Plain Balloon Research Articles

Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions

Purpose: To investigate the efficacy of scoring balloons for immediate success of percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions. Materials and Methods: Between 2013 and 2019, 398 consecutive patients with de novo femoropopliteal lesions were treated using PTA in our hospital. The procedure success rate was compared among patients undergoing PTA with vs without scoring balloons after 1:1 propensity score matching on hemodialysis, TransAtlantic Inter-Society Consensus II classification, Peripheral Arterial Calcium Scoring System (PACSS) grade, lesion length, and use of intravascular ultrasound. Propensity matching produced 84 patients (mean age 73.4±8.3; 65 men) treated with scoring balloons and 84 patients (mean age 75.6±8.7; 56 men) treated with plain balloons. Kaplan-Meier analysis investigated patency after the procedure in both groups; estimates are given with the 95% confidence interval (CI). Results: Residual stenosis <30% was achieved more often (77.4% vs 57.1%, p=0.005) and severe arterial dissection occurred less frequently (16.7% vs 29.8%, p=0.043) in the scoring balloon group vs the plain balloon group, respectively. The rate of provisional stenting was significantly lower after scoring balloon use (13.3% vs 29.8%, p=0.008). Multivariable analysis revealed that use of scoring balloons (p<0.001) and prolonged inflation time (p<0.001) were independent predictors of successful angioplasty, whereas chronic total occlusion (p=0.005) and longer lesion length (p=0.005) were predictors of an unsuccessful procedure. Among 108 patients with PACSS 0–3 lesions in the matched population, Kaplan-Meier analysis showed better primary patency at 18 months in the scoring balloon group in the intention to treat analysis [68.6% (95% CI 53.5% to 80.6%) vs 43.0% (95% CI 28.7% to 58.5%), p=0.044]. Conclusion: Scoring balloons may be effective in restoring acute lumen gain and preventing severe arterial dissection in femoropopliteal lesions. Moreover, scoring balloons might be associated with better primary patency at 18 months in PACSS 0–3 lesions.

Balloon catheters and stents with paclitaxel: are they really dangerous? A review and update.

The aim of this review is to summarize and update current research concerning the safety of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with paclitaxel (PTX) in peripheral arteries. The data from the large randomized controlled trials showed evidence of the superiority of DCBs over plain balloon angioplasty concerning efficacy. Also, the safety parameters between the two groups did not differ. However, two meta-analyses identifying an increased late mortality risk after using PTX technologies were published only a short time ago. In contradiction, a lot of following studies (meta-analyses, real-world analysis, retrospective review) published in 2019 and 2020, did not confirm any significant difference in all-cause death between PTX and no-PTX cohorts. The safety of PTX technologies still represents the most serious and controversial issue in peripheral interventions. Until it is definitively solved further research must continue. In daily practice, recommendations for the use of PTX products include the treatment of restenosis after percutaneous transluminal angioplasty (PTA) (not of de novo lesions), the maintenance of patency of bypasses, and angioplasty for limb salvage. In heavily calcified lesions, a prior debulking with atherectomy is suitable. Generally, the risks and benefits of the application of PTX devices should be considered in every single patient.

Differential efficacy between stenting and plain balloon angioplasty for femoropopliteal disease with or without total occlusion.

Background/AimsWhether the presence of chronic total occlusion (CTO) affects patency after stenting in femoropopliteal lesions is unknown. We determined the effects of plain balloon angioplasty (POBA) in comparison with those of stenting on patency for femoropopliteal CTO and stenosis (non-CTO).MethodsWe analyzed data from the Korean Vascular Intervention Society Endovascular Therapy in Lower-Limb Artery Diseases Registry, a multicenter cohort of patients with lower extremity peripheral arterial disease. Data from 1,329 patients and 1558 limbs treated with endovascular intervention for at least one femoropopliteal lesion were evaluated.ResultsAmong the 1,558 limbs, 345, 432, 275, and 506 were in the non-CTO-POBA, non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. During follow-up, loss of clinical primary patency, a composite of freedom from restenosis or clinically driven target lesion revascularization, occurred in 65 (18.8%), 68 (15.7%), 62 (22.5%), and 113 limbs (22.3%) in the non-CTO-POBA, non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. The patients in the non-CTO-stent group showed a significantly better clinical primary patency than those in the no-CTO-POBA group, whereas those in the CTO-stent and CTO-POBA groups showed no significant differences. After inverse probability of treatment weighting to balance the differences among covariates between the non-CTO-stent and non-CTO-POBA groups, the non-CTO-stent group still showed superior clinical primary patency as compared with the non-CTO-POBA group.ConclusionsIn the patients with femoropopliteal stenosis without CTO, stenting resulted in better clinical outcomes than balloon angioplasty. The presence of CTO in the femoropopliteal lesion should be considered when selecting a suitable device for performing endovascular procedures.

