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Introduction: The DESyne novolimus‐eluting coronary stent (NES) is a new‐generation drug‐eluting stent (DES) that is widely used, but clinical data are rarely reported for this stent. We compared the safety and effectiveness of the DESyne NES and the Orsiro bioresorbable polymer sirolimus‐eluting stent (SES) in patients undergoing percutaneous coronary intervention (PCI). Methods: This was a retrospective, single‐center, observational study. Between July 2017 and December 2022, patients who presented with chronic or acute coronary syndrome undergoing PCI with DESyne NES or Orsiro SES were consecutively enrolled in the present study. The primary endpoint, major adverse cardiovascular event (MACE), was a composite of cardiovascular death, target‐vessel myocardial infarction, or clinically driven target‐lesion revascularization. Results: A total of 776 patients (age 68.8 ± 12.2; 75.9% male) undergoing PCI were included. Overall, 231 patients with 313 lesions received NES and 545 patients with 846 lesions received SES. During a follow‐up duration of 784 ± 522 days, the primary endpoint occurred in 10 patients (4.3%) in the NES group and in 36 patients (6.6%) in the SES group. After multivariate adjustment, the risk of MACE did not significantly differ between groups (NES vs. SES, hazard ratio 0.74, 95% CI, 0.35–1.55, p = 0.425). The event rate of individual components of the primary endpoint was comparable between the two groups. Conclusions: Favorable and similar clinical outcomes were observed in patients undergoing PCI with either NES or SES in a medium‐term follow‐up duration. Future studies with adequately powered clinical endpoints are required for further evaluation. [ABSTRACT FROM AUTHOR]

Background: Critical limb-threatening ischaemia is a life-threatening disease which often combines with infrapopliteal arterial disease. Percutaneous transluminal angioplasty (PTA) is recommended as the first-line treatment for infrapopliteal arterial disease. Drug-eluting stent (DES) is another widely used option; however, its long-term therapeutic effect is controversial. The effectiveness of different DES for infrapopliteal arterial disease needs further exploration. Methods and results: The PubMed, EMBASE, Cochrane Library and Clinical trials were systematically searched from inception to 1 February 2023. Literatures were included if the study was original, peer-reviewed, published in English or Chinese, and contained patients diagnosed with simple infrapopliteal arterial disease or with properly treated combined inflow tract lesions before or during the study procedure. A total of 953 patients, 504 in the DES group and 449 in the PTA/bare-metal stenting (BMS) group, from 12 randomised controlled trials were included in the meta-analysis. The results showed that DES is superior to control group for improving clinical patency, reducing the restenosis rate, and reducing the amputation rate at 6 months, 1 year, and 3 years post-treatment [at 3 years, risk ratio (RR): 1.90, 95% CI 1.23-2.93; RR: 0.87, 95% CI 0.79-0.96; RR: 0.60, 95% CI 0.36-1.00, P=0.049]. In addition, subgroup analyses suggested that DES is superior to BMS and PTA in improving clinical patency and reducing target lesion revascularisation and restenosis rates at 6-month and 1-year post-treatment. The network meta-analysis indicated that sirolimus-eluting stent was superior for improving clinical patency (at 1 year, RR: 0.23, 95% CI 0.08-0.60) and reducing the restenosis rate (at 6 months, RR: 31.58, 95% CI 4.41-307.53, at 1 year, RR: 3.80, 95% CI 1.84-8.87) significantly. However, according to the cumulative rank probabilities test, everolimus-eluting stent may have the lowest target lesion revascularisation rates and amputation rates at 1-year post-treatment (the cumulative rank probability was 77% and 49%, respectively). Conclusions: This systematic review and network meta-analysis showed that DES was associated with more clinical efficacy than PTA/BMS significantly. In addition, sirolimus-eluting stent and everolimus-eluting stent may have better clinical benefits. [ABSTRACT FROM AUTHOR]

Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-inman registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in four cases (4.2%). At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization. [ABSTRACT FROM AUTHOR]

Introduction: Few researchers have investigated the optimal long-term antithrombotic therapy regimen, especially after first-generation drug-eluting stent (DES) use. This study aimed to evaluate the impact of mid-term antithrombotic therapy on long-term outcomes in patients treated with the first sirolimus-eluting coronary stent (Cypher™). Methods: Between 2004 and 2009, 1021 patients underwent Cypher™ implantation at our institute; among them, 567 patients had available data on antithrombotic therapy at year 5. We assessed patients' antithrombotic therapy at year 5 post Cypher™ implantation and examined their association with adverse events from year 5 to year 10 post Cypher™ implantation. Results: Patients with dual-antiplatelet therapy (DAPT) at year 5 had significantly lower risk of stent thrombosis (ST) than those with single-antiplatelet therapy (SAPT) (hazard ratio [HR] 0.24, p = 0.034). The HR of major bleeding in DAPT, compared to SAPT, was high, but the difference was not significant (HR 1.72, p = 0.26). Risk of major bleeding was significantly higher in patients on oral anticoagulants (OAC) than in those in other groups (OAC/SAPT; HR 5.31, p = 0.0048, OAC/DAPT; HR 3.08, p = 0.022), without significant reduction in the risk of cardiovascular events. Conclusions: The incidence of ST after Cypher™ implantation in patients with DAPT at year 5 was significantly lower than that in SAPT. However, the risk of bleeding was higher with DAPT than with SAPT. Moreover, the risk of major bleeding was significantly higher in patients on anticoagulant therapy than in other patients. New options for the use of antithrombotic drugs after percutaneous coronary intervention warrant further studies on the optimal antithrombotic therapy for first-generation DES. [ABSTRACT FROM AUTHOR]

