The fate of coronary dissections left after sirolimus-coated balloon angioplasty: A prespecified subanalysis of the EASTBOURNE study.

OBJECTIVES: We sought to understand the clinical outcomes of dissections left untreated after sirolimus drug-coated balloon (DCB) angioplasty. BACKGROUND: DCB may be a valuable alternative to stents for the treatment of native coronary lesions, but the risk of having a dissection after DCB-angioplasty is not negligible. While type A and B dissections can be safely treated conservatively, some debate exists regarding type C dissections. We previously showed the safety of dissections left untreated after second-generation paclitaxel-DCB. However, the fate of dissections after sirolimus-DCB angioplasty has not been investigated so far. METHODS: EASTBOURNE is a prospective, multicenter, international, investigator-driven study aiming to explore the safety and efficacy of a novel sirolimus-DCB. This study enrolled a consecutive, all-comer population of coronary artery disease patients and is the largest prospective study on DCB so far. Primary endpoints of the study, target-lesion revascularization (TLR), and other clinical endpoints at 12 months, have been presented elsewhere. This is a prespecified subgroup analysis of the patients left with not-flow limiting dissection after DCB angioplasty, with complete 12 months follow-up and comparison between patients left with a dissection versus patients with DCB used for de novo lesions. RESULTS: Between September 2016 and November 2020, a total of 2123 patients were enrolled at 38 study centers. Seventy-three patients were left with nonflow limiting dissections (43 type A, 27 type B, 3 type C) and underwent complete 1-year clinical follow-up. In the nondissection group, 1110 patients had de-novo coronary artery disease while 900 had in-stent restenosis. Baseline characteristics were similar between the groups, while the dissection group was associated with longer lesions (23.8 vs. 18.4 mm, p < 0.001) and more frequent use of predilation (100 vs. 91.4%, p = 0.016). At 12-month follow-up, no significant differences among the groups were found, with a total of 1.25% TLR in the dissection cohort versus 5.6% in the de-novo cohort (p = 0.13), and an overall rate of major adverse cardiovascular events of 4.4% versus 10.1% (p = 0.18). Total death (1.5 vs. 2.6, p = 0.87), cardiac death, myocardial infarction (0% vs. 2.5%, p = 0.35), and bleedings did not differ significantly among the groups as well. CONCLUSIONS: In this subgroup analysis of the EASTBOURNE study of consecutive patients treated with new-generation sirolimus DCB, dissections left untreated after angioplasty did not lead to an increase in adverse events.

DCBs as an adjuvant tool to DES for very complex coronary lesions.

Drug eluting stents (DES) have revolutionised interventional cardiology and currently represent the standard for percutaneous coronary interventions (PCI). However, due to several limitations, new strategies are required, especially in very complex lesions. Drug-coated balloons (DCB) offer an attractive therapeutic alternative, and have already obtained a Class I recommendation for the treatment of in stent restenosis (ISR) with Level A of evidence. Moreover, the role of DCB has been tested in several other settings, such as de novo large vessel disease, multivessel disease or very complex lesions, with promising results regarding safety and effectiveness. In this context, a hybrid strategy consisting in the use of a DES and DCB with the aim of reducing the amount of metal implanted and minimising the risk of ISR and stent thrombosis could become the solution for very complex lesions. Several important studies already demonstrated very good angiographic results in terms of late lumen loss and restenosis for this approach in bifurcation lesions. Moreover, for long diffuse coronary disease similar rates of MACE, TVR, and TLR at 2-year follow-up in comparison to a DES-alone strategy were found. What is more, the use of this strategy in high-bleeding risk patients could safely permit the practitioners to reduce the DAPT duration, as data is suggesting. As our daily practice already strongly incorporated this strategy and with more data expected from important trials, it is our strong believe that the hybrid approach can become a standard treatment choice in the near future.

Intravascular imaging for left main stem assessment: An update on the most recent clinical data.

Left main (LM) stem has different structural and anatomical characteristics compared to all of the other segments of the coronary tree, thus its management through percutaneous coronary intervention (PCI) is a challenge and is associated with worse clinical outcome and higher need for revascularization as compared to other lesion settings. Intravascular imaging, by means of intravascular ultrasound (IVUS) or optical coherence tomography (OCT), is an important tool for LM PCI guidance, aiming at improving the immediate performance and the long term outcome of this procedure. Following current guidelines and recent scientific findings, IVUS becomes important to firstly assess, and finally evaluate the result of LM stenting, according to the experience and preferences of the operator. The role of OCT still remains to be defined, but recent data is shedding light also on this imaging technique. The aim of this review is to highlight the latest scientific advancements regarding intravascular imaging in LM coronary artery disease.

Should paclitaxel be considered an old generation DCB? The limus era.

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).

Outcomes after stenting of renal artery stenosis in patients with high-risk clinical features.

