Intravascular delivery of an MK2 inhibitory peptide to prevent restenosis after angioplasty.

Peripheral artery disease is commonly treated with balloon angioplasty, a procedure involving minimally invasive, transluminal insertion of a catheter to the site of stenosis, where a balloon is inflated to open the blockage, restoring blood flow. However, peripheral angioplasty has a high rate of restenosis, limiting long-term patency. Therefore, angioplasty is sometimes paired with delivery of cytotoxic drugs like paclitaxel to reduce neointimal tissue formation. We pursue intravascular drug delivery strategies that target the underlying cause of restenosis - intimal hyperplasia resulting from stress-induced vascular smooth muscle cell switching from the healthy contractile into a pathological synthetic phenotype. We have established MAPKAP kinase 2 (MK2) as a driver of this phenotype switch and seek to establish convective and contact transfer (coated balloon) methods for MK2 inhibitory peptide delivery to sites of angioplasty. Using a flow loop bioreactor, we showed MK2 inhibition in ex vivo arteries suppresses smooth muscle cell phenotype switching while preserving vessel contractility. A rat carotid artery balloon injury model demonstrated inhibition of intimal hyperplasia following MK2i coated balloon treatment in vivo. These studies establish both convective and drug coated balloon strategies as promising approaches for intravascular delivery of MK2 inhibitory formulations to improve efficacy of balloon angioplasty.

Dural arteriovenous fistula may be occluded through recanalization of impaired venous sinuses.

To investigate the effect and safety of recanalization of stenosed or occluded venous sinuses for dural arteriovenous fistulas (DAVFs) and possible mechanism of DAVF formation, patients with DAVF accompanied by venous sinus stenosis or occlusion treated with balloon angioplasty and/or stenting were retrospectively enrolled. The clinical data, treatment outcomes and complications were analyzed. In 7 patients enrolled, the DAVF was Cognard IIa grade in 3 (42.9% or 3/7) and IIa + b in 4 (57.1% or 4/7) patients, including complex DAVFs in 2 (28.6% or 2/7). The angioplasty procedure was successful in all (100%) patients, including complete cure in 3 (42.9% or 3/7) patients with the initial Cognard grade IIa, transformation from Cognard grade IIa + b to I in 2 (28.6% or 2/7) patients, and unchanged Cognard grade IIa + b in 2 (28.6% or 2/7) patients. The symptoms were all improved. At 3-month angiographic follow-up, 5 (71.4% or 5/7) cases were cured, whereas 2 cases still had grade I fistulas but no clinical symptoms. Staged embolization in 2 patients resulted in significant symptom improvement. At the last follow-up of a median 4 years, no clinical symptoms were present in 5 (71.4% or 5/7) patients, intermittent headache in 1 (14.3% or 1/7), and death from trauma in 1 (14.3% or 1/7). In conclusion, endovascular recanalization of occluded or stenosed venous sinuses using balloon angioplasty and stenting is able to induce occlusion of DAVFs and is a safe and efficient treatment approach for DAVFs which are possibly caused by significant pressure increase.

Successful dilation using a Non-Slip Element Percutaneous Transluminal Angioplasty Scoring Balloon to treat in-stent restenosis of carotid artery stenting with inadequate dilation during balloon angioplasty:A case report.

BACKGROUND: Carotid artery stenting (CAS) is commonly performed to treat internal carotid artery (ICA) stenosis;however, it is associated with high recurrence rates. The treatment of in-stent restenosis (ISR) following CAS poses several challenges, and percutaneous transluminal angioplasty (PTA) is a possible treatment option. Scoring balloons used in the cardiovascular field can prevent slipping and plaque incisions during balloon expansion;however, their efficacy in treating cervical ICA ISR remains uncertain. CASE DESCRIPTION: An 81-year-old man underwent CAS for carotid artery stenosis and subsequently developed ISR. Initial PTA with a noncompliant balloon failed to achieve sufficient dilation. However, the employment of a non-slip-element (NSE) PTA scoring balloon for additional expansion resulted in successful dilation, indicating its effectiveness in treating cervical ICA ISR. The patient was discharged postoperatively without any new neurological deficits, although magnetic resonance imaging revealed new ischemic lesions. CONCLUSION: The NSE PTA balloon could be considered as a valuable and effective treatment option for ISR when conventional balloon catheters face challenges in achieving dilation, although potential risks such as debris embolization should be considered. J. Med. Invest. 71 : 303-305, August, 2024.

