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Background: Bioresorbable stent (BRS) is ideal treatment for superficial femoral artery (SFA) arteriosclerosis obliterans, allowing the target vessel to return to its normal state. A 3D-printing Fully Bioresorbable Drug Eluting Stent (PERISORB® BRS) was implanted for a successful first-in-human treatment of a SFA obstruction. Methods: A 57-year-old female patient suffered from intermittent claudication Rutherford-Becker category 3, the ankle-brachial index (ABI) was 0.70. Pre-procedure CTA showed a calcified 50 mm long severe stenosis in the distal segment of the left SFA. Results: The lesion was dilated with a diameter of 5 mm balloon, no relevant residual stenosis but a local dissection was seen during control-angiograms, the dissection was treated by implantation of a 5 mm × 76 mm 3D-printing biodegradable drug-eluting peripheral stent (PERISORB® BRS). The patient returned for follow-up visits, color duplex ultrasonography (CDUS) and digital subtraction angiography (DSA) was performed at 6-month and 16-month follow-up. No perioperative complications were found. At 16-month follow-up, ultrasonography showed stent patency and no stenosis. The Rutherford-Becker category was 1 and the ABI improved to 0.85. Conclusion: A successful first-in-human implantation was performed with the 3D-printing biodegradable drug-eluting peripheral stent (PERISORB® BRS).

Abstract Background Subjects with type 2 diabetes (T2D) have a higher risk of in-stent restenosis and stent thrombosis. The activation of the glucagon-like peptide-1 receptor (GLP-1R) has been suggested to induce several effects on the vasculature that may reduce the risk of stent failure following an angioplasty. The aim of this study is to evaluate the effect of the GLP-1R agonist exenatide on endothelialization of a modern drug-eluting stent (DES) in subjects with T2D. Methods 38 subjects with T2D who were eligible for revascularization with implantation of DES were randomized to treatment with exenatide (once weekly) plus standard treatment, or to standard treatment alone. After 12 weeks, a new coronary angiography was performed to evaluate the percentage of strut coverage (primary endpoint) and the presence of neo-atherosclerosis by optical coherence tomography. This study was approved by the Stockholm’s Ethical Review Board. Results The two groups were well balanced regarding baseline clinical characteristics. Strut coverage was 95% (88.7–98.5%) in the exenatide group and 91.4% (88.8–98.5%) in the control group (p = 0.692). There were no significant differences between groups neither in the thickness of neo-intima (0.2 mm in both groups, p = 0.471), nor the maximal in-stent obstruction by neo-intima (15.5% in exenatide group vs 14.7% in control group, p = 0.801). No significant differences were detected in the rate of target lesion revascularization between groups (p = 0.224). Conclusion Twelve weeks treatment with exenatide did not lead to a significantly better stent coverage in people with T2D. No significant differences in the occurrence of neo-atherosclerosis were detected between groups. Trial registration: The study was registered at www.clinicaltrials.gov (Rebuild Study, NCT02621489).

Objectives: Although the association of Atherogenic index of plasma (AIP) with coronary artery disease (CAD) and atherosclerosis is known, the relationship between AIP and in-stent restenosis (ISR) remains unclear. We aimed to investigate the relationship between AIP and ISR in patients with stable angina pectoris (SAP) treated with drug-eluting stent (DES). Methods: Patients with a history of DES implantation following stable angina were evaluated between January 2015 and November 2019 in this observational and retrospective study. 608 eligible patients were dichotomized into ISR+ (n=241) and ISR-(n=367). ISR was defined as the presence of 50% or greater stenosis. AIP was defined as log [TG/HDL-C]. Results: AIP levels were significantly higher in patients who developed ISR compared with those who did not (0.33 [0.15-0.52] vs 0.06 [-0.08-0.21] respectively, p<0.001). The AUC value of AIP levels for predicting ISR was 0.746 (p<0.001). Multivariate logistic regression analysis revealed that AIP, diabetes mellitus, higher LDL-C levels and lower LVEF values were independently associated with ISR. Conclusion: Multivariate analysis revealed that AIP was strongly independently associated with ISR. Using this novel inexpensive and easily calculable index may provide early recognition of ISR in patients with SAP who were treated with DES. [ABSTRACT FROM AUTHOR]

