Use Of Drug-coated Balloons Research Articles

Optimizing the life of vascular access during follow-up.

Optimizing the longevity of vascular access in hemodialysis patients remains a critical aspect of patient care, given the significant role of arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) in enabling effective dialysis. Vascular access complications, such as stenosis, thrombosis, and cannulation-related damage, continue to challenge both the functionality and the sustainability of these access points. Recent advancements underscore the importance of a robust follow-up strategy, integrating clinical evaluations with diagnostic tools like color Doppler ultrasound (CDU) and emerging interventional approaches such as drug-coated balloon (DCB) angioplasty. Regular CDU surveillance has shown promise in identifying asymptomatic stenosis, providing an opportunity for early intervention and reducing the risk of thrombotic events. This non-invasive imaging modality allows for detailed evaluation of hemodynamic changes within the vascular access, enabling timely detection and monitoring of stenotic lesions. Furthermore, the use of DCBs - angioplasty balloons coated with antiproliferative agents such as paclitaxel - offers a targeted approach to manage intimal hyperplasia and reduce restenosis rates in vascular access sites. Studies indicate that DCBs can mitigate neointimal proliferation, prolonging patency and enhancing long-term access outcomes. In this paper, we explore the synergistic role of clinical follow-up, ultrasound-based diagnostics, and drug-coated technologies in the preservation of vascular access. By examining the impact of these strategies, we aim to provide a comprehensive approach to vascular access maintenance, emphasizing the need for structured surveillance protocols and interventional techniques to optimize the lifespan of hemodialysis access points.

Delivery of N-Cadherin Targeting Peptides to Vascular Tissues by Surface-Modified Polyurethane Nanoparticles via a Drug-Coated Balloon.

Restenosis remains a long-standing limitation to effectively maintain functional blood flow after percutaneous transluminal angioplasty (PTA). While the use of drug-coated balloons (DCBs) containing antiproliferative drugs has improved patient outcomes, limited tissue transfer and poor therapeutic targeting capabilities contribute to off-target cytotoxicity, precluding adequate endothelial repair. In this work, a DCB system was designed and tested to achieve defined arterial delivery of an antirestenosis therapeutic candidate, cadherin-2 (N-cadherin) mimetic peptides (NCad), shown to selectively inhibit smooth muscle cell migration in vitro and limit intimal thickening in early animal PTA models. To enable successful tissue transfer in the current work, a nanoparticle excipient system previously demonstrated to be an effective carrier of NCad in vitro was integrated with customized DCB coating methodologies designed to prevent therapeutic loss during delivery. DCB design took into consideration four components: (1) the angioplasty balloon; (2) a poly(ethylene oxide) (PEO) monolayer acting as a hydrophilic spacer between the balloon surface and the nanoparticles to assist with improved nanoparticle release; (3) surface-modified degradable polar hydrophobic ionic polyurethane (D-PHI) nanoparticles loaded with NCad to facilitate the transport of the therapeutic peptide into vascular tissue; and (4) a PEO sacrificial coating applied over the nanoparticle excipient layer to prevent premature losses during transit to the artery. The nanoparticle-DCB platform successfully delivered NCad to rat carotid tissue, with superior efficacy and increased permeation within the vessel wall compared with soluble NCad infusion alone. Nanoscale technologies in conjunction with enhanced DCB design properties hold promise in advancing the localized delivery of preventive restenosis therapies in vascular disease.

Effectiveness of in-stent restenosis treatment using drug-eluting stents, paclitaxel-coated balloons, and sirolimus-coated balloons in managing complications after PCI in atherosclerosis patients