3:54 PM Abstract No. 19 Comparing efficacy of pharmacologic and plain angioplasty interventions in restenotic hemodialysis accesses in patients with prior plain balloon angioplasty

3:54 PM Abstract No. 19 Comparing efficacy of pharmacologic and plain angioplasty interventions in restenotic hemodialysis accesses in patients with prior plain balloon angioplasty

4:03 PM Abstract No. 20 Paclitaxel coated balloons compared with plain balloon angioplasty in the management of dysfunctional arteriovenous fistulas: a single-institution randomized clinical trial

4:03 PM Abstract No. 20 Paclitaxel coated balloons compared with plain balloon angioplasty in the management of dysfunctional arteriovenous fistulas: a single-institution randomized clinical trial

Midterm outcome of directional atherectomy versus plain balloon angioplasty with adjunctive stenting for femoropopliteal artery lesions: A single-center experience

OBJECTIVE: To examine the difference in safety and effectiveness of directional atherectomy (DA) and plain balloon angioplasty with adjunctive stenting (BA-STENT) in the treatment of de novo femoropopliteal artery occlusive lesions. MATERIALS AND METHODS: This prospective, randomized trial of DA versus BA-STENT in femoropopliteal arteries was carried out in a single medical center. Demographic data, procedural characteristics, and follow-up information were recorded. The technical, procedural, and clinical outcomes were reported. The primary endpoint was the primary stenosis-free patency rate at 12 and 18 months after the intervention. The secondary endpoints included the rates of technical success, freedom from clinically driven target lesion revascularization (TLR), limb amputation, and all-cause mortality. RESULTS: A total of 188 patients were included in this study. The DA group consisted of 89 (47.3%) patients, and the BA-STENT group consisted of 99 (52.7%) patients. There were 134 males and 54 females with an average age of 68 years, all of which had lesions of Rutherford Grade 2 and above. There was no statistically significant difference in age, gender, smoking, or comorbidities between two groups. The technical success rates were 98.9% in the DA group and 100% in the BA-STENT group (P = 0.47). There was no statistically significant difference in primary stenosis-free patency (90.0% vs. 90.6% at 6 months, 76.7% vs. 77.8% at 12 months, and 72.3% vs. 68.9% at 18 months after the intervention) or freedom from TLR (96.3% vs. 95.8% at 6 months, 88.3% vs. 91.6% at 12 months, and 86.1% vs. 85.4% at 18 months after the procedure) between the DA and the BA-STENT groups. There was no statistically significant difference in terms of distal embolization, thrombosis, and mortality between two groups. No patient underwent major amputation. CONCLUSION: For the treatment of de novo Trans-Atlantic Inter-Society Consensus (TASC) II A-C femoropopliteal artery lesions, DA demonstrated comparable results with the plain balloon angioplasty with adjunctive stenting.

Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial.

ObjectiveTo report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs).Materials and MethodsIn this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator.ResultsDemographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified.ConclusionPaclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.

Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes.

PurposeDissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions.Materials and MethodsA total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis).ResultsThe cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p=0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography.ConclusionThe presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study

ObjectivesThe aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery. BackgroundDissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes. MethodsTOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization. ResultsPatients’ mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life. ConclusionsTOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty.

