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.

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

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

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

BACKGROUND: Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. MATERIALS AND METHODS: Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. RESULTS: After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). CONCLUSION: In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). CLINICAL IMPACT: The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Impact of calcification on clinical outcomes after drug-coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system.

PURPOSE: To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. MATERIALS AND METHODS: We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at seven cardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. RESULTS: The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. CONCLUSION: The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.

Prediction of Wound Recurrence in Patients With Chronic Limb-Threatening Ischemia Undergoing Endovascular Treatment.

PURPOSE: Chronic limb-threatening ischemia due to isolated below-the-knee lesions is a factor associated with wound recurrence. However, there is a lack of data regarding wound recurrence in such cases. This study aimed to determine the predictors of wound recurrence in patients with chronic limb-threatening ischemia undergoing endovascular treatment. PATIENTS AND METHODS: This was a single-center, retrospective, observational study. We enrolled 152 consecutive patients with chronic limb-threatening ischemia (172 limbs) who achieved complete wound healing after undergoing endovascular treatment for isolated below-the-knee lesions between February 2008 and December 2017. Of these, the wound had recurred in 56 limbs (33%), and we divided the patients into 2 groups based on wound recurrence. We evaluated the recurrence rate of chronic limb-threatening ischemia and predictors of wound recurrence. Wound recurrence was defined as recurrence of the wound within 2 years of complete wound healing. RESULTS: Patients' backgrounds were similar in both groups, including mean age (72±9 vs 72±11; p=0.76) and hemodialysis (43% vs 40%; p=0.66). Pre-pedal arch type 2 (52% vs 8%; p<0.01), infrapopliteal grade 4 of the Global Limb Anatomic Staging System (77% vs 59%; p=0.02), and Wound, Ischemia, and foot Infection criteria stage 4 (43% vs 28%; p=0.04) were more common in the wound recurrence group. Multivariate Cox proportional hazard analysis identified pre-pedal arch type 2 (hazard ratio, 5.28; 95% confidence interval, 3.08-9.10; p<0.01) and Wound, Ischemia, and foot Infection criteria stage 4 (hazard ratio, 1.98; 95% confidence interval, 1.15-3.36; p=0.01) as predictors of wound recurrence after complete wound healing. CONCLUSION: Pre-pedal arch type 2 and Wound, Ischemia, and foot Infection classification system stage 4 were associated with wound recurrence in patients with chronic limb-threatening ischemia who achieved complete wound healing after undergoing endovascular treatment for isolated below-the-knee lesions.

Impact of "black rock" on clinical outcomes after endovascular therapy for de novo calcified femoropopliteal lesions.

The relationship between severity of calcification and clinical outcomes after endovascular therapy (EVT) for femoropopliteal lesions is well known. We often encounter dense calcifications in our daily practice, which are darker than normal calcifications on angiography. Accordingly, we named it "black rock" (BR), and investigated its impact on clinical outcomes after EVT. We retrospectively analyzed 677 lesions in 495 patients who underwent EVT for de novo calcified femoropopliteal lesions at our hospital between April 2007 and June 2020. BR is defined as a calcification which is 1 cm or more in length, occupies more than half of the vessel diameter, and appears darker than the body of the femur on angiography. Propensity score matching analysis was performed to compare clinical outcomes between lesions with BR [BR (+) group] and without BR [BR (-) group]. A total of 119 matched pairs of lesions were analyzed. Primary patency at 2 years was significantly lower in the BR (+) group than in the BR (-) group (48% vs. 75%, p = .0007). Multivariate analysis revealed that the presence of BR [hazard ratio (HR) = 2.23, 95% confidence interval (CI); 1.48-3.38, p = .0001], lesion length (HR = 1.03, 95%CI; 1.00-1.06, p = .0244), and no scaffold use (HR = 1.58, 95%CI; 1.06-2.36, p = .0246) were predictors of restenosis. The presence of BR is independently associated with clinical outcomes after EVT for de novo calcified femoropopliteal lesions.

Multicenter, retrospective registry of isolated atherosclerotic popliteal arteries treated with endovascular revascularization.

