Drug-coated Balloon Angioplasty Research Articles

Assessment of paclitaxel drug-coated balloon angioplasty for intracranial atherosclerotic disease based on high-resolution vessel wall magnetic resonance imaging.

To accurately assess the treatment effect of paclitaxel drug-coated balloon (DCB) angioplasty is essential for intracranial atherosclerotic disease (ICAD) patients. This study aimed to investigate the clinical feasibility of high-resolution vessel wall MRI (HR-VWI) in assessing ICAD with DCB angioplasty. Forty-five patients with intracranial atherosclerotic stenosis ≥ 70% confirmed by digital subtraction angiography (DSA) underwent HR-VWI before and after DCB angioplasty. Postoperative follow-up was performed after 6 months (±1 month). The differences of pre- and postoperative HR-VWI characteristics, including vessel and lumen area at maximal lumen narrowing (MLN), plaque area and length, degree of stenosis, plaque burden (PB), remodeling index, and plaque enhancement amplitude (PEA) were compared. The relationship between stenotic rate obtained using HR-VWI and DSA was evaluated. Each HR-VWI characteristic and clinical factor before DCB angioplasty was separately evaluated for the association with postoperative restenosis. After six months, lumen area of MLN, plaque length and area, degree of stenosis, PB, and PEA showed a significantly difference relative to the value before DCB angioplasty (all P < 0.05). Spearman correlation coefficients of 0.865 and 0.932 were revealed between DSA and HR-VWI regarding the stenotic rate analysis pre- and post-operation (both P < 0.05). ROC analysis showed PEA, plaque length, and PB before DCB angioplasty separately provided robust prediction of postoperative restenosis (area under the curve = 0.909, 0.814 and 0.743; all P < 0.05). Multivariable analysis revealed that PEA was an independent predictor of prognosis. The HR-VWI can accurately assess the treatment effect of DCB and robustly predict prognosis.

Repeat drug-coated balloon angioplasty for femoropopliteal lesions: 12-month results from a retrospective observational study

BackgroundThe clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis.ResultsThe repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43–18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17–33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08–16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21–73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01–0.44; p = 0.007).ConclusionsThe 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study.

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0mm (large group, n = 58) or < 3.0mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.

Plaque heterogeneity and the spatial distributions of its components dictate drug-coated balloon therapy

Drug-coated balloon (DCB) angioplasty is one of the potential approaches to alleviating in-stent restenosis and treating peripheral artery disease. An in-silico model has been developed for sirolimus drug eluted from an inflated balloon in a patient-specific arterial cross-section consisting of fibrous tissue, fibrofatty tissue, dense calcium, necrotic core, and healthy tissue. The convection-diffusion-reaction equation represents the transport of drug, while drug binding, both specific and non-specific, can be modelled as a reaction process. The Brinkman equations describe the interstitial flow in porous tissue. An image processing technique is leveraged for reconstructing the computational domain. The Marker and Cell, and Immersed Boundary Methods are used to solve the set of governing equations. The no-flux interface condition and convection do amplify the tissue content, and the regions of dense calcium and necrotic core limited to or extremely close to the interface pose a clinical threat to DCB therapy. Simulations predict the effects of the positioning and clustering of plaque components in the domain. This study demands extensive intravascular ultrasound-derived virtual histology (VH-IVUS) imaging to understand the plaque morphology and determine the relative positions of different plaque compositions about the lumen-tissue interface, which have a significant impact on arterial pharmacokinetics.

The Impact of Balloon Pre-dilatation Techniques on Drug-Coated Balloon Therapy for Femoropopliteal Artery Disease: Six-Month Results From the CIVILIAN Registry.

The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions. This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months. During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83-7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07-3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00-2.69, p=0.048). By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons. The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.

Usage of rotational atherectomy and drug-coated balloon angioplasty for isolated popliteal artery lesions: two-year results of a retrospective study

