Drug-eluting Balloon Research Articles

Outcome of Coronary Edge In-stent Restenosis Management by Restenting Versus Drug-Eluting Balloon

Abstract Background: The optimal therapeutic strategy for coronary intervention in edge in-stent restenosis (edge ISR) remains less well-defined. Aim: The aim of this study was to assess 12-month outcomes of re-stenting using drug-eluting stents (DESs) versus using drug-eluting balloon (DEB) for managing coronary edge ISR. Patients and Methods: One hundred and four patients with edge ISR were randomly assigned to either DES or DEB. The primary endpoint was stent failure at 12-month follow-up. Results: Significantly lower target vessel revascularization among the DEB group compared to restenting group, (7.7% vs. 23.1%, P = 0.04). Likewise, target vessel-related myocardial infarction rate was significantly lower among the DEB group than restenting (5.7% vs. 23.1%, P = 0.04). On the other hand, there were no significant differences in the rates of deaths or restenosis between the two groups. Conclusion: The DEB is superior to the DES with better both safety and efficacy.

Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry.

Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR). We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR. Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR). A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES. Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Drug-eluting devices versus angioplasty in infrapopliteal artery disease:an updated systematic review and meta-analysis

Abstract Background Clinically driven target lesion revascularization (CD-TLR) and restenosis are common complications in individuals with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease undergoing percutaneous transluminal angioplasty (PTA). Drug-eluting balloons, stents, and resorbable scaffolds have emerged as an alternative therapy that may decrease the recurrence of these complications compared to PTA. However, their efficacy and safety are still controversial. Purpose This study aims to update and provide new insights about coated balloons, stents, and resorbable scaffolds as drug-eluting devices compared to PTA in patients with CLTI and infrapopliteal artery disease. Methods We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing drug-eluting devices, such as stents, coated balloons, and resorbable scaffolds, to PTA in patients with CLTI and infrapopliteal artery disease. The primary endpoint of interest was (1) CD-TLR. We only included trials defining this outcome as angiographically confirmed restenosis associated with wound changes or change in Rutherford classification at 12 months follow-up. This study also reported the following secondary outcomes: (2) binary restenosis and (3) amputation. We performed a subgroup analysis of the drug-eluting devices and between the drug-eluting pharmacological class, comparing the limus drug family subgroup and Pactlitaxel subgroup. Results We included 6 RCTs, encompassing 1263 patients, of whom 761 (60.2%) received a drug-eluting device. The mean age was 70.94 years. In the pooled analysis, the primary endpoint of CD-TLR was not statistically significant(OR 0.79; 95% CI 0.56-1.12; p=0.64; figure 1A). Although binary restenosis (OR: 0.62; 95% CI 0.36-1.05; p= 0.04; Fig.1B) was not statistically significant, our subgroup analysis of different drug-eluting pharmacological classes was significantly different(p&amp;lt;0.01; Fig.1B). Furthermore, the -limus family subgroup presented with a significant lower (OR 0.39; 95% CI 0.25 - 0.61; p&amp;lt;0.01; Fig. 1B) binary restenosis. There was no significant difference in the amputation endpoint (OR: 1.12; 95% CI 0.52 - 2.49; p= 0.74) and among the drug-eluting devices subgroup (p=0.63; Fig. 1A) for the CD-TLR endpoint. Conclusion In this updated meta-analysis of patients with CLTI and infrapopliteal artery, drug-eluting devices were not associated with CD-TLR compared to PTA. However, the -limus drug family is associated with a more significant reduction in the binary restenosis endpoint.

Current application and results of the combined use of intravascular lithotripsy and rotational atherectomy for the treatment of calcified coronary lesions