Pharmacokinetic analyses were performed using 20 pigs for 120-days implantation, while one sirolimus-eluting stent was implanted into one of their coronary artery. At different time points, the residual sirolimus on the stent, delivered locally (to artery wall), regionally (to adjacent and downstream muscle) and systemically (to plasma and visceral organs), was detected throughout 120 days. Preclinical safety evaluation was performed using 32 pigs for 180-days implantation to study the safety of metal platform material and the effectiveness of sirolimus eluting coating on the HNS stent. The neointima area, restenosis rate and inflammatory grade for HNS and control group stents were detected and analyzed. Approximately 80% sirolimus was eluted from the sirolimus-eluting stents after 30-days implantation in vivo. Additionally, there was sustained sirolimus in the artery wall, cardiac muscle and heart throughout 120-days implantation, and sirolimus accumulated to the peak at 90-days implantation. It was inferred that the sirolimus eluting stent in this study was covered by neointima before 90-days implantation, indicating that the sirolimus eluting coating on the HNS stent was safe and effective. Very little sirolimus was distributed in visceral organs after 14-days implantation. HNS sirolimus-eluting stent exhibited lower restenosis rate and lower inflammatory grade than control group, which verified that the sirolimus-eluting coating design in this study was reasonable and practical. In addition, there were no significant difference in restenosis rate and inflammatory score between HNS bare-metal stent and drug-eluting stents, illustrating that HNS has good bio-compatibility and is suitable to use as coronary artery stent material.

Introduction Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

Objective: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymercoated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups. Methods: This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint. Results: At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population. Conclusion: Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups. [ABSTRACT FROM AUTHOR]

Background: The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. Methods: The POLBOS I and POLBOS II were international, multicentre, randomized, open‐label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug‐eluting stent (rDES) deployment. A provisional T‐stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow‐up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I—NCT02192840, POLBOS II—NCT02198300). Results: The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow‐up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73‐1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43‐2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32‐2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75‐1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75‐2.09). Conclusions: At the 6‐year follow‐up, clinically significant clinical events did not differ between BiOSS stents and rDES. [ABSTRACT FROM AUTHOR]

Diabetes mellitus (DM) is a rising global epidemic affecting more than 10% of the world population and predisposes patients to develop highly progressive and complex coronary artery disease. Despite numerous advancements in percutaneous coronary intervention procedural techniques and coronary stent platforms, clinical outcomes in DM patients have improved little compared with non-DM patients. Abluminus DES+, a biodegradable polymer sirolimus-eluting stent deployed with a drug-coated balloon, has been specifically designed to provide adequate coverage for DM patients and reduce adverse clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: This study aimed to investigate the occurrence and predictive factors of restenosis in coronary heart disease (CHD) patients underwent percutaneous coronary intervention (PCI) with sirolimus-eluting stent (SES). Methods: Demographic data, clinical features, and laboratory tests of 398 CHD patients underwent PCI with SES were retrospectively reviewed. Coronary angiography was performed to evaluate coronary stenosis before PCI and in-stent restenosis at 1-year follow-up. Results: There were 37 (9.3%) patients suffered restenosis, but 361 (90.7%) patients did not develop restenosis at 1-year follow-up. Demographic characteristic (age), cardiovascular risk factors (hypertension and hyperuricemia), biochemical indexes (fasting blood-glucose, total cholesterol, low density lipoprotein cholesterol (LDL-C) and high-sensitivity C-reactive protein (HsCRP)), cardiac function index (cardiac troponin I), lesion features (multivessel artery lesions, target lesion at left circumflex artery (LCX), two target lesions and length of target lesion), and operation procedure (length of stent) were correlated with higher restenosis risk. Moreover, age, hypertension, diabetes mellitus, LDL-C, HsCRP, and target lesion at LCX were independent predictive factors for raised restenosis risk. Based on these independent predictive factors, we established a restenosis risk prediction model, and receiver-operating characteristic curves displayed that this model exhibited an excellent predictive value for higher restenosis risk (areas under the curve 0.953 (95% CI 0.926–0.981)). Conclusion: Our findings provide a new insight into the prediction for restenosis in CHD patients underwent PCI with SES. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. Methods: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. Results: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. Conclusion: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials. [ABSTRACT FROM AUTHOR]

Background: Coronary stent neoatherosclerosis, thrombosis, and restenosis remain significant concerns with new-generation drug-eluting stents (DES). The Dual-Therapy CD34 antibody-covered sirolimus-eluting stent [dual therapy stent (DTS)] is a sirolimus-eluting stent with CD34 antibodies immobilized on its luminal surface to capture circulating endothelial progenitor cells and promote early endothelialization. We conducted a meta-analysis to determine whether the DTS was superior to standard DES.Methods: We conducted a comprehensive search for controlled randomized and non-randomized studies. We presented data using risk ratios (95% confidence intervals) and measured heterogeneity using Higgins' I2.Results: Five studies with a low risk of bias met the inclusion criteria, with a total of 1884 patients in the DTS and 1819 in standard DES arms. There was no difference between the 2 arms in the following 1-year outcomes: cardiac death [1% vs 0.9% RR 1.13 (95% CI 0.49-2.62) I2 = 0%], target lesion failure [6.2% vs 5.3% RR 1.12 (0.80-1.58) I2 = 0%], target lesion revascularization (TLR) [4.9% vs 3.4% RR 1.40 (0.93-2.10) I2 = 15%], target vessel failure [8.2% vs 6.1% RR 1.24 (0.75-2.04) I2 = 0%], target vessel myocardial infarction [1.1% vs 1.8% RR 0.73 (0.19-2.90) I2 = 62%] and stent thrombosis [0.4% vs 0.6% HR 0.85 (0.27-2.62) I2 = 0%]. However, compared with second-generation DES (EES and ZES), the DTS had significantly higher one-year TLR [5% vs. 3.1% RR 1.58 (1.02-2.46) P = 0.04 I2 = 0%].Conclusion: One-year TLR was significantly higher in the DTS arm compared with second-generation DES. There was no difference in the other 1-year clinical outcomes compared with standard DES. [ABSTRACT FROM AUTHOR]