Objectives In this study, perioperative properties and early and mid-term clinical outcomes of endovascular revascularization with a combined usage of rotational atherectomy (RA) and drug-coated balloon angioplasty (DCB) angioplasty for isolated popliteal artery lesion were reported. Methods A total of 28 patients with isolated popliteal artery stenosis who underwent combined RA and DCB angioplasty between December 2018 and September 2022 were analyzed retrospectively. Temren atherectomy system (Invamed, Ankara, Turkey) and Extender paclitaxel-coated drug-coated balloon catheter (Invamed, Ankara, Turkey) were used in all cases. The main outcome was primary patency; secondary outcomes were technical success, freedom from amputation, and mortality. Results The mean age of patients was 64.2 ± 9.1 years and the majority of the patients were male (n = 20; 71.4%). Types of the lesions were total occlusion in 24 limbs and critical stenosis in 4 limbs. The mean total occlusion length was 65.2 ± 14.2 mm. Flow-limiting dissection was seen in lesions of 2 patients (7.1%) and treated with prolonged balloon dilatation without bail-out stenting requirement. Technical success defined as an adequate vascular lumen (less than 30% stenosis) was achieved in 26 (92.8%) with a mean follow-up of 17.2 ± 8.2 months. The mean primary patency rates at 12 months and 24 months were 92.3% ± 3.2 and 81.2% ± 3.2, respectively. Complications included 1 distal embolization following RA, 2 flow-limiting dissections, and 3 puncture site hematomas. Conclusions Endovascular procedures using combined RA and DCB angioplasty seem to be effective alternative treatment modalities for the treatment of popliteal artery lesions with high rates of primary patency and freedom from TLR.

Angiosome-Targeted Infrapopliteal Angioplasty: Impact on Clinical Outcomes—An Observational Study

Background: Revascularization based on the angiosome concept (AC) is a controversial subject because there is currently no clear evidence of its efficacy, due to the heterogeneity of patients (multiple and diverse risk factors and comorbidities, multiple variations in the affected angiosomes). Choke vessels change the paradigm of the AC, and the presence or absence of the plantar arch directly affects the course of targeted revascularization. The aim of this study was to evaluate the effect of revascularization based on the AC in diabetic patients with chronic limb-threatening ischemia (CLTI). Methods: This retrospective analysis included 51 patients (40 men, 11 women), with a mean age of 69 years (66–72) and a total of 51 limbs, who presented with Rutherford 5–6 CLTI, before and after having undergone a drug-coated balloon angioplasty (8 patients) or plain balloon angioplasty (43). Between November 2018 and November 2019, all patients underwent below-the-knee balloon angioplasties and were followed up for an average of 12 months. The alteration of microcirculation was compared between directly and indirectly revascularized angiosomes. The study assessed clinical findings and patient outcomes, with follow-up investigations, comparing wound healing rates between the different revascularization methods. Patient records and periprocedural leg digital subtraction angiographies (DSA) were analyzed. Differences in outcomes after direct revascularization and indirect percutaneous transluminal angioplasty (PTa) were examined using Cox proportional hazards analysis, with the following endpoints: ulcer healing, limb salvage, and also amputation-free survival. Results: Direct blood flow to the angiosome supplying the ulcer area was achieved in 38 legs, in contrast to 13 legs with indirect revascularization. Among the cases, there were 39 lesions in the anterior tibial artery (ATA), 42 lesions in the posterior tibial artery (PTA), and 8 lesions in the peroneal artery (PA). According to a Cox proportional hazards analysis, having fewer than three (&lt;3) affected angiosomes (HR 0.49, 95% CI 0.19–1.25, p = 0.136) was associated with improved wound healing. Conversely, wound healing outcomes were least favorable after indirect angioplasty (p = 0.206). When adjusting the Cox proportional hazard analysis for the number of affected angiosomes, it was found that direct drug-coated angioplasty resulted in the most favorable wound healing (p = 0.091). At the 1-year follow-up, the major amputation rate was 17.7%, and, according to a Cox proportional hazards analysis, atrial fibrillation (HR 0.85, 95% CI 0.42–1.69, p = 0.637), hemodialysis (HR 1.26, 95% CI 0.39–4.04, p = 0.699), and number of affected angiosomes &gt; 3 (HR 0.94, 95% CI 0.63–1.39, p = 0.748) were significantly associated with poor leg salvage. Additionally, direct endovascular revascularization was associated with a lower rate of major amputation compared to indirect angioplasty (HR 1.09, 95% CI 0.34–3.50, p = 0.884). Conclusions: Observing the angiosomes concept in decision-making appears to result in improved rates of arterial ulcer healing and leg salvage, particularly in targeted drug-coated balloon angioplasty for diabetic critical limb ischemia, where multiple angiosomes are typically affected.

Chinese expert consensus on the clinical application of drug-coated balloon (2nd Edition).