Abstract Background Intravascular lithotripsy (IVL) and rotational atherectomy (RA) might be used simultaneously (Rotatripsy) to treat calcified lesions during percutaneous coronary intervention (PCI), though data on the effectiveness and sequence of their use is limited. Purpose To identify indicators for the use of Rotatripsy and to assess its safety and success rates, both acutely as at one-year follow-up. Methods Patients undergoing PCI with IVL and RA across six centers in two European countries from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Angiographic and intracoronary imaging (ICI) data were analyzed centrally. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis &amp;lt;30% by quantitative coronary analysis) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised rotatripsy-related complications and MACE at one-year follow-up. Results A total of 114 patients (75±9 years, 78% male) underwent rotatripsy for 120 lesions. Patients presented with an ACS in 58(51%) cases and chronic coronary syndrome in 56(49%). The left anterior descending artery(n=66, 55%) was the most frequently treated target vessel, with diverse lesions being addressed, including bifurcations(30%), ostial(18%), CTO(7%) and in-stent(12%) lesions. The mean burr size was 1.5±0.2mm with a maximum rotational speed of 171±15k rpm and burr/vessel ratio of 0.46±0.2. IVL involved an average of 68±25 pulses and a balloon size of 3.5±0.5mm. The predominant used sequence of rotatripsy was RA followed by IVL(n=106, 88%). Among these cases, IVL was electively combined with RA in 68(57%) lesions, and used for balloon underexpansion(n=37, 31%) and stent crossing failure after RA(n=1, 1%). Additionally, IVL served as bail-out strategy after RA and stenting in 10(8%) and preceded RA in 4(3%) lesions, particularly when balloon/stent delivery failed after IVL. After rotatripsy, stents were implanted in 116(97%) lesions and drug-eluting balloon used in 3(3%). ICI was utilized in 69(58%) target lesions. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications occurred in 4 patients(4%), and included two(2%) coronary perforations, one(1%) dissection and one(1%) burr entrapment. At one-year follow-up (present in 77(67%)), MACE was observed in 7(6%). Conclusions Rotatripsy demonstrated efficacy across diverse clinical and anatomical settings, with the majority of procedures electively employing RA before IVL. High success rates and low complication rates were observed, with few patients experiencing MACE at one-year follow-up.

Midterm results of endovascular treatment of ateriovenous fistula stenosis at Dong Nai General Hospital

Introduction: AVF stenosis is a common complication, leading to impaired dialysis function, increased risk of occlusion and increased mortality. Endovascular intervention treatment of AVF stenosis is an important technique in the management of dialysis patients, particularly at local hospitals. Methods: This is a retrospective study performed at Dong Nai general hospital from 2022-2024. Results: The success rate of endovascular intervention to treat AVF stenosis at Dong Nai General Hospital is 91%, 3-month primary patency was 93.1% and 6-month primary patency was 86.2%. Drug-coated balloons (DCB) shows superior effectiveness compared to conventional balloons (PBA) with a lower restenosis rate. Conclusion: Endovascular intervention to treat AVF stenosis at Dong Nai General Hospital has good short term and midterm results. Drug-eluting balloons have a statistically significantly lower mid-term restenosis rate than conventional balloons. Implementing this technique at provincial hospitals helps reduce the burden on central hospitals and reduce medical costs for chronic kidney failure patients requiring hemodialysis.

Stent Underexpansion Is an Underestimated Cause of Intrastent Restenosis: Insights From RESTO Registry.

Despite improvement in devices, in-stent restenosis remains a frequent and challenging complication of percutaneous coronary interventions. The RESTO (Morphological Parameters of In-Stent Restenosis Assessed and Identified by OCT [Optical Coherence Tomography]; study NCT04268875) was a prospective multicenter registry including patients presenting with coronary syndromes related to in-stent restenosis. All patients underwent preintervention OCT analysis, which led to analysis of in-stent restenosis phenotype, number of strut layers, and presence of stent underexpansion. The primary end point was the in-stent restenosis type according to the OCT morphological classification. The 1-year incidence of target vessel failure (a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) was assessed. The study included 297 patients. The culprit stent was a drug-eluting stent in 74.2% of cases. OCT analysis revealed the presence of neoatherosclerosis in 57% (52% calcified), neointimal hyperplasia in 43% (58% homogeneous), stent underexpansion (minimal stent area <4.5 mm2) in 43%, and multiple stent layers in 30%. The prepercutaneous coronary intervention OCT analysis modified the operator's strategy for management in 30% of cases. Treatment involved drug-eluting stent implantation in 61.6% and drug-eluting balloon angioplasty in 36.1% of cases with only 63.2% optimal results. The 1-year target vessel failure incidence was 11% (95% CI, 9%-13%). Residual postpercutaneous coronary intervention stent underexpansion was associated with significantly higher target vessel failure incidence (19% [95% CI, 14%-24%] versus 7% [95% CI, 5-9], P=0.01). OCT identified neoatherosclerosis and neointimal hyperplasia in comparable proportions. Stent underexpansion was frequent and favored subsequent adverse clinical outcomes.