BACKGROUND: In patients with renal artery stenosis, revascularization was seen as a mean to improve outcomes, but large studies failed to show significant benefit in general population. However, data on benefits of renal artery stenting in patients with high-risk features, such as rapidly declining renal function and cardiac destabilization syndromes, are limited, as they were excluded from trials. In this descriptive study, we aimed to evaluate short- and long-term outcomes in high-risk patients with renal artery stenosis, treated by angioplasty and stenting. We have retrospectively interrogated our local databases for renal artery percutaneous interventions; patients at high-risk (rapidly declining renal function; stable chronic renal failure and bilateral renal artery disease; severe hypertensive crisis) were selected for the current analysis. RESULTS: Of 30 patients undergoing renal artery stenting, 18 patients were deemed "high-risk." On short term, good in-hospital control of hypertension and cardiac stabilization were obtained in all patients. Renal function improved significantly only in patients admitted with rapidly declining renal function, with significant creatinine level fall from median 3.98 mg/dL to 2.02 mg/dL, p = 0.023. However, for the whole group, creatinine change was non-significant (- 0.12 mg/dL, p = NS). On the long term, five patients (27.8%) ended-up on chronic hemodialysis and six patients died (33.3%) after a median of 20 months. No death occurred during the first year after the procedure. CONCLUSIONS: Percutaneous procedures are feasible and safe in patients with high-risk renal artery stenosis, especially in those with rapidly declining renal function, probably saving some of them from the immediate need for renal replacement therapy, but long-term results are negatively influenced by the precarious general and cardio-vascular status of these patients and by the pre-existing significant renal parenchymal disease, non-related to the renal artery stenosis.

Coronary stent failure: role of a blended approach with drug-coated balloons for complex lesions.

The management of coronary artery disease by means of percutaneous approach have been focused initially to overcome the recoil and acute occlusion after vessel ballooning; therefore, to develop and improve metallic stent platforms, and later drug-eluting technologies. Contemporarily, the necessity emerged to optimize interventional procedures using functional physiologic tests and intravascular imaging guidance, but still stent failures, especially in the complex lesion setting, continue to be not negligible. This comprehensive review is focused on the technology of drug-coated balloons as a tool to treat coronary artery disease without the need for metal implantation but still eluting antirestenotic drugs such as paclitaxel or sirolimus. We delve into these technologies, the drugs, the technical aspects of the deployment and the most updated evidence also proposing a dedicated interventional algorithm. There is solid data to support the use of drug-coated balloons in patients with in-stent restenosis and de-novo small coronary artery disease but also new evidence with promising results from recent studies indicate the feasibility of this approach in complex coronary interventions, bifurcation lesions and larger coronary vessels. In this state-of-the-art review, we also propose a blended approach based on the combination of drug-eluting stents and drug-coated balloons, keeping in mind the necessity to reduce the total stent length in order to reduce the long-term risk of complications.

Efficacy and Safety of a Dedicated Left Atrial Appendage Occlusion Protocol.

OBJECTIVES: The aim of this study is to present a dedicated left atrial appendage closure protocol, which could be of great interest in the approach of frail patients. BACKGROUND: Left atrial appendage (LAA) occlusion emerged as a promising therapeutic tool for stroke prevention, as most of the atrial fibrillation (AF) related strokes result from LAA thromboembolism, with an important residual risk even for anticoagulated patients. As an internationally recognized and scientifically-based protocol for the patients with higher comorbidities has not yet been defined for this procedure in terms of anaesthesia use or post procedural antithrombotic therapy and follow-up, we developed a dedicated protocol that could be applied in frail patients. In this study we describe the mid-term outcome of our strategy. METHODS: We enrolled 32 patients that underwent percutaneous LAA occlusion under transesophageal echocardiogram guidance, using only superficial sedation. A dedicated anti-thrombotic regimen was chosen for all patients, taking into consideration their bleeding and thrombotic risk profile. All patients routinely performed echocardiography after 3 months follow-up. RESULTS: Procedural success was achieved in all cases, except for one, due to extreme angulation of the LAA neck, while one patient required general anaesthesia. Only 9.4% of the patients, having previous stroke and still at high risk for cardio-embolic events, continued anticoagulation, while 31.2% discontinued any anti-thombotic drug. While no in-hospital complication was encountered, we found one asymptomatic device-thrombosis, managed by 30 days anticoagulation. No deaths, strokes or major bleedings occurred during an average 10.3 months of follow-up. CONCLUSIONS: A tailored post-implantation anti-thrombotic regimen and the avoidance of general anaesthesia can be a safe and effective strategy for the usually frail patients requiring percutaneous LAAO.

Approaches to Peripheral Artery Disease in Diabetes: Are There Any Differences?

Peripheral artery disease (PAD) increases the risk of diabetes, while diabetes increases the risk of PAD, and certain symptoms in each disease increase the risk of contracting the other. This review aims to shed light on this harmful interplay between the two disorders, with an emphasis on the phenotype of a patient with both diabetes and PAD, and whether treatment should be individualized in this high-risk population. In addition, current guideline recommendations for the treatment of PAD were analyzed, in an attempt to establish the differences and evidence gaps across a population suffering from these two interconnected disorders.

Solid Lipid Nanoparticles: Vital Characteristics and Prospective Applications in Cancer Treatment.

Cancer nanotechnology is a new field of interdisciplinary research cutting across biology, chemistry, engineering, and medicine, aiming to lead to major advances in cancer treatment. Over the past several years, solid lipid nanoparticles (SLNs) have attracted the interest of researchers due to their ability to overcome the limitations of classic chemotherapeutics. We reviewed the most recent data on the therapeutic use of SLNs in oncology, presenting their main advantages and disadvantages, along with various production methods and different routes of administration. In accordance with these aspects, the long-term physical stability, the controlled release of the loaded drugs, and the efficient targeted delivery of drugs as methods of surpassing the pharmaceutical limitations of anticancer drugs, natural products and gene therapy have been discussed. In addition, we have also emphasized briefly the crosstalk between SLNs and the new trend in oncology, immunotherapy, as future possible antineoplastic treatment, especially in melanoma. This review highlights the potential of SLNs in providing very positive perspectives for future cancer treatment by improving the efficiency of present chemotherapy and reducing its side effects. SLNs allow targeted delivery of anticancer drugs and could improve the efficiency of current chemotherapy in neoplasia.