Paclitaxel-coated Balloon Angioplasty Research Articles

Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions.

Late lumen enlargement (LLE) - a positive remodelling phenomenon - after drug-coated balloon (DCB) angioplasty for stable coronary disease contributes to a lower restenosis rate. However, lesion characteristics promoting LLE remain unclear. This study aimed to investigate predictive lesion characteristics for LLE using serial optical frequency domain imaging (OFDI) following DCB angioplasty for de novo coronary artery lesions. This retrospective, single-centre observational study included patients with angina pectoris who underwent paclitaxel-coated balloon angioplasty without stenting under OFDI guidance as well as follow-up OFDI. OFDI endpoints were lumen volume, plaque phenotype, and procedure-associated dissection. LLE was defined as a ≥10% increase in the lumen volume of the treated lesion at follow-up. Between August 2016 and December 2019, among patients with successful DCB angioplasty, 108 lesions (83 patients) had available follow-up imaging after a median of 6.1 months. LLE was detected in 44 (40.7%) lesions. Fibrous/fibrocalcific and layered plaques had significantly larger lumen volumes at follow-up than immediately after the index procedure, whereas lipid plaques exhibited no significant difference. Medial dissection with an arc >90° revealed an increased lumen volume. Multivariate analysis showed that layered plaques (odds ratio [OR] 8.73, 95% confidence interval [CI]: 1.92-39.7; p=0.005) and medial dissection with an arc >90° (OR 4.65, 95% CI: 1.63-13.3; p=0.004) were independent LLE predictors. Layered plaques and extensive medial dissection after DCB angioplasty were associated with higher LLE occurrence in de novo coronary lesions. These findings may be clinically applicable to DCB therapeutic strategies based on plaque features.

Cardiovascular Outcomes after Paclitaxel-Coated Balloon Angioplasty versus Drug-Eluting Stent Placement for Acute Coronary Syndrome: A Systematic Review and Meta-Analysis.

Background: We conducted a systematic review and meta-analysis to examine the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo lesions in patients with acute coronary syndrome (ACS) by comparing with drug-eluting stent (DES) placement. Methods: By a systematic literature search, nine (five randomized controlled, two retrospective propensity-score matched, and two retrospective baseline-balanced) studies comparing the midterm clinical and angiographic outcomes after PCB angioplasty and DES placement were included, yielding 974 and 1130 ACS cases in PCB and DES groups, respectively. Major adverse cardiac event (MACE) was defined as a composite of cardiac mortality (CM), all-cause mortality (ACM), myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). Late luminal loss (LLL) and bleeding events (BLD) were also estimated. Results: The frequencies of MACE in PCB and DES groups were 8.42% and 10.62%, respectively. PCB angioplasty had no significant impacts on all of MACE (risk ratio: 0.90, 95%CI: 0.68-1.18, p = 0.44), CM, ACM, MI, TVR, TLR, BLD, and LLL, compared to DES placement in random-effects model. Conclusions: The present systematic review and meta-analysis showed the feasibility of PCB angioplasty for the de novo lesions in patients with ACS in comparison with DES placement by the emergent procedures.

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

Efficacy of paclitaxel-coated balloon angioplasty combined with intensive lipid-lowering therapy for ST-segment elevation myocardial infarction: insights from near-infrared spectroscopy.

Efficacy of paclitaxel-coated balloon angioplasty combined with intensive lipid-lowering therapy for ST-segment elevation myocardial infarction: insights from near-infrared spectroscopy.

Treatment of Hemodialysis Vascular Access repeated Stenosis with Paclitaxel-Coated Balloon Angioplasty: A Retrospective Study.

Introduction To report our experience of angioplasty with Paclitaxel-coated balloon (PCB) versus common balloon (CB) for the treatment of repeated failing vascular access. Methods Retrospective, single-center analysis consisting of 88 patients treated with percutaneous transluminal angioplasty (PTA) in the period from October 2020 through December 2021. Patients were divided into two groups according to the type of treatment as Paclitaxel-coated balloon (n=41) and common balloon (n=47). We analyzed target lesion primary patency and vascular access primary patency for 6 months, and the rate of complications. Results There was no significant difference in the target lesion primary patency which was similar for 6 months between the two groups (PCB group vs. CB group at 1,3,6 months; 95.12% vs. 89.36%(P=0.55), 75.61% vs. 74.47%(P=0.90), 53.66% vs. 63.83%(P=0.33), respectively). Similarly, vascular access primary patency in the PCB group and CB group was 90.24% and 89.36%(P=0.83), respectively, at 1 month, 65.85% and 68.09%(P=0.82), respectively, at 3 months, 39.02% and 53.19%(P=0.18), respectively, at 6 months. There were no major complications after endovascular treatment. Conclusion Compared to common balloon angioplasty, paclitaxel-coated balloon angioplasty have no short-term patency benefit in the treatment of vascular access repeated stenosis.

Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting

ObjectiveTo evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BackgroundThe benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. MethodsThis retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). ResultsOne hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172).After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline.Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. ConclusionAfter one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.

Angioplasty for dysfunctional arteriovenous fistulas: A meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty.

Stenosis in arteriovenous fistulas (AVF) due to neointimal hyperplasia is one of the most common causes of hemodialysis vascular access dysfunction. Treating patients with dysfunctional AVF with drug-coated balloon (DCB) angioplasty may potentially improve outcomes. This systematic review aimed to compare the effectiveness and safety of DCB angioplasty versus conventional balloon angioplasty by pooling evidence from the most recent randomized controlled trials. We conducted a comprehensive literature search in the Web of Science, Embase, and Cochrane central databases. Two independent researchers screened the article, extracted interest, and evaluated included studies for risk of bias. Pooled estimation was conducted in terms of 6-month target-lesion primary patency (TLPP) and target-lesion reintervention (TLR), as well as other outcomes. Results were expressed with odds ratio (OR) and 95% confidence interval (CI). A total of five RCTs were identified and included in the meta-analyses, with 1107 participants. DCB has a trend of a higher rate of TLPP (OR 1.79, 95% CI 0.66-4.90, p = 0.181) and a significantly lower rate of TLR (0.52, 95% CI 0.29-0.92, p = 0.034), as compared to conventional balloon angioplasty. No difference in the 6-month access circuit primary patency and reinvention was observed between the two groups. DCB may be an alternative treatment of dysfunctional AVF given a trend of a higher rate of TLPP and a significantly lower rate of TLR than conventional balloon angioplasty within 6 months after the indexed procedure. Moreover, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Considering variations in the DCB technique, further studies are warranted for a standardized process.

TCT-322 Changes in Angiography-Derived Index of Microcirculatory Resistance Following Paclitaxel-Coated Balloon Angioplasty

TCT-322 Changes in Angiography-Derived Index of Microcirculatory Resistance Following Paclitaxel-Coated Balloon Angioplasty

Clinical Outcomes of Drug-Coated Balloon Angioplasty in Peripheral Artery Disease Patients With End-Stage Renal Disease.

The objective was to determine the effectiveness and safety of paclitaxel-coated balloon angioplasty in hemodialysis patients with diabetic nephropathy (DN). The outcomes of end-stage renal disease (ESRD) patients with peripheral artery disease (PAD) and treated with drug-coated balloon (DCB) angioplasty were retrospectively evaluated. The effectiveness outcomes were clinical improvement of the Rutherford classification and target lesion revascularization (TLR). Safety outcomes were all-cause mortality and amputation. Ninety-seven patients were treated with DCB angioplasty between December 2018 and December 2020. 87 (63.8±10.1 years) achieved technical success. Most patients had a Rutherford classification of at least grade 4. The mean lesion length was 169.8±73.8 mm, almost all had arterial calcification, and 31.0% had annular calcification. Wounds were present in 73.6% of the target limbs. The mean follow-up in this cohort was 13.4±7.4 months. The wound healing rate was 61.5% at the 12-month follow-up. All-cause mortality during 12 months of follow-up was 35.6%, amputation-free survival was 58.6%, and TLR was observed in 13 (15.3%) patients. At 3 and 12 months of follow-up, the Rutherford grade significantly improved (p<0.001). The Cox proportional hazards model revealed that wounds (hazard ratio [HR]=1.404, p=0.023) and annular calcification (HR=2.076, p=0.031) were independent predictors of amputation-free survival. Drug-coated balloon angioplasty in ESRD patients was effective and safe over the medium term. Wounds and annular calcification were independent predictors of amputation-free survival. The effectiveness of DCB angioplasty in ESRD patients and the factors affecting major outcome prognosis in this population remain limited. This study contributes valuable insights into the effectiveness and safety of paclitaxel-coated balloon angioplasty for PAD in hemodialysis patients. Medical professionals can now regard DCB angioplasty as a viable treatment. Identifying wound presence and annular calcification as predictors of amputation-free survival equips medical practitioners with a more tailored approach to patient management, potentially resulting in enhanced outcomes and more precise treatment strategies.