Comparison of Clinical Outcomes between Drug-Eluting Balloons and Drug-Eluting Stents in Patients with Small Coronary Artery Disease

Background/Aims: Drug-eluting balloons (DEBs) represent a novel therapeutic approach for patients with small coronary artery disease. However, further studies are needed to compare the clinical efficacy of DEBs versus drug-eluting stents (DESs).Methods: In total, 492 patients (age, 67.9 ± 11.0 years; 339 men) with small coronary artery lesions (diameter &lt; 2.75 mm) were randomly assigned to group I (DEB) (n = 104; age, 67.2 ± 10.7 years; 83 men) and group II (DES) (n = 388; age, 68.0 ± 11.1 years; 254 men). For inverse probability of treatment weighting (IPTW) analysis, the study population was stratified into groups I (n = 269) and II (n = 280). We compared the incidences of major adverse cardiac events (MACE) between the two groups during 12 months of clinical follow-up.Results: Group I had shorter device lengths (22.4 ± 5.8 mm) compared with group II (27.4 ± 9.3 mm; p &lt; 0.001). Additionally, devices in group I were smaller in diameter (2.4 ± 0.1 mm) compared with those in group II (2.6 ± 0.1 mm; p &lt; 0.001). Left ventricular ejection fraction (LVEF) was lower in group I (53.8% ± 12.6%) than in group II (58.6% ± 11.9%; p &lt; 0.001). After IPTW, no significant differences in LVEF were observed between groups I and II. During 12 months of follow-up, the incidence of total MACE did not differ between the two groups.Conclusions: No significant differences were observed in clinical efficacy between DEB and DES for the treatment of small coronary artery disease. Therefore, DEB can be considered a viable alternative to DES in patients with small coronary artery disease.

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Comparison of the efficacy of drug-coated balloon angioplasty and conventional balloon angioplasty in the endovascular treatment of thrombosed arteriovenous dialysis fistulas.

To evaluate the efficacy and safety of paclitaxel-coated balloon angioplasty in the treatment of thrombosed arteriovenous fistulas. This prospective, randomized, controlled study investigated the use of drug-eluting balloons in the treatment of the thrombosis of arteriovenous fistulas (AVFs) at our center between January 2018 and January 2023. A total of 246 patients were included in the study. The mean age of the patients was 61.3 ± 11.5 years. Of the patients, 150 (61%) were male and 96 (39%) were female. Angioplasty was performed using a plain balloon (PB) in 126 patients (51.2%) and a drug-coated balloon (DCB) in 120 (48.8%). The control images of the patients were obtained at the sixth and 12th months. Patency was evaluated during the follow-up. There was no significant difference between the two groups in terms of age, gender, hypertension, hyperlipidemia, diabetes, fistula location, or stenosis length. No significant difference was observed between the groups regarding the number of complications observed during and after the procedure. At the end of the sixth month, the patency rate was found to be 86.7% in the DCB group and 78.6% in the PB group. The 12th-month patency rate was 77.5% in the DCB group and 57.9% in the PB group. A significant difference was detected between the two groups in relation to the 6th- and 12th-month patency rates (p = 0.034 and p = 0.046, respectively). Drug-coated balloon angioplasty is an effective approach to the treatment of thrombosed AVFs, especially in terms of prolonging primary patency and reducing the need for secondary procedures.

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

Drug-Eluting Balloons and Drug-Eluting Stents in Diabetic Patients Undergoing Percutaneous Coronary Intervention Due to Restenosis-DM-Dragon Registry.

Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01-13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings.

An Evaluation on Drug-Eluting Balloons in Arterial Circulatory Issues

Endovascular interventions have recently become the first-line treatment for arterial diseases (AD). However, there is no consensus yet on the primary endovascular method. Intensive studies carried out in recent years have been aimed not only at the treatment of existing stenosis but also at preventing the narrowing problem. Drug-eluting balloons (DEB) have recently become a new alternative treatment in this context. DEB allows the release of antiproliferative drug into the stenosis area without leaving any stent strut. It increases the therapeutic effect by preventing intimal proliferation and restenosis. Available data show that DEB has satisfactory efficacy and low risk, is superior to BMS and is noninferior to DES. It may be a suitable alternative for preventing coronary and peripheral artery diseases and in-stent stenosis. This article aims to review current data on the use of DEB in arterial diseases.