Clinical outcomes of drug-coated balloons dilatation for benign esophageal stricture.

BACKGROUND: Drug-coated balloons (DCBs) angioplasty is safe and effective for coronary artery disease. However, DCBs dilatation for the treatment of benign esophageal strictures is rarely reported. PURPOSE: We aimed to report the clinical outcomes of DCBs dilatation for patients with benign esophageal strictures. METHODS: From May 2020 to August 2023, 18 patients underwent DCBs dilatation for benign esophageal strictures. Baseline demographics were recorded and evaluated, including gender, age, comorbidities, stricture diameter and length, dilatation session, complications. RESULTS: A total of 24 dilatation sessions of DCBs were performed, with a mean of 1.3 ± 0.6 sessions per patients (range 1.0-5.0). Dysphagia score decreased significantly after DCBs dilatation (2.6 ± 1.1 vs. 0.9 ± 1.3, p = 0.0002). Both stricture diameter and stricture index decreased significantly after DCBs dilatation (p < 0.0001). No procedure-related death, massive bleeding or esophageal perforation was observed during or after DCBs dilatation. Minor complications were found in only 3 patients (16.7%). All 18 patients were successfully followed up for a median period of 12.0 months. By the end of follow up, 10 patients showed no dysphagia, 6 patients showed mild dysphagia and 2 patients showed no improvement in dysphagia. The clinical success rate of DCBs dilatation is 88.9%. CONCLUSION: DCBs dilatation may be a safe, effective and feasible treatment for benign esophageal strictures, and can be utilized as an alternative option after standard dilatation has failed. Prospective studies with large samples are needed to further validate its clinical efficacy.

The Feasibility of Thrombolysis Followed with Ultrasound-Guided Percutaneous Transluminal Balloon Angioplasty in Acutely and Sub-Acutely Thrombosed Arteriovenous Fistulas.

INTRODUCTION: Prompt resolution of arteriovenous fistula (AVF) thrombosis is essential to minimize the need for temporary dialysis catheters. Identifying the ideal timing for the management of thrombosed arteriovenous fistula (AVF) is an area that has not been thoroughly explored. Herein, we examined a local infusion of urokinase for thrombolysis followed by ultrasound-guided percutaneous transluminal balloon angioplasty (PTA) in acute and subacute AVF thromboses. METHODS: This retrospective cohort research assessed thrombosed AVF in patients referred to the Second Xiangya Hospital. We included patients who underwent local thrombolysis followed by ultrasound-guided PTA treatment between January 1, 2018, and January 1, 2020.  Results. We enrolled the records of 86 patients into the present study, including 44 patients with acute AVF thrombosis (group 1: thrombus age, < 72 hours) and 42 patients with subacute AVF thrombosis (group2: thrombus age, 72 hours to seven days). The thrombolytic success rate was 79.5% in group 1 and 42.9% in group 2 (P < .001). All patients underwent ultrasound-guided PTA to dissolve any residual thrombi regardless of thrombolytic success. Technical success after PTA procedures was achieved in 93.2% of patients in group 1 and 88.1% in group 2 (P = .417). Primary patency at six months was comparable between the two groups (67.5% vs. 64.8%, P = .564). We observed that thrombolytic effect does not affect PTA success rate, and six-month patency rate. CONCLUSION: Direct local infusion of urokinase to the affected area followed by ultrasound-guided PTA constitutes a minimally invasive and effective method for salvaging thrombosed AVF in contrast to abandoning the occluded fistula.

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches.

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

Progressive increase in vascular access blood flow after percutaneous transluminal angioplasty in patients on hemodialysis.