Introduction: Coronary artery disease (CAD) is one of the leading causes of death worldwide. One of the primary causes of CAD is atherosclerosis. One of the management strategies for atherosclerosis is Percutaneous Coronary Intervention (PCI) using drug-eluting stents (DES). This procedure involves the insertion of a catheter to place a stent that opens narrowed blood vessels due to plaque accumulation. However, this procedure may be repeated due to complications such as in-stent restenosis (ISR), which is the re-narrowing of the arterial lumen after stent placement, caused by intimal hyperplasia. Two endovascular interventions that can be options for treating ISR are re-implantation of a DES or the use of drug-coated balloons (DCB). DCB presents an alternative to re-stenting. There are two DCB treatment options: Paclitaxel Coated Balloon (PCB) and Sirolimus Coated Balloon (SCB), whose effectiveness will be compared. Methods: This literature review is written as a result of various interrelated literature studies, supported by analytical discussions. Literature search sources used six databases namely PubMed, Web of Science, Scopus, CINAHL, Proquest, and Cochrane with published years 2014-2024. The types of studies included are full text articles, systematic review, meta-analysis, randomized controlled trials, and case-control study. Summary: Both DCBs showed nearly identical angiographic courses with very low lumen narrowing in this high-risk group in the treatment of DES restenosis after 6 months. This is the first indication that SCB is as effective as the best-in-class PCB.

First-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis.

Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall. The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus. The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe. The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P < 0.001). This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR. NCT05731700.

Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes.

The evidence for optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in improving the prognosis of individuals with in-stent restenosis (ISR) is lacking. This retrospective study enrolled 588 consecutive individuals with drug-eluting stent ISR undergoing PCI from March 2010 to March 2022. Two hundred seven (35.2%) underwent OCT guidance, and 381 (64.8%) underwent angiography guidance. Clinical outcomes were analyzed using survival curves. The primary clinical endpoint was 2-year major adverse cardiovascular events (MACEs), a composite of all-cause death, myocardial infarction, and target-vessel revascularization. Compared with angiography guidance, OCT guidance demonstrated a higher frequency of drug-coated balloon use and adjunctive therapeutic modalities, including predilation, postdilation, nonslip element balloons, and noncompliant balloons (P<0.05). Following PCI, the OCT-guided group achieved a significantly larger minimum lumen diameter (2.36 versus 2.15 mm, P<0.001) and a lower percentage diameter stenosis (17% versus 20%, P<0.001) than the angiography-guided group. Survival analysis revealed significantly lower 2-year MACEs in the OCT-guided group compared with the angiography-guided group (7% versus 15%, P=0.007), validated in the propensity matching analysis (7% versus 15%, P=0.001). Multiple sensitivity analyses showed that OCT-guided PCI treatment was an independent protective factor for 2-year MACEs in individuals with drug-eluting stent ISR. Compared with angiography guidance, OCT guidance is associated with a lower 2-year MACE risk among individuals with drug-eluting stent ISR. Therefore, OCT should be actively considered for guiding PCI treatment in individuals with drug-eluting stent ISR. Url: clinicaltrials.gov. Identifier: NCT03809754.

Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review.

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives.

TCT-404 Trends of Drug Coated Balloon Use in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry

TCT-404 Trends of Drug Coated Balloon Use in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry

Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions

Abstract Background lesions at the bifurcation of coronary arteries pose a substantial difficulty due to their intricate anatomical structure and the increased risk of complications during or after the procedures. Drug-coated balloons (DCBs) have recently been recognized as a promising therapeutic strategy for managing bifurcation lesions. Objective to compare the use of drug-coated balloons versus ordinary balloons in provisional stenting of coronary artery bifurcation lesions and its impact on the procedural success rate &amp; short-term MACE Patients and Methods The current study is a prospective, longitudinal cohort, interventional two arm study that included a total of 66 patients. 40 in Control group (group A) and 26 in case group (group B). every patient is assigned to a particular group based on the operator’s preference. In both groups provisional stenting was employed, with dilation of the side branch using a standard balloon in group “A” and a drug-coated balloon in group “B”. The evaluation of the outcomes of the indexed procedure and a six-month follow-up were conducted to monitor the incidence of Major Adverse Cardiac Events (MACE). Results The mean age of patients assigned to the Group A was 57.18 ± 9.84 years, while patients assigned to the Group B had a mean age of 55.50 ± 7.74years, both groups were similar in demographic data, baseline clinical characteristics and Echocardiographic Data. The study’s primary endpoint was the occurrence of major adverse cardiac events (MACEs), at a 6-month follow-up. A significant difference was observed between the case and control groups in terms of MACE after 6 months. The incidence of MACE was 23.7% (9 out of 38 patients who continued the study after 2 cases of in- hospital mortality) in the control group, compared to only 3.9% (1 out of 26 patients) in the case group, with a p-value of 0.039. the secondary endpoints of the study, which encompassed the attainment of lesion success and procedure success, did not show a statistically significant difference between the case and control groups despite the observed variation in the complication rat Conclusion The application of drug-coated balloons in provisional stenting for coronary artery bifurcation lesions demonstrated superiority over conventional balloons in terms of short-term major adverse cardiac events (MACE), and exhibited non-inferiority in relation to lesion or procedural success.