A Comparison of Clinical Outcomes Following Femoro-Popliteal Bypass or Plain Balloon Angioplasty with Selective Bare Metal Stenting in the Bypass Versus Angioplasty in Severe Ischaemia of the Limb (Basil) Trial

Introduction - The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-1) trial is the only randomised controlled trial (RCT) to have compared a bypass surgery (BS) first with a best endovascular treatment (BET) first revascularisation strategy for the treatment of chronic limb threatening ischaemia (CTLI) due to infra-inguinal disease. BASIL-1 found that, in patients who survived for more than 2 years, BS was associated with better amputation free (AFS) and overall (OS) survival. However, these data included patients undergoing femoro-popliteal (FP) and infra-popliteal (IP) procedures. The aim of the present study is to examine outcomes in the sub-group of BASIL-1 patients who underwent FP BS or plain balloon angioplasty (PBA) +/- bare metal stent (BMS) in order to build equipoise for the BASIL-3 trial which is randomising CLTI patients to FP PBA +/- BMS vs drug coated balloon (DCB) +/- BMS vs primary drug eluting stent (DES). Methods - Outcome data were obtained from prospectively gathered BASIL-1 case record forms. Differences between BS and PBA+/-BMS were compared using the t-test, chi-squared and Wilcoxon rank sum tests according to the distribution of data using SAS v9.4. Results - A total of 311 BASIL-1 patients were studied; 128 undergoing primary SB (89 VB, 39 SynB) and 183 primary PBA+/-BMS. PBA+/-BMS patients were older and more likely to be current smokers, and SB patients were more likely to have chronic obstructive pulmonary disease (COPD). Immediate technical success was significantly better for SB (98% vs. 81%, p<0.0001). Patients undergoing SB had a longer mean index hospital admission (16 vs. 8 days, p=0.0001). However, at 12 months patients in both groups had spent an equivalent mean number of days (n = 17) in hospital. All-cause 30-day mortality was not statistically different between the two groups, PBA+/-BMS patients underwent more re-interventions within the first 30-days (2% vs 7%, p=0.06). There was no significant difference in AFS (HR 1.18, p=0.4), OS (HR 1.14, p=0.5) or LS (HR 1.09, p=0.8) between SB and PBA+/-BMS. However, FF-MALE (HR 1.51, p=0.04) and FF-R (HR=1.68, p=0.02) were significantly better following SB. FF-MALE (71% vs 58% vs 56%, p=0.02) was significantly better following VB. Resolution of rest pain (HR=0.84, p=0.2) and wound healing at 3 years (HR=0.78, p= 0.2) were similar in the two groups. Conclusion - This BASIL subgroup analysis indicates that although amputation rates and overall survival are similar, primary SB, especially VB, resulted in significantly fewer MALE and re-interventions than PBA+/-BMS. So, although an endovascular first revascularisation strategy may be a less resource intensive and morbid option in the short term, this appears unlikely to be the case in the long-term. Present data add further weight to the argument that, where possible, most patients presenting with CLTI due to FP disease should be offered VB as their primary revascularisation procedure where suitable autogenous conduit is available.

A Novel Epigenetic Drug-Eluting Balloon Angioplasty Device: Evaluation in a Large Animal Model of Neointimal Hyperplasia

Drug-eluting balloon catheters (DEBc) coated with paclitaxel (PTX) have been associated with potential safety concerns. An efficacious but less toxic balloon coating may reduce these outcomes. We evaluated a novel DEBc, Epi-Solve, coated with metacept-3 (MCT-3), a member of the histone deacetylase inhibitor (HDACi) class of epigenetic agents, in a large animal model of neointimal hyperplasia (NIH). Plain balloon angioplasty (PABA) catheters were ultrasonically coated with MCT-3 to generate Epi-Solve DEBc. An ovine model of NIH formation was established utilising partial left common carotid artery (LCA) ligation. Twenty-eight days post neointima (NI) induction, PABA, Epi-Solve or PTX-coated DEBc were deployed at the site of induced NI formation. Twenty-eight days post-intervention, ligated vessels were evaluated for attenuation of NI formation, gene expression profiles and immunohistochemical analysis. Epi-Solve DEBc demonstrated attenuation of NIH over no intervention and a trend to inhibition of NIH over PABA. Gene expression analysis and immunohistochemical studies identified significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA. Epi-Solve is a novel HDACi-coated DEBc which demonstrates significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA in an ovine model and may afford endothelial protection.

