Abstract 2775: The effect of Plasma C-Reactive Protein on Neointimal Plaque Volume at 9 Month Follow-Up After Implantation of Sirolimus Eluting Stent (SES) and Paclitaxel-Eluting Stent (PES). Intravascular Ultrasound Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jung-Sun Kim ◽  
Byung Ho Lee ◽  
Jae-Deok Kim ◽  
Hyun-Soo Kim ◽  
Sungha Park ◽  
...  
Keyword(s):  
De Novo ◽  
Coronary Stenting ◽  
Volume Index ◽  
Drug Eluting Stent ◽  
Plaque Volume ◽  
Stent Restenosis ◽  
Ultrasound Study ◽  
Significant Difference ◽  
Sirolimus Eluting Stent

Background : The aim of this study is to identify the association of hsCRP with neointimal plaque volume at 9 month follow-up IVUS after implantation of Sirolimus eluting stent (SES) and Paclitaxel-eluting stent (PES). Methods: A total of 127 patients (M:F = 78:49, age 62 ± 8 years), who underwent the elective coronary stenting for a de-novo lesion were prospectively enrolled and randomized according to type of stents (64 SES, 63PES). Infarct-related lesions within 7 days were excluded. Among them, hsCRP was serially measured in 104 patients (50 SES and 54 PES) at baseline, 48 hr after and 9 month follow-up after coronary stenting. IVUS was simultaneously performed at initial, after coronary stenting and 9 month follow-up. Neointimal volume index (neotintimal volume/stent length) at 9 month follow-up was obtained using INDEC system. Result : Baseline clinical, angiographic and IVUS parameters after stenting of both groups showed no significant differences. hsCRP was significantly increased at 48 hrs after coronary stenting but there was no significant difference between two groups (baseline: 2.9 ± 8.7 vs. 3.6 ± 7.6 mg/L, 48 hr: 10.7 ± 21.3 vs. 13.0 ± 15.3 mg/L, 9 month: 1.0 ± 1.6 vs. 1.2 ± 1.8 mg/L). At 9 month follow-up, SES showed a significantly lower neointimal volume index (0.22 ± 0.41 vs. 1.0 ± 0.9 mm 2 , p < 0.001) and lower tendency of in-stent restenosis [1 (2.2 %) vs. 6 (12.5 %), p = 0.111] than PES. Neointimal plaque volume at 9 month was significantly correlated with hsCRP at 48 hr (r= 0.426, p = 0.004) and increase of hsCRP between baseline and 48 hr (r = 0.512, p < 0.001). Also, higher increase of hsCRP between baseline and 48 hr (β = 0.469, p = 0.006) and PES (β = - 0.345, p = 0.024) were independently associated with increased neointimal volume index at 9 month follow-up after adjusting the clinical and angiographic parameters. Conclcusion: Increase of hsCRP at 48 hr after coronary stenting was significantly associated with neointimal volume in drug eluting stent (DES) era. Thus, control of acute inflammation after implantation of DES, especially PES might be beneficial for reducing neointimal plaque volume.

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.

Abstract 2150: A European and Canadian Multicenter Randomized, Double-Blind Trial of the Sirolimus-Eluting Stent (SES) in Patients with De Novo Native Coronary Artery Lesions (NEW-SIRIUS): 5-Year Clinical Outcomes

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Eric Schampaert ◽  
Joachim Schofer ◽  
Guenther Breithardt ◽  
Eric A. Cohen ◽  
Michael Schlüter ◽  
...  
Keyword(s):  
De Novo ◽  
Target Lesion ◽  
Diabetic Patients ◽  
Restenosis Rate ◽  
Cardiac Events ◽  
Double Blind ◽  
Significant Difference ◽  
Catch Up ◽  
Sirolimus Eluting Stent