Percutaneous transluminal angioplasty (PTA) is the gold standard for treating stenoses with dysfunctional vascular access. Recently, we found that vascular access blood flow (VABF) measured immediately after PTA increased over time without the need for additional procedures in the patients who underwent PTA. Therefore, this study was conducted to confirm an increase in VABF after PTA and identify the factors associated with it. Patients on chronic hemodialysis at a single institution were retrospectively reviewed and those with accesses that had a measurement of VABF immediately after PTA and within 1 month from PTA were included in the study. The relationship between clinical parameters and changes in VABF were analyzed using paired t-test and linear regression. A total of 47 PTA accesses (fistulas, 26; grafts,21) were included. The mean VABF on the day of PTA and the following measurement were 796.9 ±â€…329.1 mL/min and 1105.1 ±â€…410.3 mL/min, respectively. In the univariate analysis, the diameter of the balloon catheter used in the PTA and serum uric acid (SUA) level were significantly associated with an increase in VABF. Atrial fibrillation was a significant factor for the percentage change in vascular access. In the multivariate analysis, SUA level, balloon catheter diameter, and atrial fibrillation remained independent factors for changes in VABF and percentage change in VABF, respectively. The study identified progressive increases in the VABF after PTA without additional procedures. SUA level, balloon catheter diameter used in PTA, and atrial fibrillation were independently associated with changes in VABF.

Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial.

Importance: Previous randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial. Objective: To determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS. Design, Setting, and Participants: A randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023). Interventions: Submaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. Main Outcomes and Measures: The primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment. Results: Among 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 158 [31.5%] women) and completed the trial. The incidence of the primary outcome was lower in the balloon angioplasty group than the medical management group (4.4% vs 13.5%; hazard ratio, 0.32 [95% CI, 0.16-0.63]; P < .001). The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%. Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively. The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively. In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients. Conclusions and Relevance: In patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03703635.

Sustained efficacy of angioplasty for cerebral vasospasm after aneurysmal subarachnoid hemorrhage: Risk features and device comparison.

BACKGROUND: Cerebral vasospasm is a leading source of delayed morbidity and mortality after aneurysmal subarachnoid hemorrhage (aSAH). Angioplasty may improve vasospasm, while optimal target and device selection remains controversial. This study aimed to identify features and devices associated with sustained efficacy. METHODS: We identified consecutive patients who underwent angioplasty for aSAH vasospasm. The primary outcome was a composite of adequate angioplasty (residual narrowing < 50 %) without complications. Secondary outcomes included rates of refractory/recurrent vasospasm and sustained improvement at follow-up. Associated features were identified through multivariable analysis. Outcomes were compared between balloon and Comaneci/stentriever in a propensity-score-matched cohort. RESULTS: A total of 149 vasospastic segments underwent angioplasty: 61.7 % in the proximal anterior circulation (ICA, M1, A1), 20.1 % in distal segments (A2 and M2) and 18.1 % in the posterior circulation. Adequate angioplasty was achieved without complication in 83.2 % of vessels, with a sustainable effect in 84.3 % at follow-up. Refractory/recurrent vasospasm was observed in 17.4 %, yielding a 10.1 % retreatment rate. Notably, only 35.3 % of vessels undergoing inadequate angioplasty demonstrated improvement at follow-up. Angioplasty targeting distal MCA (adjusted OR, 0.10) or BA-V4 (aOR, 0.10), and inadequate angioplasty (aOR, 0.03) were unfavorable predictors for sustained improvement. Efficacy outcomes were similar between balloon and Comaneci/stentriever in a matched subgroup analysis. CONCLUSION: Angioplasty, when achieving residual narrowing < 50 %, demonstrated sustained improvement for vasospasm. Novel devices may exhibit comparable efficacy to balloon angioplasty for selected segments.

Clinical Outcomes of Non-Stent-Based Interventions for Symptomatic Below-the-Knee Peripheral Artery Disease in the Excellence in Peripheral Artery Disease (XLPAD) Registry.