Background: Subjects with type 2 diabetes (T2D) have a higher risk of in-stent restenosis and stent thrombosis. The activation of the glucagon-like peptide-1 receptor (GLP-1R) has been suggested to induce several effects on the vasculature that may reduce the risk of stent failure following an angioplasty. The aim of this study is to evaluate the effect of the GLP-1R agonist exenatide on endothelialization of a modern drug-eluting stent (DES) in subjects with T2D. Methods: 38 subjects with T2D who were eligible for revascularization with implantation of DES were randomized to treatment with exenatide (once weekly) plus standard treatment, or to standard treatment alone. After 12 weeks, a new coronary angiography was performed to evaluate the percentage of strut coverage (primary endpoint) and the presence of neo-atherosclerosis by optical coherence tomography. This study was approved by the Stockholm's Ethical Review Board. Results: The two groups were well balanced regarding baseline clinical characteristics. Strut coverage was 95% (88.7–98.5%) in the exenatide group and 91.4% (88.8–98.5%) in the control group (p = 0.692). There were no significant differences between groups neither in the thickness of neo-intima (0.2 mm in both groups, p = 0.471), nor the maximal in-stent obstruction by neo-intima (15.5% in exenatide group vs 14.7% in control group, p = 0.801). No significant differences were detected in the rate of target lesion revascularization between groups (p = 0.224). Conclusion: Twelve weeks treatment with exenatide did not lead to a significantly better stent coverage in people with T2D. No significant differences in the occurrence of neo-atherosclerosis were detected between groups. Trial registration: The study was registered at www.clinicaltrials.gov (Rebuild Study, NCT02621489). [ABSTRACT FROM AUTHOR]

Cardiovascular diseases are overall the leading cause of mortality and morbidity worldwide. Therefore, treating and preventing coronary heart disease are of high scientific interest. Among several percutaneous coronary intervention procedures, coronary artery stenting displayed potent activity against restenosis, often observed using other invasive therapies. Nowadays, drug eluting stents' superiority over bare metal stents is increasingly recognizable, since drug eluting stents are able to overcome problems encountered with bare metal stent technology. Within this study, we developed a novel method for performing drug-releasing experiments utilizing an affordable stent model made from a readily available silver-coated copper wire, which was further coated with poly(n-butyl methacrylate). Leoligin, previously reported to inhibit intimal hyperplasia and the regrowth of endothelial cells, was exploited along with several structural analogs in drug-releasing experiments. It was found that compounds exhibiting similar biological activity can have significantly different releasing properties, a crucial parameter to know for the selection of compounds for in vivo studies. [ABSTRACT FROM AUTHOR]

Aims: A substantial proportion of the patients undergoing percutaneous coronary intervention (PCI) have none of the of standard modifiable cardiovascular risk factors (SMuRFs): hypertension, diabetes, hypercholesterolaemia and smoking. The aim of this analysis was to compare clinical outcomes after PCI according to the number of SMuRFs. Methods: Patients with an indication for a PCI were stratified based upon the number of SMuRFs: 0, 1, 2 or 3–4. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction or clinically driven target lesion revascularization at 1-year. Inverse weighted propensity score (IWPS) adjustment was performed to adjust for differences in baseline characteristics. Results: The prevalence of SMuRFs was: 0 SMuRF 16.4 %; 1 SMuRF 27.8 %; 2 SMuRFs 34.7 % and 3–4 SMuRFs 21.1 %. Patients without SMuRFs were younger, more likely to be male and had less complex coronary artery disease. The incidence of TLF increased with the number of SMuRFs: 2.65 %, 2.75 %, 3.23 %, and 4.24 %, Ptrend

BackgroundThere is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions.MethodsConsecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated.ResultsFrom March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a “DCB-only” strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed.ConclusionsOur data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Objective: Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. Methods: Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. Results: A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. Conclusions: This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion. [ABSTRACT FROM AUTHOR]

Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent. This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure. This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent. The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus. • The DynamX Bioadaptor is a novel device with a unique uncaging mechanism. • The uncaging mechanism permits vessel motion in the treated segment. • This shall ultimately lead to a reduction of long-term adverse events. • This is the first trial to compare the bioadaptor against a drug-eluting stent (DES). • This will be the first trial to also thoroughly assesses vessel motion in DES. [ABSTRACT FROM AUTHOR]