Percutaneous coronary interventions have progressed through the era of plain balloon dilation, bare-metal stent insertion to drug-eluting stent treatment, which has significantly reduced the acute occlusion and restenosis rates of target vessels and improved patient prognosis, making drug-eluting stents the mainstream interventional treatment for coronary artery disease. In recent years, drug-coated balloons (DCBs) have become a new treatment strategy for coronary artery disease, and the drugs used in the coating and the coating technology have progressed in the past years. Without permanent implant, a DCB delivers antiproliferative drugs rapidly and uniformly into the vessel wall via the excipient during a single balloon dilation. Many evidence suggests that DCB angioplasty is an effective measure for dealing with in-stent restenosis and de novo lesions in small coronary vessels. As more clinical studies are published, new evidence is emerging for the use of DCB angioplasty in a wide range of coronary diseases, and the indications are expanding internationally. Based on the latest research from China and elsewhere, the Expert Writing Committee of the Chinese Expert Consensus on Clinical Applications of Drug-Coated Balloon has updated the previous DCB consensus after evidence-based discussions and meetings in terms of adequate preparation of in-stent restenosis lesions, expansion of the indications for coronary de novo lesions, and precise guidance of DCB treatment by intravascular imaging and functional evaluation.

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

To investigate the role of the AAC-8 scoring in predicting restenosis or occlusion of lower extremity arteries after dilatation and angioplasty with DCB

Objective: To investigate the role of the Abdominal Aortic Calcification-8 (AAC-8) scoring system in predicting restenosis or occlusion of lower extremity arteries after dilatation and angioplasty with drug-coated balloon (DCB). Methods: In this retrospective study, 62 patients who underwent dilatation and angioplasty with DCB for lower limb atherosclerotic obliterans (ASO) were enrolled from September 2018 to June 2022 in Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School. Among them who aged (73.9±11.3) years, 37 were males and 25 were females. Patients were divided into two groups according to the condition of the lower extremity arteries after dilatation and angioplasty with DCB: recurrence group (n=26) and patency group (n=36). Logistic regression was used to analyze the factors associated with restenosis or occlusion of lower extremity arteries after dilatation and angioplasty with DCB. The predictive value of the AAC-8 score for restenosis or occlusion of the lower extremity arteries after dilatation and angioplasty with DCB was analyzed using the receiver operating characteristic curves (ROC curves). Results: The postoperative follow-up was 16.30 (10.97, 24.10) months in the patency group and 9.03 (6.98, 15.31) months in the recurrence group. The results of multifactorial logistic regression analysis showed that an elevated AAC-8 score (OR=1.388, 95%CI: 1.067-1.806, P=0.015) was an associated factor of restenosis or occlusion of the lower extremity arteries after dilatation and angioplasty with DCB. The ROC curve analysis showed that the area under the curve (AUC) of the AAC-8 score for predicting restenosis or occlusion of the lower extremity arteries after dilatation and angioplasty with DCB was 0.687 (95%CI: 0.550-0.824, P=0.013), with a cut-off value of 5.5 points, a sensitivity of 65.4% and a specificity of 69.5%. Conclusions: Elevated AAC-8 score is associated with restenosis or occlusion of the lower extremity arteries after dilatation and angioplasty with DCB. When the cut-off value is 5.5, the AAC-8 score predicts restenosis or occlusion of the lower extremity arteries after DCB dilation and angioplasty with a sensitivity of 65.4% and a specificity of 69.5%.

Everolimus-encapsulation in Pluronic P123 self-assembled micelles as drug delivery systems for drug-coated balloons

Drug-coated balloons (DCBs) are effective tools for cardiovascular interventions, ensuring uniform drug delivery to occluded arteries. This research investigates the potential of Pluronic P123 (P123), a micelle-forming polymer, to solubilize and release Everolimus (EVE) from DCBs. Furthermore, it seeks to understand how the ratio of P123 to EVE affects release rates and micelle formation under physiological conditions. We tested three P123 to EVE ratios: 90:10, 75:25, and 50:50. Microscopy revealed that increasing EVE proportions resulted in more uniform coatings. Fourier-transform infrared spectroscopy (FTIR) analysis confirmed the successful incorporation of EVE into the P123 matrix without altering its chemical properties. Differential scanning calorimetry (DSC) studies showed that EVE incorporation affected the crystalline structure of P123, leading to more uniform coatings. In vitro release studies showed that all formulations had <1% drug loss in the first minute (the tracking phase); furthermore, the 90:10 ratio exhibited optimal drug release in the following 3 min, corresponding to the deployment phase in DCB angioplasty. Analysis of micelle loading capacity (LC), encapsulation efficiency (EE), size, and structure indicated an increase in both LC and EE with higher EVE content and a corresponding enlargement in micelle size. Given these findings, the optimized formula provided a consistent coating on commercial balloons, highlighting the potential of using P123 for DCB drug coating and release.

