Patients with in-stent restenoses

2007 ◽  
Vol 46 (05) ◽  
pp. 185-191 ◽  
Author(s):  
T. Nusser ◽  
B. J. Krause ◽  
M. Kochs ◽  
T. Habig ◽  
F. M. Mottaghy ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Bare Metal ◽  
Metal Stent ◽  
Post Intervention ◽  
Angiographic Restenosis

SummaryAims: We compared the intracoronary β-brachytherapy using a liquid rhenium-188 filled balloon with the slow-release, polymer-based, paclitaxel-eluting Taxus-Express stent for treatment of in-stent restenoses. Patients, methods: During the same study period, patients with restenoses in bare-metal stents were either treated with Taxus- Express stents (n = 50) or β-brachytherapy after successful angioplasty (n = 51). For brachytherapy 30 Gy in 0.5 mm tissue depth were administered. The irradiated segment exceeded the traumatized segment 7.5 mm on both sides. Primary endpoint was the minimal lumen diameter (MLD) at the target lesion at six months follow-up. Angiographic follow-up was available in 78% (n = 79/101) and clinical follow-up in all patients. Results: Baseline parameters did not differ statistically. The Taxus-Express stent resulted in a significantly larger MLD and a significantly lower percent diameter stenosis post intervention compared to β-brachytherapy, which both maintained until angiographic follow-up (primary endpoint 2.44 ± 0.74 mm versus 1.73 ± 0.74 mm, p <0.0001). Therefore, Taxus- Express stents were associated with a lower angiographic restenosis rate compared with β-brachytherapy, both for the target lesion (6.1% versus 17.4%) and the total segment (9.1% versus 23.9%). Moreover, use of Taxus-stent was associated with a clinical benefit based on a significantly lower MACE rate compared with β-brachytherapy (p <0.05). Conclusions: Paclitaxel-eluting Taxus- Express stents resulted in superior clinical and angiographic outcomes compared to intracoronary β-brachytherapy with a liquid 188Re filled balloon for treatment of restenosis within a bare-metal stent.

scholarly journals PRECLINICAL EVALUATION OF THE VASCULAR EFFECTS OF REJUVENATE® COBALT CHROMIUM CORONARY STENT SYSTEM IMPLANTED IN THE PORCINE CORONARY IN STENT RESTENOSIS MODEL

2021 ◽  
Vol 54 (2) ◽  
pp. 132-138
Author(s):  
Murtaza Najabat Ali ◽  
Mariam Mir ◽  
Piotr Buszman
Keyword(s):  
Vascular Tissue ◽  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Bare Metal ◽  
Cobalt Chromium ◽  
Metal Stent ◽  
Stent Patency ◽  
The Mean

Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up. Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software. Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days. Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 936-945
Author(s):  
Koen Deloose ◽  
Marc Bosiers ◽  
Patrick Peeters ◽  
Jürgen Verbist ◽  
Lieven Maene ◽  
...  
Keyword(s):  
De Novo ◽  
Ankle Brachial Index ◽  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Primary Patency ◽  
Metal Stents ◽  
Bare Metal ◽  
Metal Stent ◽  
Drug Coated Balloon

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

scholarly journals Immunosuppressive Therapy for Restenosis Prevention after Coronary Bare-Metal Stent Implantation -A Meta-Analysis

2019 ◽  
Author(s):  
Yun-Lang Dai ◽  
Jing Zhou ◽  
Yu-Feng Jiang ◽  
Sheng-Da Hu ◽  
Yong-Ming He
Keyword(s):  
Immunosuppressive Therapy ◽  
Meta Analysis ◽  
Bare Metal Stents ◽  
Metal Stents ◽  
Bare Metal ◽  
Angiographic Restenosis ◽  
Stent Restenosis ◽  
Risk Patients ◽  
In Stent Restenosis

Abstract Background: Previous studies revealed controversial results regarding the prevention of in-stent restenosis after coronary bare-metal stents (BMS) placement with systemic administration of immunosuppressive drugs. We therefore conducted a meta-analysis to investigate the role played by immunosuppressive therapy (IST) in reducing both in-stent restenosis and adverse clinical events after BMS implantation. Methods: We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases for randomized, controlled studies that investigated the therapeutic effects of IST after BMS insertions. Endpoints assessed were: (1) angiographic restenosis by the end of at least 6 months of follow-up; (2) target vessel revascularization (TVR); and (3) risk of major adverse cardiovascular events (MACE). MACE was defined as death, myocardial infarction and TVR. Results: Nine randomized, controlled trials including 1576 patients (mean age 62 years; follow-up of 6-12 months) were included in this analysis. Meta-analysis showed periprocedural IST + BMS significantly reduced in-stent restenosis as compared to BMS alone (RR: 0.59 [0.39-0.90], P = 0.01). In particular, IST reduced restenosis in high-risk patients (defined as patients with mean reference diameter < 3.0 mm or high periprocedural C-reactive protein level) (RR: 0.34 [0.15,0.74], P = 0.006) rather than in low-risk patients ( P for interaction = 0.06). Similarly, IST also reduced the risk of MACE (RR: 0.63 [0.50-0.80], P < 0.01) and TVR (RR: 0.57 [0.33-0.97], P = 0.04). Conclusions: Periprocedural IST reduces the risk of angiographic restenosis, TVR and MACE in patients with BMS implantation. The advantage of IST is driven mainly by a lower risk of in-stent restenosis in high-risk patients. Key words: immunosuppressive therapy, restenosis, bare-metal stents , meta-analysis

