Standard Angioplasty Research Articles

Phase 1 study to evaluate safety and preliminary efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in patients with locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC).

TPS4204 Background: Pancreatic cancer is the third most common cause of cancer death. Surgery offers the best survival rates however only a minority of patients are eligible. Approximately 15-20% of patients are deemed unresectable due to vascular involvement LA. Conversion of unresectable tumors, due to vascular involvement to resectable, is an unmet clinical need. Methods: A novel approach was developed to destroy the tumor encasing the artery combining padeliporfin, a photosensitive drug, locally activated by laser light illumination. The effectiveness of the strategy was confirmed in an orthotopic mouse model. A proof-of-concept study using 12 non-tumor pigs demonstrated an acceptable safety profile. A phase I dose escalation trial (NCT5918783) will be performed to evaluate the safety and maximal tolerated dose (MTD) of laser light dose of padeliporfin VTP. VTP will be delivered through an endovascular fiber integrated in a standard angioplasty balloon. The balloon will be advanced under fluoroscopy to the encased vascular segment of the superior mesenteric artery (SMA) and inflated. Following IV administration of padeliporfin, it will be activated by the laser light. Part A will be a classic 3+3 dose-escalation design to determine the MTD of laser light. The identified MTD will be applied in the Part B for preliminary efficacy evaluation. The primary objectives are to determine safety and MTD and/or recommended phase 2 laser light dose of VTP treatment. Secondary objectives are: rate of surgical conversion; evaluation of the pattern of disease progression (local regional and/or metastatic disease) after VTP based on CT. Standard of care surgery can be performed after 14 days post VTP. Key inclusion criteria: patients with histologically/cytologically confirmed stage III unresectable LA-PDAC in the head/uncinate process of the pancreas, with SMA solid tumor contact ˃180° with measurable disease per RECIST 1.1 and ECOG 0-1. Key exclusion criteria: metastatic disease, other malignancy, photosensitive skin diseases or porphyria, concurrent investigational therapy within past 30 days, medically uncontrolled moderate or severe ascites, previous radiation to pancreas, SMA variants. Recruitment begins in April 2024. Conversion of unresectable locally advanced pancreatic cancer to surgery is a critical unmet need. This phase I trial explores a novel approach to treat the tumor encasement enabling surgery. Clinical trial information: NCT5918783 .

Stand-Alone Rotational Atherectomy Versus Combination With Drug-Coated Balloon Angioplasty for the Endovascular Treatment of Heavily-Calcified Femoropopliteal and Popliteal Lesions.

Despite major technical advances in the endovascular treatment for peripheral artery disease (PAD), heavy calcification still represents a major obstacle to overcome both due to the high number of periprocedural complications (dissections, embolization, etc) and the limited long-term durability. A promising tool to overcome these obstacles is debulking calcified lesions with atherectomy. Since vessel preparation with atherectomy might even improve the diffusion of antiproliferative substances, we wanted to evaluate the impact of atherectomy±DCB in lower extremity PAD. To explore the safety, efficacy, and long-term durability on treatment of rotational atherectomy in heavily-calcified complex femoropopliteal and isolated popliteal lesions. In addition, we wanted to investigate whether advanced debulking strategies where atherectomy is followed by a drug-coated angioplasty bear an additional advantage over atherectomy and standard percutaneous angioplasty alone in terms of clinical success and freedom from target lesion revascularization. In total, 218 femoropopliteal and 46 popliteal predominantly heavily-calcified lesions have been investigated. Of 264 cases, in a total of 53 cases, atherectomy treatment was followed by a drug-eluting balloon (DEB) angioplasty (43 in the femoropopliteal and 10 in the popliteal lesions). The lesions were characterized by a significant length (17.3±12.1 cm) and complexity (TASC C in 48.4% and TASC D in 19.7%). During a mean follow-up of 19 (±11) months, a total of 12 patients (4.5%) died. Clinically-driven target lesion revascularization (CD-TLR) was performed in 32 (14.7%) femoropopliteal and 11 isolated popliteal (23.9%) lesions and did not differ significantly between stand-alone atherectomy and atherectomy followed by a DEB. Mean ABI was improved from 0.57±0.22 immediately before intervention to 0.86±0.23 on intervention and remained stable: 0.83±0.16 at follow-up. During follow-up, a mean Rutherford category was reduced from 3.64±1.0 to 2.38±0.98. Our real-life study provides evidence that atherectomy in combination with DEB is safe and effective but did not have a significant impact on the freedom from target lesion revascularization in our population. Additional large-scale randomized trials are needed to verify these findings. This study investigates the efficacy and safety of combining rotational atherectomy with drug-coated balloon (DCB) angioplasty for treating heavily calcified femoropopliteal and isolated popliteal lesions in peripheral artery disease (PAD). The retrospective analysis of 264 patients highlights the potential of this combination in improving procedural success and reducing periinterventional complications. While demonstrating an excellent procedural and clinical success rate over an average 19-month follow-up, the study finds no significant long-term benefit in freedom from target lesion revascularization (TLR) compared to atherectomy alone. These findings suggest the need for further research to optimize treatment strategies for complex PAD cases, particularly in evaluating the long-term clinical benefits of such combined interventions.

Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae.

to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae. consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure. The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas. APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated. APERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.

IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

PurposeTo present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. Materials and MethodsParticipants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit. ResultsTLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71). ConclusionsThis study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.

Safety Evaluation of Primary Carotid Stenting: Transcranial Doppler and MRI.

Cerebral emboli are generated by every step of standard carotid angioplasty and stenting. Primary carotid stenting (PCS) is a technique in which the use of balloon angioplasty (BA) is minimized to decrease the embolic load. The primary aim of this study is to establish the number of emboli generated by each step of primary stenting and determine the relationship to new diffusion (DWI) lesions on subsequent magnetic resonance imaging (MRI). Eighty-five patients with severe, symptomatic carotid stenosis were prospectively recruited and underwent carotid stenting. Intraoperative transcranial Doppler was performed in 77 patients. The number and size of microemboli for each of seven procedural steps were recorded. Correlation was made with the number and location of new DWI lesions. PCS was performed in 73 patients. BA was required in 12 patients. The mean number of microemboli was 114, and most microemboli were generated by stent deployment, followed by BA. Balloon techniques generated significantly more emboli than primary stenting (p = 0.017). There was a significant relationship between total microemboli and new DWI lesions (p = 0.009), and between new DWI lesions in multiple territories and the severity of pretreatment stenosis (p = 0.002). During PCS, more emboli are generated by stent deployment than during any other stage of the procedure. When BA is necessary, more malignant emboli are generated but total emboli are unchanged and there is no difference in new diffusion lesions on MRI. PCS is safe and is not inferior to historical controls for the generation of new DWI lesions.

Clinical outcomes of endovascular therapy with vascular stents for central venous obstruction in hemodialysis patients

BackgroundSymptomatic central venous obstruction (CVO) is sometimes observed in patients undergoing hemodialysis. Angioplasty is generally performed for salvage purposes, and stent implantation is performed as a last resort to prevent permanent venous occlusion. However, published reports about the clinical outcomes of stenting for CVO have been limited by the small number of included patients and the relatively old generation of analyzed stents. This study aimed to clarify the safety and efficacy of endovascular therapy (EVT) using stents for symptomatic CVO in contemporary practice. MethodsThis retrospective review was performed between May 2012 and August 2021. We retrospectively analyzed consecutive 31 lesions (31 patients, 64 ± 10.7 years old) treated with a vascular stent for elastic recoil after balloon angioplasty or recurrent stenosis <3 months after angioplasty. The primary outcome was primary patency, defined as freedom from target lesion revascularization. The secondary outcome was assisted primary patency, defined as freedom from permanent occlusion of the target stents. ResultsIn all cases, stents were successfully deployed on the target lesions. No EVT-related complications were observed. Self-expandable and balloon-expandable stents were used in 26 and 5 lesions, respectively. The median follow-up period was 18 months (interquartile range, 7–40). Kaplan-Meier analysis revealed that the primary patency rates were 66.1 % at 6 months, 61.7 % at 12 months, and 38.4 % at 24 months after EVT. The assisted primary patency rate was 70.3 % 24 months after EVT. In the multivariate analysis, younger age was the only independent predictor of target lesion revascularization (hazard ratio: 0.92, 95 % CI: 0.85–0.99, p = 0.04). ConclusionsStent implantation for CVO that is resistant to standard angioplasty seems safe and effective.

Real-world Experience With Drug-coated Balloon Angioplasty in Dysfunctional Arteriovenous Fistulae

Recent randomized trial data comparing drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (sPTA) in stenotic lesions of dysfunctional, autogenous arteriovenous fistulas has demonstrated the superiority of drug-coated devices. Strict limitations in terms of lesion type, size, length, comorbidity and location, however (as is common for randomized trials), make the results less applicable to real-world patients. The objective of this study was to evaluate the efficacy of DCB compared with sPTA for dysfunctional arteriovenous fistulae, including non-de-novo lesions and the presence of stents within the circuit.

IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae. Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated. ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48. ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.

Endovascular Management of Thrombosed Dialysis Vascular Circuits.