A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated PTA Balloon Catheters Versus Plain Balloon PTA Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated PTA Balloon Catheters Versus Plain Balloon PTA Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

Clinical Case of Successful Endovascular Treatment of Obstructive Post-thrombotic Syndrome in the Lower Extremity With Plain Balloon Angioplasty as a Standalone Method

Clinical Case of Successful Endovascular Treatment of Obstructive Post-thrombotic Syndrome in the Lower Extremity With Plain Balloon Angioplasty as a Standalone Method

Mid-Term Limb Salvage Following Plain Balloon Angioplasty for Severe Limb Ischaemia due to Infra-Popliteal Disease: A Comparison of the Basil Trial (1999-2004) with a Contemporary Series (2009-2013)

Introduction - Despite the only available level 1 evidence (from the UK NIHR HTA- funded BASIL-1 trial, B-1) showing superior outcomes from bypass, in recent years, there has been an increasing trend towards offering endovascular revascularisation (ER) to patients with severe limb ischaemia (SLI). This is frequently justified by asserting that the results of ER are likely to be significantly better now than when B-1 patients were treated. The aim of this study is to compare midterm clinical outcomes in patients undergoing IP ER in the B-1 (1999-2004) with those observed a decade later (2009-2013) in a contemporary series (CS) from an academic tertiary vascular unit.

Balloon Angioplasty Versus Stenting for the Treatment of Failing Arteriovenous Grafts: A Meta-Analysis

Introduction - to assess the outcomes of plain balloon angioplasty versus stenting for the treatment of failed or malfunctioning haemodialysis arteriovenous grafts (AVGs) for chronic haemodialysis. Methods - A systematic search of the literature was undertaken using PUBMED, EMBASE and Cochrane databases from January 2000 to September 2016 for articles comparing balloon angioplasty versus stenting in the management of failed or malfunctioning haemodialysis AVGs. Results are reported as the odds ratio (OR) and 95% confidence interval (CI). Results - The search identified eight studies (1051 patients). Balloon angioplasty alone was used in 521 patients (49.6%) and stenting in 530 patients (50.4%). At the time of the endovascular re-intervention, the mean life of AVGs was 807.7±115.4 days for the balloon angioplasty and 714.2±96.3 days for the stenting group (p=0.92). All AVGs were located in the arm. Most procedures (98.1%) were performed across the venous anastomosis, while 88% of the patients in the stenting group received a stent-graft. The technical success rate was significantly higher in the stenting group (OR 0.16, 95% CI 0.08 to 0.31, p<0.001). At 12 months, loss of primary and secondary patency was significantly higher in patients undergoing plain balloon angioplasty compared to stenting, (OR 3.54, 95% CI 2.18 to 5.74, p<0.001) and (OR 1.82, 95% 1.17 to 2.82, p=0.008), respectively. Conclusion - Stenting is associated with better technical success and patency rates compared to plain angioplasty in treating failed or malfunctioning haemodialysis AVGs and thus it should be considered as the therapeutic strategy of choice.

IVUS Directed Stent Placement Decision in a Hybrid Procedure for Lower Limb Revascularization. is Angiography Enough?

Introduction: The decision of wether to implant a stent or not after endovascuar angioplasty of the Superficia femoral artery (SFA) is clasically based on arteriographic control. Neverthless, the angiographical signs in which stent implatation indication is based are subjective and unccurate. Intravascular ultrasound (IVUS) is an intraopertive, readily availabel tool that can help to decide when angiography is unconclusive. We present a case report in which IVUS confirmed a postangioplasty dissection with critical residual stenosis inadvertent in angiography. Methods: A 56 year old male patient with Rutherford 5 lower limb ischemia underwent hybrid revascularization consisting in surgical endarterectomy of the common femoral artery and endoavascular treatment of the SFA and anterior tibial artery. A very calcified short lesion at the SFA was initially dilated with plain balloon angioplasty, without evident residual stenosis and good outflow in angiographic control, but with turbulent flow at the treated segment. IVUS confirmed critical residual stenosis secondary to intimal dissection, indicating stent implantation. Stent dimensions were decided based on measurements obtained with IVUS, which helped to identify the length and diameter of the dissected arterial segment. Complete expansion of the stent was also assesed by IVUS control. Results: The patient recovered pedal pulse immediatelly after the procedure. 3 Months after revascularization all whounds at the foot had healed, without rest pain and complete patency of all the arterial treated segments assesed by dupplex ultrasound. Conclusion: Angiographic control after angioplasty of complex lessions at the SFA is sometimes misleading, avoiding detection of local complicactions at the treated segment and jeopardizing short term patency results of endovascular procedures. IVUS provides crucial additional information when deciding whether or not to implant a stent, and could become an essential tool for these procedures in the future, even displacing arteriography as a the gold-standard for post-angioplasty control image.