Abstract Background Antithrombotic guidelines for patients undergoing percutaneous coronary interventions (PCIs) and also requiring anticoagulant medications are evolving. This study describes changes to antithrombotic therapy and associated outcomes 12-months following PCI in patients requiring ongoing anticoagulation therapy. Methods Records of patients identified from queries of electronic medical records were manually reviewed to verify changes to antithrombotic therapy from discharge to 12-months and at 12-months following PCI, and episodes of major bleeding, clinically relevant non-major bleeding (CRNMB), major adverse cardiovascular or neurological events (MACNE), and all-cause mortality outcomes during an additional 6-months follow-up. Results Patients (n = 120) receiving anticoagulation therapy at 12-months post PCI were classified into the following groups according to antiplatelet therapy status: no antiplatelet therapy (n = 16), single antiplatelet therapy (SAPT) (n = 85), and dual antiplatelet therapy (DAPT) (n = 19). Between 12- and 18-months following PCI there were 2 major bleeds, 7 CRNMB, 6 MACNE, 2 venous thromboembolisms, and 5 deaths. All but one bleeding episode occurred in the SAPT group. The odds of remaining on DAPT at 12-months were higher in patients who had PCI for acute coronary syndrome (odds ratio [OR] 2.91, 95% confidence interval [CI] 0.96, 8.77), and in those experiencing MACNE in the 12-months following PCI (OR 1.95, 95% CI 0.67, 5.66), but these associations were not statistically significant. Conclusion Most anticoagulated patients were continued on antiplatelet therapy 12-months post PCI. Bleeding was numerically more common in anticoagulated patients continuing SAPT therapy beyond 12 months. There was significant variability in antithrombotic prescribing patterns 12-months post PCI suggesting a potential opportunity for standardizing care in this patient population.

Purpose: Endovascular treatment of femoropopliteal arterial diseases remains controversial. We conducted a Bayesian network meta-analysis of randomized controlled trials aiming to investigate the efficacy differences between paclitaxel- or sirolimus-eluting stents, covered stents, drug-coated balloons, bare metal stents, and percutaneous transluminal angioplasty. Method: MEDLINE, Embase, Ovid, and other relevant online material were searched up to October 21, 2020. Primary endpoints were primary patency and target lesion revascularization at 6, 12, and more than 24 months. Results: Thirty-eight eligible trials included 6026 patients. In terms of primary patency, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (80.6), 12 (78.4), and more than 24 months (96.5) of follow-ups. In terms of target lesion revascularization, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (90.3), 12 (71.3), and more than 24 months (82.1) of follow-ups. Covered stents and bare metal stents had higher ranks in target lesion revascularization than those in primary patency. Sirolimus stents had a higher rank than paclitaxel stents. Conclusion: Drug eluting stents showed encouraging results in primary patency rates and freedom from target lesion revascularization at all phases of follow-up for femoropopliteal arterial diseases. Sirolimus stents appear to be more effective in femoropopliteal segment than paclitaxel stent. [ABSTRACT FROM AUTHOR]

Background: Antithrombotic guidelines for patients undergoing percutaneous coronary interventions (PCIs) and also requiring anticoagulant medications are evolving. This study describes changes to antithrombotic therapy and associated outcomes 12-months following PCI in patients requiring ongoing anticoagulation therapy. Methods: Records of patients identified from queries of electronic medical records were manually reviewed to verify changes to antithrombotic therapy from discharge to 12-months and at 12-months following PCI, and episodes of major bleeding, clinically relevant non-major bleeding (CRNMB), major adverse cardiovascular or neurological events (MACNE), and all-cause mortality outcomes during an additional 6-months follow-up. Results: Patients (n = 120) receiving anticoagulation therapy at 12-months post PCI were classified into the following groups according to antiplatelet therapy status: no antiplatelet therapy (n = 16), single antiplatelet therapy (SAPT) (n = 85), and dual antiplatelet therapy (DAPT) (n = 19). Between 12- and 18-months following PCI there were 2 major bleeds, 7 CRNMB, 6 MACNE, 2 venous thromboembolisms, and 5 deaths. All but one bleeding episode occurred in the SAPT group. The odds of remaining on DAPT at 12-months were higher in patients who had PCI for acute coronary syndrome (odds ratio [OR] 2.91, 95% confidence interval [CI] 0.96, 8.77), and in those experiencing MACNE in the 12-months following PCI (OR 1.95, 95% CI 0.67, 5.66), but these associations were not statistically significant. Conclusion: Most anticoagulated patients were continued on antiplatelet therapy 12-months post PCI. Bleeding was numerically more common in anticoagulated patients continuing SAPT therapy beyond 12 months. There was significant variability in antithrombotic prescribing patterns 12-months post PCI suggesting a potential opportunity for standardizing care in this patient population. [ABSTRACT FROM AUTHOR]

