Clinically-driven Target Lesion Revascularization Rates Research Articles

Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n=465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3years of follow-up, mean time to reintervention was 5.5months longer (difference 166days, 95% CI: 51, 282days; p=0.0058) for patients treated with Eluvia (n=56) than for those treated with Zilver PTX (n=30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p=0.3540) and mean time to first reintervention exceeded 2years for patients treated with Eluvia at 737days versus 645days for the Zilver PTX group (difference 92days, 95% CI: -85, 269days; p=0.3099). Simulated savings considering reinterventions occurring over 1 and 5years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Safety and effectiveness of the phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.

This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.

Role of the Global Limb Anatomic Staging System in predicting outcomes of chronic limb-threatening ischemia in patients treated by drug-coated balloons.

The Global Limb Anatomic Staging System (GLASS) was proposed to assess the procedural complexity and technical failure rate and stratify the anatomic pattern of chronic limb-threatening ischemia (CLTI). However, more evidence is needed to validate the GLASS in staging outcomes after endovascular therapy in patients with CLTI treated with drug-coated balloons (DCBs). This study aims to evaluate the role of the GLASS in predicting outcomes of CLTI patients treated with DCBs. This multicenter, retrospective cohort study enrolled patients with CLTI treated with DCBs from July 2016 to June 2019. GLASS stages were assigned for every limb. The limb-based patency (LBP) rate, clinically driven target lesion revascularization (CD-TLR) rate, clinical improvement, and safety endpoints were analyzed and compared across the GLASS stages over 12 months of follow-up. Risk factors for the loss of LBP were identified using Cox regression analysis. A total of 90 limbs were enrolled, with 55 (61.1%) having isolated femoropopliteal lesions and 35 (38.9%) having femoropopliteal and infrapopliteal lesions. Of the limbs, 17 (18.9%), 12 (13.3%), and 61 (67.8%) were assigned to GLASS stages I, II, and III, respectively. The Kaplan-Meier estimate of the 12-month LBP was 65.4%, and no difference was found among the different stages (stage I 81.1%; stage II 85.2%; stage III 54.4%; P=0.080). The LBP was lower in stage III than in stages I and II combined (stage I and II 83.5%; stage III 54.4%; P=0.027). Similar results were found for the freedom from CD-TLR rates among the different stages. The ankle-brachial index values improved from 0.42±0.29 to 0.78±0.35 at follow-up (P<0.001). The rates of mortality, any amputation, and major amputation were similar among the groups. GLASS stage III and coronary heart disease were identified as independent risk factors for the loss of LBP at 12 months. The 1-year LBP and freedom from CD-TLR rates were lower in GLASS stage III than in stages I and II. The GLASS classification could predict the outcomes of CLTI patients with femoropopliteal lesions treated with DCB.

Prospective, Multicenter Study of Rotational Atherectomy with Antirestenotic Therapy for Infrainguinal Arterial Disease

Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease. Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCBs), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). P-values <0.05 were considered statistically significant. In total, 150 patients (91.2% male; mean age, 69.8years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; P=0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P=0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P=0.01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation. The results of this study demonstrated the safety and effectiveness of the Jetstream atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.

Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions

The study aimed to assess the 24-month safety and effectiveness of a new generation drug-coated balloon (DCB) (Elutax; AR Baltic Medical, Vilnius Lithuania-also marketed as Emperor in some European countries; Aachen Resonance, Germany, and AB Medica, Italy) for the treatment of patients with femoropopliteal lesions. From January 2019 to January 2020, DCB angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoropopliteal lesions (group A) and compared with a noncontemporary control group (group B) consisting of 71 patients (71 limbs) treated with plain old balloon angioplasty (POBA) between January 2017 and January 2018. Before performing the angioplasty, both groups underwent clinical examination, ultrasound evaluation, and computed tomography angiography to delineate subject clinical and baseline lesion characteristics. Primary end point was primary patency rate at 24 months. Secondary end points included clinically driven target lesion revascularization (CD-TLR), overall survival and limb salvage rates. In both groups technical success rate was 100% with bailout stenting performed in 16.9% (9/53) of lesions in group A, while stenting was necessary in 22.5% of lesions (16/71) in group B. Patients treated with Elutax exhibited lower 24-month restenosis/reocclusion rate and improved primary patency compared to those treated with POBA (restenosis/reocclusion rate: 9.4% vs. 25.3%, CI 95% 0.01-0.30, P=0.034; primary patency: 88.2% vs. 71.5%, log rank P=0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB versus 18.3% for POBA. No device or procedure-related deaths occurred, and no 30-day mortality was observed in either group. During the follow-up period, the limb salvage rate was 94.9% for A group and 92.1% for B group. All minor amputations occurred in limbs presented with chronic limb threatening ischemia (CLTI). Overall survival was 91.7% for group A and 89.4% for group B. Paclitaxel+Dextran DCB angioplasty proved safe and effective in managing chronic lesions of femoropopliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.

Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery.

Peripheral artery disease with calcification is extremely prevalent in the elderly. Due to the calcification, it requires a different clinical approach than the more common arteriosclerosis obliterans of the lower extremity. The introduction of novel technologies such as the drug-coated balloon, directional atherectomy, supera and drug-eluting stent has improved the prognosis of these patients. This study will contribute to the development of higher-quality evidence-based medicine for clinical treatment by assessing the quality of life (QOL), clinical treatment effect, and health economics of patients with calcification. The Evolution study is designed as a prospective, multicenter, observational, real-world study. From January 2021 to December 2022, 600 patients with moderate to severe femoropopliteal artery calcification will be recruited from ten locations in China. After discharge, information on demographics, disease history, procedure details, imaging findings, and follow-up will be collected. Patients will undergo follow-up at 1, 6, 12, 18, and 24 months after operation. Technical success rate, vascular quality of life questionnaire, primary patency rate of the target lesion, clinically driven target lesion revascularization rate (CD-TLR), and health economics evaluation are all included as outcome measures. The Evolution study helps to investigate the clinical and financial results of various endovascular therapy modalities for patients with moderate and severe femoropopliteal artery calcification. These actual facts may help to harmonize therapy recommendations for peripheral artery disease. The study protocol was registered at www.clinicaltrials.gov (registration number: NCT04716361).

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

PurposeData on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB.ResultsMean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan–Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%–80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%–77.3%] and 81.9% [95% CI: 69.7%–89.6%] (log-rank p = 0.074), respectively.ConclusionsThe results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. ClinicalTrials.gov identifier: NCT01609296.Level of Evidence.Level 3, Cohort Study.

Perioperative Inflammatory Status Predicts Mid-Term Outcomes in Patients Undergoing Femoropopliteal Paclitaxel-Coated Balloon Angioplasty