TCT-439 Temporal Trends in the Use of Drug-Coated Balloons in Poland: An Analysis Based on the National Registry

TCT-439 Temporal Trends in the Use of Drug-Coated Balloons in Poland: An Analysis Based on the National Registry

Predictors of recurrent restenosis after repeat drug-coated balloon therapy for drug-coated balloon restenosis in femoropopliteal lesions: Results of the RECURRENCE study.

Despite the widespread use of drug-coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions. This multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled. The Kaplan-Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79-0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36-7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15-6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001). Repeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis.

Spanish cardiac catheterization and coronary intervention registry. 33rd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2023)

Introduction and objectivesThis article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC). MethodsAll interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board. ResultsA total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism. ConclusionsThe 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases.

Impact of multiple ballooning on coronary lesions as assessed by optical coherence tomography and intravascular ultrasound.

Optimal lesion preparation for coronary lesions has been reappraised in the interventional community, given the increasing use of drug-coated balloons for de novo lesions; however, whether multiple ballooning could achieve more favorable angiographic results compared with single ballooning remains unknown. We aimed to investigate the incremental effect of multiple ballooning on de novo coronary lesions over single ballooning as assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS) among patients undergoing percutaneous coronary intervention (PCI). Patients with chronic coronary syndrome (CCS) undergoing PCI were enrolled. Ballooning before stent implantation was repeatedly performed for three times using the same semi-compliant balloon. OCT and IVUS were performed after each balloon dilatation. Primary outcome measure was the difference in the mean lumen area between post-1st ballooning (1B) and post-3rd ballooning (3B) as assessed by OCT. A total of 32 lesions in 30 patients undergoing PCI between May 2021 and August 2022 were analyzed. Major plaque types of the lesions were fibrous (68.8%) and lipid (28.1%). Mean lumen area by OCT was significantly increased from 1B to 3B (5.9 ± 2.9 mm2 vs. 6.0 ± 2.9 mm2, difference: 0.2 ± 0.4 mm2, p = 0.040). There were significant increases from 1B to 3B in minimum lumen area by OCT (3.1 ± 1.5 mm2 vs. 3.6 ± 1.7 mm2, difference: 0.5 ± 0.6 mm2, p < 0.001) and mean dissection angle by OCT (65.6 ± 24.9° vs. 95.2 ± 34.0°, difference: 29.6 ± 25.5°, p < 0.001). Additionally, mean plaque area by IVUS was significantly decreased (8.0 ± 4.2 mm2 vs. 7.8 ± 4.1 mm2, difference: -0.2 ± 0.2 mm2, p < 0.001). Among CCS patients with mainly non-calcified lesions, multiple ballooning significantly increased the lumen area and dissection angle compared with single ballooning.

Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry: A subgroup analysis.

The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia. BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups. A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p = .0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p = .0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups. Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation. NCT02276313.

The phenomenon of drug-coating embolism during lower extremity endovascular interventions with paclitaxel-coated balloon.

