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Dual antiplatelet therapy (DAPT) with P2Y12 receptor inhibitors in conjunction with aspirin is the gold standard treatment for acute coronary syndrome (ACS) and to prevent stent thrombosis after percutaneous coronary intervention (PCI). While there have been reported allergic effects-particularly angioedema-linked to clopidogrel there is limited data on hypersensitivity reactions to ticagrelor. Here, we discuss a case of delayed-onset ticagrelor-induced angioedema in a patient, three weeks following initiation of DAPT with aspirin and ticagrelor status post-PCI with DES placement. The patient presented with acute onset tongue swelling and was successfully treated with epinephrine, steroids, and antihistamine. The C1 esterase inhibitor and tryptase levels were within normal limits. Ticagrelor was discontinued and the patient was transitioned to prasugrel for DAPT, without recurrence of symptoms. Given the few cases reported involving ticagrelor-induced angioedema, and the even rare, delayed onset cases such as those described above, it is imperative that clinicians be made aware of this adverse effect and its management., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Walia et al.)

A 67-year-old male presenting with an anterior ST-segment elevation myocardial infarction (STEMI) underwent stent placement in the left anterior descending coronary. The patient was discharged on an appropriate medical regimen containing dual antiplatelet therapy (DAPT). Four days later, the patient presented with repeat acute coronary syndrome symptomatology. Electrocardiogram demonstrated ongoing STEMI in the previously treated artery distribution. Emergency angiography revealed restenosis and total thrombotic occlusion. Post-intervention stenosis was 0% after aspiration thrombectomy and balloon angioplasty. Stent thrombosis is a high-mortality and therapeutically challenging condition requiring prepared clinicians who recognize predisposing risk factors and initiate early management., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Mijares-Rojas et al.)

Although several techniques have been reported for managing an on-wire dislodged stent in the coronary artery, very few reports have focused on the much rarer complication of an off-wire dislodged stent. In a 73-year-old man who experienced an off-wire dislodged coronary stent, the proximal elongated segment was lodged in the left main coronary artery, and the distal segment was floating in the aorta like a wind sock. After a failed attempt at retrieval using a gooseneck microsnare, the dislodged stent was successfully removed using a 3-loop vascular snare via the left radial artery. There was no obvious vascular injury. This novel technique for removing a partially floating dislodged stent was successful after conventional retrieval techniques failed., (© 2023 by the Texas Heart® Institute, Houston.)

The advancement of the drug-eluting stent technology raises the significant challenge of safe mechanical design of polymer coated stent systems. Experimental images of stent coatings undergoing significant damage during deployment have been reported; such coating damage and delamination can lead to complications such as restenosis and increased thrombogenicity. In the current study a cohesive zone modeling framework is developed to predict coating delamination and buckling due to hinge deformation during stent deployment. Models are then extended to analyze, for the first time, stent-coating damage due to webbing defects. Webbing defects occur when a bond forms between coating layers on adjacent struts, resulting in extensive delamination of the coating from the strut surfaces. The analyzes presented in this paper uncover the mechanical factors that govern webbing induced coating damage. Finally, an experimental fracture test of a commercially available stent coating material is performed and results demonstrate that the high cohesive strength of the coating material will prevent web fracture, resulting in significant coating delamination during stent deployment. [ABSTRACT FROM AUTHOR]