Drug-eluting stent in-stent restenosis (DES-ISR) remains one of the important assignments to be resolved in interventional cardiology, as it is present in 5%–10% of total percutaneous coronary intervention cases. Drug-coated balloon (DCB) utilization is promising, as it comes with long-term protection from recurrent restenosis in optimal conditions without the hazard of higher risk for stent thrombosis and in-stent restenosis. We aim to reduce the need for recurrent revascularization in DES-ISR, specifying the population in which the DCB therapy should be used. In this meta-analysis, the results of studies containing data on the time frame between drug-eluting stent implantation and the clinical presentation of in-stent restenosis and concomitant drug-coated balloon treatment were summarized. A systematic search was performed in Medline, Central, Web of Science, Scopus and Embase databases on November 11th, 2021. The QUIPS tool was used to assess the risk of bias in the included studies. The occurrence of a major cardiac adverse events (MACE) composite endpoint, containing target lesion revascularization (TLR), myocardial infarction, and cardiac death, and each of these separately, was assessed at 12 months after the balloon treatment. Random effects meta-analysis models were used for statistical analysis. Data of 882 patients from four studies were analyzed. Across the included studies, a 1.68 OR (CI 1.57–1.80, p

BackgroundAlthough ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) results in a significantly greater net clinical benefit over that with ticagrelor-based 12-month DAPT in patients with acute coronary syndrome (ACS), it remains uncertain whether this effect is dependent on body mass index (BMI). We aimed to evaluate the BMI-dependent effect of these treatment strategies on clinical outcomes.MethodsThis was a pre-specified subgroup analysis from the TICO trial (Ticagrelor Monotherapy After 3 Months in Patients Treated With New Generation Sirolimus-eluting Stent for Acute Coronary Syndrome), evaluating the interaction between BMI and treatment strategies for the primary outcome [composite of major bleeding and adverse cardiac and cerebrovascular events (MACCE): death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization]. The secondary outcomes were major bleeding and MACCE.ResultsBased on a pre-specified BMI threshold of 25 kg/m2, 3,056 patients were stratified. Patients with BMI

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. [ABSTRACT FROM AUTHOR]

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. 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). 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). 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. [ABSTRACT FROM AUTHOR]

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DES, or drug-eluting stents, have the advantage of reducing restenosis rates relative to bare-metal stents. Modeling and simulation can be used to improve device performance. In this study, a general mathematical model for releasing a hydrophobic drug from a drug-eluting stent, DES, with a biostable coating is modeled. Most mathematical models allow the drug in the polymer to be released freely. This is suitable when the initial concentration of the drug in the polymer is less than the solubility, in which case the dissolution of the drug can be considered instantaneously. On the other hand, matrix devices can be loaded above solubility to provide zero-order release. to this end, we have equipped a model with a function that determines how the dissolution processes change with the dispersed phase discharge. The general model is analyzed with some limitations, and it is reduced to a new model that is consistent with previous studies. We examine the effects of initial drug loading and dissolution rate constant in numerically solving one of the new models, which is novel in DESs. [ABSTRACT FROM AUTHOR]

