Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.

REDV-Functionalized Recombinant Spider Silk for Next-Generation Coronary Artery Stent Coatings: Hemocompatible, Drug-Eluting, and Endothelial Cell-Specific Materials.

Coronary artery stents are life-saving devices, and millions of these devices are implanted annually to treat coronary heart disease. The current gold standard in treatment is drug-eluting stents, which are coated with a biodegradable polymer layer that elutes antiproliferative drugs to prevent restenosis due to neointimal hyperplasia. Stenting is commonly paired with systemic antiplatelet therapy to prevent stent thrombosis. Despite their clinical success, current stents have significant limitations including inducing local inflammation that drives hyperplasia; a lack of hemocompatibility that promotes thrombosis, increasing need for antiplatelet therapy; and limited endothelialization, which is a critical step in the healing process. In this research, we designed a novel material for use as a next-generation coating for drug-eluting stents that addresses the limitations described above. Specifically, we developed a recombinant spider silk material that is functionalized with an REDV cell-adhesive ligand, a peptide motif that promotes specific adhesion of endothelial cells in the cardiovascular environment. We illustrated that this REDV-modified spider silk variant [eADF4(C16)-REDV] is an endothelial-cell-specific material that can promote the formation of a near-confluent endothelium. We additionally performed hemocompatibility assays using human whole blood and demonstrated that spider silk materials exhibit excellent hemocompatibility under both static and flow conditions. Furthermore, we showed that the material displayed slow enzyme-mediated degradation. Finally, we illustrated the ability to load and release the clinically relevant drug everolimus from recombinant spider silk coatings in a quantity and at a rate similar to that of commercial devices. These results support the use of REDV-functionalized recombinant spider silk as a coating for drug-eluting stents.

The role of exercise-based cardiac rehabilitation after percutaneous coronary intervention in patients with coronary artery disease: a meta-analysis of randomised controlled trials.

BACKGROUND: this study was designed to analyse patient outcomes using a combination of PCI and exercise-based cardiac rehabilitation compared with PCI alone. METHODS: PCI can improve the survival rate of patients with coronary artery disease, but it can also cause vascular endothelial cell injury, thrombosis, and even restenosis. Early cardiac rehabilitation exercise is crucial for patients with coronary heart disease after PCI. Five databases were examined for randomised controlled trials involving early cardiac rehabilitation exercise and standard treatment in patients with coronary heart disease after PCI. The search period lasted from the creation of the database (2006) until December 2022. The outcomes including angina, arrhythmia, coronary restenosis, left ventricular ejection fraction, left ventricular end diastolic diameter, 6-min walk distance, total cholesterol, heart rate, systolic blood pressure and diastolic blood pressure. RevMan 5.3 was used to analyse the data, and the Cochrane Collaboration was used to assess the quality of evidence. RESULTS: A total of 1231 patients were enrolled in this study. Angina pectoris (RR = 0.24, 95% CI [0.10, 0.57], p = 0.001), Arrhythmia (RR = 0.17, 95% CI [0.05, 0.55], p = 0.003), Coronary artery restenosis (RR = 0.10, 95% CI [0.01, 0.76], p = 0.03). CONCLUSION: Exercise after PCI improves LVEF, enhances 6MWD, lowers HR and minimises the risk of angina, arrhythmia and coronary artery restenosis in CHD patients. Exercise had no discernible effect on LVEDD, TC, SBP, or DBP.

One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis.

Background: Prospective single and multicenter studies have shown improved outcomes of patients who underwent carotid artery stenting with the novel CGuard dual-layer mesh stent at 1 year. Objectives: The aim of this study is to conduct a systematic review and meta-analysis of all published studies to assess 1-year efficacy and outcomes of CGuard in patients with carotid stenting. Methods: A systematic search was performed. All studies enrolling at least 20 patients were included in our analysis. The primary endpoints were death (all-cause, cardiovascular and ipsilateral stroke-related death) and stroke rate at 1 year. The secondary endpoint was in-stent restenosis at 1 year. Results: The final analysis included 1709 patients. The one-year all-cause mortality rate was 2.97% (39/1699, 95% CI: 1.26-6.86%, I2 = 67%, t2 = 0.3442, p < 0.01), cardiovascular-related death was 0.92% (10/1616, 95% CI: 0.35-2.39%, I2 = 34%, t2 = 0.2302, p = 0.18), and ipsilateral stroke-related death was 0.3% (1/1649, 95% CI: 0.1-0.87%, I2 = 0%, t2 = 0, p = 0.69). The one-year ipsilateral stroke rate was 1.21% (16/1649, 95% CI: 0.58-2.5%, I2 = 28%, t2 = 0.1433, p = 0.23), transient ischemic attacks (TIAs) rate was 1.78% (19/1149, 95% CI: 1.11-2.84%, I2 = 0%, t2 = 0, p = 0.69), and total composite 1-year stroke/TIA rate was 2.97% (32/1149, 95% CI: 1.84-4.77%, I2 = 0%, t2 = 0, p = 0.41). The in-stent restenosis rate at 1 year was 1.06% (13/1653, 95% CI: 0.48-2.34%, I2 = 28%, t2 = 0.2308, p = 0.22). Conclusions: This meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.