Isolated atherosclerotic popliteal lesions (IAPLs) have been considered challenging. This study aimed to investigate the efficacy of endovascular therapy (EVT) using the newer devices for IAPLs. This retrospective multicenter registry analyzed patients with lower extremity artery disease having IAPLs who underwent EVT using the newer devices between 2018 and 2021. The primary outcome was primary patency 1 year after EVT. A total of 392 consecutive patients undergoing EVT for IAPLs were enrolled. The Kaplan-Meier analysis showed that the primary patency and the freedom from target lesion revascularization were 80.9% and 87.8% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that the clinical features that were independently associated with restenosis risk were drug-coated balloon (DCB) use for younger age (< 75 years old; adjusted hazard ratio, 3.08 [95% confidence interval 1.08-8.74]; P = 0.035), non-ambulatory status (2.74 [95% confidence interval 1.56-4.81]; P < 0.001), cilostazol use (0.51 [95% confidence interval 0.29-0.88]; P = 0.015), severe calcification (1.86 [95% confidence interval 1.18-2.94]; P = 0.007), and small external elastic membrane (EEM) area measured by intravascular ultrasound (IVUS) (< 30 mm2) (2.07 [95% confidence interval 1.19-3.60]; P = 0.010). From the univariate analysis, among patients treated with DCB, younger patients (n = 141) were associated with more comorbidities including smoking (P < 0.001), diabetes mellitus (P < 0.001), end-stage renal disease (P < 0.001), history of revascularization (P = 0.046) and small EEM area (P = 0.036), compared to older patients (n = 140). Moreover, smaller post-procedural minimum lumen area measured by IVUS after DCB dilatation was observed in younger patients (12 ± 4 vs. 14 ± 4 mm2, P = 0.033). This retrospective study demonstrated that the current EVT provided an acceptable 1-year primary patency rate in patients with IAPLs. The primary patency was lower following DCB in younger patients, likely due to the higher rates of comorbidities in this patient population.

Predictive performance of J-Calc-CTO score for guidewire crossing through chronic total occlusion lesions within 30 minutes: J-CTO score modified by computed tomography coronary angiography.

The original J-CTO score predicts the difficulty of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions, but the grade of calcification has not been fully evaluated. We examined 137 patients (141 CTO lesions) who underwent coronary computed tomography angiography (CTA) pre-PCI between October 2016 and October 2021. They were randomly divided into derivation (n = 94) and validation (n = 47) groups. The degree and distribution of calcification in the occluded segment were assessed using CTA. The calcified index was defined as calcium volume divided by the length of the occluded segment. We created the J-Calc-CTO score consisting of calcification parameters associated with 30-min wire crossing in the derivation group. The validity of the J-Calc-CTO score was compared with that of the original J-CTO score using c-statistics. The procedural success rate was 96%, and 30-min wire crossing during the procedure was achieved in 29%. Dense calcification (calcified-index >12) (odds ratio [OR]: 4.63; 95% confidence interval [CI]: 1.24-22.2; p = 0.04) and calcification in the center of the lumen (OR: 7.25; 95% CI: 1.48-32.1; p = 0.02) were independently associated with 30-min wire crossing as variables evaluated using CTA. The J-Calc-CTO score was created by adding 1 point to the two parameters in place of "calcification" in the original J-CTO score. The J-Calc-CTO score showed a higher predictive value of 30-min wire crossing than the J-CTO score in the derivation (c-statistics; 0.836 vs. 0.670; p > 0.01) and validation groups (c-statistics; 0.879 vs. 0.767, p > 0.01). The degree and distribution of calcification evaluated using CTA refined the predictive value of the original J-CTO score for 30-min wire crossing.

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 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.

Scoring Model to Predict Major Amputation in Patients With Chronic Limb-Threatening Ischemia at Wound, Ischemia, and Foot Infection Clinical Stage 4 After Endovascular Therapy.