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.

Outcomes of Paclitaxel Coated Balloon Angioplasty in Claudication

Patel, Avkash MD; Turner, Jason T MD; Zhou, Christopher; Colvard, Benjamin MD; Cho, Jae MD, FACS; Kumins, Norman H MD, FACS Author Information

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.

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.

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).

Primary Patency Rate With Paclitaxel Coated Balloon Angioplasty Versus Covered Stenting of Failed Arteriovenous Grafts: a Retrospective Comparative Study

Primary Patency Rate With Paclitaxel Coated Balloon Angioplasty Versus Covered Stenting of Failed Arteriovenous Grafts: a Retrospective Comparative Study

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

Outcomes of paclitaxel-coated balloon angioplasty for in-stent calcified nodule: An optical coherence tomography study.

Paclitaxel-coated balloon (PCB) angioplasty emerges as an effective therapeutic option for in-stent restenosis (ISR). However, whether PCB angioplasty would be effective for in-stent calcified nodule (ISCN) lesions remain fully understood. This study aimed to evaluate the frequency and outcomes of ISCN in patients undergoing PCB angioplasty for ISR after second-generation drug-eluting stents (G2-DES) implantation. This study enrolled 179 lesions (160 patients) undergoing PCB angioplasty for G2-DES restenosis with optical coherence tomography guidance. According to the presence of ISCN at the minimum lumen area, the lesions were divided into two groups: the ISCN (n = 16) and the non-ISCN groups (n = 163). The primary study endpoint was the cumulative 3-year incidence of target lesion failure (TLF; a composite of cardiac death, clinically driven target vessel revascularization, and definite stent thrombosis) on a lesion basis. ISCN was observed in 16 of 179 lesions (8.9%). Cumulative 3-year incidence of TLF was significantly higher in the ISCN group than in the non-CN group (85.3% vs. 16.9%, inverse probability weighted hazard ratio [HR] 4.46, 95% confidence intervals [CIs]: 2.42-8.22, p < 0.001). Risk factors associated with TLF were ISCN (HR 4.55, 95% CI: 1.56-13.3, p = 0.005), recurrent ISR (HR 2.82, 95% CI: 1.50-3.30, p = 0.001), and early ISR (HR 2.18, 95% CI: 1.21-3.92, p = 0.009). ISCN was observed in 8.3% of G2-DES restenosis. PCB angioplasty had little effect on ISCN lesions compared with non-ISCN lesions, suggesting the need for careful clinical follow-up of patients with ISCN lesions after PCB angioplasty.

Paclitaxel-Coated versus Uncoated Balloon for Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis

Background: Several prospective controlled trials to date have assessed the safety and efficacy of paclitaxel-coated balloon angioplasty (PCBA) versus uncoated balloon angioplasty (UCBA) for femoropopliteal (FP) in-stent restenosis (ISR). Therefore, this meta-analysis of prospective controlled trials aimed to summarize the results of these trials and present reliable conclusions. Methods: We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and CNKI databases for prospective randomized controlled trials (published between January 1, 2008, and July 31, 2021; no language restrictions) comparing PCBA with UCBA in the management of FP ISR. The main endpoints were recurrent restenosis, primary patency, freedom from target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs). We assessed the pooled data using a fixed effects model. Results: Of the 206 identified studies, seven were eligible and included in our analysis (N = 593 participants). Compared with UCBA, PCBA yielded a reduction in recurrent restenosis (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.13–0.38), a better primary patency (OR, 3.59; 95% CI, 1.72–7.47), an improved likelihood of freedom from TLR (OR, 2.70; 95% CI, 1.36–5.35), greater clinical improvement (OR, 2.38; 95% CI, 1.50–3.79), and a similar mean difference in ABI (0.02; 95% CI, –0.11–0.14) and OR in MAEs (0.71; 95% CI, 0.24–2.14). Conclusions: PCBA as a treatment strategy can achieve better short-term outcomes of FP ISR management, including potent recurrent restenosis-lowering and symptom-improving capacity without increased MAEs. Therefore, it is a promising therapeutic strategy for patients with FP ISR. Systematic Review Registration: This work was registered in PROSPERO, the international prospective register of systematic reviews (number: CRD42021261574).

Multimodal Images of Crushed Superficial Femoral Artery Calcified Occlusion Treated by Paclitaxel-Coated Balloon Angioplasty.

Multimodal Images of Crushed Superficial Femoral Artery Calcified Occlusion Treated by Paclitaxel-Coated Balloon Angioplasty.