Protocol of the Dragon study: Drug-coated balloon compared with cutting balloon in treatment of arteriovenous fistula stenosis.

ObjectiveThis study aimed to analyze the safety and mid-term outcomes of a hybrid treatment method combining rotational atherectomy (RA) with drug-coated balloon (DCB) angioplasty in patients with femoropopliteal artery in-stent restenosis (ISR).MethodsThis single-center retrospective study enrolled patients from January 2018 to March 2022 who had femoropopliteal artery in-stent restenosis treated by RA and DCB. Preoperative demographics, operative details, and postoperative 12-month follow-up outcomes were analyzed statistically.Results38 consecutive patients (31 men; mean age 69.55 ± 9.18 years, range 54–91 years) with Tosaka II (n = 8) and III (n = 30) ISR were treated with RA Most patients had a high prevalence of typical vascular comorbidities. Overall, 50% of patients had chronic limb-threatening ischemia, and the average lesion length was 155.0 ± 54.8 mm. The primary patency rate, assessed by duplex ultrasound at 12 months, was 86.7%; 7.9% (3/38) of patients underwent target lesion revascularization (TLR). The overall mortality rate was 2.6% (1/38), and the ulcer healing rate reached 83.3% (5/6), with none of these patients requiring amputation. Subgroup analysis based on target lesion length (≥ 200 mm) showed that the 12-month primary patency rate was 75.0% for the ≥ 200 mm group and 95.5% for the < 200 mm group. Cox univariate regression analysis did not identify any risk factors affecting primary patency rate and freedom from clinically driven TLR (CD-TLR) at 12 months.ConclusionsRotarex®S combined with DCB seems safe and provides acceptable 12-month primary patency and TLR rates in femoropopliteal in-stent restenosis. Well-designed comparative or large registry studies are necessary to provide high quality and long-term data on this technique to provide firm conclusions on the efficacy of Rotarex®S and DCB in ISR in the femoropopliteal area.

Aim: This study aimed to evaluate the effect of ultrasound-assessed lesion morphology on the outcomes of drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) treatment for de novo dysfunctional arteriovenous fistulas (AVF) lesions. Methods: This single-center retrospective study enrolled 114 consecutive patients (mean age, 73 ± 10 years; male, 69%) with de novo dysfunctional AVF lesions who underwent percutaneous transluminal angioplasty (PTA) using DCB (n = 48) and POBA (n = 66). The morphology of the stenotic lesions, evaluated using ultrasonography, was classified into intimal hyperplasia and shrinking types. The outcome measure was 12-month primary patency. Factors associated with loss of primary patency were evaluated using Cox proportional hazards models. Results: The baseline characteristics were not significantly different between the 2 treatment groups. The 12-month primary patency rate was significantly higher in the DCB group than in the POBA group (66.8 ± 7.1% versus 35.9 ± 6.3%, P = .006). The 12-month primary patency rate in the lesions with intimal hyperplasia type was not significantly different (DCB: 70.3 ± 9.5% versus POBA: 45.9 ± 8.0%; P = .310), whereas that in the shrinking type was significantly higher in the DCB group than in the POBA group (61.9 ± 10.6% versus 15.2 ± 8.1%; P < .001). The interaction analysis demonstrated that lesion morphology had a significantly different hazard ratio (HR) for restenosis between the POBA and DCB groups (P for interaction = .031). The multivariate analysis revealed that DCB usage (adjusted hazard ratio [aHR], 0.49; 95% confidence interval [CI]: [0.28, 0.87]; P = .015), ultrasound-assessed lesion morphology (shrinking type: aHR, 1.77; 95% CI: [1.07, 2.93]; P = .026), and location of stenosis (aHR, 2.26; 95% CI: 1.15, 4.46; P = .018) were significantly associated with AVF patency after PTA. Conclusion: This study revealed that lesion morphology evaluated using ultrasonography had a differential impact on DCB and POBA outcomes. The therapeutic effect of DCB was unexpectedly confirmed in the shrinking type. Clinical Impact The effectiveness of DCB in inhibiting smooth muscle cell proliferation in intimal hyperplasia lesions was expected based on the known mechanism of action of paclitaxel. However the therapeutic effect of DCB was unexpectedly confirmed in the shrinking type too. We may not need to hesitate usage of DCB for shrinking type.