PURPOSE: We investigated the predictors of major amputation (MA) at 1 year and prepared a scoring model to stratify the clinical outcomes of chronic limb-threatening ischemia (CLTI) patients at wound, ischemia, and foot infection (WIfI) clinical stage 4 after endovascular therapy (EVT). MATERIALS AND METHODS: This study was a retrospective, observational study performed at a single center. A total of 353 CLTI patients (390 limbs) were treated with EVT between April 2007 and December 2016. Among these, limbs at WIfI clinical stages 1, 2, and 3 were excluded, and 194 limbs at WIfI clinical stage 4 (49.7%) were enrolled. The primary endpoint was major amputation (MA) free rate at 1 year. Predictors of MA at 1 year was evaluated by Cox proportional hazard analysis. RESULTS: At 1 year, the incidence of MA was 18.0% (35 limbs). Cox proportional hazard analysis revealed that hemodialysis (hazard ratio [HR] 2.63; 95% confidence interval [CI], 1.24-5.58; p=0.012), fI3 (HR 2.54; 95% CI, 1.28-5.06; p=0.008), toe wounds (HR 0.29; 95% CI, 0.094-0.88; p=0.029), and visible blood flow to the wound (HR 0.43; 95% CI, 0.21-0.89; p=0.023) were associated with MA. We assigned 1 point for positive predictors of MA, hemodialysis, and fI3; 1 point was deducted for negative predictors of MA, toe wounds, and visible blood flow to the wound. A score of -2 or -1, was defined as the low-risk group, 0 was defined as the intermediate-risk group, and +1 or +2 were defined as the high-risk group. At 1 year, MA free rate, wound healing rate, and amputation-free survival rate were stratified according to a scoring model. MA free rate was 96.6% in low-risk, 72.4% in intermediate-risk, and 67.3% in high-risk (p<0.001); wound healing rate was 67.8% in low-risk, 27.6% in intermediate-risk, and 4.1% in high-risk (p<0.001); amputation-free survival rate was 65.3% in low-risk, 44.8% in intermediate-risk, and 18.4% in high-risk (p<0.001). CONCLUSIONS: The scoring model based on the predictors of MA stratified clinical outcomes in CLTI patients at WIfI clinical stage 4.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT: Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

10-Year clinical outcomes of hemodialysis patients with peripheral arterial disease due to infrainguinal disease undergoing endovascular therapy.

Although symptomatic peripheral arterial disease (PAD) is common in patients with hemodialysis (HD), few studies have evaluated the long-term clinical outcomes of revascularization in this population. The aim of the current study was to investigate the 10-year clinical outcomes of HD patients with PAD undergoing endovascular therapy (EVT). We retrospectively analyzed 750 limbs from 578 HD patients with symptomatic PAD due to infrainguinal lesions, treated with EVT, between May 2004 and November 2011. The primary outcome was 10-year mortality and the secondary outcome was 10-year freedom from major adverse limb events (MALEs). Predictors for each outcome were evaluated by Cox proportional-hazards model. The 10-year rate of survival and freedom from MALEs was 23.6 ± 3.1% and 76.4 ± 2.9%, respectively. In the multivariate analysis, patients with over 80 years [hazard ratio (HR) 2.10; 95% confidence interval (CI) 1.58-2.80; p < 0.001], non-ambulatory status (HR 1.55; 95% CI 1.19-2.03; p = 0.001), absence of hypertension (HR 1.59; 95% CI 1.19-2.08; p = 0.001), heart failure (HR 1.36; 95% CI 1.02-1.80; p = 0.03), and tissue loss (HR 1.65; 95% CI 1.28-2.12; p < 0.001) were at an increased risk of 10-year mortality. Cerebrovascular diseases (HR 1.60; 95% CI 1.03-2.49; p = 0.038), no cilostazol use (HR 1.69; 95% CI 1.09-2.70; p = 0.021), tissue loss (HR 3.87; 95% CI 2.37-6.34; p < 0.001), and poor below-the-knee (BTK) run-off (HR 1.68; 95% CI 1.04-2.71; p = 0.035) were significantly associated with MALEs. After risk stratification analysis based on risk score assignment according to number of predictors, 10-year survival and freedom from MALE were lower in the higher score groups (10-year survival rates according to number of risk factors: 0, 35.1%; 1, 20.3%; 2-5, 10.8%; respectively, p < 0.001, 10-year freedom from MALE rates in patients with greater number of risk factors: 0-1, 90.2%; 2-3, 65.5%; 4-5, 61.6%; respectively, p < 0.001). The 10-year clinical outcomes after EVT for HD patients with PAD due to infrainguinal disease were clinically suboptimal. Risk stratification based on these predictors before EVT would be useful in estimating future adverse outcome.

One-year results for Japanese patients in RANGER II SFA.

The RANGER II SFA objective was to evaluate the safety and effectiveness of the Ranger Drug-Coated Balloon (DCB) for treating superficial femoral artery and/or proximal popliteal artery lesions; the purpose of this cohort analysis is to assess the results among Japanese study participants. Patients eligible for RANGER II SFA had symptomatic lower limb ischemia (Rutherford classification 2-4) and were randomly assigned (3:1) to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). At 12 months, assessments included freedom from major adverse events (i.e., target lesion revascularization, major amputations, or death within 1 month of the index procedure) and core laboratory-assessed primary patency. Japanese patients (n = 102) comprised 27.1% of the overall study sample. Mean lesion lengths were 79.5 ± 44.0 mm and 84.0 ± 56.8 mm among Japanese patients treated with Ranger DCB (n = 77) or PTA (n = 25), respectively. All major adverse events were clinically driven TLRs (6.6% [5/76] for Ranger DCB and 16.0% [4/25] for PTA; p = 0.2194). Kaplan-Meier estimates of primary patency were 89.3% and 72.0%, respectively, at 12 months (log-rank p = 0.2134). Japanese patients treated with Ranger DCB maintained a high patency rate through 12 months and a low re-intervention rate.Trial registration clinicaltrials.gov identifier: NCT03064126.

