BioMime – A Sirolimus-eluting Coronary Stent System for the Treatment of Patients with De Novo Coronary Lesions – meriT-1 Report

2011 ◽  
Vol 6 (1) ◽  
pp. 39
Author(s):  
Keyword(s):  
Stent Thrombosis ◽  
Time Course ◽  
De Novo ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Cardiac Events ◽  
End Points ◽  
Safety And Efficacy ◽  
Binary Restenosis

Background:Since the first reported use of percutaneous transluminal coronary angioplasty, advances in the interventional cardiology arena have been fast paced. Developers and clinicians are adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. BioMime™ sirolimus-eluting stent (SES) is a step towards biomimicry. The stent is built on a strut of ultra-low thickness (65μm), a cobalt–chromium platform using an intelligent hybrid of closed and open cells allowing for morphology-mediated expansion. It employs a well-known antiproliferative – sirolimus – that elutes from a known biodegradable copolymer formulation within 30 days. The resultant stent demonstrates almost 100% endothelialisation at 30 days in preclinical models.Methods:The meriT-1 was a prospective, single-arm, single-centre trial to evaluate the safety and efficacy of BioMime SES in 30 patients with a single de novo lesion in native coronary arteries. The primary safety and efficacy end-points were major adverse cardiac events (MACE) at 30 days and in-stent late lumen loss at eight months, as measured using quantitative coronary angiographic (QCA) method. Secondary safety and efficacy end-points included MACE at one and two years and angiographic binary restenosis at eight-month angiographic follow-up. Other end-points included the occurrence of stent thrombosis at acute, subacute, late and very late periods and the percentage of diameter stenosis by QCA.Results:No MACE were observed and the median in-stent late luminal loss in 20 (67%) subjects studied by QCA was 0.15mm, with 0% binary restenosis at eight-month follow-up. No stent thrombosis was observed up to one-year follow-up.Conclusions:In comparison to currently available DES, BioMime SES appears to have a considerable scientific basis for prevention of neointimal proliferation, restenosis and associated clinical events.

Moving Towards Biomimicry – The Development of the Novel BioMime™ Sirolimus-eluting Coronary Stent System

2010 ◽  
Vol 6 (2) ◽  
pp. 78 ◽  
Author(s):  
Ashok Seth ◽  
Keyword(s):  
Time Course ◽  
Interventional Cardiology ◽  
Percutaneous Transluminal Coronary Angioplasty ◽  
Coronary Stent ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Cardiac Events ◽  
Stent System ◽  
Cobalt Chromium Stent ◽  
Transluminal Coronary Angioplasty

Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advances in the interventional cardiology arena have been fast-paced. Within the last 10 years, these developments have been exponential. Developers and clinicians are fast adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. The BioMime™ sirolimus-eluting coronary stent is a new step towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65µm) cobalt–chromium stent platform using an intelligent hybrid of close and open cells allowing for morphology-mediated expansion, and employs a well-known antiproliferative – sirolimus – that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and a low coating thickness of 2µm. The resultant stent demonstrated almost 100% endothelialisation at 30 days in pre-clinical models and 0% major adverse cardiac events (MACE) at six months in the primary efficacy and safety clinical study.

Time course, predictors and clinical implications of stent thrombosis following primary angioplasty

2013 ◽  
Vol 110 (10) ◽  
pp. 826-833 ◽  
Author(s):  
Maurits T. Dirksen ◽  
Christian Spaulding ◽  
Henning Kelbæk ◽  
Martin Schalij ◽  
Leif Thuesen ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Time Course ◽  
Independent Predictor ◽  
Prognostic Significance ◽  
Bare Metal Stents ◽  
Primary Angioplasty ◽  
Drug Eluting Stent ◽  
Metal Stents ◽  
Ischaemia Time