Background : NEW-SIRIUS is the pooled analysis of the E-SIRIUS (n=352) and C-SIRIUS (n=100) studies, respectively, performed in Europe and Canada. Identical in design, these are multicenter randomized, double-blind trials examining the safety and efficacy of the sirolimus-eluting stent (SES) vs. an identical bare-metal stent (BMS) in 452 patients to treat de novo native long lesions in small coronary arteries, with adjunctive clopidogrel for only 2 months. Methods : The primary endpoint was in-stent minimum lumen diameter (MLD) at 8-month follow-up. Among the secondary endpoints were major adverse cardiac events(MACE) at 1, 6, 9 and 12 months, and annually up to 5 years post-procedure, as well as target lesion revascularization (TLR), target vessel revascularization (TVR) and protocol-defined stent thrombosis. Results : At 8 months, the MLD was 2.27±0.47mm in the SES vs. 1.36±0.66 mm in the BMS (p < 0.001). The binary in-lesion restenosis rate was 5.1% in the SES vs. 44.2% in the BMS (p < 0.001). At 4 years, there was a significantly lower incidence of MACE (SES: 15.1% vs BMS: 33.9%, p < 0.001), primarily driven by a significant difference in clinically-driven TLR rates (SES: 7.1% vs. BMS: 26.0%, p < 0.001). A subgroup analysis in diabetic patients (45 SES, 60 BMS) demonstrated that the in-stent MLD was larger in SES than in BMS (2.20±0.47 vs 1.14±0.64 mm, p < 0.001) and the binary in-lesion restenosis rate was reduced from 56.1% (BMS) to 10.0% (RRR: 82.2%, p < 0.001) at 8 months. At 4 years, the freedom from MACE in diabetic patients was 80.0% in the SES vs. 61.7% in the BMS (p = 0.031), again mainly driven by an improved freedom from clinically driven-TLR (SES: 90.8% vs. BMS: 66.9%, p=0.005), with no evidence of a late catch-up effect. Conclusion : Up to 4 years, SES were superior to BMS in the total cohort as well as in the diabetic subgroup without evidence of a late catch-up. Five-year follow-up data, including antiplatelet therapies utilization and a diabetic subgroup analyses will be available by July 2007 and presented.

P2694Early and late restenosis after excimer laser coronary angioplasty and paclitaxel-coated balloon combination therapy for drug-eluting stent restenosis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Higaki ◽  
K Nishioka ◽  
K Suruga ◽  
H Takemoto ◽  
T Nakano ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Excimer Laser ◽  
Coronary Angioplasty ◽  
Drug Eluting Stent ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
Late Restenosis ◽  
Excimer Laser Coronary Angioplasty

Abstract Background Drug-eluting stent restenosis (DES-ISR) is associated with poorer outcomes than those of bare-metal stent restenosis after treatment with paclitaxel-coated balloon (PCB), and late restenosis after PCB angioplasty for DES-ISR is a residual problem. Excimer laser coronary angioplasty (ELCA) is thought to be advantageous for ISR treatment by removing neointima. However, whether the combination of ELCA and PCB angioplasty is more effective than the use of PCB only angioplasty in DES-ISR has not been studied so far. Purpose We evaluated the efficacy of ELCA and PCB combination therapy for DES-ISR at mid-and late-term after revascularization. Methods From January 2014 to March 2016, 166 DES-ISR lesions were treated with ELCA and no-ELCA prior to PCB. Two serial angiographic follow-ups were planned for the patients (at 6–12 and 18–24 months after procedure). Acute procedural and follow-up angiographic results were assessed by quantitative coronary angiography. ELCA and no-ELCA group included 74 lesions and 92 lesions, respectively. Results There was no significant difference between the two groups in the clinical characteristics except the prevalence of hemodialysis, the rate of first-generation DES (37.9% vs 36.8%, p=0.897), previous stent size (2.90±0.39 mm vs 2.77±0.39 mm, p=0.063), and reference vessel diameter (2.65±0.46 mm vs 2.60±0.65 mm, p=0.593). Early follow-up angiography was performed in 66 lesions (89.1%) of ELCA group, and was done in 76 lesions (82.6%) of no-ELCA group. In the ELCA group, percentage diameter stenosis (%DS) just after procedure and at 6–12 months later were significantly smaller than those of no-ELCA group. Besides, target lesion revascularization (TLR) rate at 6–12 months after procedure was tended to be lower in the ELCA group. Late follow-up angiography was performed for 93 lesions (81.6%) of the remaining 114 lesions (excluding TLR lesion), late restenosis was found 9 lesions (18.6%) in the ELCA group and 11 lesions (24.4%) in the no-ELCA group (p=0.504). Late luminal loss was similar in both groups (0.37±0.71 mm vs 0.24±0.82 mm, p=0.438), and %DS at 12–18 months after revascularization was not different between the two groups. Changes of %DS and TLR rate Conclusions %DS in the ELCA group was smaller at just after procedure and the advantage was kept even after 1-year. However, late restenosis and TLR at 2-year after revascularization for DES-ISR could not be reduced by ELCA and PCB combination therapy.

scholarly journals The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Chengbin Zheng ◽  
Jeehoon Kang ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Target Lesion ◽  
University Hospital ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
2Nd Generation ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
In Stent Restenosis

Objectives. The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background. The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods. We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results. TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions. Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration. This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).