Scoring model to predict low image quality of drug-eluting stent evaluated by computed tomography coronary angiography.

Evaluation of in-stent restenosis (ISR) by computed tomography coronary angiography (CTCA) is less invasive but often impossible. We aimed to create a scoring model for predicting which drug-eluting stents (DES) cannot be evaluated with CTCA. We enrolled 757 consecutive implanted DES assessed with CTCA. Non-diagnostic evaluation was defined as poor/not evaluative by two different observers. These stents were randomly divided into a derivation (n = 379) and validation (n = 378) group. In the derivation group, we assessed predictors using logistic regression analysis and created a scoring model that would stratify non-diagnostic evaluation of DES-ISR. The validity of this scoring model was evaluated in the validation group using receiver-operating characteristic analysis. The percentage of non-diagnostic stents was 19/21% in the derivation/validation group (p = 0.71). Non-diagnostic evaluation was independently associated with implanted stent diameter (2.25-2.5. vs. 2.5-3 vs. > 3.0 mm), severe calcification, stent-in-stent lesion, and type of DES (stainless vs. CoCr vs. PtCr) in the derivation group. The predicting system of implanted DES non-diagnostic by CTCA (PIDENT) for non-diagnostic evaluation, including these four baseline factors, was derived (C-statistic = 0.86 in derivation group, cutoff: 8 points). The PIDENT score had a high predictive value for non-diagnostic DES in the validation model (C-statistic = 0.87, sensitivity 86%, specificity 74%, cutoff 8 points, p < 0.001). The PIDENT score, consisting of baseline characteristics including implanted stent diameter, severe calcification, stent-in-stent lesion, and type of DES, could identify non-diagnostic evaluation of DES-ISR with CTCA. The PIDENT score was valuable in reducing nonevaluable and meaningless CTCA for DES-ISR.

The effects of different silicatization and silanization protocols on the bond durability of resin cements to new high-translucent zirconia.

OBJECTIVE: The aim of this study was to assess the influence of different silicatization protocols with various silane treatment methods on the bond performance to high-translucent zirconia. MATERIALS AND METHODS: High-translucent zirconia specimens were assigned to five groups according to mechanical surface pretreatment: as-sintered (Con), 0.2 MPa alumina sandblasting (AB2), tribochemical silica coating (TSC), 0.2 and 0.4 MPa glass bead air abrasion (GB2) and (GB4). Each group was subjected to 4 different cementation protocols: Panavia SA Universal (SAU), Panavia SA plus (SAP), silane + SAP (S-SAP), and Universal adhesive + SAP (U-SAP). Tensile bond strength (TBS) was measured after 24 h and 10,000 thermocycling (TC). Surface topography, surface energy, and elemental composition of the abraded zirconia surface analyses were completed. TBS data was analyzed using the Weibull analysis method. Surface roughness and surface energy were compared by one-way ANOVA analysis of variance (α = 0.05). RESULTS: After 24 h, higher TBS was achieved with all cementation protocols in AB2 and TSC, also, in GB2 with all protocols except U-SAP, and in GB4 with SAU and S-SAP. After aging, GB4/S-SAP, GB2/S-SAP, AB2/U-SAP, and TSC/S-SAP showed the highest bond strength. GB groups showed the lowest surface roughness and highest surface energy. CONCLUSION: Glass bead abrasion achieved the durable bond strength to high-translucent zirconia using a separate silane coupling agent while altered surface chemistry, surface energy, and roughness without effect on morphology. CLINICAL RELEVANCE: Glass bead air abrasion is an alternative to alumina sandblasting and tribochemical silica coating and improves bond strength to high translucent zirconia.

Feasibility of the novel proximal superficial femoral artery puncture technique to recanalize chronic total occlusions.

