A 2024 scientific update on the clinical performance of drug-coated balloons.

Continuous advances in the field of interventional cardiology have led to the development of drug-coated balloons (DCB). These represent a promising device for overcoming the well-known limitations of traditional metallic stents, which are associated with a persistent yearly increased risk of adverse events. This technology has the ability to homogeneously transfer the drug into the vessel wall in the absence of a permanent prosthesis implanted in the coronary vessel. Robust data support the use of DCB for the treatment of in-stent restenosis, but there is also currently growing evidence from long-term follow-up of large randomised clinical trials regarding the use of these devices in other scenarios, such as de novo small and large vessel disease, complex bifurcations, and diffuse coronary disease. Other critical clinical settings such as diabetes mellitus, high bleeding risk patients and acute coronary syndromes could be approached in the upcoming future by using DCB, alone or as part of a blended strategy in combination with drug-eluting stents. There have been important scientific and technical advances in the DCB field in recent years. The purpose of this paper is to review the most current data regarding the use of DCB, including the mid- and long-term follow-up reports on the safety and efficacy of this novel strategy in different clinical and angiographic scenarios.

Peripheral Artery Disease Ultrasound Assessment in Predicting the Severity of Coronary Artery Disease.

Atherosclerosis in a progressive disease that is systemic in nature, and hence the simultaneous presentation of coronary artery disease (CAD) and peripheral artery disease (PAD) is not uncommon. As clinically manifested PAD is associated with worse cardiovascular outcomes, the timely identification of subclinical atherosclerosis seems of utmost importance. Ultrasonography (US) is an ideal imaging modality for assessing PAD that is easy to use, accurate, widely available and avoids unnecessary exposure to radiation. Several US parameters have been proposed in the assessment of PAD, with varying prognostic usefulness, depending on disease location. The aim of this review is to summarize the most important evidence available on the association between US-detected atherosclerosis in different vascular sites and the presence and severity of CAD, as well as the impact of the early detection of PAD on the outcomes of patients presenting with CAD.

The role of drug-coated balloons for coronary bifurcation management: results from the prospective EASTBOURNE-BIF study.

BACKGROUND: Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in which a sirolimus-DCB was used for the treatment of bifurcation lesions. METHODS: Overall, 194 patients with bifurcations lesions identified in the EASTBOURNE study (Medina 1.1.1/1.1.0/1.0.1/0.1.1/0.1.0) were compared with 1049 patients with de-novo lesions from the same registry. Both a blended-strategy using a drug-eluting stent in the main branch and a DCB in the side branch as well as a full-DCB approach were used in the treatment of bifurcation lesions. RESULTS: At one year of follow-up the study primary endpoint, target-lesion revascularization occurred at a similar rate in the bifurcation group versus the de-novo group (4.2 vs. 2%, P=0.28). Similar outcomes were observed in terms of all-cause death (3.3 vs. 1.4%, P=0.138), major adverse cardiovascular events (8.8 vs. 5.2%, P=0.081) and the rate of spontaneous myocardial infarction (2.8 vs. 1.0%, P=0.117). CONCLUSIONS: The results of EASTBOURNE-BIF study show how the use of this DCB alone or in combination with drug eluting stents could represent a safe and effective alternative to stents for the treatment of bifurcations.

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.

Superficial Calcified Plates Associated to Plaque Erosions in Acute Coronary Syndromes.

This study investigates the clinical relevance and therapeutic implications of the OCT identification of intracoronary superficial calcified plates (SCPs) in acute coronary syndromes (ACSs). In 70 consecutive ACS patients (pts), we studied the three main underlying ACS mechanisms: plaque erosion (PE), plaque rupture and eruptive calcified nodule (CN). The PE lesions, occurring on an intact fibrous cap overlying a heterogeneous substrate, were identified in 12/70 pts (17.1%). PE on superficial calcified plates (PE-SCP) represented 58.3% of the PE lesions (7/12 pts) and had a 10% overall incidence in the culprit lesions (7/70 pts). PE-SCP lesions occurred mostly on the left anterior descending artery, correlated with white thrombi (85.7%) and had a proximal intraplaque site (71.4%). PE-SCP lesions were treated conservatively, as nonsignificant lesions, in 4/7 pts. Our study emphasizes that the coronary calcium-related ACS risk is not only associated with the spotty calcifications or CN but also with the PE-SCP lesions.

The role of optical coherence tomography in guiding percutaneous coronary interventions- is left main the final challenge?

Left main (LM) coronary artery disease is a high-risk lesion subset, with important prognostic implications for the patients. Recent advances in the field of interventional cardiology have narrowed the gap between surgical and percutaneous approach of this complex lesion setting. However, the rate of repeat revascularization remains higher in the case of percutaneous coronary intervention (PCI) on long-term follow-up. As such, the need for better stent optimization strategies has led to the development of intravascular imaging techniques, represented mainly by intravascular ultrasound (IVUS) and optical coherence tomography (OCT). These techniques are both able to provide excellent pre- and post-PCI guidance. While IVUS is an established modality in optimizing LM PCI, and is recommended by international revascularization guidelines, data and experience on the use of OCT are still limited. This review paper deeply analyzes the current role of OCT imaging in the setting of LM disease, particularly focusing on its utility in assessing plaque morphology and distribution, vessel dimensions and proper stent sizing, analyzing mechanisms of stent failure such as malapposition and underexpansion, guiding bifurcation stenting, as well as offering a direct comparison with IVUS in this critical clinical scenario, based on the most recent available data.

Distinctive Morphological Patterns of Complicated Coronary Plaques in Acute Coronary Syndromes: Insights from an Optical Coherence Tomography Study.

Optical coherence tomography (OCT) is an ideal imaging technique for assessing culprit coronary plaque anatomy. We investigated the morphological features and mechanisms leading to plaque complication in a single-center observational retrospective study on 70 consecutive patients with an established diagnosis of acute coronary syndrome (ACS) who underwent OCT imaging after coronary angiography. Three prominent morphological entities were identified. Type I or intimal discontinuity, which was found to be the most common mechanism leading to ACS and was seen in 35 patients (50%), was associated with thrombus (68.6%; p = 0.001), mostly affected the proximal plaque segment (60%; p = 0.009), and had no distinctive underlying plaque features. Type II, a significant stenosis with vulnerability features (inflammation in 16 patients, 84.2%; thin-cap fibroatheroma (TCFA) in 10 patients, 52.6%) and a strong association with lipid-rich plaques (94.7%; p = 0.002), was observed in 19 patients (27.1%). Type III, a protrusive calcified nodule, which was found to be the dominant morphological pattern in 16 patients (22.9%), was found in longer plaques (20.8 mm vs. 16.8 mm ID vs. 12.4 mm SS; p = 0.04) and correlated well with TCFA (93.8%; p = 0.02) and inflammation (81.3%). These results emphasize the existence of a wide spectrum of coronary morphological patterns related to ACS.

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.

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.