Paclitaxel-coated Balloon Research Articles

Smooth muscle cell-targeted RNA ligand promotes accelerated reendothelialization in a swine peripheral injury model

The local delivery of antiproliferative agents to inhibit neointimal growth is not specific to vascular smooth muscle cells (VSMC) and delays reendothelialization and vascular healing. This investigation was intended to evaluate the effect of luminal delivery of a VSMC-specific aptamer on endothelial healing. The impact of an RNA aptamer (Apt 14) was first examined on the migration and proliferation of primary cultured porcine aortic endothelial cells (ECs) in response to invitro scratch wound injury. We further evaluated the impact of Apt 14 on reendothelialization when delivered locally in a swine iliofemoral injury model. Although Apt 14 did not affect EC migration and proliferation, invitro results confirmed that paclitaxel significantly inhibited EC migration and proliferation. En face scanning electron microscopy demonstrated confluent endothelium with elongated EC morphology in Apt 14-treated arteries 14 and 28days post-treatment. In contrast, vessels treated with paclitaxel-coated balloons displayed a cobblestone morphology and significant platelet and fibrin attachment at cell junctions. These results provide the first evidence of the efficacy of a cell-targeted RNA aptamer to facilitate endothelial healing in a clinically relevant large animal model.

Endovascular treatment of re-stenotic iliac artery stents with drug-eluting balloons.

To evaluate the results of revascularization of stenotic iliac stents using drug-eluting balloons (DEBs). Seventy-four patients with various levels of iliac stent restenosis were enrolled to study. All restenotic stents were treated using paclitaxel-coated balloons. Through a follow-up median period of 24months (4-24months), there were no in-stent re-restenosis in 55 patients (74.3%) and there was one in class 1 (1.4%), four in class 2 (5.4%), and fourteen in class 3 (18.9%). We conclude that; DEBs can be used for restenotic iliac artery stents for some Type C and D lesions, in addition to Types A and B with satisfacting results.

Treatment of Peripheral Artery Disease Using Injectable Biomaterials and Drug-Coated Balloons: Safety and Efficacy Perspective.

The possibility of injectable biomaterials being used in the therapy of peripheral artery disease (PAD) is investigated in this article. We conducted a thorough review of the literature on the use and efficacy of biomaterials (BMs) and drug-coated balloons (DCBs). These BMs included hydrogels, collagen scaffolds, and nanoparticles. These BMs could be used alone or in combination with growth factors, stem cells, or gene therapy. The treatment of peripheral artery disease with DCBs is increasingly common in the field of interventional angiology. Studies have been carried out to examine the effectiveness of paclitaxel-coated balloons such as PaccocathTM in lowering the frequency with which further revascularization operations are required. PCB angioplasty and angioplasty without paclitaxel did not significantly vary in terms of mortality, according to the findings of a recent meta-analysis that included the results of four randomized controlled studies. On the other hand, age was found to be a factor that predicted mortality. There was a correlation between the routine utilization of scoring balloon angioplasty along with DCBs and improved clinical outcomes in de novo lesions. In both preclinical and clinical testing, the SelutionTM DCB has demonstrated efficacy and safety, but further research is required to determine whether or not it is effective and safe over the long term. In addition, we reviewed the difficulties involved in bringing injectable BMs-based medicines to clinical trials, including the approval processes required by regulatory bodies. Injectable BMs have a significant amount of therapeutic promise for PAD, which highlights the need for more research and clinical studies to be conducted in this field. In conclusion, this research focuses on the potential of injectable BMs and DCBs in the treatment of PAD as well as the hurdles that must be overcome in order to translate these treatments into clinical trials. In this particular field, there is a demand for further research as well as clinical trials.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval

ABSTRACT Objectives Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. Methods Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). Results Fifty-two subjects were enrolled, 69% men, median age 69 (49–83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (−0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. Conclusion The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Safety and Efficacy of a Hybrid Approach Combining a Paclitaxel-Coated Balloon With a New Generation Drug-Eluting Stent in Patients With De Novo True Coronary Bifurcation Lesions