Chronic total occlusion (CTO) of the superficial femoral artery (SFA) with flush occlusion is sometimes difficult to be treated by endovascular treatment (EVT). The guidewire could not pass the proximal cap because the entry of the CTO could not be detected by angiography. Thus, a retrograde approach is considered; however, there was a risk of jeopardizing the adjacent deep femoral artery by subintimal angioplasty. Moreover, the retrograde approach is not feasible when the distal artery could not be punctured because of stenosis, occlusion, or uncomfortable positioning for patients during EVT. Therefore, we considered a novel technique to overcome this problem, called the Proximal superficial femoral Artery Puncture to RecanalIze the Chronic totAl occlusion (PAPRICA) technique. In this technique, to establish wire externalization, a retrograde puncture was performed from the proximal site of the SFA-CTO under ultrasound guidance, and the guidewire was advanced retrogradely from the puncture needle via the CTO site. After wire externalization, the guide catheter could be advanced into the SFA ostium. By pulling up the externalization wire, a strong backup and improved coaxial alignment of the guide catheter were achieved. This report presents two successful cases of flush SFA-CTO using this novel technique.

Comparison of ultrasound-guided versus angiography-guided endovascular treatment for femoropopliteal artery occlusive disease.

PURPOSE: This study aimed to compare the efficacy of ultrasound-guided and angiography-guided intraluminal approach for femoropopliteal (FP) artery occlusive disease. METHODS: A retrospective analysis was performed using the data collected regarding patients that underwent endovascular treatment (EVT) for FP artery occlusive disease between January 2010 and April 2018 at two centers. A total of 221 consecutive de novo lesions were analyzed according to the method of recanalization. Propensity score-matched analysis was performed to compare the clinical outcomes of recanalization methods for FP occlusive lesions. The prognostic value was analyzed based on the number of guidewires, wire cross time, distal puncture rate, radiation exposure, the amount of contrast media, primary patency, and clinically driven-target lesion revascularization (CD-TLR) at 1 year. RESULTS: A total of 44 matched pairs of patients were analyzed after propensity score-matched analysis. The number of guidewires, distal puncture rate, wire passage time, radiation exposure, and the amount of contrast media were significantly lower in the ultrasound-guide group, with 3.4 vs. 4.7, 9.1% vs. 54.5%, 47 min vs. 83 min, 207 mGy vs. 821 mGy, 66 ml vs. 109 ml, respectively (p < .01), but there were no significant differences between the two groups in terms of primary patency and CD-TLR. CONCLUSIONS: The ultrasound-guided EVT for FP occlusive disease significantly reduced the number of guidewires, wire cross time, the rate of distal puncture, radiation exposure, and the amount of contrast media used.

Efficacy of the novel technique HIRANODOME in preventing distal embolization during endovascular treatment of femoropopliteal lesions.

OBJECTIVES: The efficacy and clinical outcomes of a novel technique "HIRANODOME" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated. BACKGROUND: Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative. METHODS: Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate. RESULTS: The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%). CONCLUSIONS: The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions.

Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion.

AIMS: We aimed to evaluate the efficacy of stentless strategy by drug-coated balloon (DCB) angioplasty following directional coronary atherectomy (DCA) for left main (LM) bifurcation lesions. METHODS: A total of 38 patients who underwent DCB angioplasty following DCA for LM bifurcation lesions were retrospectively enrolled. The primary endpoint was target vessel failure (TVF) at 12 months. Secondary endpoints included procedure-related major events during the hospitalization, major adverse cardiac events at 12 months, ischemia-driven target lesion revascularization (TLR) at 12 months, and bleeding complications defined as the Bleeding Academic Research Consortium criteria ≥2 at 12 months. RESULTS: Among these 38 lesions, 31 lesions were de novo LM bifurcation lesions and 7 lesions were stent edge restenosis at the left anterior descending (LAD) ostium. The mean % plaque area (%PA) after DCA was 44.0 ± 7.4%. TVF at 12 months occurred in 1 lesion (3.2%) of de novo LM bifurcation lesion and in 3 lesions (42.9%) of stent edge restenosis at the LAD ostium. All events of TVF were ischemia-driven TLR by percutaneous coronary intervention. Among 4 TLR cases, %PA after DCA was high (55.9%) in the de novo LM bifurcation lesions; on the other hand, %PA after DCA was low (42.4%, 38.7%, and 25.7% in the 3 cases) in stent edge restenosis at the LAD ostium. No procedure-related major events were observed during hospitalization. There was no cardiac death, no myocardial infarction, no coronary artery bypass grafting, and no bleeding complications at 12 months. CONCLUSIONS: Stentless strategy by DCB angioplasty following DCA for de novo LM bifurcation lesions resulted in acceptable outcomes. On the other hand, its efficacy was limited for stent edge restenosis at the LAD ostium even after aggressive debulking by DCA.