Abstract 2161: Impact of Target Lesion Revascularization During the First Year After Bare-Metal or Sirolimus-Eluting Stenting on Five-Year Cardiac Outcomes

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Meredith Mulhearn ◽  
Victor Novack ◽  
Riya S Chacko ◽  
Lena Novack ◽  
Laura Mauri ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Cardiac Death ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Adverse Outcomes ◽  
Target Lesion Revascularization ◽  
Metal Stents ◽  
Bare Metal ◽  
Cardiac Outcomes ◽  
Increased Risk

Background: The association of restenosis requiring target lesion revascularization (TLR) and late cardiac outcomes after drug-eluting versus bare metal stents (BMS) has not been previously assessed. Methods: We hypothesized that restenosis requiring TLR within 1 year after stenting would be associated with increased risk of adverse cardiac outcomes during the next 4 years. Of 1058 patients randomized to sirolimus-eluting (SES) or BMS in the SIRIUS trial, 37 were excluded due to multivessel (6) or SVG (1) stenting or the occurrence of TLR within the first 30 days (30), leaving 515 SES and 506 BMS. Patients with TLR for restenosis indication between 31–360 days after the index procedure (TLR group) were compared with all others (Non TLR group) for outcomes during years 2–5. The primary endpoint was a composite of cardiac death, any MI or any repeat revascularization. The secondary endpoint was cardiac death or any MI. All events were adjudicated by an independent committee. Event rates were estimated using Kaplan-Meier (KM) method and compared using log rank. The correlates of the primary and secondary endpoints were tested using Cox proportional hazards regression. Results: TLR occurred in 120 (11.8%) patients. TLR patients had lower frequency of SES (24.2% vs. 53.9%, p<0.001), more diabetes (35.8% vs. 25.2%, p=0.02) and smaller diameter vessels (2.7±0.5 vs. 2.8±0.5 mm, p=0.04). TLR presented with MI in 7 (5.8%) patients, including CKMB >5 times normal in 6 (5.0%) patients. The primary endpoint occurred in 42 (36.1%) TLR and 211 (24.3%) Non TLR patients (log-rank p = 0.002). Cardiac death or MI occurred in 16 (13.8%) TLR patients and 57 (6.6%) Non TLR patients (log-rank p = 0.005). TLR was an independent predictor of the primary endpoint (Hazard ratio [HR] 1.6, 95% CI 1.2–1.9) and of cardiac death or MI (HR 1.9, 95% CI 1.3–2.4). Other independent predictors of cardiac death or MI were diabetes (HR 2.2, 95% CI = 1.7–2.6) and prior MI (HR 1.9, 95% CI 1.3–2.4). SES compared with BMS was not significantly associated with the primary endpoint or cardiac death or MI. Conclusions: Restenosis requiring TLR during 31–360 days after successful stenting is associated with an increased risk of adverse outcomes, including cardiac death or MI, in subsequent years.

Bare metal stents can maintain arterial patency in traumatic occlusion

2018 ◽  
Vol 2 (1) ◽  
Author(s):  
Viktor A Reva ◽  
Jonathan J Morrison ◽  
Alexey V Denisov ◽  
Alexey B Seleznev ◽  
Gennady G Rodionov ◽  
...  
Keyword(s):  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Control Group ◽  
Bare Metal ◽  
Metal Stent ◽  
Ovine Model ◽  
Stent Group ◽  
Stent Deployment ◽  
Arterial Patency