Background Very late stent thrombosis (ST) is a concern in the era of drug-eluting stents (DESs), and ST is associated with peri-DES coronary artery aneurysmal lesions or coronary evaginations. An increasing number of cases of concurrent systemic allergic reaction and ST have been reported as Kounis syndrome (KS) in the literature. The number of patients with very late ST caused by KS is small, and further investigation of the potential pathophysiology is required. Case summary We report a case of KS that manifested as systemic urticaria followed by very late ST 14 years after placement of two sirolimus-eluting stents (SESs). Three months after the event of ST, coronary evaginations at the stented segments were detected on intravascular optical coherence tomography. Discussion Coronary evaginations are associated with local hypersensitivity, stent malapposition, uncovered strut, and flow disturbance that may predispose to ST. Systemic allergic reactions are known to promote platelet adhesion and aggregation. This case of KS suggests a pathophysiology in which the synergic effects between the coronary evaginations and a systemic allergic reaction may contribute to very late ST. For patients with Type 3 KS, performing follow-up intracoronary imaging tests may be important to confirm potential coronary evaginations, especially in patients with SESs. [ABSTRACT FROM AUTHOR]

• At 5 years, target lesion revascularization was significantly lower in the everolimus-eluting stent (EES) group than in the sirolimus-eluting stent (SES) group. • The rate of stent thrombosis was significantly less in the EES group than in the SES group. • Hemodialysis and the type of stent were independent risk factors for primary outcome. • EES offers a safe and effective treatment throughout 5 years. Use of the everolimus-eluting stent (EES) instead of the sirolimus-eluting stent (SES) has been shown to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) out to 3 years. However, it is not known whether the differences in efficacy and safety outcomes remain constant throughout 5 years. This was a retrospective, non-randomized, observational study. We followed 1460 consecutive patients undergoing PCI in our institutions from April 2005 to March 2012. There were 718 cases in patients with SES (SES group) and 742 with EES (EES group). Ten-month angiographic follow-up results and 5-year clinical follow-up outcomes were compared between the EES and SES groups. The primary outcome of this study was major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST). At 5 years, the rates of target lesion revascularization (TLR), TVR, recurrent MI and ST were significantly lower in the EES group compared to the SES group (TLR: 4.6% vs. 8.2%, p < 0.05; TVR: 5.0% vs. 9.0%, p < 0.05; recurrent MI: 1.5% vs. 4.4%, p < 0.05; ST: 1.2% vs. 3.9%, p < 0.05). Thus, MACE were significantly lesser in the EES group compared to the SES group (8.8% vs. 12.8%, p = 0.006). EES improved clinical outcomes compared to SES, and specifically, was associated with reductions in TVR, ST, and recurrent MI out to 5 years. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. Methods: The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Clinical follow-up was performed at 1, 6, and 12 months. Major adverse cardiac event occurred at 30 days and subsequently at 6 months and at long-term follow-up of 1 year was analyzed. Results: MACE observed at 1 and 6 months follow-up was 16 (1.38%) and 21 (1.83%) respectively. Cumulative 1 year MACE was 26 (2.35%) with 16 (1.39%) all cause death, 4 (0.35%) MI and 6 (0.52%) TLR. In addition, ST was observed in 1 (0.09%) patient. Conclusions: The present study suggests that the BioMime SES is safe and effective in a “real-world”, all-comers CAD patients, indicating low rates of MACE. CTRI Acknowledgement No: REF/2016/07/011808.

Context: The role of percutaneous coronary intervention in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. Aim: The aim of this study was to examine the incidence of clinical outcomes after utilization of Indolimus, biodegradable polymer coated sirolimus-eluting stent (SES), in multivessel coronary stenting in an unselected patient population. Settings and Design: From April-2012 to June-2014, patients with multivessel (≥2 vessels) disease were examined in the retrospective, nonrandomized, observational, multicenter MULTIDES study. Materials and Methods: A total of 151 patients, exclusively treated with Indolimus SES in multivessel, were included in the study. The study was conducted in accordance with the Declaration of Helsinki and country-specific regulatory requirements. All patients signed informed consent form. Statistical Analysis Used: Continuous variables are presented as mean ± standard deviation and categorical variables as counts and percentages. All data were analyzed using Statistical Package for Social Sciences program. Results: The mean age was 53.7 ± 10.7 years; male gender represented 108 (71.5%) patients. A total of 314 Indolimus stents were implanted. Clinical follow-up was performed at 30-day, at 6-month, and at 9-month. The primary endpoint, major adverse cardiac events (MACEs) at 9-month follow-up, occurred in 5 (3.3%) patients, consisting of 1 (0.7%) cardiac death, 2 (1.3%) myocardial infarction, 2 (1.3%) target lesion revascularization, 0 (0%) target vessel revascularization, and 0 (0%) stent thrombosis. Conclusion: The present study describes that Indolimus implantation is safe and effective treatment in multivessel CAD, showing low rates of MACEs during 9-month follow-up.

Background: Genoss drug-eluting stent (DES) (Genoss Company Limited) is a new ultrathin sirolimus-eluting stent with an abluminal biodegradable polymer and a cobalt-chromium platform., Aims: The aim of this study was to evaluate vascular healing and neointimal coverage after implantation of the Genoss DES using optical coherence tomography (OCT) 6 months postimplantation., Methods: From August 22, 2019 to June 17, 2020, this multicenter, observational, investigator-initiated study enrolled 20 patients who underwent OCT examination 6 months after Genoss DES implantation and provided informed consent. An analyst, blinded to the patients' and procedural information analyzed OCT images at an independent core laboratory., Results: Of the 20 patients, 19 with 27 stents in 21 lesions from 21 vessels were included in the analysis, while one patient withdrew consent and was unwilling to undergo follow-up OCT. OCT analysis was performed 204.4 ± 31.9 days after Genoss DES implantation. A total of 4285 stent struts from 661 cross-sections were analyzed. Strut tissue coverage was observed in 98.7 ± 4.3% of struts, with 0.1 ± 1.2% malapposed struts per lesion. The mean thickness of neointimal hyperplasia (NIH) on the covered struts was 0.12 ± 0.04 mm., Conclusions: Six months after stent implantation, most Genoss DES struts were covered with a thin layer of NIH that was evenly distributed along the stent length. This pilot study evaluated the outcomes of 6 months dual antiplatelet therapy in the context of ultrathin strut stents, providing insight into developing ethical standards and a scientific foundation for conducting an adequately designed clinical trial., (© 2023 Wiley Periodicals LLC.)