summaryPrimary percutaneous coronary intervention (pPCI) has improved survival as compared to thrombolysis. Concerns still remain regarding the risk of stent thrombosis in the setting of STEMI, especially after drugeluting stent (DES) implantation. Therefore, the aim of this study was to report on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long-term safety and effectiveness of DES as compared to BMS in patients undergoing pPCI for STEMI. Follow-up data were collected for 3–6 years after the procedure. ST was defined as definite or probable, based on the ARC definition. The study population consists of 6,274 STEMI patients undergoing primary angioplasty with BMS or DES. At 1201±440 days, ST occurred in 267 patients (4.25%). Most of the events were acute or subacute (within 30 days) and very late (> 1 years), with different distribution between DES vs BMS. Patients with ST were more often diabetic (21.7% vs 15.1%, p=0.005), more frequently had post-procedural TIMI 0–2 flow (14.0% vs 9.3%, p = 0.01), and were less often treated with dual antiplatelet therapy at one year follow-up. Diabetes (p = 0.036), post-procedural TIMI 0–2 Flow (p = 0.013) and ischaemia time > 6 hours (p = 0.03) were independent predictors of ST. Post-procedural TIMI 0–2 flow (p = 0.001) and ischaemia time > 6 hours (p < 0.001) were independent predictors of early ST, ischaemia time > 6 hours (p=0.05) was independent predictor of late ST, whereas diabetes (p = 0.022) and use of DES (p=0.002) were independent predictors of very late ST. ST was associated with a significantly higher mortality (23.6% vs 6%, p < 0.001). The greatest impact on mortality was observed with subacute (40.4%) and late (20.9%) ST, as compared to acute (12.5%) and very late (9.1%) ST. ST was an independent predictor of mortality (HR [95%CI]=3.73 [2.75–5.07], p < 0.001). In conclusion, ST occurs relatively frequently also beyond the first year for up to six years after pPCI in STEMI, with higher late occurrence rates among patients treated with first generation DES. ST after pPCI is a powerful predictor of mortality, especially subacute ST.

Long-Term Follow-Up After Treatment of Drug-Eluting Stent Restenosis and De Novo Lesions Using SeQuent Please Paclitaxel-Coated Balloons

Angiology ◽  
2018 ◽  
Vol 70 (5) ◽  
pp. 414-422
Author(s):  
Dai Zhang ◽  
Yan Sun ◽  
Xiaoli Liu ◽  
Fang Liu ◽  
Yujing Cheng ◽  
...  
Keyword(s):  
De Novo ◽  
Coronary Vessels ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Cardiac Events ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting

Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.

scholarly journals Role of BMS in Des ERA

2016 ◽  
Vol 01 (01) ◽  
pp. 028-032
Author(s):  
Guru Kumar C ◽  
Phani kotewsar Rao
Keyword(s):  
Stent Thrombosis ◽  
Chronic Stable Angina ◽  
Target Vessel ◽  
Cobalt Chromium ◽  
Cardiac Events ◽  
Target Vessel Revascularization ◽  
Coronary Syndrome ◽  
The Common

AbstractBACKGROUND: DES has gained significant importance in coronary interventions due to its superiority of decrease in target vessel revascularization when compared to BMS. In this DES era, we want to study the role of BMS as it is more economical.MATERIAL AND METHODS: We have analyzed acute coronary syndrome (ACS) and chronic stable angina patients who underwent BMS implantation between January 2011 to March 2011 under government health scheme of Andhra Pradesh.RESULTS: We retrospectively analyzed the cardiac events in 4181 BMS implanted patients. 1938 (46.4%) patients were followed for 365 days. More men than women with 40 to 69 years were there. ST elevation MI was the common presenting symptom in 1902patients (45.49%). 1881 patients (44.98%) were diabetic. Single vessel disease was more common 2522(60.32%), Multivessel disease was seen in 210 patients (5.02%). LAD being the common vessel involved followed by RCA. Primary PCI was done in 320 patients(7.65%).Out of 4181 patients, 9366 lesions were stented with BMS, stainless steel BMS was used in 4988(53.26%) and cobalt chromium BMS was used in 4378 (46.74%) patients.Out of 4181 patients, 1938 patients (46.4%) were followed up of 1yr, post PCI 686 (35.4%) patients had worsening angina, 226(11.66%) patients had worsening heart failure, 17 (0.88%) patients had repeat STEMI, 11(0.56%) patients had repeat NSTEMI, 16(0.82%) patients had subacute stent thrombosis, 27(1.39%) patients developed late stent thrombosis, 51 patients (2.63%) underwent repeat target vessel revascularization(TVR). 52 (2.68%) patients died due to cardiac cause with in one year of follow up.CONCLUSIONS: Our study show that even in present era of DES, BMS implantation is effective and associated with less mortality and less stent thrombosis and less chances of target vessel revascularization with the limitations (as it was telephonic follow up).