BackgroundSimple and effective risk models incorporating biomarkers associated with left main coronary artery (LMCA) stenosis are limited. This study aimed to validate the novel Bio-Clinical SYNTAX score (Bio-CSS) incorporating N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with LMCA stenosis.MethodsPatients who underwent percutaneous coronary intervention (PCI) for LMCA stenosis using a drug-eluting stent (n = 275) were included in the study. We developed the Bio-CSS incorporating NT-proBNP and validated the ability of the Bio-CSS to predict major adverse cardiac events (MACEs) and compared its performance to that of the SYNTAX score (SS) and SS II. The MACEs were defined as death, non-fatal myocardial infarction (MI), and repeat revascularizations.ResultsThe Bio-CSS (34.7 ± 18.3 vs. 51.9 ± 28.4, p < 0.001), as well as SS (23.6 ± 7.3 vs. 26.7 ± 8.1, p = 0.003) and SS II (29.4 ± 9.9 vs. 36.1 ± 12.8, p < 0.001), was significantly higher in patients with MACEs. In the Cox proportional hazards model, the log Bio-CSS (hazard ratio 8.31, 95% CI 1.84–37.55) was an independent prognostic factor for MACEs after adjusting for confounding variables. In the receiver operating characteristic curves, the area under the curve of the Bio-CSS was significantly higher compared to those of SS (0.608 vs. 0.706, p = 0.001) and SS II (0.655 vs. 0.706, p = 0.026). Patients were categorized into the three groups based on the tertiles of the Bio-CSS. Patients in the highest tertile of the Bio-CSS had significantly higher MACEs compared to those in the lower two tertiles (log-rank p < 0.001).ConclusionIn patients who underwent PCI for LMCA stenosis, the novel Bio-CSS improved the discrimination accuracy of established combined scores, such as SS and SS II. The addition of NT-proBNP to the clinical and angiographic findings in the Bio-CSS could potentially provide useful long-term prognostic information in these patients.

Bioresorbable scaffolds (BRS) emerged as an alternative to conventional stents with a fundamental idea, to avoid a permanent metallic cage with all its harmful effects on the vessel. The Absorb BVS was the first widely studied device with the promising concept of performing a percutaneous coronary intervention, giving the necessary initial support to maintain vessel integrity and avoid acute vessel thrombosis. After a period, complete resorption of the device without leaving in the vessel any metallic structure would theoretically offer several benefits as the reduction of the inflammatory response and recovering normal vasomotor function, recovering access of jailed side-branches and segments for surgical revascularization, and the reduction of very late stent thrombosis derived from late acquired malapposition. However, cumulative evidence from the different absorb randomized trials (ABSORB II, ABSORB III, ABSORB China, ABSORB Japan) raised significant concerns, due to an elevated rate of scaffold thrombosis, target lesion failure and target vessel failure, when compared to contemporary everolimus drug-eluting stents. Several mechanisms arose explaining scaffold failure; some were strictly related to the device itself, and others related to the operator and the lesion itself. Newer generation BRS are under development targeting the main limitations of the ABSORB BVS, mainly focusing on reducing strut thickness, improving the mechanical structure with faster resorption times, and a better crossing profile. The story of BRS is not over yet, with ongoing refinements in the quest for the ideal stent. • The ideal device to be used for PCI should relief the coronary obstruction with virtually no side effects. • BRS provided the possibility of restoring vessel integrity without leaving in the vessel any metallic structure. • Evidences of an higher-than expected rate of target vessel failure, mainly driven by an high rate of ScT and ScR has reduced the initial enthusiasm. [ABSTRACT FROM AUTHOR]

A major limitation of the treatment of low-grade upper tract urothelial carcinoma is the difficulty of intracavitary instillation of adjuvant therapy. Therefore, the aim of this in vitro study was to develop and to assess a new design of biodegradable ureteral stent coated with a silk fibroin matrix for the controlled release of mitomycin C as a chemotherapeutic drug. For this purpose, we assessed the coating of a biodegradable ureteral stent, BraidStent®, with silk fibroin and subsequently loaded the polymeric matrix with two formulations of mitomycin to evaluate its degradation rate, the concentration of mitomycin released, and changes in the pH and the weight of the stent. Our results confirm that the silk fibroin matrix is able to coat the biodegradable stent and release mitomycin for between 6 and 12 h in the urinary environment. There was a significant delay in the degradation rate of silk fibroin and mitomycin-coated stents compared to bare biodegradable stents, from 6–7 weeks to 13–14 weeks. The present study has shown the feasibility of using mitomycin C-loaded silk fibroin for the coating of biodegradable urinary stents. The addition of mitomycin C to the coating of silk fibroin biodegradable stents could be an attractive approach for intracavitary instillation in the upper urinary tract. [ABSTRACT FROM AUTHOR]