BackgroundThe use of drug-coated balloon in the management of true bifurcation lesions appears to be an attractive option to reduce the rate of stent thrombosis and restenosis particularly at the level of the side branch ostium. We aim to assess the safety and the efficacy of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon to treat the side branch ostium in patients with de novo true bifurcation. MethodsFrom September 2020 to March 2022, 45 patients with a de novo true bifurcation lesion Medina (1.1.1) or Medina (0.1.1) were enrolled. All patients underwent a percutaneous coronary intervention with the hybrid approach. Clinical assessment with functional stress imaging test was scheduled at 6 months. In case of documented ischemia, coronary angiography was performed. The primary endpoint was the composite of target lesion failure at 6 months including cardiac death, target vessel MI or ischemia-driven target lesion revascularization. The secondary endpoints were technical success, defined by performing the percutaneous coronary intervention without an additional drug-eluting stent at the level of the side branch ostium, and clinical success, defined by a technical success associated with the absence of severe complications during in-hospital phase. ResultsThe immediate results show a technical success of the procedure in the majority of cases (88.9 %) with a low rate of bailout side branch stenting (11.1 %). The clinical success was obtained in 86.7 % and only one patient experienced a severe in-hospital complication. A side branch ostial lesion length > 10 mm was the only independent predictor of clinical failure of the procedure (OR 12.49, 95 % CI 1.17–133.6; p = 0.037). At 6 months, the TLF was low and occurred in 1 patient (2.2 %). No cardiac death was observed. No TVMI was observed. Importantly, at 6 months, no side branch thrombosis was observed. ConclusionThe use of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon in the side branch to treat true bifurcation lesions appears to be safe and efficient with few immediate complications and with satisfactory results at mid-term follow up.

PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III

You have accessJournal of UrologyCME1 Apr 2023PD35-08 4 YEARS OF THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III Rachel Mann, Jessica Delong, Ramon Virasoro, and Sean Elliott Rachel MannRachel Mann More articles by this author , Jessica DelongJessica Delong More articles by this author , Ramon VirasoroRamon Virasoro More articles by this author , and Sean ElliottSean Elliott More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003333.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Optilume Drug Coated Balloon has been studied in three clinical investigations (ROBUST I, II and III). ROBUST I was the first in man trial conducted as a single arm, prospective multicenter study in Latin America (4 sites, 53 subjects) followed by ROBUST II assessing early feasibility (5 sites, 15 subjects), and ROBUST III, the randomized pivotal trial (79 Optilume). Optilume data combined from all three studies are presented here. METHODS: A total of 148 subjects were treated with Optilume in ROBUST I, II and III in Latin America, Canada, and the United States. Men with strictures ≤ 3cm and 1-4 prior endoscopic interventions were treated with Optilume. Follow-up was completed at 3 months, 6 months and annually thereafter. All studies were designed to follow subjects through 5 years with Robust I at 4-year follow-up, Robust II at 3-year follow-up and Robust III at 2-year follow-up, currently. Outcomes included International Prostate Symptom Score (IPSS), quality of life, freedom from reintervention, erectile function, flow rate, and post-void residual volume. Subjects receiving secondary treatment were considered failures. The safety endpoint assessed serious urinary events. RESULTS: At the time of this abstract submission, IPSS improved in all patients treated with Optilume from 22.5 at baseline to 7.8 at 4 years. Peak urinary flow rate (Qmax) had a sharp improvement and was sustained through follow-up in all trials (7.1 to 14). Freedom from repeat intervention is approximately 73% at 4 year follow-up (Figure 1). Results will be updated at the time of the presentation. CONCLUSIONS: Subjects with recurrent bulbar strictures treated with Optilume® paclitaxel-coated balloon exhibited significant improvement in symptomatic and functional outcomes through 4 years post treatment with demonstrably improved recurrence rates. There was no impact on erectile function and there were no serious adverse events. Source of Funding: Urotronic © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e977 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rachel Mann More articles by this author Jessica Delong More articles by this author Ramon Virasoro More articles by this author Sean Elliott More articles by this author Expand All Advertisement PDF downloadLoading ...

Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels.

We retrospectively examined the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo stenosis in large coronary vessels (LV; pre- or postprocedural reference vessel diameter ≥ 2.75 mm) in comparison with placement of drug-eluting stents (DESs).Consecutive de novo stenotic lesions in the LV electively and successfully treated with either PCB (n = 73) or DESs (n = 81) from January 2016 to December 2018 at our center were included. The primary endpoint was the incidence of target lesion failure (TLF), including cardiac death, nonfatal myocardial infarction, and target vessel revascularization. The impact of PCB on TLF was examined using Cox proportional hazards models by including 39 variables. The secondary endpoint, angiographic restenosis, defined as a follow-up percent diameter stenosis > 50, was examined in angiographic follow-up lesions after PCB angioplasty (n = 56) and DES placement (n = 53). This retrospective investigation was conducted in July 2022.The mean PCB size and length were 3.23 ± 0.42 and 18.4 ± 4.3 mm, respectively. The TLF frequency in the PCB group (6.8% during the mean observational interval of 1536 ± 538 days) was not significantly different from that in the DES group (14.6%, 1344 ± 606 days, P = 0.097). PCB was not a significant predictor of TLF in the univariate analysis (hazard ratio: 0.424; 95%CI: 0.15-1.21; P = 0.108). There was no angiographic restenosis after PCB angioplasty.The present observational single-center study showed that PCB for de novo stenosis in the LV had no significant adverse impact on TLF and had favorable angiographic outcomes.