For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization. A total of 566 patients underwent BTK and 494 BTK + FP interventions; 72% were men, with a mean age of 68.4 ± 10.9 years. Diabetes mellitus was more prevalent in the BTK-only group (76.5% vs 69%, p = 0.006). Mean Rutherford class was 4.2 ± 1.18; chronic limb-threatening ischemia was more frequent in the BTK group (55.3% vs 49%, p = 0.040). Moderate to severe calcification was more frequent in the BTK + FP group (21.2% vs 27.1%, p = 0.024), as was lesion length (110.6 ± 77.3 vs 135.4 ± 86.3 mm, p <0.001). Nearly 81% of lesions were treated with percutaneous transluminal angioplasty. Drug-coated balloon (1.6% vs 14%, p <0.001) and atherectomy (38% vs 58.5%, p <0.001) use was more frequent in the BTK + FP group. The rate of procedural success was higher in the BTK + FP group (86% vs 91%, p = 0.009), with amputation being the most common complication at 3.3% within 30 days after the procedure. The rates of 1-year MALE (21.2% vs 22.3%, p = 0.675) and mortality (4.6% vs 3.4%, p = 0.3) were similar between the BTK and BTK + FP groups. Nonstent treatment for BTK PAD with concomitant FP intervention leads to high procedural success and similar rates of 1-year MALE compared with isolated BTK intervention. Condensed Abstract: The vast majority of below-the-knee (BTK) peripheral artery disease (PAD) interventions are performed with balloon angioplasty. Presence of inflow femoropopliteal PAD in patients who undergo BTK interventions can affect the outcome of the procedure. This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK PAD and in patients who underwent an additional femoropopliteal PAD intervention.

ECG changes following balloon pulmonary angioplasty in patients with chronic thromboembolic pulmonary hypertension: a retrospective study.

PURPOSE: This research evaluates the effect of balloon pulmonary angioplasty (BPA) on cardiac electrophysiological changes in patients with chronic thromboembolic pulmonary hypertension (CTEPH). METHODS: Involving a retrospective analysis of 39 CTEPH patients (average age 61 ± 11), who had at least two BPAs and paired ECGs pre- and post-surgery, we examined changes in ECG indicators of right ventricular hypertrophy and their correlation with hemodynamic results. RESULTS: BPA yielded marked improvements in cardiac function and hemodynamics. ECG parameters, specifically the Lewis criteria and Butler-Leggett score, correlated strongly with hemodynamics and were predictive of a mean pulmonary arterial pressure (mPAP) ≥ 35mmHg. Notably, QRS complex axis normalization was observed in 25 patients, with 14 fully normalizing (range - 30° to + 90°). The qR pattern in V1 vanished in 9 cases, and 75% of the patients in qR pattern in V1 group had QRS complex electrical axis completely returned to normal range. The qR V1 group had higher mPAP and pulmonary vascular resistance (PVR), and lower cardiac output and index compared to the non-qR V1 group, alongside a higher Butler-Leggett score. CONCLUSIONS: BPA enhances cardiac function and hemodynamics in CTEPH patients, with certain ECG measures such as Lewis criteria and Butler-Leggett score reflecting the severity of hemodynamic impairment. The reversal of QRS axis deviation and the disappearance of the qR pattern in lead V1 may serve as valuable indicators for assessing post-BPA satisfaction in CTEPH patients.

Benefits and Challenges of Drug-Coated Balloons in Peripheral Artery Disease: From Molecular Mechanisms to Clinical Practice.

Multiple clinical trials have reported favorable outcomes after drug-coated balloon therapy for peripheral artery disease in above-the-knee and below-the-knee lesions and in both de novo and in-stent restenosis. However, there are still insufficient data to identify and tackle the risk factors associated with a higher risk of restenosis, which is the primary concern for patients who are treated with an endovascular approach. A modern armamentarium, which includes improved lesion preparation techniques such as plaque modification balloons, mechanical atherectomy, intravascular lithotripsy, and imaging, is crucial for obtaining better long-term clinical outcomes. Moreover, a better understanding of the molecular properties of drug-coated balloons has led to improved devices that could tackle the shortcomings of previous generations. This comprehensive review focuses on drug-coated balloon technology as a tool to treat peripheral artery disease and the effects of the molecular mechanisms involved in preventing vascular restenosis.

Current surgical management of chronic thromboembolic pulmonary disease.