Abstract 2168: Sirolimus-eluting Stent Implantation at Proximal Site Inhibits In-stent Restenosis in Bare Metal Stent Placed at Distal Site of de novo Lesion in Same Coronary Artery

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Hajime Takano ◽  
Jyun-ei Obata ◽  
Yoshinobu Kitta ◽  
Yasushi Kodama ◽  
Akira Mende ◽  
...  
Keyword(s):  
Coronary Artery ◽  
De Novo ◽  
Bare Metal Stent ◽  
Metal Stent ◽  
Stent Restenosis ◽  
Proximal Site ◽  
Distal Edge ◽  
Sirolimus Eluting Stent ◽  
Distal Site

Drug-eluting stent (DES) suppresses peri-stent distal edge stenosis via a local diffusion of the drug. Diffusion of sirolimus into coronary blood flowing may cause an accumulation of this drug in coronary bed beyond the distal edge of sirolimus-eluting stent (SES). Thus, this study examined whether SES implantation may exert anti-proliferative action on bare metal stent (BMS) placed distally in the same coronary artery. Methods and Results: We prospectively examined 114 consecutive patients with stable coronary artery disease who met the following inclusion criteria: elective, successful percutaneous coronary intervention for a long de novo lesion or two adjacent de novo lesions treated with more than two stents in the same coronary artery, implantation of BMS (2.25 mm in size, 12 ~ 18 mm in length) in the distal site because no DES was available due to small vessel size, quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) at stent placement and at 6 months or during the 6 months follow up after the stenting. At the proximal site adjacent to the distal BMS, SES was implanted without gap in 57 patients (SES-BMS), and BMS in the remaining 57 patients (BMS-BMS). Patients with in-stent restenosis (ISR, defined as > 50% diameter stenosis), developed at the proximal stent during the 6 months follow up, were excluded from the further analysis (all of them were 14 patients with BMS-BMS). Clinical, lesion, and procedural variables at stenting were comparable between SES-BMS (n = 57) and BMS-BMS (n = 43) groups. The QCA of the distal BMS showed less late luminal loss (0.49 ± 0.06 vs. 0.91 ± 0.08 mm, p < 0.01) and a lower ISR rate (13% vs. 36%, p < 0.01) in the SES-BMS group than the BMS-BMS group. The SES-BMS group also had less neointimal hyperplasia volume (25.1 ± 2.2 vs. 37.1 ± 2.5 mm 3 , p < 0.01) than the BMS-BMS group in the IVUS which examined a 10-mm length of the distal BMS from the distal edge of the proximal stent. Target lesion revascularization (TLR) of the distal BMS was less frequent in the SES-BMS group compared with the BMS-BMS group (9% vs. 19%, p < 0.01). Conclusions: SES implantation inhibits ISR and TLR in BMS at distal site of de novo lesion in same coronary artery. These findings may have an implication for stent strategy in long lesions.

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.

Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry

2012 ◽  
Vol 101 (9) ◽  
pp. 709-716 ◽  
Author(s):  
Ralf Zahn ◽  
Franz-Josef Neumann ◽  
Heinz-Joachim Büttner ◽  
Gert Richardt ◽  
Steffen Schneider ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Coronary Stenting ◽  
Long Term Follow Up ◽  
Sirolimus Eluting Stent

scholarly journals Health-Related Quality of Life following Cytoreductive Radical Prostatectomy in Patients with de-novo Oligometastatic Prostate Cancer

Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5636
Author(s):  
Michael Chaloupka ◽  
Lina Stoermer ◽  
Maria Apfelbeck ◽  
Alexander Buchner ◽  
Vera Wenter ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
De Novo ◽  
Health Related Quality ◽  
Significant Difference ◽  
Related Quality ◽  
Health Related