This study aimed to compare access and target lesion patency rates between undersized and apposed/oversized lateral-edge covered stents in patients with hemodialysis access-related central venous occlusive disease (CVOD). A retrospective analysis of 76 hemodialysis patients undergoing endovascular treatment for CVOD was conducted. All of the patients received undersized covered stents at the medial edge. Based on lateral-edge sizing, the patients were divided into undersized (n = 14) and apposed/oversized (n = 62) groups. Patency outcomes were compared using the log-rank test, and multivariable analysis was used to identify risk factors associated with the primary outcome. The 12-month access primary patency rate was significantly higher in the undersized group than in the apposed/oversized group (76.4% vs. 25.9%, p = 0.047). The 12-month target lesion primary patency rate was also higher in the undersized group; however, the difference was not statistically significant (76.4% vs. 52.1%, p = 0.186). Factors associated with the primary outcome included older age (odds ratio [OR] = 1.03, p = 0.011), coronary artery disease (OR = 2.03, p = 0.041), stenting to central veins for access thrombosis (OR = 3.53, p = 0.001), more stents (OR = 3.11, p = 0.002), apposed/oversized lateral stent edge (OR = 2.73, p = 0.044), and higher stent-to-vessel ratio (OR = 1.19, p = 0.022). The 12-month primary patency rate was better in the undersized group than in the apposed/oversized group. Endovascular treatment with undersized covered stents may be a feasible approach for hemodialysis access-related CVOD. Larger randomized studies are required to confirm these findings.

ObjectiveEndovascular recanalization is the preferred treatment for peripheral vascular diseases. This study evaluated the short-term outcomes of endovascular therapy for transplant renal artery stenosis (TRAS) administered based on anatomical foundations and three-dimensional digital subtraction angiography (3D-DSA).MethodsPatients with TRAS treated with endovascular therapy at a single center between October 2022 and October 2023 were retrospectively analyzed. The primary endpoint was the 12-month primary patency rate, defined as uninterrupted vessel patency without reintervention. Secondary endpoints included secondary patency rate (patency maintained after reintervention), blood pressure, and serum creatinine (Scr) levels.ResultsThe study included 23 patients (mean age: 41.1 ± 11.5 years; 9 females). All patients underwent successful plain old balloon angioplasty (POBA); 13 underwent POBA plus balloon-expandable bare-metal stent (BMS) deployment. The procedure-related complication rate was 13.04%. Technical success was defined as <30% residual stenosis with restoration of antegrade flow at completion angiography and was achieved in all cases (100%). The median follow-up was 14.9 ± 2.3 months (range11-19 months). The 12-month primary and secondary patency rates were 86.96% and 100%, respectively. The primary patency rates significantly differed between the POBA + BMS (100%) and POBA-only (70%) groups (P = 0.032). The systolic and diastolic blood pressure, pulse pressure, and Scr levels significantly differed pre- and post-operatively. No stent-related complications occurred.ConclusionsEndovascular treatment of TRAS based on anatomical foundations and 3D-DSA is safe and effective with a high patency rate. POBA with BMS might be a better solution.

Most clinical trials of drug-coated balloon (DCB) for the treatment of femoropopliteal artery stenosis chose 12-month primary patency rate (PPR) or 6-month late lumen loss (LLL) as the primary endpoint. It is still debatable whether 6-month LLL can be served as an appropriate surrogate endpoint for 12-month PPR. This study aimed to identify whether LLL can serve as an appropriate surrogate endpoint in peripheral DCB clinical trials, and shed light on the selection of primary outcome for subsequent confirmatory clinical trials of DCB in the treatment of femoropopliteal artery stenosis. The linear regression model was used to evaluate the correlation between 12-month PPR and 6-month LLL. Pooled standardized mean differences (SMDs) and relative gain between the DCB and plain old balloon angioplasty (POBA) group were computed to assess the consistency and surrogacy, using fixed or random effect model as appropriate. The coefficient of variation (CV) was calculated for both endpoints to compare their degree of variation overall and at study level. A total of 34 studies are eligible for this study. A significant negative linear correlation was found between 12-month PPR and 6-month LLL (R2=0.67, slope=-0.309, p=0.007). The SMD (DCB-POBA) of LLL and PPR was -0.76 (95% confidence interval [CI]: -0.98, -0.54), and 0.59 (95% CI: 0.46, 0.72) (p=0.18). The pooled relative gain of PPR (43%, 95% CI: 35%, 50%) was significantly lower than that of LLL (72%, 95% CI: 61%, 84%) (p<0.001). Coefficient of variation of LLL was larger than that of PPR overall in DCB and POBA groups. Although a significant moderate correlation was observed between 12-month PPR and 6-month LLL, PPR shows more conservative and robust than LLL, which may exaggerate clinical benefits. Late lumen loss should be used discreetly depending on different situations and clinical benefits for patients.Clinical ImpactThis study addresses the critical issue of primary endpoint selection in clinical trials of drug-coated balloon for femoropopliteal artery stenosis. By elucidating the moderate correlation between 6-month late lumen loss (LLL) and 12-month primary patency rate (PPR), the findings underscore the limitations of LLL as a surrogate endpoint due to its variability and potential to overstate clinical benefits. The study advocates for the use of 12-month PPR as a more robust and conservative endpoint in pivotal trials, particularly for novel devices. These findings provide clinicians with a nuanced understanding of outcome measures, promoting evidence-based decision-making and regulatory alignment to ensure patient benefits in vascular interventions.