LEA 38. Retrograde Use of the Outback Re-entry Catheter in Complex Infrainguinal Arterial Recanalization

The objective of this study was to demonstrate the efficacy and safety of the Outback (Cordis, Santa Clara, Calif) re-entry catheter in complex retrograde subintimal infrainguinal arterial recanalization for patients affected by critical limb ischemia. Between 2015 and 2019, the Outback re-entry catheter was used to re-enter the true lumen in 29 patients with critical limb ischemia who underwent retrograde superficial femoral artery, with or without popliteal artery subintimal recanalization, after failed guidewire and catheter-assisted re-entry. The retrograde access site was distal superficial femoral artery in 21 patients, proximal anterior tibial artery in 5 patients (Fig 1), and proximal peroneal artery in 3 patients. The re-entry target was common femoral artery in 27 patients, proximal superficial femoral artery in 1 patient, and proximal anterior tibial artery in 1 patient. Technical success was 89% (26/29). In all the successful cases, the re-entry was accurate (Fig 2), without damage to the profunda femoral artery. In 25 of 26 successful cases, the lesion was stented after plain balloon angioplasty. Supera (Abbott, Abbott Park, Ill) stent (with the proximal one always deployed from the retrograde access) was the most commonly used stent in 19 cases. The Outback was inserted through a 6F sheath in 13 cases and without any sheath in 16 cases (always when the retrograde access was at the level of below-knee vessels), passing the device over a 0.018-inch guidewire. In all cases, there were no significant complications correlated to the retrograde access. The use of the Outback re-entry catheter after complex retrograde subintimal infrainguinal recanalization has been demonstrated to be effective and safe. The possibility of passing it over a 0.018-inch guidewire gives the chance of doing it without inserting a sheath, reducing the size of the access and possible complications.Fig 2Precise re-entry obtained at the level of the short superficial femoral artery stump and at the anterior tibial origin in two different cases, with wire always eventually passed into the sheath coming from the antegrade access.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Prevention of neointimal formation after angioplasty using tetramethylpyrazine-coated balloon catheters in a rabbit iliac artery model.

Restenosis remains a clinical problem; drug-coated balloons (DCBs) have demonstrated high efficiency in this situation. DCBs prevent neointimal hyperplasia by inhibiting cell proliferation and migration. Tetramethylpyrazine (TMP) is a traditional Chinese medicine originally isolated from the rhizome of Ligusticum Walliichii, which can inhibit platelet aggregation and smooth muscle cell proliferation. We hypothesized that TMP-coated balloons (TCB) could reduce neointimal hyperplasia through the NF-κB signalling pathway. Twenty-one New-Zealand White rabbits (2.5-3.0 kg, male) were fed high-fat diets; 36 bilateral iliac artery stenosis models were successfully established by balloon straining. Rabbits were randomly treated with TCB (n=20) or plain balloons (PBA, n=16) (3 died during model construction). Angiographies were recorded at baseline, the immediate period, and 4 weeks later. Animals were euthanized and arteries collected for histological analysis and immunohistochemical staining. Protein expression of proliferating cell nuclear antigen (PCNA) and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) p65 of the vessel samples were analyzed using Western blotting. No difference existed in the baseline lesion characteristics or procedural results. Angiographic follow-up was successfully performed on 18 rabbits (TCB: n=20, PBA: n=16), except for 3 deaths related to the operation. Treatment with TCB was superior to that with PBA, with lower late lumen loss (0.45±0.23 vs. 0.84±0.17 mm, P<0.01). Pathological analysis confirmed the efficiency of TCB through decreasing the area stenosis rate compared with PBA (46.48%±8.22% vs. 75.24%±6.10%, P<0.01). As determined by Western blotting, significant reductions occurred in PCNA and NF-κB p65 protein intensity in the TCB group versus the PBA group (all P<0.01). TCB efficiently mitigated restenosis in the rabbit iliac artery model. This study elucidated that TCB could restrain intimal hyperplasia of vessels by inhibiting the activation of the NF-κB pathway to reduce inflammatory response and decrease the rate of cell proliferation through suppressing PCNA expression.

