Treatment of cephalic arch stenosis in dysfunctional arteriovenous fistulas with paclitaxel-coated versus conventional balloon angioplasty

Background Treatment of cephalic arch stenosis (CAS) with standard plain old balloon angioplasty (POBA) in dysfunctional arteriovenous fistulas (AVF), is associated with early re-stenosis and higher failure rates compared to other lesions. Paclitaxel-coated balloons (PCB) may improve patency rates. This is a retrospective cohort study. Patients who underwent POBA or PCB for CAS over a 3-year period were included. Outcomes compared were circuit primary patency rates (patency from index procedure to next intervention), circuit primary assisted-patency rates (patency from index procedure to thrombosis), and target lesion (CAS) patency rates (stenosis > 50%) at 3, 6 and 12 months. Results Ninety-one patients were included. Sixty-five (71.4%) had POBA, while 26 (28.6%) had PCB angioplasty. There were 62 (68.1%) de-novo lesions. CAS was the only lesion that needed treatment in 24 (26.4%) patients. Circuit primary patency rates for POBA versus PCB groups were 76.2% vs. 60% (p = 0.21), 43.5% vs. 36% (p = 0.69) and 22% vs. 9.1% (p = 0.22) at 3, 6 and 12-months respectively. Circuit assisted-primary patency rates were 93.7% vs. 92% (p = 1.00), 87.1% vs. 80% (p = 0.51) and 76.3% vs. 81.8% (p = 0.77), whilst CAS target lesion intervention-free patency rates were 79.4% vs. 68% (p = 0.40), 51.6% vs. 52% (p = 1.00) and 33.9% vs. 22.7% (p = 0.49) at 3, 6 and 12-months respectively. Estimated mean time to target lesion intervention was 215 ± 183.2 days for POBA and 225 ± 186.6 days for PCB (p = 0.20). Conclusion Treatment of CAS with PCB did not improve target lesion or circuit patency rates compared to POBA.

Endothelial Recovery in Bare Metal Stents and Drug-Eluting Stents on a Single-Cell Level

Objective: Healing processes, particularly reendothelialization, are essential for vascular homeostasis after plain old balloon angioplasty and stent implantation. Drug-eluting stents (DES) are commonly used for percutaneous coronary intervention because restenosis rates are reduced as compared with bare metal stents. However, in addition to understanding the nature of regenerated endothelial cells, concerns over incomplete stent healing persist, and the molecular effects of antiproliferative drug coatings on endothelium remain poorly understood. Approach and Results: We used the rabbit iliac artery model to analyze differences in stent endothelialization in bare metal stents and DES. Histology and immunohistochemistry confirmed that stent coverage was significantly greater in bare metal stents than in DES at 30 days after stent implantation. Single-cell RNA sequencing revealed a more immature transcriptomic signature of neointimal endothelial cell harvested from stented arteries in comparison with native and plain old balloon angioplasty–treated arteries. Whereas the genetic signature of bare metal stents was overall proangiogenic with enrichment of genes involved in endothelial proliferation, sprouting, and migration, as well as extracellular matrix assembly, DES-derived endothelial cell showed upregulation of genes associated with angiogenesis inhibition and endothelial activation. Conclusions: Single-cell RNA sequencing analysis identified unique transcriptional changes within regenerated endothelium after plain old balloon angioplasty and stent implantation. These data suggest unique endothelial transcriptional differences, which characterize the different response of the endothelium to vascular injury and may help explain why long-term responses in DES remain suboptimal.

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

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

Post-procedural quantitative flow ratio gradient and target lesion revascularization after drug-coated balloon or plain-old balloon angioplasty

Background Balloon angioplasty, including drug-coated balloon (DCB), is an important option of percutaneous coronary interventions (PCI), even in the drug-eluting stent era. Although quantitative coronary angiography (QCA) has been frequently used to determine the optimal endpoint of balloon angioplasty, physiological assessment may add incremental prognostic values. Quantitative flow ratio (QFR) has evolved as a novel 3D QCA-based physiological index to estimate fractional flow reserve without hyperemia nor pressure guidewire, offering both anatomical and functional lesion assessments. This study aimed to characterize post-procedural anatomical and physiological indexes by QFR and to compare their prognostic impacts on long-term clinical outcomes. Methods This retrospective study included 98 patients with de novo (n=39) or in-stent restenosis (n=59) lesions who underwent PCI with DCB (n=69) or plain-old balloon angioplasty (POBA, n=29). All lesions were analyzed by QCA and QFR. QCA analysis measured lesion length, reference lumen diameter (RLD), minimum lumen diameter (MLD) and percent diameter stenosis (%DS) at pre- and post-procedures as anatomical indexes. QFR analysis measured post-procedural QFR of target vessel (QFR-vessel) and QFR-gradient (ΔQFR between proximal and distal segments of the lesion) as physiological indexes. Primary endpoint was target lesion revascularization (TLR) within 1-year post-procedure. Results Target lesion profiles were as follows: lesion length 26.3±16.6 mm, RLD 2.90±0.70 mm, MLD 0.94±0.32 mm and %DS 79.3±18.6%. At post-procedure, MLD, residual %DS, QFR-vessel and QFR-gradient of target lesions were 1.88±0.49 mm, 34.7±10.6%, 0.84±0.13 and 0.06±0.04, respectively. During 1 year post-procedure, TLR occurred in 19 (19%) patients. Patients with TLR showed smaller MLD (1.66±0.45 mm vs. 1.93±0.49 mm, p=0.028) and QFR-vessel (0.79±0.03 vs. 0.85±0.01, p=0.06), and greater residual %DS (42.7±11.3% vs. 32.8±9.5%, p=0.0002) and QFR-gradient (0.12±0.06 vs. 0.04±0.02, p&lt;0.0001) at post-procedure compared with those without. In multivariate analysis including several clinical characteristics and anatomical indexes, QFR-gradient at post-procedure was independently associated with TLR within 1-year, demonstrating higher prognostic value compared with post-procedural MLD and residual %DS (Figure). The receiver-operating characteristics curve analysis identified the best cut-off value of QFR-gradient as 0.08 for predicting 1-year TLR after balloon angioplasty, irrespective of balloon type (DCB or POBA) (Figure 1). Conclusions Post-procedural QFR-gradient within the lesion was an independent and stronger predictor of subsequent TLR, compared with anatomical indexes. Further studies are warranted to investigate whether QFR guidance to optimize PCI procedure could improve clinical outcomes in patients with balloon angioplasty. Figure 1 Funding Acknowledgement Type of funding source: None