Background: Very long-term angiographic results after sirolimus-eluting stent (SES) implantation have not been clarified. This study investigated serial angiographic results of early (<1year), late (1-5years), and very late (>5years) follow-up after SES implantation and the progression process to very late SES failure.Methods: We analyzed 631 lesions undergoing serial coronary angiography at early, late, and very late follow-up after SES implantation. The results of 205 lesions undergoing very late target lesion revascularization (VL-TLR; TLR beyond 5years) for acute coronary syndrome (ACS; 83) and non-ACS (122) were evaluated in comparison with 426 non-TLR lesions as a control group.Results: Non-TLR lesions showed no attenuated decline of minimum lumen diameter from postprocedure (2.51±0.47mm), early (2.37±0.58mm), late (2.22±0.60mm), up to very late (2.01±0.63mm) follow-up. In VL-TLR lesions, compared to non-TLR lesions, late lumen loss (LLL) from postprocedure to early follow-up was similar, but delayed LLL from early to late follow-up was significantly larger (0.25±0.48mm vs. 0.15±0.46mm, p=0.01). Although the delayed LLL was significantly larger in non-ACS lesions (0.29±0.44mm) than in non-TLR lesions (p<0.01), it was similar in ACS (0.19±0.52mm) and non-TLR lesions (p=0.54). Very delayed LLL from late to very late follow-up was 1.65±0.82mm in ACS lesions and 1.10±0.76mm in non-ACS lesions.Conclusions: Progression of in-stent luminal narrowing did not attenuate beyond 5years after SES implantation. In very late SES failure, stent-related ACS lesions showed gradual luminal narrowing and subsequent rapid progression beyond 5years, whereas non-ACS lesions had progressive luminal narrowing within 5years. [ABSTRACT FROM AUTHOR]

Sirolimus-eluting stents (SES), especially those deployed at distal sites, cause more coronary vasospasm and endothelial dysfunction in the chronic phase compared to bare-metal stents (BMS). In comparison, endothelial dysfunction is less frequently induced by the Biolimus-A9 eluting stent (BES). A 75-year-old man with effort-induced angina pectoris previously underwent a total of three SES implantations in the left anterior descending coronary artery (LAD) and right coronary artery (RCA) in 2010 and 2011. He was referred to our hospital for the management of chest discomfort at rest in August 2014. We diagnosed this patient with coronary spastic angina (CSA) and coronary endothelial dysfunction (CED) induced by the SES, together with an atherosclerotic lesion in the left main coronary artery (LMCA). Adequate medication for CSA and CED and intervention for the atherosclerotic lesion contributed to improvement of vascular function and disappearance of his symptoms. < Learning objective: The frequency of endothelial dysfunction induced by Biolimus-A9 eluting stents (BES) is less than that induced by Sirolimus-eluting stents (SES), although all drug-eluting stents are more likely to cause coronary vasospasm and endothelial dysfunction in the chronic phase, especially at distal deployment sites, as compared to bare-metal stents (BMS). Adequate medication for coronary spastic angina (CSA) and endothelial dysfunction, and interventions for atherosclerotic lesions are useful for improving vascular function and cardiac symptoms.> [ABSTRACT FROM AUTHOR]

Backgrounds The difference in clinical presentations (acute coronary syndrome [ACS] and stable coronary artery disease [SCAD]) and related angiographic morphologies of sirolimus-eluting stent (SES) failure requiring target lesion revascularization (TLR) during early-term (< 1 year), late-term (1–5 years), and very late-term periods (> 5 years) remains unknown. Methods Among 4484 lesions undergoing SES implantation, clinically-driven TLR was performed on 105 lesions during early-term, 169 lesions during late-term, and 147 lesions during very late-term period. Angiographic morphological patterns were divided into focal or non-focal patterns and stent-edge or stent-body patterns. Results The proportion of ACS substantially increased in very late TLR lesions (57.1%) from early (40.0%, p = 0.01) and late TLR lesions (36.7%, p < 0.001). The proportions of both stent-edge and non-focal patterns were higher in very late TLR lesions than in early and late TLR lesions. Although the stent-edge pattern tended to be more prevalent in SCAD lesions than in ACS lesions during the early- and late-term periods, it was more frequently observed in ACS lesions than in SCAD lesions during the very late-term period (65.5% vs. 47.6%, p = 0.04). The non-focal pattern was more frequent in ACS lesions than in SCAD lesions during all 3 periods. However, the proportion of the non-focal pattern in ACS lesions was extremely high during the very late-term (90.5%) compared with the early- (47.6%, p < 0.001) and late-term periods (48.4%, p < 0.001). Conclusions Stent-related ACS became more common beyond 5 years after SES implantation. Stent-edge and non-focal patterns were the main angiographic morphologies of very late SES failure, particularly causing ACS. [ABSTRACT FROM AUTHOR]

Aims The optimal treatment strategy for coronary bifurcation lesions is still unknown. The aim of the study was to assess applicability of the new cobalt-chromium version of the sirolimus-eluting dedicated bifurcation Bi OSS® LIM C stent in comparison with regular sirolimus-eluting Orsiro® stent in a porcine coronary model. Methods A total of 13 Bi OSS® LIM C stents and 6 Orsiro® stents were implanted in normal nonatherosclerotic porcine straight coronary arteries of six animals using 1.2:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imaging. Vascular response was assessed by quantitative coronary angiography ( QCA), optical coherence tomography ( OCT), and histological analyses. Results OCT performed at 28 days confirmed that all stents were patent with no signs of thrombus. In morphometric analysis, no differences between groups regarding stent diameter ( P=.141), neointima area ( P=.247), % area stenosis ( P=.293), or % diameter stenosis ( P=.069) were observed. Also, no significant differences were noted between groups regarding their histopathology scores. The injury and inflammation scores were low (mean grade<1) in all groups. Conclusions The novel Bi OSS® LIM C stent demonstrates good short-term vascular effects in a porcine coronary bifurcation model which are comparable with Orsiro® stents. [ABSTRACT FROM AUTHOR]