Background: There are no available data about clinical outcomes of simple stenting for ostial left circumflex (LCX) lesions using current generation drug-eluting stents (cDES).Objective: We assessed clinical outcomes after simple stenting using cDES for ostial LCX lesions.Methods: We identified 81 consecutive patients who underwent PCI using cDES for ostial LCX lesions at New Tokyo Hospital, Matsudo, Japan between January 2010 and December 2016. An ostial LCX lesion was defined as a lesion with more than 75% stenosis by visual assessment and within 3 mm of the left main (LM) stem. The primary endpoint was target lesion failure (TLF). TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Additionally, we also assessed the revascularization for LM to left anterior descending artery (LAD) after ostial LCX stenting.Results: The TLF rate at 3 years after PCI was 24.5%. Furthermore, the rate of TLR and revascularization for LM-LAD after ostial LCX stenting were significantly higher in patients who were previously undergone stent implantation in ostial segment of LAD.Conclusion: Clinical outcomes after cDES implantation for ostial LCX lesion could be acceptable. However, it could have better to be avoided in patients who previously received stent implantation in ostial segment of LAD. [ABSTRACT FROM AUTHOR]

Abstract Objective To compare the mortality rates of patients with claudication and de novo femoropopliteal lesions treated with and without paclitaxel coated devices (PCD). Background A recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions but also with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with PCD. Methods Comparison of two historical cohorts of patients presenting with claudication and de novo femoropopliteal lesions treated with and without PCD between 2008 and 2018. Results After review of 5219 arteriograms in patients presenting with peripheral artery disease, 700 consecutive patients were included consisting in 72.6% of male (n = 508). Mean age was 68.1 ± 8.5 years. 45.7% of the patients (n = 320) had a treatment including a PCD. Mean femoropopliteal lesion length was 123 ± 91 mm including 44.6% of occlusions. Patients of the control group were censored at crossover to paclitaxel when applicable. Mortality rates at 1, 2 and 5 years were 4.6%, 7.5%, 19.4% and 1.6%, 6.2%, 16.6% in the non-PCD and PCD groups respectively. The relative risks of death when using PCD were 0.35 (p = 0.03), 0.83 (p = NS) and 0.86 (p = NS) at 1, 2 and 5 years respectively. Conclusion There was no excess mortality in patients with claudication and de novo femoropopliteal lesions treated with paclitaxel coated devices at 1, 2 and 5 years of follow-up in this cohort. The current study suggests that additional prospective randomized studies properly powered to study mortality are necessary.

Severely calcified coronary lesions remain a formidable hurdle for percutaneous coronary intervention as it averts the stent delivery and complete stent apposition. To overcome this Achilles heel of an interventional cardiology, a current US FDA approved method named shockwave intravascular lithotripsy (S-IVL; Shockwave Medical, Inc) is used for its treatment. Herein, we report a case of a 53-year-old dyslipidemic male with severely calcified left anterior descending artery (LAD) lesion that was successfully treated with S-IVL and drug-eluting stent implantation. At first, the patient was presented with complaints of chest pain and breathlessness. His coronary angiogram revealed heavily calcified stenosis in diffuse mid LAD—completely totally occluded mid-diagonal (D) 1 that was checked through retrograde filling via collateral and calcified stenosis in ostial D2, mild stenosis in ostial left circumflex and mild stenosis at distal before crux 50% stenosis in dominant right coronary artery. Following this, it was decided to proceed with primary percutaneous coronary intervention with S-IVL to LAD. After successful delivery of S-IVL to LAD, a Tetriflex sirolimus eluting stent (Sahajanand Medical Technologies Ltd., Surat, India) was successfully implanted at LAD. Finally, the patient’s condition was stabilized and discharged after two days of index procedure.

