Drug-coated balloons versus conventional percutaneous transluminal angioplasty for treatment-naïve dysfunctional arteriovenous fistulas.: A 10-year single center retrospective study.

OBJECTIVES: To compare the primary patency and restenosis rates in treatment naieve dialysis arteriovenous fistulas (AVFs) after drug-coated balloons (DCB) versus plain balloon angioplasty (PTA). METHODS: This retrospective study included 157 patients who underwent AVF angioplasty for treatment-native AVF stenosis between January 2012 to 2022. The fistulas were Brachiocephalic (75%), Brachiobasilic (17%), and radiocephalic (8%). The index intervention was with either DCB or percutaneous transluminal angioplasty (PTA) with subsequent follow up. Patients with central venous stenosis, thrombosed fistula, fistula stents, AV graft or surgical intervention after the index procedure were excluded. RESULTS: Arteriovenous fistula angioplasty was done in 28 patients using DCB and in 129 patients using PTA. A total of 108 patients presented with a single stenosis, 42 with 2 stenoses, and 7 with 3 stenoses. The location of these stenoses was in the venous outflow (57%), the juxta anastomotic segment (31%), and cephalic arch (12%). The median time to re-intervention for the PTA was 216 days compared to 304 days for the DCB (p=0.079). Primary patency at 6 months was 60.4% for PTA and 75% for DCB (p=0.141) CONCLUSION: Although DCB angioplasty of treatmentnaïve dysfunctional AVF tends to improve the time to intervention and 6-month primary patency compared to PTA, this difference did not reach statistical significance.

Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives.

The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an anti-proliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application. Additionally, it aims to discuss future important perspectives.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

INTRODUCTION: Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. METHODS: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). RESULTS: A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. CONCLUSION: Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

A latent bleeding complication in ipsilateral common femoral puncture involving delayed diagnosis: a case report.

BACKGROUND: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications. CASE PRESENTATION: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography. CONCLUSION: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.

Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES: This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS: An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS: Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS: Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.

Comparison of Drug-Coated Balloon to Drug Eluting Stent in Patients with In-Stent Restenosis: A Systematic Review and Meta-Analysis.

In-stent restenosis (ISR) is the gradual narrowing of the stented coronary segment, presenting as angina or leading to an acute myocardial infarction. Although the incidence has decreased with the use of newer drug-eluting stents (DES), it still carries significant mortality & morbidity. We compared the two most common interventions, i.e. drug-coated balloons (DCB) vs drug-eluting stents (DES) for managing DES-related ISR. Electronic databases were searched to identify all randomized controlled trials (RCTs) comparing DCB to DES in patients with DES-ISR. The Mantel-Haenszel method with a random effects model was used to calculate pooled risk ratios (RR). Five trials comprising 1,100 patients (577 in DCB and 523 in DES group) were included in the final study. The mean follow-up was 42 months. DCB was found to have a higher risk for target lesion revascularization (TLR) (RR: 1.41, p: 0.02) compared to DES. No difference was observed in all-cause mortality, target vessel revascularization (TVR), myocardial infarction, or stroke between the two intervention arms. In conclusion, management of DES-ISR with DCB has a higher risk of TLR as compared to re-stenting with DES. Both therapeutic interventions are comparable in other terms of efficacy and safety profile.

Method for assessing coating uniformity of angioplasty balloons coated with poly(lactic-co-glycolic acid) nanoparticles loaded with quercetin.

In this study, we aim to quantify coating uniformity and correlate fluorescence intensity to drug loading for drug-coated angioplasty balloons (DCB) coated with 5, 10, 15, or 20 layers of poly(lactic-co-glycolic acid) nanoparticles (NPs) entrapped with quercetin. Uniformity was quantified from histograms and horizontal line profiles of microscopic fluorescent images acquired with sample specific parameters, and cracks in the coating were measured and counted. The fluorescence of images acquired with global parameters was correlated with quercetin loading measured via gravimetric/HPLC analysis. More layers on DCBs may be associated with less uniform coatings, as indicated by differences in histogram standard deviations. The line profile percent deviation from average for each sample was <20%. Cracks were present on all balloons, but their length was not significantly different between samples. The 5-layer DCBs had the fewest cracks, whereas the 15-layer DCBs had the most cracks. A strong positive correlation (R = 0.896) was identified between fluorescence intensity and drug loading. A relationship between the number of layers and coating uniformity seems to exist, but further investigations are required for confirmation. Fluorescence intensity appears to strongly predict drug loading, demonstrating that fluorescent imaging may be a viable alternative to drug release studies.

Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0-1.0 and 2.0; IQR: 1.0-3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0-38.0 mm and 42.0 mm; IQR: 28.0-67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions.

Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design.

BACKGROUND: Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. STUDY DESIGN: The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. DISCUSSION: The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. TRIAL REGISTRATION: Registered on clinicaltrial.gov (NCT04561739).

Efficacy and safety of drug-coated balloons in chronic total coronary occlusion recanalization: a systematic review and meta-analysis.