Previous studies have demonstrated that patients with small coronary artery lesions are at increased risk for late cardiac events after percutaneous coronary intervention. It remains uncertain whether second-generation drug-eluting stents have an advantage over first-generation drug-eluting stents in patients with small vessel lesions. Our aim was to compare in the 3-year clinical impact between second-generation everolimus-eluting stents (EES) and first-generation sirolimus-eluting stents (SES) in small vessel lesions. Four-hundred forty-four patients with small vessel lesions defined as reference diameter <2.5 mm were treated with EES (237 patients, 265 lesions) or SES (207 patients, 220 lesions) and completed 3-year follow-up. We compared the major adverse clinical events (MACE) between the two groups. EES had no significant impact on the MACE rate compared with SES (4.6 vs. 7.2%, p = 0.14). No significant differences were observed in the individual components of cardiac death (1.7 vs. 1.9%, p = 0.78), myocardial infarction (1.3 vs. 3.4%, p = 0.12), and ischemia-driven target lesion revascularization (2.3 vs. 4.6%, p = 0.13) in EES and SES, respectively. Stent thrombosis, however, was significantly less in the EES group than in the SES group (0.7 vs. 3.4%, HR: 0.53, 95% CI 0.38-0.88, p < 0.05). EES implantation did not significantly impact 3-year MACE rates compared to SES implantation in small vessel lesions. A significant reduction in the overall rate of stent thrombosis was observed in recipients of EES. While the SES group showed increasing rates of late and very late thrombosis, the EES group did not. EES offers a safe and effective treatment for small vessel lesions. [ABSTRACT FROM AUTHOR]

A 67-year-old man was admitted to our hospital due to chest pain at rest. Seven years previously, the patient underwent percutaneous coronary intervention (PCI) of the left ascending artery and implanted sirolimus-eluting stent (SES). Coronary angioscopy (CAS) performed at that time showed a white plaque at the SES site. Two years after the first PCI, repeat CAS demonstrated light yellow plaques at the SES site. At the time of his presentation to our hospital, coronary angiography showed in-stent restenosis at the SES site, and CAS demonstrated the plaque rupture with presence of dense yellow plaque and various thrombi. After distal protection, drug-eluting balloon treatment was performed. Collected specimens from culprit sites included foamy macrophages, cholesterin crystals, neutrophils, and fibrin, suggesting that progressive neoatherosclerosis at the SES site triggered the acute coronary syndrome. This study highlights the importance of ensuring careful patient follow-up after SES implantation. < Learning objective: After 1st generation drug-eluting stent implantation, careful follow up is warranted, as the process of neoatherosclerosis can be ongoing and contribute to in-stent restenosis.> [ABSTRACT FROM AUTHOR]

A 65-year-old man who underwent percutaneous coronary intervention with sirolimus-eluting stents (SESs) 2 years ago was admitted with recurrent acute chest pain. Coronary angiography showed thrombotic occlusion within the SESs. After aspiration thrombectomy, multi-focal peri-stent contrast staining (PSS) was observed. Optical frequency domain imaging (OFDI) showed intracoronary thrombus, incomplete stent apposition (ISA), and multiple inter-strut hollows. Intravascular ultrasound (IVUS) images showed positive vessel remodeling. We deployed bare-metal stents in the SESs. Follow-up angiography showed no in-stent restenosis or PSS. OFDI showed well-covered stent surface with homogeneous neointima, without ISA. Additionally, IVUS images showed that the vessel remodeling had not worsened. [ABSTRACT FROM AUTHOR]

Introduction: Coronary bifurcation lesions pose therapeutic challenges during percutaneous coronary interventions. Dedicated bifurcation stents are one of the treatment options available. Areas covered: This paper will analyze the results of the BiOSS (Bifurcation Optimization Stent System) Clinical Program with a special focus on the cobalt-chromium BiOSS LIM C stent which has recently been introduced into the market (CE 2016). The stent is characterized by a strut thickness of 70 µm and sirolimus concentration of 1.4 µg/mm2. Expert commentary: The first BiOSS stent was a bare metal one, but shortly after a paclitaxel-eluting version was introduced – BiOSS Expert stent (CE 2010). After acceptable results of BiOSS Expert stent were obtained in registries as well as in the randomized clinical trial POLBOS I, a way for improvement was to change paclitaxel into the – olimus drug. Sirolimus has been chosen and the BiOSS LIM stent was developed (CE 2012). BiOSS LIM is the dedicated bifurcation stent with stainless steel platform that releases sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids. Nevertheless, the idea to reduce late lumen loss and as a result TLR rate by using thinner struts appeared. Therefore, presently first-in-man registry with BiOSS LIM C is ongoing. [ABSTRACT FROM PUBLISHER]

Background Arterial repair delays after intracoronary implantation of Cypher sirolimus-eluting stents (SES), a representative first-generation drug-eluting stent. It remains unclear whether this delay would catch up with bare metal stents (BMS) during extremely long observation. The aim of this study was angioscopic observation of extremely late arterial repair after Cypher SES implantation. Methods Thirty-seven SES and 17 BMS were implanted into 22 and 9 patients with angina pectoris, respectively. Duration after implantation (DAI) ranged from 3 to 10.5 years in both stents. Coronary angioscopy revealed neointimal stent coverage (NSC), presence of in-stent yellow plaque (YP), and mural thrombi (MT). NSC was semi-quantified into 4 grades (grade 0, no coverage; grade 1, thin coverage; grade 2, thick coverage; grade 3, fully embedded into neointima). Results In the BMS-implanted lesions (BMSL), NSC was either grade 1 (24%) or grade 3 (74%), with rare YP and no MT. In the SES-implanted lesions (SESL), NSC was various, i.e. grade 0 (5%), grade 1 (59%), grade 2 (22%), and grade 3 (14%). YP and MT were observed in 27 and 24% of in SESL, respectively. In SESL with DAI > 8 years ( n = 5), NSC was either grade 1 (40%) or grade 3 (60%), although YP and MT were more frequently observed (60 and 40%, respectively). Conclusions Arterial repair after SES implantation caught up with BMS at around 8 years with regards to NSC, although prevalence of YP and MT remained still greater in SESL than BMSL at extremely late phase. [ABSTRACT FROM AUTHOR]