Background: The jailing strut configuration with link-free and distal guidewire recrossing (LFD) at the side branch orifice (SBO) reduces incomplete stent apposition (ISA) after kissing balloon technique (KBT) in crossover stenting of coronary bifurcation lesions (CBLs). However, data regarding vascular healing after KBT are lacking. We investigated vascular healing 9 months after crossover stenting followed by KBT with optical coherence tomography (OCT) guidance in a prospective multicenter registry. Methods: Fifty-nine patients with CBLs (LFD, 35 patients; non-LFD, 24 patients) were studied. The jailing configuration of the SB and the wire-recrossing position, incidence of ISA and uncovered struts, and neointima unevenness score (NUS) in the main vessel (MV) after 9 months were determined by off-line 3D-OCT in the core laboratory. Results: The ISA rate was significantly higher at the SB ostium and distal MV after KBT in the non-LFD group, compared to the LFD group. After 9 months, incidence of ISA (18.3 ± 18.2 vs. 6.0 ± 8.7%, p

Background: Biodegradable polymer drug eluting stents (BP-DES) may offer the advantage of vascular healing in ST-segment elevation myocardial infarction (STEMI). Long-term outcome data comparing BP-DES and second-generation durable polymer drug eluting stents (DP-DES) in STEMI is lacking. This study aims to compare the long-term clinical outcomes of BP-DES versus second-generation DP-DES in STEMI.Methods: This is an observational study of consecutive patients with STEMI who received either BP-DES (n = 854) or DP-DES (n = 708) during primary percutaneous coronary intervention (PCI) from 1st February 2007 to 31st December 2016. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization with follow up till 30th November 2019.Results: The baseline demographics, lesion and procedural characteristic were similar between the two groups except for more prior MI and chronic obstructive pulmonary disease in the BP-DES group. At a median follow up of 4.2 years (interquartile range: 2.6-6.2 years), the incidence of TLF was similar between BP-DES and DP-DES (adjusted hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.70-1.26). Likewise, incidence of major adverse cardiovascular events (MACE: all-cause death, any MI or target vessel revascularization) and definite stent thrombosis were similar in both groups (MACE: adjusted HR 1.04, 95% CI 0.82-1.32; definite stent thrombosis: adjusted HR 1.06, 95% CI 0.31-3.64).Conclusion: Among patients with STEMI who underwent primary PCI, BP-DES and DP-DES implantation was associated with similar long-term clinical outcomes. [ABSTRACT FROM AUTHOR]

An ultra-thin, fracture-resistant and bioresorbable stent may be advantageous for provisional stenting in vessel bifurcations, if catheter passage and side-branch post-dilatation is facilitated to prevent a 'stent jail' by struts obstructing the orifice of a major side branch. We studied a highly radiopaque, slowly bioresorbable zinc alloy stent characterized by a novel design of a radiopaque-marked region of ultra-thin struts in the center of the stent. The stent is characterized by an extended range flexibility and high fracture resistance. Zn-stents and Zn-drug eluting stents (DES) were implanted opposite to rigid Nitinol stents into both femoral artery bifurcations of 21 juvenile pigs, followed for one and three months and studied by angiography and histomorphometry. Results and conclusion: Bare Zn-stents with thinner stent struts showed less neointimal hyperplasia compared to Zn-stents with thicker struts. Neointimal formation was further reduced by 12% in Zn-alloy DES. Both, bare Zn-stents and Zn-DES, can be precisely positioned into the femoral artery bifurcation, allowing easy balloon catheter passage through the very thin strut mesh. Side branch orifices remained open after Zn-stent deployment without stent jailing. No stent fractures or particles emboli occurred after the deployment. A Zn-stent with ultra-thin center struts may be useful for provisional stenting in vessel bifurcations. [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.

Background: In the elderly people with unprotected left main distal bifurcation lesions (ULMD), percutaneous coronary intervention (PCI) is often selected as first choice treatment strategy because of perioperative high risk of coronary artery bypass graft surgery due to their large number of comorbidities. Also, some recent papers reported that geriatric nutritional risk index (GNRI) is also strongly associated with clinical outcomes after interventional procedures in elderly patients., Objectives: We assessed clinical outcomes after PCI for ULMD and the impact of GNRI in elderly patients., Methods: We identified 669 non dialysis patients treated with current generation drug-eluting stent for ULMD from MITO registry. We divided the patients to the following 2 groups; elderly group (n = 240, age ≥75) and young group (n = 429, age <75). Additionally, we could calculate GNRI and divided elderly group into 2 group based on the median value of the GNRI. The primary endpoint was all-cause mortality., Results: All-cause mortality was significantly higher in elderly group [adjusted hazard ratio (HR) 2.37; 95% confidence interval (CI), 1.40-4.02; p = 0.001]. All-cause mortality was significantly higher in low GNRI elderly group compared to other 2 groups (Adjusted HR of elderly with low GNRI: 3.56, 95%CI (1.77-7.14), p < 0.001). Cardiovascular mortality was comparable between two groups. TLR rate was significantly lower in elderly group (adjusted HR 0.57; 95% CI, 0.34-0.97; p = 0.035)., Conclusions: The elderly had higher all-cause mortality after PCI for ULMD compared to young people. Especially, the elderly with low GNRI were extremely associated with poorer outcomes., (© 2024 Wiley Periodicals LLC.)