scholarly journals Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
You-Jeong Ki ◽  
Kyung Woo Park ◽  
Jeehoon Kang ◽  
Chee-Hoon Kim ◽  
Jung-Kyu Han ◽  
...  
Keyword(s):  
Propensity Score ◽  
Stent Thrombosis ◽  
Real World ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Composite Outcomes

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

Impact of hinge motion on stent edge restenosis after new generation drug-eluting-stent implantation in RCA

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Jimba ◽  
M Ikutomi ◽  
D Nishijyo ◽  
M Yamasaki ◽  
A Shindou ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Biomechanical Properties ◽  
Plaque Burden ◽  
Drug Eluting Stent ◽  
Landing Zone ◽  
Binary Restenosis ◽  
Drug Eluting ◽  
New Generation ◽  
Hinge Angle

Abstract Background Edge restenosis still occurs after stent implantation, even by using new generation drug-eluting stents (DES) considered to have favorable biomechanical properties. Mechanical stress imposed on the stent edge are thought to be aggravated by hinge motion at a point between the stented and unstented segments, inducing chronic local inflammation and neointimal overgrowth. Purpose The aim of this study was to investigate the association between the development of edge restenosis and hinge motion in right coronary artery (RCA) where the excessive vessel movement is commonly observed. Methods Among consecutive 650 lesions in RCA where new generation DESs were implanted between 2009 and 2019, 427 serial lesions with sets of angiographies at baseline and follow-up (6–18 month) were included. In addition to conventional quantitative angiography analysis, hinge angle at stent edges was measured (Fig. 1). All the appropriate data for intravascular imaging were analyzed for both stent edges and reference segments. Results Binary restenosis occurred in 43 lesions, and 39 of them were referred to re-intervention. Fifty five percent of them were related to stent edges (15 at proximal and 9 at distal edges). Classical risk factors including diabetes and hemodialysis were more prevalent in the restenosis group (p&lt;0.05). Hinge angle was statistically larger in edge restenosis group than body restenosis or no restenosis group (17.3° vs 11.6° vs 10.6°, p&lt;0.001, Fig. 2). In per-edge analysis, hinge angle, dissection and residual plaque ratio were the independent predictors for binary restenosis (Table 1) with the optimal cut-off value of hinge angle 11.5°. The coexistence of excessive hinge angle and residual plaque burden had an amplified effect on the angiographic stenotic progression at stent edge (p for interaction &lt;0.001) and the incidents of binary restenosis (16.7% vs 1.7% p&lt;0.01, Figs. 3,4). Conclusion Substantial stress determined by angulation at the stent edge and its interaction with residual plaque can be considered as one of the plausible mechanisms for edge restenosis. For tortuous RCA lesions, it would be important to decide the stent-landing zone for minimizing hinge motion and optimize the future stent design. Funding Acknowledgement Type of funding source: None

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  
Keyword(s):  
Real World ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Chromium Alloy ◽  
Cobalt Chromium ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

Abstract P476: Safety and Efficacy of Balloon Mounted Drug-Eluting Stent in the Treatment of Symptomatic Intracranial Atherosclerotic Disease Multicenter International Experience

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Endovascular Treatment ◽  
Medical Management ◽  
Randomized Clinical Trials ◽  
Atherosclerotic Disease ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Intracranial Atherosclerotic Disease ◽  
Drug Eluting

Introduction: Intracranial atherosclerotic disease (ICAD) is a common cause of refractory stroke. Randomized clinical trials failed to prove the safety and efficacy of the endovascular treatment options of symptomatic ICAD (sICAD). However, there are many concerns regarding inclusion criteria in these trials which made them less effective than standard medical management. Herein, we aim to study the safety and efficacy of drug-eluting balloon mounted stents (DES) in the treatment of sICAD. Methods: A retrospective review of endovascular database from 10 comprehensive stroke centers inside and outside the USA from January 2017 to January 2020 was reviewed. Patients were included if they had symptomatic intracranial stenosis ≥70% in the target vessel, failed best medical management, and underwent intracranial stenting with DES. The primary outcome was the occurrence of ischemic stroke, hemorrhage, or mortality within 72 hours of the procedure. Secondary outcomes included rates of symptomatic and angiographic recurrence within 6 months of the procedure. Results: There was a total of 129 patients, the median age was 65 [58-72] years, 40 (31%) were females. The intracranial stenotic lesions were located in anterior circulation in 74 (57.4%) of cases [24 (18.6%) supraclinoid ICA, 5 (3.9%) cavernous ICA, 17 (13.2%) petrous ICA, 5 (19.4%) MCA-M1, and 3 (2.3%) M2] and in posterior circulation in 55 (42.6%) of cases [36 (27.9) vertebral artery V4 segment, 18 (14%) basilar and 1 (0.7%) PCA]. Recurrent stroke was the qualifying event in 101 (78.3%) while transient ischemic attacks (TIA) were identified in 28 (21.7%) of cases. The median time from the qualifying event to stenting was 6 [2-24] days. Strokes were reported within 72 hours of the procedure; 2 (1.6%) ischemic, 2 (1.6%) hemorrhagic strokes and 2 (1.6%) patients suffered inpatient mortality. The median follow-up time was 6 [3-6.75] months. Among 99 patients who had clinical follow up 2 (2%) had TIA and 6 (6.1%) had strokes. Fifty-one patients had follow-up imaging of whom symptomatic ISR was reported in 8 (15.7%). Conclusion: Our study has shown that in appropriately selected patients with sICAD, endovascular treatment using DES is safe and effective. Prospective randomized clinical trials are warranted.

Abstract 5992: Comparison of 4 Years Efficacy and Durability of Sirolimus-Eluting Stent and Paclitaxel- Eluting Stent Deployment in Patients with Very Long Coronary Lesions: Multicenter Registry in Asia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sunao Nakamura ◽  
Hisao Ogawa ◽  
Jang-Ho Bae ◽  
Yeo Hans Cahyadi ◽  
Wasan Udayachalerm ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Stent Thrombosis ◽  
Late Stent Thrombosis ◽  
Cardiac Events ◽  
Stent Deployment ◽  
Very Late Stent Thrombosis ◽  
Coronary Lesion ◽  
Coronary Lesions ◽  
Sirolimus Eluting Stent

Aim : The aim of this study is to compare the 4 years safety and durability of Sirolimus-eluting stent (SES) and Paclitaxel-eluting stent (PES) deployment on the outcome of patients with very long coronary lesions (VLL). Methods : A prospective analysis of 656 patients 730 lesions (male 70.4%, mean age 66.9 yrs) with very long coronary lesion (≥40mm) (368 SES and 288 PES) in five high volume Asian centers after successful stenting in VLL was performed. Lesion locations of VLL were LAD 48.2% (SES 50.2%, PES 45.7%), LCX 18.5%, RCA 33.3%. Complete clinical follow-up to 4 years is being analyzed for all patients. Results : The baseline clinical characteristics between 2 groups were similar. At 4 years overall cardiac events of SES (16.3%) were lower than PES (24.0%) (p=0.03). See table for clinical results. Conclusion : The use of SES and PES in patients with very long coronary lesion was safe and feasible with low acute complication and low incidence of restenosis. SES showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) at 4 years clinical follow-up. SAT (sub acute stent thrombosis), LAST (late stent thrombosis: ~1year), VLAST (very late stent thrombosis: 1year~ 4years) MACE (death, myocardial infarction, CABG and PCI).

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