We conducted a retrospective examination of the very long-term outcomes of placing sirolimus (SES) and paclitaxel (PES)-eluting stents in patients with ST-elevation myocardial infarction (STEMI). This was a nonrandomized, retrospective, single-center study that included 872 first STEMI patients who underwent successful placement of either SES ( n = 547) or PES from November 2004 to April 2012. The primary end point was the incidence of severe cardiac events comprising cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis (ST). The frequency of target lesion revascularization (TLR) was also compared. A propensity score-matched analysis was used to adjust the 29 baseline variables. In the baseline-adjusted cohorts in 231 STEMI patients in each arm, the frequency of the primary end point in the SES group (5.6 %) during the follow-up duration of 2583 ± 806 days was not significantly different from that in the PES group (6.1 %, follow-up: 1866 ± 699 days). The cumulative primary end point-free ratio in the SES group was not significantly different from that in the PES group ( p = 0.503). The frequency of TLR in the SES group (7.5 %) was significantly lower than that in the PES group (16.9 %, p = 0.005), with and the significantly higher cumulative TLR-free ratio in the SES group than that in the PES group ( p < 0.001). The very long-term clinical outcomes after SES or PES placement for STEMI patients were statistically equivalent. SES showed the better angiographic outcomes for STEMI compared to PES. [ABSTRACT FROM AUTHOR]

BackgroundNo data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents (BP‐SES). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP‐SES with durable‐polymer everolimus‐eluting stents (DP‐EES) in patients undergoing percutaneous coronary intervention. Methods and ResultsA total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP‐SES (n=1063) or DP‐EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP‐SES arm and 107 patients (10.4%) in the DP‐EES arm (risk ratio [RR] 1.00, 95% CI 0.77–1.31, P=0.979). There were no significant differences between BP‐SES and DP‐EES with respect to cardiac death (RR 1.01, 95% CI 0.62–1.63, P=0.984), target‐vessel myocardial infarction (RR 0.91, 95% CI 0.60–1.39, P=0.669), target‐lesion revascularization (RR 1.17, 95% CI 0.81–1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56–3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP‐SES arm and 4 cases (0.4%) in the DP‐EES arm (P=0.423). In the prespecified subgroup of patients with ST‐segment elevation myocardial infarction, BP‐SES was associated with a lower risk of target‐lesion failure compared with DP‐EES (RR 0.48, 95% CI 0.23–0.99, P=0.043, Pinteraction=0.026). ConclusionsComparable safety and efficacy profiles of BP‐SES and DP‐EES were maintained throughout 2 years of follow‐up. Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

Introduction: Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. Methods: A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt–chromium coronary stent system (Supralimus-Core®). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. Results: The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. Conclusions: In vivo acute stent recoil of the Supralimus-Core® has higher radial strength compared to other available standard drug-eluting stents.

Very late stent thrombosis occurs more frequently with drug-eluting stents and tends to occur despite dual antiplatelet therapy or after long periods of clopidogrel discontinuation. Stent thrombosis commonly presents with myocardial infarction or death. We report a 41-year-old Arab male with very late stent thrombosis after 59 months of sirolimus-eluting stent implantation and -49 months after clopidogrel discontinuation despite aspirin continuation, presenting with exertional angina. He underwent successful percutaneous coronary intervention. This case underlines the need for novel stent designs as well as newer therapeutic strategies in preventing very late stent thrombosis among patients receiving drug-eluting stents.

Introduction: Coronary artery disease is the most common catastrophic disease in India. The safety and effectiveness of dual vessel sirolimus-eluting stent (SES) implantation (used as an intervention in CAD) is currently unknown in Indian population. The purpose of this study was to investigate one year clinical outcomes of patients with dual vessel coronary artery disease after implantation of the Supralimus-Core SES, in a "real-world" setting. Materials and Methods: We evaluated 60 patients between April-2011 and August-2012, who underwent dual vessel percutaneous coronary intervention (PCI) with the SupralimusCore SES implantation at the same index procedure. Dual vessels were defined as involvement of two major epicardial vessels (right, left anterior descending, circumflex, or left main coronary arteries) or one major epicardial vessel and a branch (≥2.5 mm in diameter) originating from another major epicardial vessel. The primary endpoint was target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR) at one year. Secondary endpoint included combined (definite, probable and possible) stent thrombosis (ST). Results: A total of 120 lesions were treated in 60 enrolled patients (mean age 56.0±9.2 y; 80.0% male) with average stent length of 23.1±8.5 mm. Among 60 patients, diabetes, hypertension and hypercholesterolemia were present in 15 (25.0%), 22 (36.7%) and 25 (41.7%) patients respectively. Indications for PCI were unstable angina in 30 (50.0%) patients and stable angina in 11 (18.3%) patients. Overall, 40 (33.3%) lesions were classified as complex (American College of Cardiology/American Heart Association type B2/C). The cumulative TLF rate was 5.0% (n=3) at one year. Cardiac death, MI and clinically-driven TLR occurred in 1 (1.7%), 0 (0%) and 2 (3.3%) patients, respectively at one year follow-up. The Kaplan-Meier curve of the freedom from overall events at one year was 95.0%. According to the Academic Research Consortium definition, there were no events of stent thrombosis during one year. Conclusion: Our study shows that, dual vessel SupralimusCore SES implantation allows safe and effective treatment with low rates of TLF at one year follow-up in Indian population.