To evaluate the association of perioperative inflammatory status, as determined using the neutrophil-to-lymphocyte ratio (NLR) and high-sensitivity C-reactive protein (hs-CRP) level, with the efficacy of femoropopliteal paclitaxel-coated balloon (PCB) angioplasty. The data of 122 patients (138 limbs) were retrospectively analyzed (median follow-up time, 21months). The pre- and postoperative NLRs and hs-CRP levels were evaluated to determine their predictive value for mid-term primary patency and clinically driven target lesion revascularization (CD-TLR) during follow-up. Cox regression and Kaplan-Meier survival analyses were performed to investigate the predictive value of the inflammatory parameters and clinical risk factors. The study population had a median age of 67.2±9.2years, and 85.2±3% of them were men. Approximately, 18.0±3% of the cases were classified under Rutherford grade II; 52.5±4%, grade III; 24.6±3%, grade IV; 4.1±1%, grade V; and 0.8±0.7%, grade VI. The 12- and 24-month cumulative patency rates were 81.2±27.0% and 60.4±30.1%, respectively, and the freedom from CD-TLR rates were 90.8±19.1% and 82.5±28.3%, respectively. Severe lesion calcification was identified as an independent risk factor for CD-TLR (hazard ratio [HR]=1.51, 95% confidence interval [CI]=1.05-3.01), while hypertension was found as a protective factor for primary patency (HR=0.54, 95% CI=0.30-0.93). The patients with Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions had more than a 2-fold increased adjusted risk of both primary patency loss and CD-TLR compared with those with TASC A/B lesions (HR=2.44 for primary patency loss; HR=2.51 for CD-TLR). The perioperative NLRs and hs-CRP levels were stratified into three grades. The patients with a higher preoperative hs-CRP level (>9.2 vs. 0.6-9.2 vs. <0.6mg/L by each tertile) had a 2.4-fold increased adjusted risk of primary patency loss compared with those with a lower preoperative hs-CRP level. The patients with a higher hs-CRP level on the first postoperative day (>13.0 vs. 7.7-13.0 vs. <7.7mg/L by each tertile) had a 1.8-fold increased adjusted risk of primary patency loss compared with those with a lower hs-CRP level. In contrast, the patients with a higher NLR at 4-6hr postoperatively (>3.6 vs. 2.5-3.6 vs. <2.5 by each tertile) showed better primary patency (adjusted HR=0.57) than did those with a lower NLR. A higher hs-CRP level on the first postoperative day was the only inflammatory marker associated with a high risk of CD-TLR (adjusted HR=2.37). Perioperative inflammatory status serves as a valuable prognostic parameter for assessing the potential risk stratification of outcomes after paclitaxel-coated balloon (PCB) angioplasty.

Mid- and long-term outcomes and prognostic factors of drug-coated balloon angioplasty for treatment of femoropopliteal long lesions

Objective: To examine the effective and safe outcomes of drug-coated balloon (DCB) angioplasty for the treatment of femoropopliteal long lesions in mid-term and long-term follow-up. Methods: The clinical data of 114 patients with symptomatic (Rutherford 2 to 6) femoropopliteal long lesions who underwent angioplasty with DCB between June 2016 and May 2021 at Department of Vascular Surgery,Beijing Tsinghua Changgung Hospital were retrospectively analyzed. A total of 75 males and 39 females were enrolled, aged (71.9±8.4)years (range: 49 to 89 years). Among 138 lesions in 114 patients, there were 111 de nove lesions (80.4%, 111/138). Total occlusions were recanalized in 116 limbs (84.1%, 116/138). The lesion length was (280.9±78.7)mm (range: 150 to 520 mm). DCB angioplasty combined with debulking devices was used in 59 lesions (42.8%, 59/138).The bail-out stent implantation was performed in 27 limbs (19.6%, 27/138). The Kaplan-Meier method was used to evaluate cumulative primary patency rate, freedom from the clinically driven target lesion revascularization (CD-TLR) rate and accumulate survival rate. Univariate and multivariate analyses with Cox proportional hazards models were performed to determine the significant prognostic factors for primary patency. Results: DCB angioplasty was completed in 114 patients. The technical success rate was 98.2%(112/114). The mean follow-up time was 18 months (range: 3 to 54 months).The results showed that primary patency rates at 12, 24 and 36 months postoperatively were 87.5%, 75.2% and 55.1%, respectively. Freedom from CD-TLR rate at 12, 24 and 36 months postoperatively were 92.4%, 81.8% and 68.7%, respectively. Accumulate survival rate at 12, 24 and 36 months postoperatively were 96.2%, 94.0% and 80.2%. Multivariate Cox's regression analyses showed that chronic limb-threatening ischemia(CLTI) (HR=2.629, 95%CI:1.519 to 4.547, P<0.01) and hyperlipidemia (HR=2.228, 95%CI: 1.004 to 4.948, P=0.026) were independent prognosis factors for primary patency in DCB treatment of femoropopliteal long lesions. Conclusions: DCB provided favorable outcomes for the treatment of femoropopliteal long lesions. CLTI and hyperlipidemia are independent prognosis factors for restenosis after DCB angioplasty.

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

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. 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.

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Effect of Procedural Technique on Cardiovascular Outcomes Following Second-Generation Drug-Eluting Resorbable Magnesium Scaffold Implantation

BackgroundThis study sought to assess target lesion failure (TLF) and clinically driven target lesion revascularization (CD-TLR) through 1 year following second-generation drug-eluting magnesium scaffold (Magmaris) implantation using a dedicated technique (so-called "4 P's" strategy). Methods and resultsThe 4 P's strategy stands for: correct patient selection, proper scaffold sizing, pre-dilatation (<20% residual stenosis), post-dilatation. All the patient and lesion characteristics, preparation, and sizing of the device were compared in patients with TLF and CD-TLR through 1-year follow-up. We analyzed 315 patients for this study. At 1 year, there were 14 TLFs and 10 CD-TLRs. The TLF rates were 7.7%, 4.9%, and 4.1%; while the CD-TLR rates were 7.7%, 2.5%, and 3.2% in the undersized, properly sized, and oversized vessel groups, correspondingly. Diameter stenosis (DS) after pre-dilatation in patients with TLF and CD-TLR was significantly greater than in those without TLF and CD-TLR. In patients with a properly sized scaffold, DS after pre-dilatation was similar in patients with and without TLF and CD-TLR. However, in patients with non-properly sized scaffolds, greater post-balloon DS was observed in patients with TLF and CD-TLR. ConclusionsImproper sizing and poor lesion preparation before Magmaris implantation appear to be related to TLF during 1-year follow-up.

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions.

PurposeDrug-coated balloons have shown successful results in treating peripheral arterial occlusive disease. However, using multiple balloons for long femoropopliteal lesions (>15 cm) remains challenging; their safety and efficacy need to be explored. Therefore, we aimed to evaluate the outcomes of multiple drug-coated balloons for long femoropopliteal lesions in terms of the primary patency, freedom from clinically-driven target lesion revascularization, and mortality.MethodsBetween April 2015 and September 2018, 96 patients (117 limbs) who underwent balloon angioplasty using at least 2 drug-coated balloons for femoropopliteal lesions were retrospectively reviewed. Lesions were classified as Trans-Atlantic Inter-Society Consensus (TASC) classification C or D. The outcomes were analyzed using Kaplan-Meyer analysis.ResultsThe mean age of 96 enrolled patients was 70.8 ± 9.8 years, and 83 patients were males (86.5%). Critical limb-threatening ischemia was found in 29 cases (24.8%). The mean lesion and drug-coated balloon lengths per limb were 292.3 ± 77.8 mm and 325.0 ± 70.2 mm, respectively. The technical success rate was 99.2%. A total of 82.1% were followed-up for more than 6 months. The primary patency rates at 12 and 24 months were 71.4% and 41.7%, respectively; freedom from clinically-driven target lesion revascularization rates were 96.4% and 71.0% at 12 and 24 months, respectively. The Kaplan-Meier estimate of the 2-year overall cumulative mortality rate was 20.8%. All identified mortalities appeared to be less associated with paclitaxel.ConclusionDrug-coated balloons can be effectively used without drug-related mortality, even for long lesions, such as TASC classification C or D femoropopliteal lesions.

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial (ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort

Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis. All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis. A total of 109 patients (113 legs) were included (45% male; mean age, 72±10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24±13months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P=0.008). DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late "catch-up" phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders.

Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis

The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45±0.14 at baseline and 0.84±0.12 at 12months (P<0.05). The WIQ score was 30.45±21.14 at baseline and 52.68±29.75 at 12months (P<0.05). The Kaplan-Meier estimate of the primary patency rate at 12months was 86.2% (25/29), and freedom from CD-TLR rate at 12months was 89.7% (26/29). The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

The influence of color on emotion in visual stimulation: An event-related potential study

The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR.From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ).Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29).The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%–75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.