Impact of adjunctive use of guide extension catheter on midterm outcome of drug-coated balloon angioplasty.

Introduction The drug-coated balloon (DCB) is an attractive alternative to a drug-eluting stent (DES) for in-stent restenosis (ISR)1 and de novo small vessels2. However, the large profiles of DCBs make drug delivery to the lesion difficult. Because the additive effect of DCB over a plain balloon is derived only from the antiproliferative drug3, we hypothesised that the adjunctive use of a guide extension catheter (GEC) might enhance the efficacy of the DCB by preventing drug loss and improve the clinical outcomes. Methods This before-and-after cohort study included patients who underwent DCB angioplasty at Ogaki Municipal Hospital. ...

P4143IL-6 production in the vascular adventitia and adventitia-media-crosstalk in neointima formation

Abstract Background The aim of this study was to analyze the impact of the adventitial layer on vascular remodeling processes and to define the underlying cellular mechanisms. Methods and results Morphometric analysis of human coronary arteries and of murine femoral arteries at several times following vascular intervention revealed a significant correlation of neointimal and adventitial thickening (R2=0.6845, P&lt;0.001 for human samples; R2=0.6845, P&lt;0.001 for human samples. Immunohistochemical staining for the proliferation marker Ki-67 was performed 7, 14, and 21 days following injury of the murine femoral artery. Formation of a neointimal lesion at 21 days was preceded by high adventitial proliferation rates at 7 and 14 days (85.00±6.041 Ki67+adventitial cells vs. 5.118±0.633 Ki-67+neointimal cells at 7d, P&lt;0.0014; 28.80±5.240 Ki-67+adv. cells vs. 19.40±2.468 Ki-67+neoint. cells at 14d, P&lt;0.006, n=17). Complete removal of the adventitial layer prevented neointima formation, attributing pivotal importance to the adventitial layer (luminal stenosis: 71.73±3.77% vs. 7.44±1.71%, n=5, P&lt;0.0001). Re-transplantation of the aortic adventitia of ubiquitously GFP expressing C57BL/6-Tg (CAG-EGFP)1Osb/Jmice around the medial vascular layer of the femoral artery where the native adventitia has been removed completely restored neointima formation. Importantly, only very view GFP+cells were present in the neointimal layer, indicating that a direct contribution of adventitial cells to the neointimal lesion represents an extremely rare event. To investigate a potential paracrine effect of the activated adventitial layer, we explanted adventitial transplants 14 days following injury and transplantation and incubated the respective samples in serum-free media for 24 hours. BrdU incorporation assays and scratch wound assays revealed significantly increased proliferation and migration rates of human coronary artery SMCs in response to the supernatant of adventitial transplants compared to the supernatant of control samples. Further secretome analyses of the same adventitial supernatants identified predominantly interleukin (IL)-6 to trigger SMC proliferation and migration. Accordingly, serum-free media incubated with adventitial grafts of IL-6−/− mice prevented SMC proliferation and migration. Transplantation of the adventitia of IL-6−/− mice into C57BL/6J wild type mice was not sufficient to trigger neointima formation. Plain old balloon angioplasty, bare metal stent implantation, or drug-eluting stent implantation in swine coronary arteries and analysis for Ki-67+ cell counts supported the hypothesis in the large animal model and a more clinical setting. Conclusion Acute vascular injury is followed by an expansion of cytokine-producing adventitial cells, whose paracrine function and especially whose release of IL-6 is essential for the subsequent induction of the proliferation and migration of local SMC and thus for neointima formation.