Systemic immune-inflammation index and in-stent restenosis in patients with acute coronary syndrome: a single-center retrospective study.

BACKGROUND: In-stent restenosis (ISR) has been shown to be correlated with inflammation. This study aimed to examine the relationship between systemic immune-inflammation index (SII, an innovative inflammatory biomarker) and ISR in acute coronary syndrome (ACS) patients after drug-eluting stent (DES) implantation. METHODS: Subjects who were diagnosed with ACS and underwent DES implantation were enrolled retrospectively. All individuals underwent follow-up coronary angiography at six to forty-eight months after percutaneous coronary intervention (PCI). SII was defined as [(platelet count × neutrophil count)/lymphocyte count], and Ln-transformed SII (LnSII) was carried out for our analysis. Multivariate logistic regression analysis was employed to assess the association between LnSII and DES-ISR. RESULTS: During a median follow-up period of 12 (11, 20) months, 523 ACS patients who underwent follow-up angiography were included. The incidence of DES-ISR was 11.28%, and patients in the higher LnSII tertile trended to show higher likelihoods of ISR (5.7% vs. 12.1% vs. 16.0%; P = 0.009). Moreover, each unit of increased LnSII was correlated with a 69% increased risk of DES-ISR (OR = 1.69, 95% CI 1.04-2.75). After final adjusting for confounders, a significant higher risk of DES-ISR (OR = 2.52, 95% CI 1.23-5.17) was found in participants in tertile 3 (≥ 6.7), compared with those in tertiles 1-2 (< 6.7). Subgroup analysis showed no significant dependence on age, gender, body mass index, current smoking, hypertension, and diabetes for this positive association (all P for interaction > 0.05). CONCLUSION: High levels of SII were independently associated with an increased risk of DES-ISR in ACS patients who underwent PCI. Further prospective cohort studies are still needed to validate our findings.

Drug-coated balloon therapy for in-stent restenosis in patients with iliofemoral deep vein thrombosis: A single-arm observational study.

BACKGROUND: Iliofemoral deep vein thrombosis (IFDVT) causes severe symptoms and affect the quality of life to a great extent. Endovascular thrombectomy and stent implantation have been a feasible strategie to alleviate the signs and symptoms of IFDVT. However, venous in-stent restenosis (ISR) has become an emerging non-negligible problem. METHODS: To evaluate the histological characteristics of venous ISR, neointima of arterial and venous ISR patients were collected and examed. To explore the effect of drug-coated balloon (DCB) on venous ISR lesions, we conducted a single-center retrospective case series study involving IFDVT patients with ISR after venous stenting who were treated with paclitaxel-coated balloon dilatation. RESULTS: We found a collagen-rich matrix but not elastin, as well as fewer cells and less neovascularization in venous intimal hyperplasia compared with neointima in arteries. Thirteen IFDVT patients were involved in the study, with average preoperative stenosis degree of 87.69% ± 13.48%. After intervention, the stenosis degree was significantly reduced to 14.6% ± 14.36% immediately (p < 0.0001) and to 16.54% ± 15.73% during follow-up (p < 0.0001). During follow-up, the VEINES-QOL scores (p < 0.0001), VEINES-Sym scores (p < 0.0001), and Villalta scores (p = 0.04) of patients was improved significantly compared with those before intervention. No major adverse events were observed. CONCLUSIONS: The use of DCB may have a positive effect in the treatment of venous ISR by targeting intimal hyperplasia. Moreover, the application of DCB dilatation in IFDVT stenting patients with ISR is deemed safe and effective.