Background: The standard approach to an occlusive vascular injury is open arterial reconstruction, although endovascular stenting is becoming more common, despite limited evidence. The aim of this study is to examine the performance of bare-metal stents in an ovine model of occlusive arterial trauma. Methods: Through a groin incision, a 2 cm segment of the left superficial femoral artery (SFA) was bluntly injured using a hemostat and injection of air to achieve thrombosis. Animals then underwent a stent deployment (Stent group, n=5) or no-treatment (Control group, n=5). In the Stent group, recanalization of the thrombotic lesion, thromboaspiration and bare-metal stent deployment were performed. Enoxaparin 1.5 mg/kg was given to all animals. The stent group animals were fed Clopidogrel 75 mg and Aspirin 125 mg daily. Angiography and doppler ultrasound were used to evaluate arterial patency during the 7-day observation period. Results: A thrombosis was obtained in all cases. After the fall in the systolic velocity (SV, cm/sec) in both the Control (43 (36–56) to 6 (0–16); p<0.001) and Stent Groups (45 (32–53) to 8 (0–12); p<0.001), stent implantation resulted in a significant permanent increase of the SV. Day 7 angiography confirmed SFA patency in all (5/5) stented animals, with persisting occlusions in the Control group (p=0.008). There was no evidence of distal emboli in the run-off arteries. Conclusions: Bare-metal stent implantation restores arterial patency of a traumatic occlusive lesion in a standardized ovine model with a short follow-up period.

scholarly journals Midterm outcomes of endovascular treatment with bare metal stents for Leriche syndrome patients

2020 ◽  
Vol 32 (1) ◽  
pp. 83-88
Author(s):  
Bihui Zhang ◽  
Guochen Niu ◽  
Ziguang Yan ◽  
Yinghua Zou ◽  
Xiaoqiang Tong ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Survival Rates ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Metal Stents ◽  
Bare Metal ◽  
Free Survival ◽  
Leriche Syndrome ◽  
Related Mortality

Abstract OBJECTIVES This study was undertaken to evaluate the acute and midterm results of endovascular treatment with bare metal stents (BMS) for Leriche syndrome patients. METHODS Patients with Leriche syndrome treated with BMS from August 2008 to May 2017 were included in the study and followed up. The primary endpoints were primary restenosis-free survival rates at 1, 2 and 3 years. The secondary endpoints were secondary restenosis-free and freedom from target lesion revascularization survival rates at 1, 2 and 3 years; technical success rate; complication rate; procedure-related mortality rate; and clinical status improvement at follow-up. RESULTS Twenty patients were included and the follow-up duration was 34.7 ± 18.7 months (0–86 months). The 1-, 2- and 3-year primary restenosis-free survival rates were 94.4%, 88.1% and 73.5% and the secondary patency rates were 94.4%, 94.4% and 86.6%, respectively. The freedom from target lesion revascularization survival rates of patients at 1, 2 and 3 years were 94.4%, 88.1% and 79.3%, respectively. The aortoiliac lesions were successfully treated with BMS bilaterally in 17 patients (85.0%) and unilaterally in another 3 patients (15.0%). The complication rate was 10.0% and the procedure-related mortality rate was 0%. Mean ankle-brachial index increased significantly from 0.43 ± 0.20 before the procedure to 0.95 ± 0.21 after the procedure (P &lt; 0.001), and to 1.00 ± 0.19 at the end of the follow-up (P &lt; 0.001). Improvement in symptoms occurred in most patients soon after the endovascular procedure (95.0%) and at follow-up (88.2%). CONCLUSIONS Endovascular treatment with BMS is effective and safe for patients with Leriche syndrome according to 3-year follow-up results.

Abstract 3438: Comparison of Endothelial Progenitor Cell Capture Stent with Bare Metal Stent In Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Tay Lik-Wui Edgar ◽  
Chua Melissa-Co ◽  
Lee Chi-Hang ◽  
Low Adrian ◽  
Lim Jimmy ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Endothelial Progenitor Cell ◽  
Progenitor Cell ◽  
Bare Metal Stents ◽  
Bare Metal Stent ◽  
Metal Stents ◽  
Bare Metal ◽  
Primary Pci ◽  
Metal Stent ◽  
The Mean

Background: The endothelial progenitor cell (EPC) capture bio-engineered stent (Genous ® stent, OrbusNeich) was designed to attract circulating EPCs and promote rapid endothelization. The aim of this study was to compare clinical outcomes between patients with ST-segment elevation myocardial infarction (STEMI) who received this stent versus those who received Liberte (Boston Scientific) bare metal stents. Methodology: Three hundred and forty two patients who presented to our centers with STEMI without cardiogenic shock and underwent primary PCI with either EPC Capture-or bare metal stent implantation were enrolled in this study. All patients received dual anti-platelet therapy for a month; and statin therapy was initiated soon after PCI. The study endpoints were major adverse cardiac events (MACE) at 30 days, 6 months and 1 year. Results: A total of 164 EPC Capture stents and 178 BMS were implanted. Baseline patient characteristics were comparable in the 2 groups. The mean lesion length in the 2 groups were 20.4.0 ± 5.1 and 22.8 ± 7.6mm, and the mean reference vessel diameter 3.14 ± 0.65 and 2.70 ± 1.14 mm respectively. At 6 months, the results were: Conclusion: There was no significant difference in MACE at 6 month between EPC Capture-and bare metal stents in patients with STEMI who underwent primary PCI. The 1-year data will be presented at the meeting.

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