BACKGROUND: With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI. METHODS: We systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis. RESULTS: Five studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I2 = 0%, p = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I2 = 0%, p = 0.873) and 1.2% (95% CI -0.2-2.6%, I2 = 13.7%, p = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I2 = 51.7%, p = 0.082) and 7.1% (95% CI 3.0%-11.2%, I2 = 57.6%, p = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5-65.3%, I2 = 0%, p = 0.742), 3.3% (95% CI 1.1-5.4%, I2 = 0%, p = 0.865) and 17.5% (95% CI 12.9-22.0%, I2 = 0%, p = 0.623), respectively. CONCLUSION: Accordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.

Systematic Review on Role of Drug Eluting Stent (DES) Versus Drug-Coated Balloon (DCB) in Small Vessel Coronary Artery Disease.

PURPOSE OF REVIEW: This review aims to explain the current advancements in the treatment modalities for small vessel coronary artery disease (SVCAD) and de novo lesions post-percutaneous coronary intervention (PCI), focusing on drug-coated stents (DES) and drug-coated balloons (DCB). Its goal is to address the lack of standards in the management of these lesions and to assess the potential of DCB as a preferential treatment strategy over DES in the long term. RECENT FINDINGS: Technological advancements have improved drug-eluting stents (DES) and drug-coated balloons (DCB) which offer a more promising avenue for managing SVCAD. According to new data, DCBs, initially recognized for their efficacy in preventing restenosis within three to five years of stent placement, may offer superior outcomes compared to DES in certain clinical scenarios. This review shows that DCBs have a favorable therapeutic profile in the treatment of SVCAD, and they could be considered as an alternative to DES. Although the initial data is compelling, definitive conclusions cannot be met without further large-scale, long-term clinical trials. The implication of these findings suggests a shift in the future of SVCAD management and requires additional research to substantiate the long-term benefits of DCB use in SVCAD. Should ongoing and future studies corroborate the current evidence, DCB could emerge as the standard of care for SVCAD, significantly influencing clinical practices and future research.

The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore - 12 Months Results of the PRISTINE Registry.

PURPOSE: The aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore. METHODS: PRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. RESULTS: Seventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint. CONCLUSIONS: The Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS. LEVEL OF EVIDENCE: Level 2b, Individual Cohort Study.

Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE â ¢ Trial.

BACKGROUND: Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain. OBJECTIVES: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions. METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months. RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370). CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).

Efficacy of Drug-Coated Balloon Angioplasty in Pulmonary Vein Stenosis or Total Occlusion.

BACKGROUND: Current therapies for pulmonary vein stenosis (PVS) or pulmonary vein total occlusion (PVTO) involving angioplasty and stenting are hindered by high rates of restenosis. OBJECTIVES: This study compares a novel approach of drug-coated balloon (DCB) angioplasty and stenting with the current standard of care in PVS or PVTO due to pulmonary vein isolation (PVI). METHODS: A retrospective single-center study analyzed patients with PVS or PVTO due to PVI who underwent either angioplasty and stenting (NoDCB group; December 2012-December 2016) or DCB angioplasty and stenting (DCB group; January 2018-January 2021). Multivariable Andersen-Gill regression analysis assessed the risk of restenosis and target lesion revascularization (TLR). RESULTS: The NoDCB group comprised 58 patients and 89 veins, with a longer median follow-up of 35 months, whereas the DCB group included 26 patients and 33 veins, with a median follow-up of 11 months. The DCB group exhibited more PVTO (NoDCB: 12.3%; DCB: 42.4%; P = 0.0001), with a smaller reference vessel size (NoDCB: 10.2 mm; DCB: 8.4 mm; P = 0.0004). Follow-up computed tomography was performed in 82% of NoDCB and 85% of DCB, revealing lower unadjusted rates of restenosis (NoDCB: 26%; DCB: 14.3%) and TLR (NoDCB: 34.2%; DCB: 10.7%) in the DCB group. DCB use was associated with a significantly lower risk of restenosis and TLR (HR: 0.003: CI: 0.00009-0.118; P = 0.002). CONCLUSIONS: The novel approach of DCB angioplasty followed by stenting is effective and safe and significantly reduces the risk of restenosis and reintervention compared with the standard of care in PVS or PVTO due to PVI.

Drug-coated balloons for coronary artery disease: An updated review with future perspectives.