Intrastent Restenosis: A Comprehensive Review.

The primary objective of this paper is to delineate and elucidate the contemporary advancements, developments, and prevailing trajectories concerning intrastent restenosis (ISR). We aim to provide a thorough overview of the most recent developments in this area, covering various aspects such as pathophysiological insights, therapeutic approaches, and new strategies for tackling the complex challenges of ISR in modern clinical settings. The authors have undertaken a study to address a relatively new medical challenge, recognizing its significant impact on the morbidity and mortality of individuals with cardiovascular diseases. This effort is driven by the need to fully understand, analyze, and possibly improve the outcomes of this emerging medical issue within the cardiovascular disease field. We acknowledge its considerable clinical implications and the necessity for innovative methods to mitigate its effects on patient outcomes. Therefore, our emphasis was directed towards elucidating the principal facets of the condition's prevalence, expounding upon the foundational mechanisms underscoring conspicuous restenosis, and delineating the risk factors relevant in shaping the contemporary landscape of diagnostic and therapeutic modalities. This thorough examination aims to provide a comprehensive understanding of the various dimensions of the condition, including epidemiological data, pathophysiological complexities, and clinical considerations critical for evaluating and enhancing current diagnostic and treatment approaches.

Impact of diabetes mellitus on clinical outcomes after first episode in-stent restenosis PCI: Results from a large registry.

BACKGROUND: Diabetes mellitus (DM) is associated with a high rate of major adverse cardiac events (MACE) after de novo coronary artery percutaneous coronary intervention (PCI). Whether patients with DM undergoing PCI for in-stent restenosis (ISR) experience a similar heightened risk of MACE is not known. Hence, we sought to compare the clinical outcomes of patients with and without DM undergoing PCI for ISR. METHODS: Patients undergoing first episode ISR PCI between January 2015 and December 2021 were included. The primary outcome of interest was MACE (all-cause death, myocardial infarction [MI], and target lesion revascularization [TVR]) at 1-year. RESULTS: A total of 3156 patients (56.7% with DM) underwent PCI for ISR during the study period. Patients with DM were younger, more likely to be female, and had a higher prevalence of comorbidities. At 1-year follow-up, DM was associated with a higher rate of MACE (22.4% vs. 18.7%, unadjusted HR 2.03, 95%CI(1.27-3.25), p = 0.003). All-cause mortality and MI were significantly more frequent among people with DM at 1-year follow-up. The rate of TVR was similar in both groups (17.9% vs. 16.0%, unadjusted HR 1.14, 95%CI (0.94-1.37), p = 0.180). On adjusted analysis, there was no significant difference in the rate of MACE (AHR 1.07, 95%CI(0.90 - -1.29), p = 0.444), all-cause death (AHR 1.54, 95%CI(0.93-2.54), p = 0.095) or MI (AHR 1.10, 95%CI(0.74-1.63), p = 0.652). CONCLUSION: ISR PCI in patients with DM was associated with a higher rate of MACE at 1-year follow-up. However, this increased risk was no longer significant after adjusting for baseline characteristics.

Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

[OCT analysis of in-stent neointima over 5 years post-DES implantation].

Objective: To investigate the characteristics of neointimal hyperplasia (NIH) in patients with in-stent restenosis (ISR) over 5 years post-drug-eluting stent (DES) implantation based on optical coherence tomography (OCT). Methods: In this cross-sectional study, patients with DES-ISR who underwent OCT examination at PLA General Hospital between March 2010 and March 2022 were retrospectively included. All patients were divided into≤5 years DES-ISR group and>5 years DES-ISR group according to the time interval after DES implantation. Quantitative and qualitative analyses were conducted on OCT images to compare the clinical data and lesion characteristics of two patient groups. Furthermore, the independent clinical predictive factors of in-stent neoatherosclerosis (ISNA) were analyzed by multivariable logistic regression. Results: A total of 230 DES-ISR patients with 249 lesions were included, with an age of (63.1±10.4) years and 188 males (81.7%). The median interval after DES implantation was 6 (2, 9) years. There were 117 patients (122 ISR lesions) in the≤5 years DES-ISR group, and 113 patients (127 ISR lesions) in the>5 years DES-ISR group. Compared with≤5 years DES-ISR,>5 years DES-ISR showed more heterogeneous patterns (65.4% (83/127) vs. 48.4% (59/122), P=0.007), diffuse patterns (46.5% (59/127) vs. 31.2% (38/122), P=0.013), macrophage accumulations (44.1% (56/127) vs. 31.2% (38/122), P=0.035) in NIH and higher prevalence of ISNA (83.5% (106/127) vs. 72.1% (88/122), P=0.031). According to multivariable logistic regression, the independent predictive factor for ISNA was female (OR=0.44, 95%CI 0.21-0.90, P=0.026). Female (OR=0.48, 95%CI 0.23-0.99, P=0.046) and low-density lipoprotein cholesterol level (OR=1.62, 95%CI 1.01-2.59, P=0.046) were independent predictive factors, respectively, for lipid ISNA. Calcified ISNA was independently associated with time interval of post-DES implantation (OR=1.18, 95%CI 1.07-1.29, P=0.001). Conclusion: DES-ISR patients with a time interval of>5 years after stent implantation have a higher prevalence of ISNA and more complex lesions. Gender, the level of low-density lipoprotein cholesterol, and the time interval post-DES implantation are independently correlated with ISNA, lipid ISNA, and calcified ISNA.

