Surgeons National Surgical Quality Improvement Program files (2012-2015) were reviewed, and three groups of patients undergoing isolated FP revascularization were identified by Current Procedural Terminology codes. All patients underwent femoral endarterectomy. The hybrid group (HYB) had a concomitant antegrade endovascular FP intervention and was compared with patients with concomitant FP bypass with vein (BPV) and FP bypass with nonvein graft (BPG). The demographics, comorbidities, and outcomes of the three groups were analyzed. The χ2 and analysis of variance tests with post hoc analysis were used. A multivariable logistic regression analysis was performed to identify predictors of readmission, reoperation, and mortality. RESULTS: There were 1480 patients in the analysis. Compared with patients undergoing BPV and BPG, patients in the HYB group tended to be older (P = .016) and were less likely to be smokers (P < .001). They had fewer infected wounds (P = .001) and were more likely to have American Society of Anesthesiologists score ≤3 (P = .01) and claudication (P < .01). HYB patients had significantly fewer bleeding transfusions (P = .01) and less overall morbidity (P < .001) compared with BPV and BPG patients. The three treatment groups did not differ in frequencies of mortality and major amputation. Among the groups, BPV was associated with the longest operating time (P < .001), whereas HYB had significantly shorter hospital stay (P < .001). HYB was also associated with significantly lower rates of reoperation (P = .017) and readmission (P = .007). On multivariable regression, patients undergoing BPG were at increased risk of readmission (odds ratio [OR], 1.48 [1.00-2.17]) compared with HYB. HYB surgery was associated with less morbidity compared with BPV (OR, 1.38 [1-1.9]) and BPG (OR, 1.77 [1.3-2.38]). CONCLUSIONS: Hybrid procedures have favorable perioperative outcomes compared with open bypass for FP revascularization. Additional research on the long-term outcomes of hybrid procedures is needed.

Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis.

PURPOSE: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). METHODS: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. RESULTS: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). CONCLUSION: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.