Treatment of renal artery fibromuscular dysplasia with drug-eluting balloon angioplasty and intravascular imaging: a case report

Fibromuscular dysplasia (FD) is a segmental, non-inflammatory and non-atherosclerotic disease of vascular smooth muscle of unknown etiology, which leads to stenosis of smalland medium-sized arteries. The choice of surgical treatment tactics for renal artery FD depends on the severity of clinical manifestations and the response to the conservative drug treatment used. Young age, female sex, high blood pressure with failure to achieve target values with therapy, as well as the absence of atherosclerotic involvement of other arterial systems gives reason to suspect renal artery FD. According to modern guidelines, the invasive treatment of hemodynamically significant renal artery stenoses includes transluminal drug-eluting balloon angioplasty. In this disease, renal artery stenting is not recommended. However, stent implantation is required if balloon angioplasty did not give the optimal result or in case of periprocedural complications, such as arterial dissection. Open reconstructive surgery is indicated for complex anatomy of the related artery, macroaneurysms in which stent grafts are ineffective, refractory intimal fibroplastic lesions, increased risk of endovascular treatment, or after unsuccessful endovascular intervention. The article presents a case of a young patient with renal artery FD, renovascular arterial hypertension, who successfully underwent renal artery transluminal drugeluting balloon angioplasty.

Drug-eluting stent vs. Balloon angioplasty in patients with in-stent restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IntroductionIn-stent restenosis (ISR) is seen in up to 20% of cases and is the primary cause of percutaneous coronary intervention (PCI) failure. With the use of re-stenting with a drug-eluting stent (DES), plain old balloon angioplasty (BA) use is decreasing. We aim to compare the efficacy and safety profile of DES over BA in the management of ISR. MethodsElectronic databases were searched to identify all randomized controlled trials (RCTs) comparing DES to BA for coronary ISR. The mantel-Haenszel method with a random effects model was used to calculate pooled risk ratios (RR). ResultsFour trials comprising 912 patients (543 in DES and 369 in the BA group) were included in the final study. The mean follow-up was 45 months. DES was found to be superior with a lower requirement of target vessel revascularization (TVR) (RR: 0.45, 95% CI: 0.31–0.64, p-value <0.0001), and target lesion revascularization (TLR) (RR: 0.59, 95%CI: 0.44–0.78, p-value 0.0002) compared to BA. However, all-cause mortality, cardiovascular mortality, incidence of myocardial infarction (MI), and target lesion thrombosis were not different between the two intervention arms. ConclusionDES was found to be superior to BA for the management of coronary ISR with a reduction in the risk of TLR and TVR. No difference in mortality, risk of MI, or target lesion thrombosis was observed between the two interventions.

Use of Drug Eluting Balloons and 1–2-Year outcomes in Tauranga Hospital Cardiac Catheterisation Laboratory— An Audit

Use of Drug Eluting Balloons and 1–2-Year outcomes in Tauranga Hospital Cardiac Catheterisation Laboratory— An Audit

Drug-Eluting Balloon for Coronary In-Stent Restenosis: Could it be an Emerging Strategy?

Despite significant improvement in PCI, including drug-eluting stent (DES) applications, in-stent restenosis (ISR) remains a problem. ISR is challenging to manage. Repeat stenting with bare metal stent (BMS), repeat stenting with DES and bioresorbable vascular scaffolds is primarily used to prevent and treat ISR. Current European guidelines recommend DES or a drug-eluting balloon (DEB) to treat ISR with a Class I indication. However, its use in coronary artery interventions has not yet been approved in the United States. DEB allows the application of the antiproliferative drug to the ISR site without leaving an additional layer of stent strut. Studies show that DEB is superior to plain balloon alone and comparable to DES in ISR treatment. They are increasingly preferred due to their good therapeutic effect in preventing intimal proliferation and restenosis. This review aims to provide an overview on the feasibility of using DEB in ISR management based on current knowledge