Triglyceride-glucose index for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

OBJECTIVE: To evaluate the triglyceride-glucose index (TyG index) for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents. PATIENTS AND METHODS: Subjects with iliac artery stenosis, who underwent an iliac stent intervention and were followed up for at least 2 years were included in the study. Subjects were grouped according to TyG index (Group A, TyG index ≤8.848; Group B 8.849 ≤TyG index ≤9.382 and Group C TyG index ≥9.383). The subject's baseline characteristics, blood parameters, claudication distance, Transatlantic Intersociety Consensus classification, target lesion localization, stent direction, number of stents that were applied, and stent type were noted. Pre- and 1st and 2nd-year post-procedure Rutherford statuses, ankle-brachial index, and stenosis degree were recorded. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), Group B and Group C were combined and compared with Group A. RESULTS: In total, 255 subjects were evaluated (female, n=77-30.2%, male, n=178-69.8%). The mean age of the subjects was 66.00±10.00 years (range from 39 to 90 years). The pre-procedure Rutherford measurements were significantly different among the groups (p=0.001). The rates of mild claudication and resting pain in Group A were higher than those in Groups B and C. The rate of moderate claudication in Group C was higher than that in Groups A and B. The rate of severe claudication in Group B was higher than that in Groups A and C. One year after the procedure, there were more asymptomatic cases in Group A than in Groups B and C (p=0.001). The rate of mild claudication in Group C was lower than that in Groups A and B. The rate of moderate claudication in Group C was higher than that in Group A. The rate of severe claudication in Group C was higher than that in Groups A and B. Two years after the procedure, the Rutherford measurements and the rates of mild claudication in Groups A and B were higher than those in Group C. The rate of severe claudication in Group C was higher than that in Groups A and B (p=0.001). One year after the procedure, the computed tomography angiography (CTA) measurements and the rate of full patency in Group A were higher than that in Groups B and C. The rate of 0-50% stenosis in Group B was higher than that in Groups A and C. The rate of 50-70% stenosis in Group C was higher than that in Group A. Two years after the procedure, the CTA measurements and the rates of 70-99% stenosis and 100% occlusion in Group C were higher than those in Groups A and B. The TyG index has high specificity and NPV. However, specificity and PPV levels were found to be quite low. CONCLUSIONS: The TyG index was found to be an easy-to-use marker for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.

BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Drug-Coated Balloons for Treatment of Internal Carotid Artery Restenosis After Stenting: A Single-Center Mid-Term Outcome Study.

PURPOSE: Endovascular and surgical treatments of stenosis of the extracranial internal carotid artery (ICA) are common procedures, yet both introduce a risk of restenosis due to endothelial hyperplasia. Drug-coated balloons (DCBs) are designed to decrease neointimal hyperplasia, however rarely used in the neurovascular setting. This study retrospectively analyzes mid-term results of DCB-treated in-stent restenosis (ISR) of the ICA. MATERIALS AND METHODS: The medical history, comorbidities, and periprocedural data of patients receiving DCB treatment for > 50% ISR of the ICA after carotid artery stenting were analyzed. Follow-up after DCB treatment was performed with Doppler ultrasound. Suspicious cases were checked with CT- or MR-angiography and-if there was agreement between the modalities-validated with digital subtraction angiography. Potential risk factors for restenosis and differences in outcomes after PTA with three types of DCB balloons were evaluated. RESULTS: DCB treatment was performed in 109 cases, 0.9% of which involved in-hospital major stroke; no minor strokes occurred. A total of 17 patients (15.6%) had recurrent ISR after DCB treatment, after a mean time of 30.2 months (7-85 months). Tobacco use was significantly associated with a higher incidence of recurrent ISR. CONCLUSION: DCB angioplasty for ISR is an effective treatment that may delay and decrease restenosis. Treating comorbidities and adopting lifestyle changes may additionally help prevent ISR.