There is a risk of distal embolization lower extremity endovascular interventions. Possibly a drug-coating embolism caused by coating detachment from intravascular devices. This review focuses on providing updated information on distal embolism in endovascular revascularization of lower extremity arteries, including the use of drug-coated balloons. Drug-coating embolism is a special case of distal embolization during recanalization of the arteries of the lower extremities. Preclinical studies have demonstrated embolization of drug-coated balloons during angioplasty of lower extremity arteries. However, the clinical role of drug-coating embolism is not completely clear. A 2020 meta-analysis found an increased risk of major lower extremity amputation after drug-coated balloon angioplasty in patients with critical limb ischemia. But long-term research is emerging to support the safety of using these devices. Perhaps a more thorough assessment of the quality of life and the degree of compensation of lower limb ischemia with an intraoperative assessment of the frequency of peripheral embolizations using ultrasound emboli detection, as well as microcirculation with transcutaneous oximetry and laser Doppler flowmetry of the operated lower limb will allow a more detailed study of the phenomenon of drug-coating embolism and its impact on long-term clinical outcomes. According to the results of preclinical studies, the use of paclitaxel-coated balloons leads to an increase in the concentration of paclitaxel in distal skeletal muscles. However, paclitaxel concentration in skeletal muscle was significantly higher in first-generation DCBs. The non-target effects of drug-coating balloon are not fully understood and require further study. Understanding the phenomenon of drug-coating embolism can help physicians to better assess the patient risk and to minimize complications.

A New Frontier for Drug-Coated Balloons: Treatment of "De Novo" Stenosis in Large Vessel Coronary Artery Disease.

Background: Drug-coated balloons (DCB) are a well-established option for treating in-stent restenosis endorsed by European Guidelines on myocardial revascularization. However, in recent years, a strategy of "leaving nothing behind" with DCB in de novo coronary stenosis has emerged as an appealing approach. Methods: We performed a systematic review to evaluate the current literature on the use of drug-coated balloons in the treatment of de novo stenosis in large vessel disease. Results: Observational studies, as well as randomized studies, demonstrated the safety of DCB percutaneous coronary interventions (PCI) in large vessel disease. The rate of major adverse cardiac events is even lower compared to drug-eluting stents in stable coronary artery disease. Conclusions: DCB PCI is feasible in large vessel disease, and future large, randomized studies are ongoing to confirm these results.

Data sources and applied methods for paclitaxel safety signal discernment.

Following the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources. Studies and data sources were identified through comprehensive searches. original research studies, clinical trials, comparative studies, multicenter studies, and observational cohort studies written in the English language and published from January 2007 to November 2021, with a follow-up longer than 36 months, were included in the review. Data quality of available data sources identified was assessed in three groupings. Moreover, accepted data-driven methodologies that may help circumvent the limitations of the extracted studies and data sources were extracted and described. There were 39 studies and data sources identified. This included 19 randomized clinical trials, nine single-arm studies, eight registries, three administrative claims, and electronic health records. Methodologies focusing on the use of existing premarket clinical data, the incorporation of all contributed patient time, the use of aggregated data, approaches for individual-level data, machine learning and artificial intelligence approaches, Bayesian approaches, and the combination of various datasets were summarized. Despite the multitude of available studies over the course of eleven years following the first clinical trial, the FDA-convened advisory panel found them insufficient for comprehensively assessing the late-mortality signal. High-quality data sources with the capabilities of employing advanced statistical methodologies are needed to detect potential safety signals in a timely manner and allow regulatory bodies to act quickly when a safety signal is detected.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Using Drug-coated Balloons in Treating Coronary Bifurcation Lesions; Immediate and Short-term Outcomes

Background: Coronary bifurcation lesions present a technical challenge during percutaneous coronary intervention (PCI), accounting for 15-20% of all cases. Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DES), offering the potential to reduce the risk of neointimal hyperplasia and the need for long-term dual antiplatelet therapy (DAPT). Methods: This prospective, interventional two-arm trial involved 66 patients undergoing PCI for coronary bifurcation lesions at seven centers in Cairo, Egypt, from December 2021 to October 2023. Patients were divided into two groups: Group A (n=40), treated with ordinary balloons, and Group B (n=26), treated with DCBs. The primary outcomes assessed were procedural success, occurrence of Major Adverse Cardiac Events (MACE) over a six-month period, and changes in coronary dimensions as measured by quantitative coronary angiography (QCA). Results: Group B demonstrated a significantly lower incidence of MACE at 6 months (3.8%) compared to Group A (23.7%) (p=0.032). Fluoroscopy time was reduced in the DCB group (51.31 ± 28.12 minutes) compared to the control (69.33 ± 29.10 minutes, p=0.015). Acute lumen gain in the side branch was greater in the DCB group (2.15 ± 0.74 mm) compared to the control group (1.22 ± 0.94 mm, p=0.000). Late lumen gain after 6 months was also significantly higher in Group B (0.88 ± 0.15 mm) compared to Group A (-0.13 ± 0.28 mm, p=0.001). Conclusion: The use of drug-coated balloons (DCBs) for coronary bifurcation lesions reduces major adverse cardiac events (MACE) and improves procedural success rates.