The use of coronary stents in coronary angioplasty has evolved dramatically in its design, type materials, polymers, and a variety of drugs, the use of coronary stents covered nitric oxide have shown satisfactory results in practice, however compared to the results reported drug-eluting stents, there is little information. Objectives: The aim of this study was to compare clinical outcomes of a stainless steel stent Bioactive nitric oxide coated titanium (BAS) and a drug-eluting stent zotarolimus (DES) in daily clinical practice. Methods: A retrospective, analytical, descriptive and comparative study aimed at evaluating the safety and efficacy of two devices with different characteristics in our population. The primary endpoints were: death, acute infarction (AMI), and re intervention injury Treated (RLT). Results: A total of 759 patients were included in the study which was performed angioplasty to a single vessel. Were divided into two arms 382 with DES and 377 patients with BAS, the one year follow up was carried in 95%. After this follow-up period, primary points (cardiovascular death, myocardial infarction, TLR and stent thrombosis) for arm DES vs BAS; 9.5% vs 8.5% P = NS but with shorter periods of dual antiplatelet therapy for arm BAS 6.9 ± 4.1 vs 11.1 ± 2.5 months DES P = .0001. The results were independent of the clinical syndrome of presentation. Conclusions: After one year of follow no statistically significant difference in major clinical events, there was a trend in favour of BAS vs SM with respect to revascularization of the target lesion without reaching statistical significance. [ABSTRACT FROM AUTHOR]

Local hemodynamic environment is a determinant factor in drug delivery from a drug eluting stent (DES) to the target arterial tissue. By using a simplified model of a DES, we demonstrated that if a DES had a drug release mode of uniform rate the drug released from the stent will distribute non-uniformly along the stent due to the flowing blood, with a significantly higher drug concentration at the distal part of the stent than that at the proximal one. This may explain why a DES could retard neointimal formation and vascular remodeling in downstream coronary segments. To solve this problem, we thereafter optimized the drug release mode of the DES as an exponential function. The simulation results showed that the optimized drug release mode could lead to a fairly uniform drug concentration distribution along the stent. Therefore, the present study suggested that to achieve a more effective result, optimization of drug eluting strategy (drug release mode) for the DES would be essential. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the drug distribution in arteries treated with DES-BMS stenting strategy and to analyze the influence of proximal DES on distal segments of BMS. A straight artery model ( Straight Model) and a branching artery model ( Branching Model) were constructed in this study. In each model, the DES was implanted at the proximal position and the BMS was implanted distally. Hemodynamic environments, drug delivery and distribution features were simulated and analyzed in each model. The results showed that blood flow would contribute to non-uniform drug distribution in arteries. In the Straight Model the proximal DES would cause drug concentration in BMS segments. While in the Branching Model the DES in the main artery has slight influence on the BMS segments in the branch artery. In conclusion, due to the blood flow washing effect the uniformly released drug from DES would distribute focally and distally. The proximal DES would have greater influence on the distal BMS in straight artery than that in branching artery. This preliminary study would provide good reference for atherosclerosis treatment, especially for some complex cases, like coronary branching stenting. [ABSTRACT FROM AUTHOR]

Background and Purpose: NOBORI biolimus A9-eluting stent (BES) is the third generation drug eluting stent (DES) with only abluminal biodegradable polymer. Recent clinical trials have indicated that the BES is non-inferior to the XIENCE V everolimus-eluting stent (EES). Meanwhile, potential superiority of biodegradable polymer BES over current generation DES has not been addressed. The aim of this preclinical study was to assess and compare the biocompatibility of both BES and EES in porcine coronary arteries.Methods and Materials: BES with length of 24-mm (n=9) and EES with length of 23-mm (n=9) were both implanted in porcine coronary arteries. At 28 days endothelium-dependent vasomotion was assessed by acetylcholine (Ach) and subsequently measurements of endothelial superoxide production, histological evaluations and microarray gene analyses were performed.Results: Angiographic and histological in-stent stenoses were significantly suppressed in BES compared with EES. Histopathological assessment showed lower inflammatory score as well as fibrin and injury scores in BES as compared with EES. On the contrary, paradoxical vasoconstriction to Ach was frequently observed in EES-treated vessels compared with BES-treated vessels. Additionally, gene expressions of inflammatory cytokines and chemokines were upregulated in vessels treated with EES compared with BES in microarray pathway specific analyses.Conclusions: Implantation of BES revealed less inflammation and foreign-body immunoreaction than EES, suggesting more enhanced biocompatibility of BES compared with EES at 28 days in porcine coronary arteries. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Major limitation for the use of stent in the treatment of coronary artery disease is development of stent restenosis. The impact of intravascular ultrasound (IVUS) guidance during drug eluting stent (DES) implantation is presently not yet well established. PATIENTS AND METHODS: For the present study, we included 30 patients who received DES with IVUS-guided stenting (Group A) and 30 patients receiving the DES without IVUS-guided stenting (Group B). The patients were evaluated for their ninth month control angiographies and were followed during two years for the development of relevant clinical events after the DES implantations. The angiographic and clinical results were compared between the groups. RESULTS: After the percutaneous intervention, the minimal luminal diameter and net acute gain were significantly increased in Group A in respect to Group B (3.3 ± 0.34 vs. 2.8 ± 0.33, p < 0.01). Moreover, the rate for performing post-dilatation following stent implantation was higher in Group A than in Group B (p = 0.01). By contrast, stent restenosis rates were similar between the groups (p > 0.3). CONCLUSIONS: The present results indicate that the use of IVUS for the implantation of DES can increase the success rate of the intervention. The IVUS guidance during DES implantation can be complementary percutaneous intervention, in particularly by detecting the situations that need for post-dilatation. [ABSTRACT FROM AUTHOR]

Background The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. Methods/design The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. Discussion The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). [ABSTRACT FROM AUTHOR]

To improve the tissue penetration efficiency (PE % ) of hydrophilic-drugs in non-vascular drug eluting stents (DES), we designed photochemical tissue penetration (PTP) invested DES (PTP-DES). The PTP technology was applied to the stent as a covering membrane to generate singlet oxygen. Singlet oxygen damages the epithelial layer, so the PE % of released drugs could be improved. To prepare the PTP-DES membrane, chlorin e6 (Ce6, photosensitizer) was incorporated in a gemcitabine (GEM) eluting polyurethane (PU) membrane (Ce6–GEM–PU). Ce6–GEM–PU has smooth surface that is ∼40 μm thick. The photoactivity of Ce6 was maintained for 2 weeks ( in vitro GEM releasing period). In a separate cell culture system, both 1.5 folds higher PE % and an improved tumor cell growth inhibition effect were shown after light exposure. Additionally, in tissue penetration experimental system, 2 folds increased in the PE % of GEM was induced by laser exposure at 80 J/cm 2 . Additionally, improved PE % of hydrophilic molecules (Fluorescein and GEM) was confirmed in colon tumor bearing mice. Consequentially, tumor growth, when implanted with Ce6–GEM–PU, was effectively inhibited without significant side effects. Based on these results, we believe that the PTP-DES system has great potential for improving the therapeutic effect of conventional DES. [ABSTRACT FROM AUTHOR]

Backgrounds Edge dissections after intervention have been studied with imaging techniques, however, functional assessment has not been studied yet. We investigated the relationship between fractional flow reserve (FFR) and the angiographic type of stent edge dissections and tried to assess the use of FFR-guided management for edge dissection. Methods 51 edge dissections assessed by FFR were included in this prospective observational study. FFR was measured for each type of edge dissection and compared with quantitative coronary angiographic findings. Clinical outcomes were evaluated based on FFR measurements. Results Edge dissections were classified as type A (47.1%; 24/51), type B (41.2%; 21/51), type C (2.0%; 1/51) and type D (9.8%; 5/51). Mean FFR in type A dissection was 0.87 ± 0.09, in type B 0.86 ± 0.07, in type C 0.72 and in type D 0.57 ± 0.08. All type C and D dissections (6/51) had FFR = 0.8 and were treated with additional stents. Among the 45 type A and B dissections, 8 had a FFR = 0.8 (17.8%), and 50% received additional stenting. All dissections with FFR > 0.8 were left untreated except one long dissection case. There was no death, myocardial infarction or target lesion revascularization during hospitalization or the follow-up period (median 152 days; IQR 42-352 days). Conclusions FFR correlates well with an angiographic type of edge dissection. Angiographic findings are sufficient for deciding the treatment of severe dissections such as types C and D, while FFR-guided management may be safe and effective for mild edge dissections such as types A and B. [ABSTRACT FROM AUTHOR]