Enhanced in-stent luminal visualization and restenosis diagnosis in coronary computed tomography angiography via coronary stent decomposition algorithm from dual-energy image.

Stent implantation is a principal therapeutic approach for coronary artery diseases. Nonetheless, the presence of stents significantly interferes with in-stent luminal (ISL) visualization and complicates the diagnosis of in-stent restenosis (ISR), thereby increasing the risk of misdiagnoses and underdiagnoses in coronary computed tomography angiography (CCTA). Dual-energy (DE) CT could calculate the volume fraction for voxels from low- and high-energy images (LHEI) and provide information on specific three basic materials. In this study, the innovative coronary stent decomposition algorithm (CSDA) was developed from the DECT three materials decomposition (TMD), through spectral simulation to determine the scan and attenuation coefficient for the stent, and preliminary execution for an in vitro sophisticated polyether ether ketone (PEEK) 3D-printed right coronary artery (RCA) replica. Furthermore, the whole-coronary-artery replica with multi-stent implantation, the RCA replica with mimetic plaque embedded, and two patients with stent further validated the effectiveness of CSDA. Post-CSDA images manifested no weakened attenuation values, no elevated noise values, and maintained anatomical integrity in the coronary lumen. The stents were effectively removed, allowing for the ISL and ISR to be clearly visualized with a discrepancy in diameters within 10%. We believe that CSDA presents a promising solution for enhancing CCTA diagnostic accuracy post-stent implantation.

Systemic immune inflammation index and its implication on in-stent restenosis among patients with acute coronary syndrome.

OBJECTIVE: This study aims to assess the predictive value of the Systemic Immune Inflammation Index (SII) in determining in-stent restenosis (ISR) likelihood in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI). METHODS: The study enrolled 903 ACS patients undergoing PCI, categorized into ISR (+) and ISR (-) groups based on control coronary angiography results. Demographic, clinical, laboratory, and angiographic-procedural characteristics were systematically compared. RESULTS: The ISR (+) group encompassed 264 individuals (29.2%), while the ISR (-) group comprised 639 individuals (70.8%). Patients had a mean age of 55.8 ±â€…10.2 years, with 69% being male. The ISR (+) group had higher diabetes and smoking prevalence and notably larger stent dimensions. Lab parameters showed significantly elevated creatinine, total cholesterol, red cell distribution width, white blood cell and neutrophil counts, SII index and C-reactive protein (CRP) in the ISR (+) group, while lymphocyte levels were lower. Binary logistic regression identified stent diameter (odds ratio [OR]: 0.598, 95% confidence interval [CI]: 0.383-0.935; P  = 0.024), stent length (OR: 1.166, 95% CI: 1.132-1.200; P  < 0.001), creatinine (OR: 0.366, 95% CI: 0.166-0.771; P  = 0.003), CRP (OR: 1.075, 95% CI: 1.042-1.110; P  = 0.031), and SII index (OR: 1.014, 95% CI: 1.001-1.023; P  < 0.001) as independent ISR predictors. CONCLUSION: The SII index exhibits potential as a predictive marker for ISR in ACS patients post-PCI, indicating systemic inflammation and heightened restenosis risk. Integrating the SII index into risk models could identify high-risk patients for targeted interventions.

Prognostic impact of in-stent restenosis in normal weight, overweight, and obese patients undergoing percutaneous coronary intervention.

BACKGROUND: Among patients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI. METHODS: Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into four BMI categories: normal weight (BMI 18.5-25 kg/m2 ), overweight (25.0-29.9 kg/m2 ), class I obesity (30.0-34.9 kg/m2 ), class II-III obesity (≥35.0 kg/m2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year. RESULTS: Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj. hazard ratio (HR): 1.99, 95% confidence interval [CI]: 1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR: 2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR. CONCLUSIONS: At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR.