Standard Drug-eluting Stent Research Articles

Coronary bifurcation lesion treatment with the BioMime™ Branch sirolimus-eluting coronary side-branch stent system: A single-center experience

BackgroundCoronary bifurcation lesions (CBL) comprise 15 %–20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES. MethodsThis is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation. ResultsFifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69.0 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation. ConclusionsThis is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.

Endothelial Progenitor Cells in Coronary Atherosclerosis and Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

IntroductionThe role of endothelial progenitor cells (EPCs) in atherosclerosis progression and neointimal growth after percutaneous coronary intervention (PCI) remains controversial. The purpose of this study was to perform a systematic review and meta-analysis of studies on EPCs in patients who had PCI. MethodsWe searched Pubmed, Embase and Cochrane databases and reviewed cited references up to August 31, 2021. Overall, we selected 9 studies, including 4612 patients. ResultsLower baseline EPC count was associated with a significantly greater occurrence of in-stent restenosis (HR 1.33; 95% CI 0.97–1.82, P = 0.045). As for EPC coating, there was no significant difference in the 1-year occurrence of cardiac death between EPCs-capturing drug-eluting stents (DES) and standard DES (Relative Risk [RR] 1.146; 95% CI 0.666–1.974, P = 0.98), but target lesion revascularization (RR 1.727; 95% CI: 1.199–2.487, P = 0.025), and target vessel failure (RR 1.591; 95% CI 1.213–2.088, P = 0.04) were significantly more common with EPCs-capturing DES than with standard DES. ConclusionCirculating EPC count might improve risk stratification after PCI, as it is correlated with the occurrence of in-stent restenosis. Currently available EPCs-capturing DES use was associated with an increased risk of 1-year adverse events, mainly driven by an increase in target lesion revascularization and target vessel failure, not cardiac death.

Long term outcomes of ultrathin versus standard thickness second-generation drug eluting stents: Meta-analysis of randomized trials.

Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease. Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown. PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial. We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05). In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.

Comparative Study Between Biodegradable-Polymer Stents and Standard Drug-Eluting Stents in Diabetic Patients Presenting With Acute Coronary Syndrome

Comparative Study Between Biodegradable-Polymer Stents and Standard Drug-Eluting Stents in Diabetic Patients Presenting With Acute Coronary Syndrome

Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery

Although the drug-eluting stent (DES) has become the standard for percutaneous coronary intervention (PCI)-based revascularization, concerns remain regarding the use of DES, mainly due to its permanent rigid constraint to vessels. A drug-eluting bioresorbable stent (BRS) was thus developed as an alternative to DES, which can be absorbed entirely after its therapeutic period. Magnesium (Mg)-based BRSs have attracted a great deal of attention due to their suitable mechanical properties, innovative chemical features, and well-proven biocompatibility. However, the primary disadvantage of Mg-based BRSs is the rapid degradation rate, resulting in the early loss of structural support long before the recovery of vascular function. Recently, a new type of patented Mg–Nd–Zn-Zr alloy (JDBM) was developed at Shanghai Jiao Tong University to reduce the degradation rate compared to commercial Mg alloys. In the present investigation, a poly(d,l-lactic acid)-coated and rapamycin eluting (PDLLA/RAPA) JDBM BRS was prepared, and its biosafety and efficacy for coronary artery stenosis were evaluated via in vitro and in vivo experiments. The degree of smooth muscle cell adhesion to the PDLLA/RAPA coated alloy and the rapamycin pharmacokinetics of JDBM BRS were first assessed in vitro. JDBM BRS and commercial DES FIREHAWK were then implanted in the coronary arteries of a porcine model. Neointimal hyperplasia was evaluated at 30, 90, and 180 days, and re-endothelialization was evaluated at 30 days. Furthermore, Micro-CT and optical coherence tomography (OCT) analyses were performed 180 days after stent implantation to evaluate the technical feasibility, biocompatibility, and degradation characteristics of JDBM BRS in vivo. The results show the ability of a PDLLA/RAPA coated JDBM to inhibit smooth muscle cell adhesion and moderate the drug release rate of JDBM BRS in vitro. In vivo, low local and systemic risks of JDBM BRS were demonstrated in the porcine model, with preserved mechanical integrity after 6 months of implantation. We also showed that this novel BRS was associated with a similar efficacy profile compared with standard DES and high anti-restenosis performance. These findings may confer long term advantages for using this BRS over a traditional DES.

Clinical Outcomes of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Stent Versus Standard Drug-Eluting Coronary Stents: A Meta-Analysis.

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. 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. 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%]. 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.

A Study Comparing the Outcomes Between the Orsiro Sirolimus Eluting Stent and Xience Everolimus Eluting Stent in the ST-Elevation Myocardial Infarction Population

Background: At present, the Xience everolimus eluting stent (X-EES) is considered the gold standard drug-eluting stent (DES). The Orsiro sirolimus eluting stent (O-SES) with a biodegradable polymer coating has been shown in subanalyses of the BIOSCIENCE trial to have possible improved outcomes compared to Xience in the STEMI population; however, research in this subset remains limited.

Drug-eluting stents vs bioresorbable stents (scaffolds) vs drug-eluting balloons: the advantages and drawbacks of new technologies.

2016;11(3-4):124. VII. nacionalni sastanak o kardiovaskularnim intervencijama s međunarodnim sudjelovanjem VI. sastanak intervencijskih kardioloskih medicinskih sestara i tehnicara The introduction of bare-metal stents (BMS) significantly advanced the field of interventional cardiology by reducing the number of reinterventions. In order to reduce restenosis, drug-eluting stents (DES) were developed, and are further differentiated by stent platform, polymer type, and active substance. The first generation of DES, paclitaxel-eluting stents (PES) and sirolimus-eluting stents, are no longer used as the second generation of stents are superior: zotarolimus-eluting stents (ZES) and everolimuseluting stents (EES). They are biocompatible, cause less inflammatory reactions, and become covered with endothelium more quickly. Resolute zotarolimus-eluting stents (R-ZES) and EES are comparable, and are superior in relation to other DES’s. Meta-analyses of studies have proven DESs with bioresorbable polymer (biolimus and sirolimus) superior to 1st generation DESs (sirolimus) in their reduced revascularisation of target veins and reduced incidence of in-stent thrombosis in a 5-year period. However, if these stents are compared with the new generation of DESs, it becomes clear that the percentage of target vessel reintervention is comparable. DESs with resorbable polymer are comparable to R-ZES in their incidence of in-stent thrombosis and mortality rates, while they are inferior to EES. It is difficult to design a non-polymer DES due to problems in attaining a stable concentration of anti-proliferation drug necessary to prevent neointimal hyperplasia. The first studies are promising, and have shown no significant differences in the later loss of lumens, angiographic restenosis, or revascularization of target veins due to restenosis as compared to a standard DES with paclitaxel. The time necessary to release this drug is one month, and its application would reduce the length of dual antiplatelet therapy, thus completely eliminating rare indications for the application of BMS.1-3

Serial intravascular ultrasound analysis of complex bifurcation coronary lesions treated with the Tryton Bifurcation Stent in conjunction with an everolimus-eluting stent: IUVANT (Intravascular Ultrasound Evaluation of Tryton Stent) study.

To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina.

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study

BackgroundCoronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device. ObjectiveTo investigate the feasibility, safety and effectiveness of the Tryton™ Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions. MethodsThe SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433). ResultsAmong 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred. ConclusionsThis prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.

Optimization of Tryton Dedicated Coronary Bifurcation System With Coregistration of Optical Coherence Tomography and Fractional Flow Reserve

The Tryton-Side Branch Stent (Tryton Medical, Newton, Massachusetts) is 1 dedicated bifurcation system, designed to be implanted in the side branch (SB) along with placement of a standard drug-eluting stent (DES) in the main vessel [(1)][1]. The procedure is completed by a final kissing balloon

Hemocompatibility of drug-eluting coronary stents coated with sulfonated poly (styrene-block-isobutylene-block-styrene)

The presence of polymer coating on a coronary stent is a major mediator of coronary inflammation reaction thereby affects re-endothelialization. Poly(styrene-block-isobutylene-block-styrene) (SIBS) is one of the most attractive alternatives to serve as stent coating, but has shown less than optimal biocompatibility. Increasing the sulfonic acid content in the polymer can result in increased strength and hydrophilicity. The present study was undertaken to determine the mechanism of action and in vivo efficacy of sulfonated SIBS (S-SIBS) designed specifically as a stent polymer with reduced inflammatory potential and greater endothelialization preservation potential. The blood compatibility of S-SIBS in vitro and its ability to support the attachment of human umbilical vein endothelial cells (HUVECs) were first assessed to get some insight into its potential use in vivo. Baer metal stent (BMS), S-SIBS-coated stent without drug (BMS Plus S-SIBS), standard drug-eluting stent (DES) and S-SIBS-coated drug-eluting stent (DES Plus S-SIBS) were then implanted in the coronary arteries of a porcine model. Neointimal hyperplasia was evaluated at 28 and 180 days, and re-endothelialization was evaluated at 7 and 28 days post stents implantation. The results showed that DES Plus S-SIBS exhibited similar ability to reduce neointimal hyperplasia but preserved endothelialization compared with standard DES. These results suggest potentially promising performance of S-SIBS-coated stent in human clinical applications of coronary stenting.

In vivo assessment of stent recoil of biodegradable polymer-coated cobalt–chromium sirolimus-eluting coronary stent system

IntroductionImmediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. MethodsA 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. ResultsThe 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. ConclusionsIn vivo acute stent recoil of the Supralimus-Core® has higher radial strength compared to other available standard drug-eluting stents.

Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials

Drug-eluting stents (DES) are a major advance in interventional cardiology; however concerns have been raised regarding their long-term safety due to the permanent nature of the polymer. New generation stents with biodegradable polymers (BDS) have recently been developed. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCTs) comparing the safety and efficacy profile of BDS vs. durable polymer DES. The MEDLINE/CENTRAL and Google Scholar databases were searched for RCTs comparing safety and efficacy of BDS vs. DES. Safety endpoints were mortality, myocardial infarction (MI), and stent thrombosis (ST). Efficacy endpoints were target vessel revascularisation (TVR), target lesion revascularisation (TLR) and six-month in-stent late loss (ISLL). The meta-analysis included eight RCTs (n=7,481). At a median follow-up of nine months, as compared to DES, BDS use did not increase mortality (OR [95% CI] = 0.91 [0.69-1.22], p=0.53) or MI (OR [95% CI] = 1.14 [0.90-1.44], p=0.29). Rate of late/very late ST was significantly reduced in BDS patients (OR [95% CI] = 0.60 [0.39-0.91], p=0.02), as was six-month ISLL (mean difference [95% CI] = -0.07 [-0.12; -0.02] mm, p=0.004) in comparison with DES patients. Rates of TVR and TLR were comparable between BDS and DES. BDS are at least as safe as standard DES with regard to survival and MI, and more effective in reducing late ST, as well as six-month ISLL. Further large RCTs with long-term follow-up are warranted to definitively confirm the potential benefits of BDS.

Effect of a novel drug-eluted balloon coated with Genistein before stent implantation in porcine coronary arteries

The major drawback of stent implantation in native human coronary vessels is the occurrence of restenosis. Drug-eluting stents significantly reduce restenosis after percutaneous coronary intervention (PCI), but may be associated with persistent local inflammation involved in the restenosis mechanisms. In this setting coating coronary devices with anti-inflammatory agents represents an intriguing alternative to stent-based local drug delivery. The aim of the present study was to test in a porcine model the safety and efficacy of a novel Genistein-eluting balloon preceding coronary stenting. Female piglets underwent PCI in a randomized fashion with either a Genistein-eluting or a standard balloon angioplasty, followed in all vessels by bare-metal stent implantation. Pigs were sacrificed at different time points to appraise safety (i.e. endothelialization) and efficacy (i.e. anti-inflammatory and anti-proliferative effects): 1, 4, and 6-8 weeks following PCI. Overall analysis was conducted on 14 piglets. Twenty-five bare-metal stents were implanted preceded by angioplasty with a conventional balloon in 13 vessels and by the Genistein-eluted balloon in 12. No untoward effects were reported in either group. Healing and endothelialization appeared universal within 4 weeks. The Genistein-eluted balloon group disclosed a significant reduction, at four weeks from implantation, of the peri-stent inflammatory cells count (mononucleocytes 39 +/- 32 Vs. 96 +/- 29 per square millimetre, P = 0.019). This effect did not clearly translate into a trend towards a reduced neointimal hyperplasia at 6-8 weeks (0.13 +/- 0.11 Vs. 0.14 +/- 0.09, P = 0.835). This study provides the first in vivo demonstration of the anti-inflammatory effects of a Genistein-eluting balloon in PCI, warranting further research including the combination of a Genistein-eluting balloon with standard drug-eluting stent.

Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions

To report clinical and angiographic follow-up at 6 months after implantation of the Tryton Side-Branch Stent dedicated to bifurcation, in conjunction with standard workhorse drug-eluting stent (DES). Patients having angina or silent myocardial ischaemia with de novo bifurcation lesions were enrolled at three sites. The Tryton stent was first placed in the side-branch and a standard DES subsequently implanted in the main-branch. The primary endpoint was freedom from in-hospital major adverse cardiac events (MACE) following procedural success. Angiographic and clinical follow-up was performed at 6-months. Quantitative coronary angiography (QCA) was analysed with a new dedicated bifurcation software. Thirty patients were enrolled. At six months clinical follow-up was available in 100% with angiographic follow-up performed in 78%. The primary endpoint was met in 93.3%. The MACE rate at 6 months was 9.9%. QCA analysis demonstrated late luminal loss of 0.17 mm with no restenosis in the side branch. In conjunction with a workhorse DES to treat bifurcation lesions, the Tryton side-branch stent demonstrated acceptable clinical outcome and low side-branch late loss at six months.