Chronic thromboembolic pulmonary disease (CTEPD) with or without pulmonary hypertension (PH) is an important potential consequence of venous thromboembolic disease. Untreated CTEPD with pulmonary hypertension (CTEPH) is associated with high rates of morbidity and mortality. Several treatment options are now available for patients with CTEPD and CTEPH, including pulmonary endarterectomy (PEA), balloon pulmonary angioplasty, medical therapy or a combination of therapies. Choice of treatment depends on the location of the thromboembolic disease burden, presence and severity of PH and patient factors, including frailty, parenchymal lung disease and other comorbidities. PEA is a complex surgery that can result in excellent outcomes and resolution of disease, but also comes with the risk of serious perioperative complications. This manuscript examines the history of PEA and its place in Australasia, and reports on outcomes from the main Australasian CTEPH expert centre. It provides a summary of up-to-date guidance on how PEA should be utilised in the overall management of these patients and describes opportunities and challenges for the future diagnosis and management of this disease, particularly in the Australasian setting.

Long-term clinical efficacy of drug-coated balloon angioplasty for TASCII C/D femoropopliteal lesions in older patients with chronic limb-threatening ischemia: A retrospective study.

This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.

Differential effects of balloon pulmonary angioplasty on chronic thromboembolic pulmonary disease.

BACKGROUND: Decreased diffusing capacity of the lungs for carbon monoxide (DLco) is associated with microvascular damage in chronic thromboembolic pulmonary hypertension (CTEPH). Balloon pulmonary angioplasty (BPA) is an effective treatment for CTEPH, but the efficacy of BPA in patients with CTEPH with low DLco remains unclear because BPA does not directly address microvascular damage. This study investigates the influence of microvasculopathy on BPA in CTEPH according to DLco. METHODS: We retrospectively analysed data from patients with inoperable CTEPH who underwent BPA at the University of Tokyo Hospital from July 2011 to August 2023. The patients were classified into two groups based on their preprocedural DLco (normal DLco (ND) and low DLco (LD) groups), with a DLco cut-off value of 80%. We compared the patient characteristics and effectiveness of BPA between the groups. RESULTS: Among the 75 patients, 36 were in the LD group. The LD group had a shorter 6-minute walking distance (324±91 vs 427±114 m) than the ND group but the mean pulmonary artery pressure (mPAP) was similar (38.9±7.3 vs 41.1±9.2 mm Hg) before BPA. BPA improved the haemodynamic status and exercise tolerance in both groups. The LD group exhibited a higher mPAP (25.1±7.4 vs 21.5±5.6 mm Hg) and required more sessions of BPA (median 6 vs 4). Based on the analysis of covariance adjusted for baseline values, low DLco significantly correlated with mPAP (sß=-0.304, 95% CI -7.015 to -1.132, p=0.007) and pulmonary vascular resistance (sß=-0.324, 95% CI -141.0 to -29.81, p=0.003). CONCLUSIONS: BPA was associated with an improvement in the haemodynamic status and exercise tolerance in patients with CTEPH even with low DLco. However, low DLco may attenuate the effect of BPA on mPAP and pulmonary vascular resistance and require more treatment sessions.

Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial.

This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease. Clinicaltrials.gov Registration:NCT01858428.

Feasibility of revascularization after gelatin sponge embolization for hemoptysis during balloon pulmonary angioplasty.

BACKGROUND: Vessel injury is a common complication during balloon pulmonary angioplasty (BPA). For persistent hemoptysis, gelatin sponge embolization (GSE) is considered, but its impact on subsequent perfusion in embolized vessels remains unknown. This study explores the feasibility of revascularization in vessels post-GSE. METHODS: We included 64 vessels from 50 patients with chronic thromboembolic pulmonary hypertension who experienced hemoptysis during BPA in 2012-2023. Twenty-four vessels were treated conservatively (conservative group), while 40 were treated with GSE for persistent hemoptysis or desaturation despite conservative treatment (GSE group). We assessed hemoptysis-related parameters, perfusion of injured vessels pre- and post-treatment, and hemodynamic parameters through multiple BPA sessions. RESULTS: Hemoptysis resolved immediately after the procedure in 67% of patients, including 70% of those in the GSE group, and all cases resolved by the next day. Of 37 embolized vessels, 41% showed spontaneous perfusion improvement in subsequent sessions. BPA was reperformed in 22 embolized vessels, with 86% showing further improvement, resulting in 70% of all embolized vessels finally showing improvement in perfusion. In both groups, clinical and hemodynamic parameters significantly improved after BPA. CONCLUSIONS: Perfusion of embolized vessels improved after GSE, suggesting that GSE is safe for the treatment of severe persistent hemoptysis after conservative treatment.