Objective The study aimed to compare ultrasound-guided brachial plexus block (BPB) with local anesthesia (LA) on efficacy, safety and 12-month patency rate for percutaneous transluminal angioplasty (PTA) treatment of dysfunctional arteriovenous fistula (AVF). Methods Consecutive patients with dysfunctional AVF who underwent PTA from January 2021 to December 2022 were included. Overlap weighting was performed to adjust for significant differences between the two groups. The primary efficacy outcomes included visual analogue scale (VAS) score and 12-month target-lesion primary patency rate. The secondary efficacy outcomes included target-lesion primary-assisted patency rate, secondary patency rate, access-circuit thrombosis rate, access-circuit reintervention rate, and number of reinterventions within 12 months. Univariate analysis and multivariate analysis by log-binomial regression were used to identify the independent factors associated with intraoperative pain. Results 218 patients were included in the study: 82 patients underwent PTA under BPB and 136 patients underwent PTA under LA. After overlap weighting, the baseline, lesion characteristics and intraoperative details had no significant difference between the two groups. Patients under BPB had significantly lower VAS scores than those under LA (2.4 ± 1.4 vs 5.1 ± 1.9, p < 0.001). The 12-month target-lesion primary patency rate was significantly higher in the BPB group than that in the LA group (58.3% vs 40.0%, p = 0.037). The 12-month target-lesion primary-assisted patency rate and access-circuit secondary patency rate were significantly higher in the BPB group than those in the LA group (p = 0.023 and p = 0.028). The access-circuit thrombosis rate was significantly lower in the BPB group (10.0%) than that in the LA group (28.3%) (p = 0.011). BPB was the only independent factor associated with mild pain (p < 0.001, OR: 0.037, 95%CI: 0.011–0.119). Conclusions BPB could decrease the intraoperative pain and improve the 12-month primary patency rates compared with LA for patients underwent PTA treatment of dysfunctional AVF.

Arteriovenous fistula outcomes in the elderly

Debulking Combined with Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis.

Approximately 5.8 million people experience peripheral arterial disease (PAD) in the United States today. Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD. New-generation nitinol stents, drug-coated stents, drug-coated balloons (DCB), covered stents, and directional or orbital atherectomy devices have shown promising results. However, clinical equipoise persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study populations, length of lesions treated, definitions of "patency" and "restenosis," and follow-up methods in the up-to-date pivotal trials. A prospective protocol was developed. We performed a literature search using PubMed from January 2011 to July 2021. All published articles including endovascular interventions in the SFA with reported 12-month "primary patency" rates as endpoints were included. We identified 25,051 patients in 124 studies reporting 12-month primary patency rates in patients with SFA disease. Primary patency rates were (weighted average) 82.6% for drug-eluting stents, 77.2% for drug-coated balloons, 75.2% for covered stents, 73.9% for nitinol self-expanding stents, 66.1% for atherectomy, and 44.5% for bare balloon angioplasty. The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 44.5% to 82.6%. The increased variation in inclusion criteria, lesion length, and complexity of lesions between studies does not allow direct comparison between the individual devices. Larger randomized trials in specific patient populations comparing these modalities are needed well before we can make proper recommendations on the superiority of one device over the other.

Safety and Efficacy of Excimer Laser Atherectomy Combined with a Drug-Coated Balloon in de Novo Femoral Popliteal Artery Disease: A Retrospective Study

Endovascular approach to superficial femoral artery (SFA) disease, the most common cause of symptomatic peripheral arterial disease, remains fraught with high failure rates. Newer devices including second-generation nitinol stents, drug-coated stents, drug-coated balloons, covered stents, cryo-therapy, LASER, and directional atherectomy have shown promising results. Clinical equipoise still persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study population, length of lesions treated, definition of "patency" and "restenosis," and follow-up methods in the pivotal trials. A prospective protocol was developed. We performed a literature search using PubMed from January 2006 to November 2013. Published articles including endovascular interventions in SFA or popliteal arteries with reported 12-month "primary patency" or "binary restenosis" rates as endpoints were included. We identified 6,024 patients in 61 trials reporting 12-month primary patency rates in patients with femoropoliteal disease. Primary patency rates were (weighted average) 77.2% for nitinol stents, 68.8% for covered stents, 84% for drug eluting stents, 78.2% for drug eluting/coated balloon, 60.7% for cryoballoon, 51.1% for LASER atherectomy, 63.5% for directional atherectomy and 70.2% with a combination of endovascular devices. The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 51% to 85%. The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparison between them. Larger randomized trials in specific patient populations comparing those modalities is needed before we can make safe recommendation of the superiority of one device over the other.

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

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

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Combination of RotarexⓇS Rotational Atherothrombectomy and Drug-Coated Balloonangioplasty for Femoropopliteal Total In-Stent Occlusion