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.

Impact of a Less Than 50% Residual Stenosis Following Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention. In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and <dissection grade D before DCB (the successful VP group). The primary outcome measure was primary patency, and its associated factors were evaluated. The median follow-up period was 2.1 (interquartile range=1.1-2.7) years. Successful VP was achieved in 163 patients (60.8%). Primary patency and freedom from clinically-driven target lesion revascularization (CD-TLR) were significantly higher in the successful VP group than in the nonsuccessful VP group (54.2% vs 33.0%, p<0.001; 69.9% vs 57.7%, p=0.047). In the successful VP group, high-dose DCB and low-dose DCB were comparable in primary patency and freedom from CD-TLR (53.2% vs 53.6%, p=0.48; 68.7% vs 70.9%, p=0.69). In nonsuccessful VP group, high-dose DCB demonstrated numerically higher primary patency but not statistically significant than low-dose DCB (44.5% vs 16.0%, p=0.06), whereas no significant difference in freedom from CD-TLR was observed (56.0% vs 58.9%, p=0.29). On multivariate analysis, successful VP and preballoon size to reference vessel diameter ratio were significantly associated with primary patency. Achieving successful VP before DCB was independently associated with primary patency in DCB FP intervention. This study revealed that the successful vessel preparation (VP) before DCB and preballoonsize to reference vessel diameter ratio were independently associated with primary patency in DCB femoropopliteal intervention. When successful VP was achieved only before DCB treatment, the clinical outcomes were comparable between high-dose DCB and low-dose DCB at midterm follow-up.To maximized DCB efficacy, successful VP is very important in daily clinical practice.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery

ObjectiveThe aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. MethodsWe conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. ResultsPatients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. ConclusionsThis post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Comparison of mid-outcome among bare metal stent, atherectomy with or without drug-coated balloon angioplasty for femoropopliteal arterial occlusion.

This study evaluated the outcomes of a bare metal stent (BMS), DCB alone, atherectomy plus a drug-coated balloon (AT + DCB) and AT alone for the treatment of femoropopliteal artery occlusion. Four groups were included in this retrospective cohort study: 119 patients underwent the BMS procedure, 89 patients underwent DCB alone, 52 patients underwent AT + DCB, and 61 patients underwent AT alone. Patients were followed-up at 1, 6, 12 and 24months after the procedure, the clinical outcomes and complications were assessed, and the primary outcomes were primary patency and restenosis. AT + DCB showed a lower bailout stent, and BMS displayed a higher retrograde puncture, flow-limiting dissection and postdilation (p < 0.05). For all procedures, the walking distance, ABI and pain score post-procedure were significantly improved compared with the pre-procedure values (p < 0.001). The restenosis rate was higher in BMS (21.0%) and AT alone (24.6%) than in DCB (10.1%) alone and AT + DCB (11.5%) (p = 0.04); there was no difference in amputation or clinically driven target lesion revascularization among procedures. The primary patency rates were 77.7%, 89.4%, 88.0% and 73.7% in the BMS, DCB alone, AT + DCB and AT alone groups at 24months, respectively (p = 0.03), while the secondary patency and main adverse events (stroke, MI and death) were similar. Proximal concavity, proximal target vessel diameter ≥ 5mm, runoff number ≥ 2 and DCB use were protective factors for primary patency. Our results suggested that AT + DCB and DCB alone were associated with higher primary patency, and DCB devices (combined with/without AT) should be the preferred choice for FP lesions.

Early outcomes of drug-coated balloon angioplasty of infrapopliteal lesions in diabetic foot

Abstract: PURPOSE: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with diabetic foot. METHODS: We analyzed 6-month follow-up data from the prospective PRIME-WIFI study with 203 consecutive patientswith diabetic foot who underwent DCB angioplasty for infrapopliteal arterial occlusive disease. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, and complete wound healing. RESULTS: The mean age was 69.78 ± 9.50 years and 61 were female. A total of 271 lesions, with an average length of 26.02 ± 12.94 cm, accepted DCB angioplasty. Both infrapopliteal runoff score and pedal runoff score improved significantly after procedure compared with baseline. The score changes were − 5.73 and − 0.39, respectively (P &lt; 0.001 for both). Within 6-month follow-up, 16 of the 203 patients died and 32 (15.76%) were lost to follow-up. By Kaplan–Meier analysis, at 6 months postprocedure, freedom from MAE was 85.77% (95% confidence interval [CI], 80.92%–90.91%); AFS was 88.88% (95% CI, 84.49%–93.49%); and freedom from major amputation, all-cause death, and CD-TLR were 95.65% (95% CI, 92.73%–98.65%), 92.57% (95% CI, 88.88%–96.4%), and 95.51% (95% CI, 92.51%–98.61%), respectively. During the 6-month follow up, complete wound healing was achieved in 67.11% patients. CONCLUSION: In patients with diabetic foot, DCB angioplasty of infrapopliteal lesions was effective and safe.