REVASCULARIZATION WITHOUT DES: A CASE REPORT ABOUT METALLIC–LESS REVASCULARIZATION TECHNIQUES

Abstract Rational 56 years old patient, admitted to our service for myocardial infarction without ST elevation. In medical history he had dyslipidaemia, hypertension and familiarity for cardiovascular disease, without previous cardiological problems. The patient went to the ER for chest pain, started after his work shift. When admitted to the ER, the patient was still symptomatic for chest pain, with resolution after 3 hours after somministration of analgesics, with normal pressure and heart rate. An ECG was performed, without relevant findings, at the blood exams significative movement of cardiac troponins. At the echocardiogram apical hypokinesia of left ventricle with preserved ejection fraction. Technical Resolution Coronarography was performed, with evidence of severe diffuse atheromatic disease of the left anterior descending artery (LAD) at the proximal segment and sub–occlusive stenosis at the middle segment. Due to the diffuseness of the atherosclerotic disease on the LAD, which would have required a complete stenting of the artery, which using classical Drug Eluted Stents would have led to a complete metallization of the artery, in such a young patient who does not have medical history suggesting a progression of the atheromatic disease, metallic–less techniques were chosen. The two lesions were pre–dilatated with a non–compliant (NC) balloon. The proximal lesion was treated with a bioresorbable scaffold (BVS) Magmaris 3x25 mm, post–dilatated with a NC balloon, without complications. The distal segment was treated with a Drug Eluting Balloon (DEB) Pantera Lux 2.5x20 mm, expanded for 90 seconds, with evidence of focal dissection, not flow limiting.At the clinical follow–up performed at one and three months, the patient was asymptomatic for angina, without any cardiovascular event. Clinical Implications When facing coronaropathy in a young patient, it is a good option to treat the coronary with techniques that do not leave metallic material in the arteries, which exposes young patients to a higher rate of complications if compared to older patients. When it is preferred to use this kind of techniques, the options can be DEB or BVS. As seen in this case report, often the DEB can lead to complications. It’s well–known that every DEB complication needs a DES to fix it. However, little is proven and studied about the use of BVS on de–novo lesions and on coronary injuries as complications of “conventional” PCI, as well as those derived from DEB delivery.

Drug-Eluting Balloons in Calcified Coronary Lesions: A Meta-Analysis of Clinical and Angiographic Outcomes.

Background: The usefulness of drug-eluting balloons (DEBs) has not been fully elucidated in calcified coronary lesions (CCLs). This meta-analysis aimed to evaluate the efficacy of DEBs compared to a drug-eluting stent (DES) in this setting. Methods: PubMed, EMBASE and Cochrane were searched through December 2023. The primary endpoint was 12 months major adverse cardiac events (MACE). Secondary endpoints included clinical outcomes and angiographic results after PCI and at a 12-month follow-up. Results: Five studies and a total of 1141 patients with 1176 coronary lesions were included. Overall, the DEB was comparable to DES in MACE (RR = 0.86, 95% CI: 0.62-1.19, p = 0.36), cardiac death (RR = 0.59, 95% CI: 0.23-1.53, p = 0.28), myocardial infarction (RR = 0.89, 95% CI: 0.25-3.24, p = 0.87) and target lesion revascularization (RR = 1.1, 95% CI: 0.68-1.77, p = 0.70). Although the DEB was associated with worse acute angiographic outcomes (acute gain; MD = -0.65, 95% CI: -0.73, -0.56 and minimal lumen diameter; MD = -0.75, 95% CI: -0.89, -0.61), it showed better results at 12 months follow-up (late lumen loss; MD = -0.34, 95% CI: -0.62, -0.07). Conclusions: This meta-analysis showed that the DEB strategy is comparable to DES in the treatment of CCLs in terms of clinical outcomes. Although the DEB strategy had inferior acute angiographic results, it may offer better angiographic results at follow-up.

Improved Ultrasound-Guided Balloon-Assisted Maturation Angioplasty Using Drug-Eluting Balloons in the First Autogenous Arteriovenous Fistula Procedure: Early Experience.

In patients with end-stage renal failure requiring hemodialysis, autogenous arteriovenous fistula (AVF) is preferred over tunneled dialysis catheters due to lower complications and costs. However, AVF maturation failure remains a common issue due to small vein size, multiple venipunctures, and other factors. Guidelines recommend using vessels of >2 mm for forearm AVFs and >3 mm for upper arm AVFs. This study investigates the use of intraoperative Doppler ultrasound (DUS)-guided Balloon-Assisted Maturation (BAM) with drug-eluting balloons (DEB) during initial AVF creation. Data from 114 AVF procedures, of which 27.2% underwent BAM, were analyzed. BAM was performed in 25 distal radio-cephalic and 6 proximal brachio-cephalic AVFs. With DUS guidance, vein stenosis was identified and treated using DEB. Technical success was achieved in all cases, with no early mortality. Early BAM-related complications were minimal, and no AVF thrombosis occurred. AVF maturation time was 15 days (SD: 3), and no further complications were reported during a mean follow-up of 10.38 months. Using BAM with DEB during AVF creation led to successful maturation and dialysis use without the need for secondary procedures. This study emphasizes the importance of identifying AVF failure risk early and utilizing DUS-guided procedures to enhance AVF outcomes. A more liberal use of intraoperative BAM could limit reinterventions in patients undergoing AVFs.

Salutary Effects of mTOR Inhibition on Deep Veins in Vivo: Results from the Sirolimus Trial with Drug-Eluting Balloon (STRIDE)

Salutary Effects of mTOR Inhibition on Deep Veins in Vivo: Results from the Sirolimus Trial with Drug-Eluting Balloon (STRIDE)