The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES. [ABSTRACT FROM AUTHOR]

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process. [ABSTRACT FROM AUTHOR]

Very late stent thrombosis (VLST) is a serious complication after percutaneous coronary intervention. However, the best therapy for VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage remains unknown. In these cases, neointimal coverage was nearly complete and no late-acquired malapposition was detected at 18 months after Endeavor zotarolimus-eluting stent (ZES) implantation for the treatment of VLST with late-acquired incomplete stent apposition after sirolimus-eluting stent implantation. We presented that Endeavor ZES implantation may become an attractive therapeutic strategy for the treatment of VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt–chromium sirolimus-eluting stents (CoCr-SES) was less known.Methods: A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching.Results: The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p = 0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p = 0.938) and target lesion revascularization (1.2% versus 1.1%; p = 0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p = 0.012) demonstrated a significant increase in the DM group.Conclusions: This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.Key messagesThe overall rate of adverse clinical events in both diabetic and non-diabetic patients was <10%, indicating a satisfying long-term safety and efficacy performance of CoCr-SES, even in high–risk diabetic patients.DM significantly increased the risk of MACE (HR 1.3; 95% CI: 1.0–1.6) in patients undergoing CoCr-SES implantation. [ABSTRACT FROM PUBLISHER]

Objectives: We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method.Methods: In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures. Vessel segments with BPS were harvested to evaluate polymer degradation with a NMR method, whereas BP-SES to analyze sirolimus tissue uptake and retention. Additionally, 8 BP-SES were implanted for histological analysis for 90 days of follow-up.Results: The NMR showed a gradual absorption of the polymer over the 6 consecutive time points, from 5.48 µg of the polymer on the stent at 1-day follow-up, through 4.33 µg at 3 days, 3.16 µg at 7 days, 2.42 µg at 14 days, 1.92 µg at 28 days to 1.24 µg in the last day of the study. The curve of polymer degradation corresponds well with the pharmacokinetic profile of sirolimus eluted from its surface and measured at identical time points. In histopathology, at 90 days, complete healing and biocompatibility were reported.Conclusions: The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution. [ABSTRACT FROM AUTHOR]

AIMS: The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT). METHODS AND RESULTS: A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups. CONCLUSION: BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES. [ABSTRACT FROM AUTHOR]

This study aimed at comparing the mid-term clinical outcome of everolimus-eluting (EES) with sirolimus-eluting (SES) stents in the provisional bifurcation stenting guided by intravascular ultrasound (IVUS). We compared the clinical outcome up to 9-month follow-up results of the prospective J-REVERSE registry of 300 non-left main bifurcation lesions in 298 patients treated with EES ( n = 240) and SES ( n = 60). The SB dilation with the kissing balloon technique (KBT) was performed in 54 %. The patient and lesion characteristics of the groups were similar. The incidences of SB dissections, occlusions, stenting, and slow flow were similar. A greater luminal volume gain was achieved in the proximal MV after KBT compared in non-KBT treated lesions in the EES group (7.9 ± 2.4 versus 7.0 ± 2.0 mm/mm, p = 0.002), though not in the SES group. The SB diameter stenosis in the non-KBT treatment at 9 months was greater than the KBT in both groups. The incidence of target lesion revascularisation (TLR) was 5.0 % in the EES versus 8.3 % in the SES group ( p = 0.35), and the incidence of major adverse cardiac events, including TLR, myocardial infarction, stent thrombosis, and death was 5.4 % in the EES versus 11.7 % in the SES group ( p = 0.15). IVUS-guided provisional stenting with EES achieved a greater luminal gain after than without KBT, and similar clinical outcomes as with SES up to 9-month follow-up. [ABSTRACT FROM AUTHOR]

Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups ( p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively ( p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups. [ABSTRACT FROM AUTHOR]

We conducted a lesion-based retrospective sub-analyses of diabetes mellitus (DM), diffuse long lesions (stented segment ≥40 mm; LLs), and small vessels (SVs; reference diameter ≤2.6 mm) in patients who received sirolimus- (SESs) or paclitaxel-eluting stents (PESs) for nonrandom treatment of de novo native coronary stenosis in a clinical practice setting. During the period from May 2007 to February 2009, 490 of 682 PES-treated and 293 of 386 SES-treated lesions were angiographically followed up within 1500 days of PCI, and the retrospective investigation was conducted in April 2013. The frequencies of target lesion revascularization (TLR; any recurrent PCI including both marginal stent restenosis) and binary in-stent restenosis (percentage diameter of in-stent stenosis >50 %) upon follow-up angiography, evaluated by adjusting 25 baseline variables using propensity score matching analysis, after placement of SESs and PESs were the following: DM ( n = 124 per arm), 14.5 vs. 15.3 % ( p = 0.842), and 14.5 vs. 16.1 % (0.856); LLs ( n = 81), 16.0 vs. 21.0 % (0.433), and 12.3 vs. 22.2 % (0.117); SVs ( n = 107), 11.2 vs. 29.9 % (<0.001), and 11.2 vs. 30.8 % (<0.001), respectively. The p values of log-rank tests for the cumulative TLR-free ratios after SES and PES placement were 0.504 in DM, 0.625 in LLs, and <0.001 in SVs group, respectively. Thus, compared to PES, SES showed the equivalent efficacy for DM, the tendency to be superior for LLs due to approximately 24-45 % reductions in TLR and binary restenosis rates, and the promising superiority for SVs on the angiographic outcomes during a long-term observational interval. [ABSTRACT FROM AUTHOR]

Aims The purpose of the present study was to investigate the relationship between in-stent neoatherosclerosis (NA) and native atherosclerosis progression of untreated coronary segments. Methods and results In-stent NA was assessed by optical coherence tomography (OCT) among patients included in the SIRTAX-LATE OCT study 5 years after drug-eluting stent (DES) (sirolimus-eluting and paclitaxel-eluting stents) implantation. Neoatherosclerosis was defined as the presence of fibroatheroma or fibrocalcific plaque within the neointima of stented segments with a longitudinal extension >1.0 mm. Atherosclerosis progression in untreated native coronary segments was evaluated by serial quantitative coronary angiography (QCA). The change in minimal lumen diameter (MLD) was serially assessed within matched segments at baseline and 5-year angiographic follow-up. The key clinical endpoint was non-target lesion (non-TL) revascularization throughout 5 years. A total of 88 patients with 88 lesions were available for OCT analysis 5 years after DES implantation. In-stent NA was observed in 16% of lesions with the majority of plaques being fibroatheromas (11.4%) followed by fibrocalcific plaques (5.7%). A total of 704 non-TL segments were serially evaluated by QCA. Between baseline and 5-year follow-up, the reduction in MLD was significantly more pronounced in patients with NA (-0.25 mm, 95% CI -0.36 to -0.17 mm) when compared with patients without NA (-0.13 mm, 95% CI -0.17 to -0.10 mm, P = 0.002). Similarly, non-TL revascularization was more frequent in patients with NA (78.6%) when compared with patients without NA (44.6%, P = 0.028) throughout 5 years. Conclusions In-stent NA is more common among patients with angiographic and clinical evidence of native atherosclerosis progression suggesting similar pathophysiological mechanisms. [ABSTRACT FROM AUTHOR]