Background Despite advancements from balloon angioplasty to drug-eluting stents, primary patency rates after endovascular revascularization of peripheral artery disease have remained inferior compared to surgery. Endovascular revascularization has been limited by restenosis and mechanical stent failure. Thus, there is increased research into other nonstent-based local drug delivery modalities, which can provide an active drug to inhibit restenosis focally and avoid the risk of systemic adverse effects. Methods This review will summarize the unique properties of paclitaxel and studies on paclitaxel local delivery for the treatment of peripheral artery disease. A MEDLINE search for relevant peer-reviewed scientific literature published in English was conducted. Search terms included but were not limited to paclitaxel pharmacodynamics, paclitaxel local drug delivery, and drug eluting balloons, with a focus on the use of paclitaxel in the context of coronary and peripheral vascular disease. Results The primary search produced 182 results of which 51 papers were relevant. Of the 51 relevant papers, 27 were original research papers and 24 were either review papers, commentary or opinion papers. Conclusions Paclitaxel has several chemical properties, which make it ideal for local drug delivery including its hydrophobicity, ability to concentrate into the arterial intima layer and prolonged effect on cells even after brief exposure periods. Local delivery of paclitaxel via injection catheters, balloon catheters and coated balloons has shown encouraging results in terms of efficacy and safety in small-scale animal and clinical studies. Additional preclinical and clinical studies are needed to determine the long-term efficacy and safety of these treatments in humans. [ABSTRACT FROM AUTHOR]

T and small protrusion (TAP) is a stenting technique that is utilized for the management of coronary bifurcation lesions when using a two-stent strategy. This technique is also useful whenever stenting of a main vessel (MV) jeopardizes a side branch (SB) or when a sub-optimal result is encountered in a daughter vessel after starting with one-stent approach. The conversion from one-stent strategy to TAP could be achieved smoothly and often leads to good results. Technically, optimal positioning of the SB stent to achieve the required protrusion into the lumen of the MV remains a challenge. Toward that goal we propose an added step that involves inflating a balloon in the MV to serve as an anvil with simultaneous pullback of the SB stent, to be followed by stent deployment. We refer to this approach as the snuggle T and protrusion (S-TAP) technique owing to close contact between the SB stent and the MV balloon during simultaneous inflation. In this manuscript, we detail this interventional technique and provide a demonstrative case study. [ABSTRACT FROM AUTHOR]

Background: In patients undergoing percutaneous coronary intervention (PCI), drug eluting stents (DES) are currently the standard of care. Stent design and alloy composition, biocompatibility of the drug-eluting polymer coating, the antiproliferative agent properties and release are the three main characteristics that affects DES performance. Cre8 (Alvimedica, Istanbul, Turkey) is a polymer-free amphilimus-eluting stents (PF-AES). In this study, we aimed to investigate the clinical efficacy and safety of Cre8 DES in daily cardiology practice., Methods: Patients presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) including unstable angina pectoris (USAP), myocardial infarction with and without ST-segment elevation and treated with PCI using Cre8 DES between December 2015 and 2016 were retrospectively analyzed in this study., Results: Between December 2015 and 2016, 808 lesions of 664 patients treated with Cre8 DES in a single center were included in this retrospective analysis. The mean age of study group was 60 years (between 33 and 93 years) and were predominantly consisting of male patients (79.4%). The median follow-up duration was 487 days (min: 30 days, max: 919 days) and two-thirds of all patients presented with ACS. The culprit lesion was on left anterior descending artery (LAD) (40.5%) and right coronary artery (RCA) (25.9%) in most of the patients. The procedural success rate was 97.3%. Most of the lesions were type B1 (40.6%) according to American College of Cardiology/American Heart Association (ACC/AHA) coronary lesion classification. The device oriented primary end-point defined as target lesion failure (TLF) occurred in 52 (6.4%) of 808 lesions. The primary safety end-point was cardiac death in 20 patients (3.0%) and target vessel myocardial infarction in 2 patients (0.3%). Target vessel revascularization (TVR) occurred in 29 patients (4.4%) as primary safety endpoint. Multivariable logistic regression analysis revealed diabetes mellitus and ejection fraction as the predictors of mortality and device oriented primary end-point., Conclusions: This trial revealed clinical efficacy and safety of Cre8 stents in real world practice. Device oriented primary end points were similar with previous studies which are randomized, open label in nature and showed the efficacy and safety of Cre8 stent towards latest generation DES., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 The Author(s). Published by IMR Press.)