A functional hemodialysis vascular access is the lifeline for patients with end-stage kidney disease and is considered a major determinant of survival and quality of life in this patient population. Hemodialysis therapy can be performed via arteriovenous fistulas, arteriovenous grafts, and central venous catheters (CVCs). Following dialysis vascular access creation, the interplay between several pathologic mechanisms can lead to vascular luminal obstruction due to neointimal hyperplasia with subsequent stenosis, stasis, and eventually access thrombosis. Restoration of the blood flow in the vascular access circuit via thrombectomy is crucial to avoid the use of CVCs and to prolong the life span of the vascular access conduits. The fundamental principles of thrombectomy center around removing the thrombus from the thrombosed access and treating the underlying culprit vascular stenosis. Several endovascular devices have been utilized to perform mechanical thrombectomy and have shown comparable outcomes. Standard angioplasty balloons remain the cornerstone for the treatment of stenotic vascular lesions. The utility of drug-coated balloons in dialysis vascular access remains unsettled due to conflicting results from randomized clinical trials. Stent grafts are used to treat resistant and recurrent stenotic lesions and to control extravasation from a ruptured vessel that is not controlled by conservative measures. Overall, endovascular thrombectomy is the preferred modality of treatment for the thrombosed dialysis vascular conduits.

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 12months, assessments included freedom from major adverse events (i.e., target lesion revascularization, major amputations, or death within 1month 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 ± 44.0mm and 84.0 ± 56.8mm 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 12months (log-rank p = 0.2134). Japanese patients treated with Ranger DCB maintained a high patency rate through 12months and a low re-intervention rate.Trial registration clinicaltrials.gov identifier: NCT03064126.

An unusual complication due to a standard coronary angioplasty procedure: Intramyocardial dissecting hematoma.

An unusual complication due to a standard coronary angioplasty procedure: Intramyocardial dissecting hematoma.

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1month of the index procedure), and patient outcomes were analyzed. Mean lesion length was 82.5 ± 48.9mm for the Ranger DCB group (n=278) and 79.9 ± 49.3mm for the control group (n=98). Ranger DCB was superior to PTA (82.9% [n=194 of 234] vs. 66.3% [n=57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p=0.0013). Noninferior freedom from major adverse events (94.1% [n=241 of 256] vs. 83.5% [n=76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p<0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p=0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).

Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

BackgroundPaclitaxel drug‐coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow‐up have raised uncertainty regarding long‐term mortality.ObjectivesTo evaluate the effect of paclitaxel exposure on the long‐term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.MethodsThe IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long‐term safety, sites were requested to obtain vital status follow‐up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD‐TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.ResultsThe rate of long‐term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log‐rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD‐TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.ConclusionsIn pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.

Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas

BackgroundStandard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes.MethodsIn this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data.ResultsA total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points; 95% CI, −5.5 to 5.0; P=0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses.ConclusionsDrug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.)

The Technique of Eversion Endarterectomy of the Common Femoral Artery

We provide a video depiction of the eversion technique when applied to the femoral endarterectomy. The eversion technique has comparable outcomes to the standard patch angioplasty femoral endarterectomy, and has several advantages, including eliminating the use of patch material.

Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis

The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39–2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39–1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83–9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90–8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23–2.75). No statistically significant differences were found. Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA.

The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes

ObjectivesThe goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial. BackgroundInitial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population. MethodsIN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile. ResultsFreedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. ConclusionsTibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733)

Standardisation of Technique and Volume of Iodinated Contrast Administration During Infrainguinal Angioplasty.

Acute Kidney injury is recognised to occur after administration of iodinated contrast during endovascular interventions for peripheral arterial disease. There are no standardised protocols for contrast delivery during infrainguinal angiography. The objective of this paper is to review published practice regarding the technique of conventional infrainguinal angiography and intervention, and describe a standard set of subtraction views, injection rates and contrast volumes for infrainguinal angioplasty. Database searches and review of papers containing (Angioplasty or Angiography) and ("lower limb" or peripheral or infrainguinal) and (method or technique or guidelines or protocol) was performed and defined procedures assessed. A small number of papers provided specific technical details relating to contrast volumes and angiography views. There was considerable variation from authors who have described the contrast volumes used for lower limb angiography. We describe our simple and consistent method. The precise pathophysiology of contrast related nephropathy is under scrutiny. There is interest in new technology to minimise contrast induced kidney injury. Few publications specify iodinated contrast doses, injection volumes or imaging views for infrainguinal arteriography. Standard infrainguinal angioplasty can be performed with conventional equipment using relatively small volumes of contrast by following a systematic technique.

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.