(1) Background: local treatment of the primary tumor has become a valid therapeutic option in de-novo oligo-metastatic prostate cancer (PC). However, evidence regarding radical prostatectomy (RP) in this setting is still subpar, and the effect of cytoreductive RP on postoperative health-related quality of life (HRQOL) is still unclear. (2) Methods: for the current study, patients with de-novo oligo-metastatic PC (cM1-oligo), defined as ≤5 bone lesions in the preoperative staging, were included, and matched cohorts using the variables age, body-mass index (BMI), and pT-stage were generated. Patient-reported outcome measures (PROMS) were assessed pre- and postoperatively using the validated EORTC-QLQ-C30, IIEF-5, and ICIQ-SF questionnaires. The primary endpoint for univariate and multivariable analysis was good general HRQOL defined by previously validated cut-off values. (3) Results: in total, 1268 patients (n = 84 (7%) cM1-oligo) underwent RP between 2012 and 2020 at one tertiary care center. A matched cohort of 411 patients (n = 79 with oligo-metastatic bone disease (cM1-oligo) and n = 332 patients without clinical indication of metastatic disease (cM0)) was created. The median follow-up was 25mo. There was no significant difference in good general HRQOL rates between cM1-oligo-patients and cM0-patients before RP (45.6% vs. 55.2%, p = 0.186), and at time of follow-up (44% vs. 56%, p = 0.811). Global health status (GHS) worsened significantly in cM0-patients compared to baseline (−5, p = 0.001), whereas GHS did not change significantly in cM1-oligo-patients (+3.2, p = 0.381). In multivariate analysis stratified for good erectile function (IIEF5 > 18; OR 5.722, 95% CI 1.89–17.36, p = 0.002) and continence recovery (OR 1.671, 95% CI 1.03–2.70, p = 0.036), cM1-oligo was not an independent predictive feature for general HRQOL (OR 0.821, 95% CI 0.44–1.53, p = 0.536). (4) Conclusions: in this large contemporary retrospective analysis, we observed no significant difference in HRQOL in patients with the oligometastatic bone disease after cytoreductive radical prostatectomy, when compared to patients with localized disease at time of surgery.

scholarly journals Drug-Eluting Balloons versus Second-Generation Drug-Eluting Stents for Treating In-Stent Restenosis in Coronary Heart Disease after PCI: A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Wen-Juan Xiu ◽  
Hai-Tao Yang ◽  
Ying-Ying Zheng ◽  
Yi-Tong Ma ◽  
Xiang Xie
Keyword(s):  
Observational Studies ◽  
Second Generation ◽  
Meta Analysis ◽  
Drug Eluting Stents ◽  
Randomized Controlled ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
In Stent Restenosis

Background. In-stent restenosis (ISR) remains a common problem following percutaneous coronary intervention (PCI). However, the best treatment strategy remains uncertain. There is some controversy over the efficacy of drug-eluting balloons (DEBs) and second-generation drug-eluting stents (DESs) for treating ISR. Methods. A meta-analysis was used to compare the efficacy of the DEB and second-generation DES in the treatment of ISR. The primary endpoint is the incidence of target lesion revascularization (TLR). The secondary endpoint is the occurrence of target vessel revascularization (TVR), myocardial infarction (MI), all-cause death (ACM), cardiac death (CD), major adverse cardiac events (MACEs), minimum luminal diameter (MLD), late luminal loss (LLL), binary restenosis (BR), and percent diameter stenosis (DS%). Results. A total of 12 studies (4 randomized controlled trials and 8 observational studies) including 2020 patients with a follow-up of 6–25 months were included in the present study. There was a significant difference in the MLD between the two groups during follow-up (P=0.007, RR = 0.23, and 95% CI: 0.06–0.4 mm). There was no significant difference in LLL, BR, or DS% and the overall incidence of MACEs between the two groups. Subgroup analysis showed no significant difference in the incidence of primary and secondary endpoints when considering RCTs or observational studies only. Conclusions. The efficacy of the DEB and second-generation DES in the treatment of ISR is comparable. However, our results need further verification through multicenter randomized controlled trials.

Sign in / Sign up

Export Citation Format

Share Document