Background: Drug-eluting stents (DES) are used to treat lower extremity arterial disease. During DES treatment, aneurysmal degeneration occasionally occurs, especially with fluoropolymer-based DES. However, the incidence of pseudoaneurysms after DES placement is rarely reported in the lower extremity region, although there have been several reports on pseudoaneurysm formation after DES pla-cement in the coronary artery region., Case Summary: We report the case of a 64-year-old man who presented with fever and pain in his left hand after dialysis. Bacteremia was diagnosed by blood culture, and after admission, he developed pain on the medial side of the right thigh. A pseudoaneurysm was observed in the right superficial femoral artery (SFA) at the proximal end of a previously placed DES. The bacteremia was thought to have been caused by a pseudoaneurysm of the left superficial brachial artery, and the pseudoaneurysm of the left superficial brachial artery was removed after antibiotic treatment. The pseudoaneurysm of the right SFA rapidly expanded after admission, but the expansion rate was reduced after infection control. Seven months after the first admission, the pseudoaneurysm of the left SFA was re-moved and in situ revascularization performed using a rifampicin-soaked Dacron graft., Conclusion: Although pseudoaneurysm after DES placement in the lower extremity region is rare, it must be considered in patients with bacteremia., Competing Interests: Conflict-of-interest statement: The authors declare that they have no competing financial interests or personal relationships that may have influenced the work reported in this study., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Warfarin, along with aspirin and clopidogrel, has long been recommended for patients with atrial fibrillation (AF) who are undergoing percutaneous coronary intervention with a drug-eluting stent (PCI-DES). However, this triple therapy has been known to increase the risk of bleeding complications. Meanwhile, there is no evidence from prospective trials on the use of ticagrelor in a dual therapy. We here aimed to compare the antiplatelet drug ticagrelor as a dual antithrombotic agent to aspirin and clopidogrel in bleeding events.Methods: In this multicenter, active-controlled, open-label, randomized trial, patients with AF taking warfarin who had undergone PCI-DES were randomly assigned to the ticagrelor therapy group (Dual group) or the clopidogrel plus aspirin therapy group (Triple group). The primary and secondary endpoints were overall bleeding events and major bleeding events, respectively, according to the Thrombolysis in Myocardial Infarction (TIMI) criteria at 6 months. Cardiovascular events [re-PCI, surgical bypass, myocardial infarction (MI), heart failure, rehospitalization due to angina pectoris, stent thrombosis and death due to cardiovascular causes] at 6 months were also recorded.Results: A total of 296 patients from 12 medical centers in China were randomized after PCI-DES to either the Dual therapy group (n = 148) or the Triple group (n = 146) for 6 months. The overall incidence of bleeding events at 6 months was 36.49% in the Dual therapy group and 35.62% in the Triple group [hazard ratio, 0.930; 95% confidence interval (CI), 0.635 to 1.361; P = 0.7088]. The incidence of the secondary endpoint over 6 months was 4.73% in the Dual therapy group and 1.37% in the Triple group (hazard ratio, 0.273; 95% CI, 0.057 to 1.315; P = 0.1056). Cardiovascular event occurrence was also comparable in both groups at 6 months (18.24 vs. 16.44%; hazard ratio, 0.845; 95% CI, 0.488 to 1.465; P = 0.5484).Conclusions: The incidence of total bleeding events in AF patients treated with ticagrelor was comparable to that in patients treated with clopidogrel plus aspirin at 6 month; Meanwhile, the incidence of cardiovascular events were also comparable between the groups.Clinical Trial Registration: MANJUSRI, ClinicalTrials.gov# NCT02206815, 2014, August 1st