Should We Still Do Plain Old Balloon Angioplasty following Rotational Atherectomy in Drug-Eluting Stent Era?

Background Drug-eluting stent (DES) is well known effective in severely calcified lesion after rotational atherectomy (ROTA). However, there are still some situations when metal stents should be avoided and plain old balloon angioplasty (POBA) emerges as the preferred option. The aim of present study is to explore that whether POBA is comparably effective to DES in large and calcified coronary pretreated by ROTA in clinical outcomes. Methods A retrospective analysis of consecutive patients treated for severely calcified lesions in large (≥ 3 mm) coronary using ROTA + DES or ROTA + POBA was performed. Major adverse cardiac events (MACE) including all cause/cardiac death and target lesion revascularization (TLR) at 1- and 2-year post-treatment, were compared between groups, with Cox regression analyses to identify independent predictors of TLR and MACE. Results The analysis included 285 cases in the ROTA + DES and 47 in the ROTA + POBA group, while no relevant between-group differences in clinical baseline characteristics were found. Of note, lesion length was greater in the ROTA + DES group (37.2 mm versus 19.3 mm, p < 0.001), with 8.4% lesions being chronic total occlusion in this group, but none in the ROTA + POBA group. The in-hospital/30-day mortality rate (5.3%, DES, and 6.4%, POBA), as well as the 12- and 24-month all-cause/cardiac mortality rate (9.3% and 7.7%, respectively) were not significantly different between groups. TLR rates were not significantly different between groups at 12-month (4.6%, DES, and 4.3%, POBA) and 24-month (5.3%, DES and 6.4%, POBA) respectively. Conclusions Outcomes were comparable for ROTA + DES and + POBA in severely calcified large coronary arteries intervention, with respect to mid-term death or TLR rate, especially for short lesion < 20 mm.

Factors Related to the Success of Endovascular Therapy with Plain Old Balloon Angioplasty of Central Vein Stenosis in Haemodialysis Patients

Introduction: Central venous stenosis (CVS) or occlusion is a severe complication in hemodialysis patients, which significantly decreases the patency of all vascular dialysis access components, including arteries and branches, AV anastomosis, peripheral veins, and central veins. The main etiology of CVS is mostly secondary to the placement of temporary or permanent dialysis catheters in the subclavian vein, internal jugular vein, and femoral vein. Standard endovascular therapy for central venous stenosis is conventional balloon angioplasty. Method: This is a retrospective study using medical records from June 2013 to August 2018. Patients who underwent plain old balloon angioplasty (POBA) procedures in the CVS condition due to the installation of hemodialysis catheter access were included in this study. The analysis was performed to assess the characteristics and data distribution of each variable. Results: Significant factors related to the success of endovascular procedure in patients with central venous stenosis with POBA were the onset of clinical symptoms (<3 months; p <0.001), duration of catheter placement (<2.5 months; p <0.001), history of previous catheter placement (no more than once, p <0.001), initial stenosis (<80; p <0.001), and diameter of POBA (≥ 10 mm; p <0.001). Conclusion: Some factors influenced the success of the POBA procedure for overcoming CVS. The need to understanding the use of hemodialysis catheter access according to the guideline is important. Keywords: central venous stenosis, endovascular therapy, plain old balloon angioplasty

Effect of drug-coated balloons in treatment of stenosis of the femoral artery and vein bypass graft not responding to plain old balloon angioplasty: a case report

Background The use of drug-coated balloons (DCBs) with anti-proliferative agents in treating femoropopliteal lesions was approved in Japan in 2017. A better limb salvage rate or amputation-free rate of DCBs relative to plain old balloon angioplasty (POBA) has been reported; however, there is little evidence of the direct effect on intimal hyperplasia (IH). Case presentation A 70-year-old man with chronic limb-threatening ischemia and foot gangrene had undergone bypass surgery from the left common femoral artery to the dorsalis pedis artery 2 years earlier. We evaluated the bypass graft using ultrasonography and found stenosis around the proximal anastomotic site, presumably due to IH. POBA was performed every 3 months due to the repeated re-stenosis of the lesion. Since using the DCB, no restenosis has been detected to date (10 months). Conclusion DCB might be an effective tool for treating re-stenosis due to IH or vein grafts that do not respond to POBA.