The efficacy and safety of atherectomy combined with drug-coated balloon angioplasty vs. drug-coated balloon angioplasty for the treatment of lower extremity artery disease: a systematic review and meta-analysis.

This study aimed to systematically evaluate the efficacy and safety of atherectomy followed by drug-coated balloon angioplasty (A-DCB) in comparison with drug-coated balloon (DCB) angioplasty alone for the treatment of lower extremity artery disease (LEAD). Systematic literature search was performed using several online databases including MEDLINE (via PubMed), Europe PMC, and ScienceDirect databases from inception until February 21st, 2024. We included all studies comprised three main variables including A-DCB, DCB, and LEAD. The primary outcomes were primary patency and target lesion revascularization (TLR). Whereas secondary outcomes were all-cause mortality, post-procedural complications, and clinical characteristics. A total of 15 studies (10 cohort studies and 5 randomized controlled trials studies) consisting of 1,385 participants with mean age 68.7 ± 8.9 were included. In comparison with DCB alone, A-DCB was significantly associated with a higher risk of primary patency [RR = 1.16 (95% CI = 1.07-1.26); P < 0.001; I 2 = 20.9%, P-heterogeneity = 0.221] and lower risk of TLR [RR = 0.61 (95% CI = 0.46-0.81); P < 0.001; I 2 = 0%, P-heterogeneity = 0.475]. Subgroup analysis showed that only directional, rotational, and laser atherectomy increased the probability of primary patency, but only rotational atherectomy decreased the risk of TLR. Regarding secondary outcomes, A-DCB was substantially associated with a lower likelihood of bailout stenting, any amputation, and major amputation, as well as higher ankle brachial index (ABI) following follow-up duration. Meta-regression analysis suggested that pre-intervention s (p = 0.015) and pre-intervention Rutherford classification (p = 0.038) were significantly affected the association between A-DCB and primary patency. Begg's funnel plot and Egger's test analyses indicated no publication bias in this meta-analysis. The addition of atherectomy improves primary patency and reduces the risk of TLR with similar safety outcomes. www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022382831, PROSPERO (CRD42022382831).

Angiography-Based Computational Modeling for In Vivo Assessment of Endothelial Dynamic Strain in Coronary Arteries with De Novo Lesions: Comparison of Treatment Effects of Drug-Coated Balloons Between Small and Large Arteries

Acute morphological changes in de novo coronary lesions after drug-coated balloon (DCB) angioplasty can affect endothelial mechanics and consequently clinical outcomes. Angiography-based computational modeling has been validated to assess endothelial dynamic strain (EDS) in coronary arteries in vivo. The EDS was calculated on the basis of pre- and post-DCB angiography. Parameters of quantitative coronary angiography and EDS were quantified at cross-sections in the treated segments. A total of 336 and 348 lesion cross-sections were included in the small/large vessel groups, respectively. The acute lumen gain after DCB was significantly higher in large than small vessels (relative changes: 21.3% [17.4%, 25.1%] vs. 7.4% [4.8%, 10.1%], P &lt; 0.001). Before treatment, three indices of EDS were significantly higher in small than large vessels (for ED-EDS: 29.2% [19.8%, 44.8%] vs. 20.4% [14.3%, 30.2%]; for ES-EDS: 26.8% [18.9%, 37.7%] vs. 18.3% [13.9%, 25.4%]; for TA-EDS: 19.1% [13.9%, 27.8%] vs. 14.3% [10.5%, 20.1%], P &lt; 0.001). After treatment, the EDS in small vessels significantly decreased (P &lt; 0.001). ED-EDS showed the highest correlation with pre-DCB DSP (r = 0.43, P &lt; 0.001) and post-DCB MLD (r = 0.35, P &lt; 0.001). The levels of EDS parameters for small or large vessel lesions significantly differed. Further study is required to examine the clinical value of EDS in predicting cardiac events after DCB treatment.

Role of drug coated balloon angioplasty in treatment of recurrent dysfunctional arteriovenous fistulae for hemodialysis.

Role of drug coated balloon angioplasty in treatment of recurrent dysfunctional arteriovenous fistulae for hemodialysis.

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

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