Since the advent of coronary stents, two of the most common long-term complications after percutaneous coronary intervention (PCI) are in-stent restenosis (ISR) and stent thrombosis (ST). Although the rates of ST have been nearly abolished and ISR rates have declined with the current gold-standard second-generation drug-eluting stents (DES), late ISR of DES remains a valid concern in the field of interventional cardiology. The drug-coated balloon (DCB) is a non-stent technology that relies on the concept of targeted homogeneous drug delivery from an inflated balloon to restore luminal vascularity, treat atherosclerosis, and overcome some limitations of PCI, including ISR and prolonged dual antiplatelet therapy to prevent ST by leaving nothing behind. Most clinical evidence on coronary DCBs predominantly comes from small, randomized data and registries using paclitaxel DCBs for ISR and de novo lesions in the coronary space. Since 2014, outside the United States, DCBs have been approved for the treatment of ISR, with a class I recommendation by the European Society of Cardiology. The Food and Drug Administration very recently approved the Agent DCB to treat ISR in patients with coronary artery disease in the US. Additionally, recent randomized clinical data also showed DCB's safety and efficacy for the treatment of de novo small-vessel disease and high-bleeding-risk patients, while their role for other clinical situations including acute coronary syndrome, large-vessel disease, bifurcation lesions, and long-diffuse distal lesions is currently under investigation. Herein, we review the evidence-based role of DCBs in the treatment of coronary lesions and offer future perspectives.

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial.

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.

The efficacy of atherectomy combined with percutaneous transluminal angioplasty (PTA)/drug-coated balloon (DCB) compared with PTA/DCB for infrapopliteal arterial diseases: A systematic review and meta-analysis.

OBJECTIVES: With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT). This study was designed to perform a meta-analysis to investigate the efficacy of AT combined with percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) compared with PTA or DCB for infrapopliteal arterial diseases. METHODS: This is a systematic review and meta-analysis. The Pubmed, Web of Science, and Cochrane Library were systematically searched for articles published up to November 2022, reporting using atherectomy devices for infrapopliteal arterial patients. Randomized controlled trials and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. Then, we analyzed the efficacies of the AT (AT + PTA or DCB) group and the non-AT (DCB or PTA) group for infrapopliteal arterial patients. RESULTS: We identified 6 studies with 1269 patients included in this meta-analysis. The risk ratios (RRs) of primary patency for patients treated with atherectomy group compared to non-atherectomy group at 6 months was 1.03 (95% confidence intervals (CIs) 0.86-1.23, p = .74), at 12 months was 1.05 (95% CIs 0.84-1.30, p = .66), in the subgroup analysis between AT combined with DCB and DCB alone, the RRs of primary patency was 1.56 (95% CIs 1.02-2.39, p = .04). The RRs of freedom from target lesion revascularization (TLR) at 6 months was 1.04 (95% CIs 0.93-1.17, p = .45), at 12 months was 1.20 (95% CIs 0.83-1.75, p = .33). The RRs of mortality at 6 months was 0.57 (95% CIs 0.29-1.11, p = .10), and at 12 months was 0.79 (95% CI 0.50-1.25, p = .31). The RRs of limb salvage at 12 months was 0.99 (95% CIs 0.92-1.07, p = .87). The standardized mean difference (SMD) of (Ankle-brachial index) ABI at 12 months was 0.16 (95% CIs 0.06-0.26, p = .001). CONCLUSIONS: According to this systematic review and meta-analysis, no significant advantages were found with the addition of atherectomy to balloon angioplasty in the below-the-knee segment. Only in the analysis of a small subgroup of atherectomy + DCB versus DCB alone was the primary patency rate at six months significantly higher when adding atherectomy. No further significant differences were found related to 12 months of primary patency, TLR, limb salvage, and mortality among groups.

Comparison of angiographic change in side-branch ostium after drug-coated balloon vs. drug-eluting stent vs. medication for the treatment of de novo coronary bifurcation lesions.

OBJECTIVES: Data on side-branch (SB) ostial effect after drug-coated balloon (DCB) treatment in the context of de novo coronary bifurcation lesions are limited. We aimed to investigate the angiographic outcomes of SB ostium after DCB treatment compared with drug-eluting stents (DESs) implantation in the main vessel (MV) or optimal medical therapy (OMT) for the treatment of de novo coronary bifurcation lesions. METHODS: Serial angiographic changes in the SB ostium were compared between DCB, DES, and medication alone for MV treatment. Δ value was calculated by subtracting the follow-up value from the pre-procedure value. RESULTS: A total of 132 bifurcation lesions were included for analysis (44 lesions in DCB group; 38 lesions in DES group; 50 lesions in OMT group). The minimal lumen diameter (MLD) of SB ostium showed an increase at follow-up in the DCB group, whereas a decrease was observed in both the DES and OMT groups (ΔMLD: -0.16 ± 0.45 mm for DCB group vs. 0.50 ± 0.52 mm for DES group vs. 0.08 ± 0.38 mm for OMT group, p < 0.001). The diameter stenosis (DS) of SB ostium showed a marked decrease at follow-up in the DCB group, in contrast to an increase observed in both the DES and OMT groups (ΔDS: 8.01 ± 18.96% for DCB group vs. -18.68 ± 18.60% for DES group vs. -2.05 ± 14.58% for OMT group, p < 0.001). CONCLUSIONS: In de novo coronary bifurcation lesions, DCB treatment on the MV demonstrated favorable angiographic outcomes in the SB ostium at 6-9 month follow-up compared to DES implantation or OMT.