Paclitaxel exerts antiplatelet and antithrombotic activities: Additional benefit from use of paclitaxel-coated balloons and -eluting stents in coronary revascularization and prevention of in-stent restenosis

IntroductionPaclitaxel is a microtubule-stabilizing drug used to treat several types of cancer, including ovarian and breast cancer. Because of its antiproliferative effect on vascular smooth muscle cells, balloons and stents are coated with paclitaxel for use in coronary revascularization and prevention of in-stent restenosis (ISR). However, mechanisms underlying ISR are complicated. Platelet activation is one of the major causes of ISR after percutaneous coronary intervention. Although the antiplatelet activity of paclitaxel was noted in rabbit platelets, the effect of paclitaxel on platelets remains unclear. This study investigated whether paclitaxel exhibits antiplatelet activity in human platelets. Methods and resultsPaclitaxel inhibited platelet aggregation induced by collagen but not that induced by thrombin, arachidonic acid, or U46619, suggesting that paclitaxel is more sensitive to the inhibition of collagen-induced platelet activation. Moreover, paclitaxel blocked collagen receptor glycoprotein (GP) VI downstream signaling molecules, including Lyn, Fyn, PLCγ2, PKC, Akt, and MAPKs. However, paclitaxel did not directly bind to GPVI and cause GPVI shedding, as detected by surface plasmon resonance and flow cytometry, respectively, indicating that paclitaxel may interfere with GPVI downstream signaling molecules, such as Lyn and Fyn. Paclitaxel also prevented granule release and GPIIbIIIa activation induced by collagen and low convulxin doses. Moreover, paclitaxel attenuated pulmonary thrombosis and delayed platelet thrombus formation in mesenteric microvessels without significantly affecting hemostasis. ConclusionPaclitaxel exerts antiplatelet and antithrombotic effects. Thus, paclitaxel may provide additional benefits beyond its antiproliferative effect when used in drug-coated balloons and drug-eluting stents for coronary revascularization and prevention of ISR.

Differences in Biologic Drug Effects and Distal Particulate Embolization in Three Paclitaxel-Coated Balloons for Femoropopliteal Lesions in a Rabbit Model

Background: A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix]). Methods and Results: The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745–2170] pmol/mg vs 638 [160–2075] pmol/mg vs 25 [10–304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0–20.4] degree vs 1.4 [1.2–5.2] degree vs 0.8 [0.5–2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1–58] pmol/mg vs 15 [13–21] pmol/mg vs 42 [19–108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3–4] vs 4 [3–7] vs 2 [1–2], respectively), which was consistent with the measured tissue paclitaxel concentrations. Conclusion: These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact: The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia.

Superficial Femoral Artery in-Stent Restenosis Treated with Paclitaxel-Coated Balloon Angioplasty - Results of Three-Year Follow-Up.

In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. Investigate the 3year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. 105 patients were included. Two patients had technical failure and required an additional stent, and were thus excluded. 103 patients were analyzed. Primary patency was 91.26, 80.47, and 67.71%, respectively, in the first, second, and third year after the procedure. There were no deaths 30days after the procedure. There were no major amputations during the 3year follow-up. Paclitaxel-coated balloon angioplasty with the Lutonix™ 035 device was a safe and effective treatment to superficial femoral artery in-stent restenoses. The results were maintained along the 3year follow-up.

Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world.

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.

The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report. There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05. Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window. JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms. NCT03206762.

Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study

The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions. BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2-4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12months. We enrolled 158 patients with 158 lesions. Mean age was 67.6±9.6years, diabetes was present in 53.8% (n=85), and previous peripheral intervention/surgeries in 17.1% (n=27). Lesions were 4.1±0.9mm in diameter and 74±50mm long with a mean diameter stenosis of 91±13%; 58.2% (n=92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30days, consisting of 1 target lesion revascularization. At 12months, binary restenosis was present in 18.7% (n=26) and target lesion revascularization was performed in 1.4% (n=2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12months, defined as improvement of at least 1 Rutherford class, was 95.3% (n=130). The median walking distance per 6-minute walk test was 279m at baseline and improved by 50m at 30days and by 60m at 12months; the visual analogue scale changed from 76.6±15.6 at baseline to 80.0±15.0 at 30days and 78.6±14.6 at 12months. Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).

A retrospective study from a single center to compare outcomes in 79 patients with in-stent restenosis treated with paclitaxel-coated balloon angioplasty or drug-eluting stent implantation

BackgroundDespite the recent progress made in drug-eluting stents (DESs), in-stent restenosis (ISR) is still a common complication of percutaneous coronary interventions. This retrospective study from a single center aimed to compare outcomes in 79 patients with ISR treated with paclitaxel-coated balloon (PCB) angioplasty or DES implantation.ResultsFrom January 2017 to December 2021, 83 ISR lesions from 79 patients were included. Thirty-two were treated with PCB and 51 treated with available DES in the catheterization laboratory. Baseline characteristics were similar in both groups. Mean time between index angioplasty and restenosis was 27 months with a minimum of 4 months and a maximum of 70 months. Concerning Mehran ISR angiographic classification, classes II and III were more likely treated with DES. Stenosis diameter and minimal lumen diameter (MLD) were similar in both groups. PCB used was significantly shorter than DES: Mean length was 19.75 ± 5.7 versus 22.1 ± 16.5 (p < 0.001), respectively. Angiographic results immediately after intervention were similar in both groups: In-segment MLD after the procedure was 2.5 ± 0.4 in the DES group and 2.26 ± 0.55 in the PCB group. A median follow-up of 20 months was achieved for 68 patients, and 11 were lost to follow-up. There was also no difference in both groups regarding free from events survival.ConclusionsThe findings from this study support recent international studies that have shown no significant differences between DES and PCB and in-stent restenosis. This suggests that PCB use is an option to consider in our local daily practice.

Early-phase restenosis following directional coronary atherectomy and paclitaxel-coated balloon angioplasty: a histopathological analysis.

A 58-year-old man with hypertension and dyslipidaemia was hospitalized for angina pectoris. He underwent directional coronary atherectomy (DCA) followed by dilatation with a 3.5 × 15 mm paclitaxel-coated balloon (PCB) for severe stenosis in the proximal segment of the left anterior descending coronary artery (LAD) (Panels A–C). Intravascular ultrasound (IVUS) demonstrated a large, layered, and mostly highly echoic plaque (Panel E). The lesion was successfully resected (Panels B and F), and sufficient coronary blood flow was achieved (Panels C and G). Histopathological analysis of the retrieved DCA specimen showed smooth muscle cell (SMC)-rich fibrous plaque (α-smooth muscle actin) without macrophages (CD68) (Panels I1–4). The patient was re-admitted 6 months later for chest pain. Coronary angiography identified restenosis in the proximal LAD (Panel D). We decided to repeat DCA and then implant a drug-eluting stent. IVUS of the restenotic lesion showed a plaque with iso and high echogenicity (Panel H). Histopathological analysis of the DCA specimens revealed the proliferation of numerous stellate cells and a proteoglycan-rich matrix. Immunostaining also demonstrated that these cells were mostly SMCs, with very few macrophages (Panels J1–4).

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention

Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort.

Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease.

Paclitaxel drug-coated balloons (DCB) have been shown to reduce target lesion revascularization (TLR) rate, but recently an association between paclitaxel and an increase in mortality at 5-year was reported. We reviewed the 5-year mortality and freedom from TLR rates from a single center among patients that received DCB. Consecutive patients that received DCB from July 8, 2015 to November 27, 2019 with follow-up obtained from medical records and review of official death certificates were reviewed. The primary objective was total mortality and TLR rates with cumulative exposure to paclitaxel-coated balloons. Demographic, angiographic, clinical, and procedural variables were collected. Causes of mortality were classified according to death certificates. Descriptive analysis was performed on all variables. Kruskal-Wallis test was used to compare the total length of DCBs in those who were alive and those who died by the end of study. Kaplan-Meier (KM) was used to plot the freedom from mortality up to 5 years. A total of 91 symptomatic patients received the Lutonix balloon at index to treat femoropopliteal arterial disease and subsequently received either Lutonix or in.PACT during the follow-up phase for additional procedures. Age was 68.4 ± 10.8 years (56.0% males). Critical limb ischemia was present in 20.9%. There was no statistical difference in mortality between the median total number of balloons used among patients who were alive versus those who died (2.5 vs. 3.0, p -value = 0.89). Also, there was no statistical difference in the total length of DCB balloons used between those who were alive and those who died at the end of the study (p-value = 0.39). There were no in-hospital amputation or death. At 5-year follow-up KM freedom from TLR was 78.5%. A total of 13 patients died during follow-up. Of these 10 received only the Lutonix balloon and 3 did receive both Lutonix and In.PACT. The yearly KM freedom from mortality for the Lutonix only cohort were 92.7, 89.1, 85.5, 83.6, and 81.8% at 1, 2, 3, 4, and 5 years, respectively. Freedom from TLR and mortality at 5 years appears to be favorable with the use of DCB, predominantly Lutonix balloon in this cohort. This data needs to be supported prospectively by a larger number of patients.