Objective: This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest., Methods: The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278)., Results: The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14)., Conclusion: No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings., (Copyright © 2022 European Society for Vascular Surgery. All rights reserved.)

A nanofiber composite mat of PU and Eudragit ® L100-55 was created using electrospinning process. The pH dependent release of paclitaxel was successfully done with the use of PU/EL100-55 nanocomposite mats as the controlling platform. The morphology of the nanofiber composites was surveyed using FESEM and ratios of the polymers affects the diameter of the nanofiber. Characterization of the nanofiber composite mat was done using FTIR, DSC-TGA method. The release rate of paclitaxel was determined and analyzed by in vitro drug release method. In order to mimic the condition of a human duodenum, the fibers were submersed on PBS of different pH levels (4.0, 6.0,) respectively, and then analyzed using high performance liquid chromatography (HPLC). Composite mats submersed in PBS with pH 4.0 showed lesser release profile compared to mats submersed in PBS with pH of 6.0. The composite mat has adequate mechanical properties and in vitro cell biocompatibility indicating that the material can be used for drug eluting stent cover application. [ABSTRACT FROM AUTHOR]

Large interests have been focused on the role of drug-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) and concerns have emerged regarding an higher risk of stent thrombosis. Aim of the current study was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of sirolimus-eluting stent (SES) as compared to paclitaxel-eluting stent (PES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of SES versus PES for STEMI. No language restriction was applied. Primary study endpoint was the occurrence of major adverse cardiac events (MACE). Secondary endpoints were the occurrence of death, reinfarction, stent thrombosis, target-vessel revascularization (TVR). Individual patient data were obtained from 4 out of 5 trials identified, including a total of 1,000 patients, 504 (50.4 %) randomized to SES and 496 (49.6 %) randomized to PES. At long-term follow-up (1,021 [372-1,351] days), no difference was observed between SES and PES in terms of TVR (10 vs 11.6 %, HR [95 % CI 0.73 [0.45-1.16], p = 0.18, p het = 0.92]) (primary endpoint) or death (9.4 vs 10.4 %, HR [95 % CI 0.95 [0.58-1.54], p = 0.82, p het = 0.89]), reinfarction (8.2 vs 10.4 %, HR [95 % CI 0.91 [0.53-1.57], p = 0.73, p het = 0.83]), stent thrombosis (7.4 vs 4.6 %, HR [95 % CI 1.04 [0.55-2.05], p = 0.92, p het = 0.65]), and MACE (10 vs 13.6 %, HR [95 % CI 0.86 [0.63-1.18], p = 0.36, p het = 0.84]) (secondary endpoints). The present pooled patient-level meta-analysis demonstrates that, among STEMI patients undergoing primary PCI, SES and PES are associated with a similar outcome at long-term follow-up, in terms of death, reinfarction, stent thrombosis, TVR and MACE. [ABSTRACT FROM AUTHOR]