Clinical validity of the Japanese below-the-knee chronic total occlusion scoring system for the prediction of successful guidewire crossing.

OBJECTIVE: To validate the Japanese below-the-knee (J-BTK) chronic total occlusion (CTO) score for the prediction of successful guidewire crossing (S-GC) in angiographic evaluation. METHODS: A prospective, multicenter, nonrandomized study examined 751 consecutive BTK CTOs in 497 patients treated with endovascular therapy in 16 Japanese medical centers from April 2021 to March 2022. The cohort was classified into 2 groups: an S-GC group and a failed guidewire crossing group. RESULTS: The J-BTK CTO score, which assigned one point to "Blunt type at the proximal entry point," one point to "Calcification at the proximal entry point," one point to "Reference vessel diameter <2.0 mm," one point to "CTO length ≥200 mm," and two points to "No outflow of the target vessel," was used to categorize BTK CTOs into 4 grades with varying probabilities of S-GC: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of S-GC in each grade (grades A, B, C, and D) were 97.5%, 89.1%, 62.5%, and 27.3%, respectively. The area under the receiver-operating characteristic curve for S-GC was 0.8304. Although the previous J-BTK CTO study enrolled only de novo lesions, both de novo and restenotic lesions were evaluated in this study. De novo lesions have a lower chance of S-GC (odds ratio: 0.24, 95% confidence interval: 0.09-0.67) in the multivariate analysis, and the area under the receiver-operating characteristic curve of the modified J-BTK CTO score, which additionally assigned two points to "De novo lesion," was 0.846. The modified J-BTK CTO score showed an appropriate calibration (Hosmer-Lemeshow P = .957). CONCLUSIONS: The J-BTK CTO score and the modified J-BTK CTO score predict the probability of an S-GC of BTK CTOs and stratify the difficulty of endovascular therapy for BTK CTOs in angiographic evaluation.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

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.

A novel endovascular method of atherectomy for calcified common femoral and popliteal disease using the crosser system: Crossbow and Rambow techniques.

OBJECTIVES: This study aims to report the efficacy and safety of new atherectomy methods using the Crosser system for calcified lesions in the common femoral and popliteal artery: the Crosser system supported by bended 0.014 wire (Crossbow) technique and retrograde approach of sheathless Crosser system supported by bended 0.014 wire (Rambow) technique. MATERIALS AND METHODS: This report describes a single-center, retrospective study. A total of 23 patients (mean ± SD age, 73 ± 10 years; 19 men) with symptomatic peripheral artery disease received the Crossbow technique and Rambow technique for treatment of calcified common femoral and popliteal disease; these patients were enrolled between October 2013 and October 2015. The primary efficacy outcome was acute technical success, defined as achievement of residual stenosis < 30% for stenting and < 50% for angioplasty or atherectomy. The primary safety outcome was assessed on the basis of angiographic complications. RESULTS: The Crossbow and Rambow techniques were undertaken in 100% and 17% of the patients, respectively. Acute technical success was achieved in 96% of the patients. There were two embolic events. CONCLUSION: Crossbow and Rambow techniques could be effective atherectomy methods of calcified common femoral and popliteal disease. Regarding safety, embolic protection devices may be needed for our atherectomy methods.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Clinical expert consensus document on standards for lower extremity artery disease of imaging modality from the Japan Endovascular Treatment Conference.

Imaging modalities have developed to provide precise information in the assessment of lower extremity artery disease (LEAD), including both quantitative measurements and morphological assessment. However, a lack of standardization for the evaluation methods introduces inconsistency and potential risk. This consensus document from Japan Endovascular Treatment Conference (JET) summarizes the methods of measurement and assessment of intravascular ultrasound (IVUS), optical frequency domain imaging (OFDI), and angioscopy. We propose standardized approaches for the evaluation of these modalities in endovascular therapy (EVT).

Prediction of Technical Failure of Inframalleolar Angioplasty in Patients with Chronic Limb Threatening Ischaemia.

OBJECTIVE: This study sought to: determine anatomically evaluated predictors of the technical failure of inframalleolar angioplasty (IMA), develop a predictive model for unsuccessful IMA, and investigate the effect of IMA on clinical outcomes in patients with chronic limb threatening ischaemia (CLTI). METHODS: This single centre retrospective observational study enrolled 159 patients with CLTI who underwent IMA for de novo occluded lesions between November 2017 and May 2021. These patients were divided into two groups: the Failed IMA group (n = 62) and the Successful IMA group (n = 97). RESULTS: In multivariable analysis, no target vessel outflow (OR 39.8, 95% CI 10.7 - 148, p < .001), medial artery calcification (MAC) grade (OR 4.91, 95% CI 1.40 - 17.3, p = .010), and occluded pedal arch (OR 5.2, 95% CI 1.2 - 22.7, p = .030) were identified as independent predictors of IMA technical failure. The risk prediction model had an area under the receiver operating characteristic curve (AUC) of 0.93; after bootstrapping adjustment for optimism, this value represented a corrected AUC of 0.95. The patients in the Successful IMA group had a significantly higher proportion of wound healing at 12 months than those in the Failed IMA group (log rank p = .030). IMA technical failure was associated with a significant change in the proportion of wound healing (HR 0.59, 95% CI 0.37- 0.94, p = .030). CONCLUSION: No target vessel outflow, MAC grade, and occluded pedal arch were independent predictors of IMA technical failure. Additionally, successful IMA was associated with better wound healing outcomes at 12 months. Furthermore, a model incorporating these three predictors precisely predicted IMA technical failure.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials.

PURPOSE: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. RESULTS: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. CONCLUSION: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.