Midterm Results of Drug-Coated Balloon and Bare Metal Stent in the Treatment of TASCII C/D Femoropopliteal Artery Occlusive Disease: A Retrospective Multicenter Study.

This study aimed to compare midterm efficacy between drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of TASCII C/D femoropopliteal artery lesions. The clinical data of patients with TASCII C/D femoropopliteal artery disease admitted to 3 vascular surgery centers from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into DCB group and BMS group. The DCB group was further subdivided into DCB alone subgroup and DCB+BMS subgroup. Study primary outcomes were freedom from clinical-driven target lesion reintervention (FCD-TLR) at 24 months postprocedure. Secondary outcomes included ankle brachial index (ABI), Rutherford classification, major amputation rate, and mortality. A total of 410 consecutive patients were enrolled. At 24 months follow-up, in DCB group (114 patients) relative to BMS group (296 patients), FCD-TLR (86.00% vs 71.91%, p=0.039), and ABI (0.53±0.11 vs 0.47±0.19, p=0.007) were higher; mean Rutherford class was lower (1.57±0.68 vs 3.31±1.39, p=0.000); and major amputation rate (0.87% vs 4.05%, p>0.05) and all-cause mortality (8.92% vs 6.41%, p>0.05) were statistically similar. In DCB alone, subgroup relative to DCB+BMS subgroup, FCD-TLR (90.00% vs 85.00%, p>0.05), major amputation rate (0 vs 1.08%, p>0.05), and all-cause mortality rate (9.09% vs 8.69%, p>0.05) were statistically similar, while FCD-TLR was higher in the DCB+BMS subgroup (90.00% vs 71.91%, p=0.045). At midterm follow-up of patients treated for TASCII C/D femoropopliteal artery disease, use of DCB or of DCB combined with rescue BMS appeared similarly efficacious, and yielded more favorable outcomes than use of BMS. The efficacy of drug-coated balloons relative to that of bare metal stents for the treatment of complex femoropopliteal artery lesions, particularly TASCII grade D lesions, remains uncertain. There is a scarcity of multicenter comparative studies, and in this multicenter retrospective study with up to 24-month follow-up, use of drug-coated balloon alone or combined with rescue bare metal stent appeared similarly efficacious while yielding more favorable outcomes than use of bare metal stent alone in the treatment of TASCII grade C/D femoropopliteal artery lesions. Randomized studies are warranted.

Efficacy and risks of drug-coated balloon treatment for coronary artery disease: A meta-analysis

IntroductionCoronary artery disease (CAD) often leads to myocardial ischemia and impaired cardiac function, significantly impacting the well-being and quality of life (QOL) of individuals. The use of drug-coated balloon (DCB) treatment has become a widespread approach in CAD management. However, currently, there is limited evidence available for the meta-analysis of DCB treatment in CAD. Materials and methodsA systematic search was conducted across databases including PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Database, and VIP Database, covering data from the inception of each database up to April 2023. Randomized controlled trials (RCTs) regarding DCB treatment were meticulously chosen based on independent assessment of eligibility and scope by three researchers. Literature screening and data extraction were independently performed by two researchers, while methodological quality of the enrolled studies was assessed using the risk of bias (ROB) tool developed by the Cochrane Collaboration. Meta-analysis was conducted using RevMan 5.3. ResultsFollowing the screening process, seven studies were included. Four studies demonstrated an odds ratio (OR) of 0.66 for target lesion revascularization (TLR), five reported an OR of 0.41 for postoperative myocardial infarction (MI), four indicated a mean difference (MD) of 6.03 in the degree of stenosis (DOS), five exhibited an MD of 0.13 for late lumen loss (LLL), five reported an OR of 0.33 for cardiac death, and two presented an OR of 1.01 for binary restenosis (BR). ConclusionDCB demonstrated a comparable efficacy to drug-eluting stents (DES) in treating CAD, with relatively lower associated risks.