We performed a propensity score-matching comparison of the midterm clinical and angiographic outcomes after primary stenting between using bare-metal stents (BMSs) and sirolimus-eluting stent (SES; Cypher Bx Velocity) for ST-segment elevated myocardial infarction (STEMI), because, in the drug-eluting stent era, the indication of the BMSs when a large balloon diameter is required remained to be controversial. This was a single-center, nonrandomized, retrospective study investigated in October 2013 by enrolling STEMI patients treated with primary stenting using either SES ( n = 468) or BMS ( n = 171) between September 2004 and December 2011. In 204 patients, the baseline-adjusted values produced similar mean maximum balloon sizes (BMS 3.67 ± 0.47 mm; SES 3.70 ± 0.56 mm; p = 0.477), and the incidence rates of binary in-stent restenosis (% diameter stenosis >50 % on secondary angiography) after SES placement (7.8 %) was significantly lower than that after BMS placement (23.5 %; p = 0.002). In baseline-adjusted 300 patients, the incidence of the clinical endpoints comprising cardiac death, nonfatal recurrent MI, and definite stent thrombosis after SES placement (11.3 %; 1241 ± 786 days; p = 0.557) was not significantly different from after BMS placement (8.7 %; mean follow-up period, 549 ± 486 days; p = 0.557). SES was not significantly related to the clinical endpoint [hazard ratio 2.31; 95 % confidence interval (CI) 0.88-6.08; p = 0.089). BMS did not offset the SES's angiographic efficacy for primary stenting for STEMI patients, despite placed using a large-sized balloon. [ABSTRACT FROM AUTHOR]

Objective: The intra-coronary stents provided great benefit after percutaneous transluminal coronary angioplasty (PTCA); however, high in-stent restenosis rates, even up to 25-30%, is the the main concern. Cytotoxic drug-eluting stents were developed to overcome this challenge. Whereas, they interfered vessel healing and endothelization process which led to increased risk of stent thrombosis. A bioinert molecule, polyzene-F(PzF), was applied to the surface of a new generation stent to provide anti-inflammatory and antithrombogenic property. We aimed to compare the sirolimuseluting stent with PzF-coated cobalt-chrome stent in terms of early inflammatory response and long-term major adverse cardiac events (MACE) rates. Methods: Stable coronary artery disease patients treated with PzF-coated cobalt-chrome stent formed the 1st group (n=19), and those received sirolimus-eluting stent (n=13) formed the 2nd group. Serum hsCRP and IL-6 levels were measured before percutaneous coronary intervention (pre- PCI), and after 1st and 10th days (post-PCI 1, and post-PCI 10, respectively) of PCI. The patients were followed-up to 1 year in terms of MACE experience. Results: The study groups were comparable in terms of pre-PCI, post-PCI-1 and post-PCI-10 serum hsCRP and IL-6 levels. Four of 19 patients (21%) in the 1st group and 1 of 13 patients (8%) in the 2nd group experienced MACE during 1-year follow-up; whereas this difference was not statistically significant (p=0.26). Conclusion: Although, the PzF-coated cobalt-chrome stent was claimed to have lower anti-inflammatory and antithrombogenic properties, we showed similar inflammatory response and long-term MACE rates compared to sirolimuseluting stent. Prospective, randomized, large scale studies are needed to clarify this issue. [ABSTRACT FROM AUTHOR]

Objectives This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area [ASSA]) on periprocedural myocardial infarction (PMI) and clinical outcomes in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES). Background To date, there are no reports on the impact of ASSA on PMI and clinical outcomes. Methods We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI. Results After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm 2 vs. SES: 67.6 ± 48.4 mm 2 , p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI. Conclusions BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI. [ABSTRACT FROM AUTHOR]

The aim of this study was to check effectiveness of drug-eluting stents for prevention of restenosis resulting from neointimal hyperplasia. Twenty-one sirolimus-eluting stents (SESs) and bare metal stents (BMSs; control) were compared by implantation into left and right balloon-injured external iliac arteries of New Zealand White rabbits, respectively. Under general anesthesia and angiography, using 3-mm coronary balloon catheters, stents were successfully deployed. Anticoagulant therapy was not given to any animal. Rabbits were allotted into three groups at 7, 14, and 21 days (7 rabbits in each group). Each stented vessel of sacrificed rabbits was subjected to a resin-embedding technique and methyl methacrylate sections were obtained using a tungsten carbide knife for staining. In histological examination, SESs showed marked reductions in almost all parameters. Morphometric results showed that arteries with SESs had a larger luminal area (P < 0.0001), lower intimal (P < 0.001) and medial (P < 0.001) thickness, and lower intimal index (P < 0.003) as opposed to arteries stented with BMSs. Luminal narrowing in SESs was 0% and reendothelialization was similar in both stented groups (90.48%). SESs showed marked reduction in nonocclusive peristrut fibrin deposition versus BMSs. Thus, the SES was more effective for prevention of restenosis than the BMS in rabbit. [ABSTRACT FROM AUTHOR]

The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an 'oculo-stenotic reflex' bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). Background The optimal treatment for drug-eluting in-stent restenosis remains controversial. Methods The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. Results The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES = 14%, SES = 18%, POBA = 20%; p = 0.65), death (EES = 2.3%, SES = 6.2%, POBA = 6.1%; p = 0.61), MI (EES = 4.8%, SES = 2.1%, POBA = 2.5%; p = 0.69), TLR (EES = 11.9%, SES = 12.1%, POBA = 24%; p = 0.78), and TVR (EES = 11.9%, SES = 24.8%, POBA = 22.2%; p = 0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p = 0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. Conclusions In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome. [ABSTRACT FROM AUTHOR]