A pilot study of a novel paclitaxel-coated angioplasty catheter for lower extremity peripheral artery disease: a pilot study.

The aim of the study was to report our preliminary results and real-world experiences regarding the use of a novel paclitaxel-coated balloon catheter in a cohort of patients with lower extremity peripheral artery disease at different stages. A prospective cohort pilot study was conducted and the study group was made up of a total of 20 patients with peripheral artery disease who underwent endovascular balloon angioplasty with BioPath 014 or 035, a novel paclitaxel-coated, shellac containing balloon catheter. Eleven patients had a total of 13 TASC II-A lesions, 6 patients had a total of 7 TASC II-B lesions, 2 patients had TASC II-C lesions, 2 patients had TASC II-D lesions. In 13 patients, a single attempt with a BioPath catheter was adequate to treat a total of 20 target lesions, whereas in 7 patients more than one attempt with a different sized BioPath catheter was necessary. In 5 patients, total or near-total occlusion in the target vessel was initially treated with an appropriate sized chronic total occlusion catheter. Thirteen (65%) patients had at least one categorical improvement in Fontaine classification and none had symptomatic worsening. The BioPath paclitaxel-coated balloon catheter seems to offer a useful alternative to the similar devices for treatment of femoral-popliteal artery disease. These preliminary results warrant confirmation with further research to reveal the safety and efficacy of the device.

Meta-Analysis on Clinical Outcomes of Paclitaxel-Coated Balloon Angioplasty in Femoral Popliteal Artery Occlusion

Meta-Analysis on Clinical Outcomes of Paclitaxel-Coated Balloon Angioplasty in Femoral Popliteal Artery Occlusion

Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions

Background: Bifurcation treatments make up ca. 15–20% of coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions, especially with side branches involved, remains a challenge.Objective: To evaluate long-term clinical and angiographic outcomes after using a paclitaxel-coated balloon for the treatment of side branches in patients with true bifurcation lesions.Methods: Eighty patients with coronary artery disease were enrolled after true bifurcation lesion stenting. All patients were randomized at the 1:1 ratio to the group of main branches stenting followed by the dilatation of side branches with drug-eluting balloons and provisional stenting group.Results: Long-term results were analyzed after 12 months. The most common bifurcation lesion involved the left anterior descending artery and diagonal branch (57.5%). Late lumen loss in the side branch (0.51 ± 0.22 vs 0.33 ± 0.24 mm) and in both the bifurcation branches (main branch + side branch) (1.06 ± 0.29 vs 0.79 ± 0.27 mm) was significantly higher in the patients after provisional stenting.Overall postoperative incidence of major adverse cardiovascular events was 17.5% and 7.5% (p = 0.31) in the provisional stenting and drug coated balloon groups, respectively. Patients with drug-eluting balloons for the treatment of side branches had a more pronounced decrease in angina symptoms after 12 months. Multivariate analysis showed that diabetes mellitus (OR: 10.9) and glomerular filtration rate (OR: 0.95) were independent predictors of major adverse cardiovascular events in bifurcation interventions.Conclusion: Drug-eluting balloons for the dilatation of side branches after the stenting of main branches are superior to provisional stenting in terms of the late lumen loss. Received 31 August 2022. Revised 17 November 2022. Accepted 18 November 2022. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovData collection and analysis: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoStatistical analysis: T.K. Eraliev, D.A. Khelimskii, A.G. BadoianDrafting the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoCritical revision of the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovFinal approval of the version to be published: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. Gorgulko