EARLY AND INTERMEDIATE-TERM OUTCOMES WITH DRUG-ELUTING STENTS IN HIGH-RISK PATIENTSWITH SYMPTOMATIC INTRACRANIAL STENOSIS

Neurosurgery ◽  
2006 ◽  
Vol 59 (5) ◽  
pp. 1044-1051 ◽  
Author(s):  
Adnan I. Qureshi ◽  
Jawad F. Kirmani ◽  
Haitham M. Hussein ◽  
Pansy Harris-Lane ◽  
Afshin A. Divani ◽  
...  
Keyword(s):  
High Risk ◽  
Target Lesion ◽  
Intracranial Stenosis ◽  
Drug Eluting Stents ◽  
Free Survival ◽  
Angiographic Restenosis ◽  
Drug Eluting ◽  
Ischemic Events ◽  
Major Stroke

Abstract OBJECTIVE To report the 1-month and intermediate-term results of treatment of symptomatic intracranial stenosis using drug-eluting stents. BACKGROUND Patients with intracranial stenosis who are at high risk because of either high-grade stenosis or medication failure may have an annual risk of recurrent ischemic events in excess of 40%. Drug-eluting stents may reduce the rate of ischemic events in patients with a low restenosis rate. METHODS We determined rates of technical success (defined as reduction of target lesion to stenosis <30%) and 1-month major stroke or death in patients with symptomatic intracranial stenosis (≥70% and/or medication failure). Patients' clinical and follow-up information during a mean period of 14.3 ± 7 months were obtained. Kaplan-Meier analysis was performed to determine the rate of major stroke-free survival during 12 months. RESULTS There were 18 patients (mean age, 58 ± 16 yr; 12 were men) treated with either a sirolimus-eluting stent (n = 14) or a paclitaxel-eluting stent (n = 4) for stenosis located in the: intracranial internal carotid artery (n = 6), proximal middle cerebral artery (n = 4), intracranial vertebral artery (n = 4), vertebrobasilar junction (n = 2), or basilar artery (n = 2). There was one major stroke and no death observed in the 1-month follow-up. At the 6-month follow-up examination, no major stroke or death was observed. Major stroke-free survival was 86% (±standard error of 9%) at 12 months after the procedure. One symptomatic angiographic restenosis was observed during the follow-up period. CONCLUSION A low rate of major stroke or death was observed after treatment of symptomatic intracranial stenosis using drug-eluting stents in high-risk patients.

scholarly journals Prognostic implications of 2018 ESC/EACTS guideline-endorsed high ischaemic risk features on clinical outcomes after PCI with drug-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wang ◽  
B.O Xu ◽  
R Gao ◽  
K Dou
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Clinical Outcomes ◽  
Bleeding Risk ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Funding Source ◽  
Medical Sciences ◽  
Drug Eluting ◽  
Ischemic Events

Abstract Background Recently, the 2018 ESC/EACTS guidelines on myocardial revascularization have been proposed to standardize the definition of high ischemic events risk (HIR) features. However, the prevalence and the expected ischemic event rate of HIR patients defined by ESC/EACTS-endorsed criteria are currently unknown in the real-world percutaneous coronary intervention practice. We sought to investigate the impact of HIR features on clinical outcomes after drug-eluting stents implantation and whether this effect is influenced by high bleeding risk (HBR). Methods Between January 2013 and December 2013, a total of 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. The primary ischemic endpoint was target lesion failure (TLF) (comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization] and the primary bleeding endpoint was clinically relevant bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Guideline-endorsed HIR features were in the present study and definitions were as follows: diffuse (defined as lesion length ≥20 mm) multivessel disease in patients with diabetes, CKD (defined as estimated glomerular filtration rate <60 ml/min/1.73 m2), ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, and treatment of CTO, and history of ST-elevation myocardial infarction. HBR was defined based on the highest quartile of PARIS bleeding score (≥6 or <6). Results Median follow-up was 29 months. 5149 patients had at least 1 HIR feature (50.6%), who experienced significantly increased risks of TLF (adjusted hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.32–1.93; P<0.001), compared to those with non-HIR features. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HRadjust: 0.85 [0.66–1.09]; P=0.200). By including ESC/EACTS-endorsed HIR criteria as a continuous variable within the same multivariable models, the risk of adverse ischemic events tended to be greater as the number of high-risk procedural characteristics increased (per number of high-risk features increase: for TLF, HRadjust: 1.15, 95% CI: 1.07–1.23; P trend<0.001; for MACE, HRadjust: 1.33, 95% CI: 1.22–1.46; P trend<0.001). There was no statistical interaction between HBR and HIR features in regard to TLF (adjusted Pinteraction=0.855) and clinically relevant bleeding (adjusted Pinteraction=0.269), suggesting a consistent effect within ESC/EACTS-endorsed HIR features. Results were consistent when categorizing patients into HBR according to PARIS bleeding risk score ≥8 points. Conclusions ESC/EACTS-endorsed HIR criteria were associated with a substantial risk of ischemic events, with no increase in clinically relevant bleeding in routine clinical practice; and theses associations did not seem to be modified by HBR status. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Rastan ◽  
Noory ◽  
Zeller
Keyword(s):  
Limb Salvage ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Target Lesion Revascularisation ◽  
Randomized Studies ◽  
Drug Eluting ◽  
The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

P2798Final 5-year outcomes of the TRIAS High Risk of Restenosis; a multi-centre, randomized trial comparing endothelial progenitor cell capturing stent with drug-eluting stents

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L S M Kerkmeijer ◽  
P Woudstra ◽  
M Klomp ◽  
D N Kalkman ◽  
C Varma ◽  
...  
Keyword(s):  
High Risk ◽  
Cardiac Death ◽  
Vessel Wall ◽  
Thrombus Formation ◽  
Stable Coronary Artery Disease ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Endothelial Progenitor ◽  
Drug Eluting

Abstract Background One of the major long-term disadvantages of percutaneous coronary intervention (PCI) remains in-stent restenosis and need for repeat revascularisation. The polymer-regulated delivery of cytotoxic or cytostatic drugs, on drug-eluting stents (DES), impede the natural healing response of the damaged vessel wall. In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. It is hypothesized that after immobilisation the EPCs differentiate into a functional endothelial layer and that this layer will prevent neointimal proliferation and thrombus formation. Anti-CD34+ antibodies are able to capture the EPCs. The Genous stent consist of a bare-metal stent with anti-CD34+ antibody coating. Purpose Demonstrating long-term performance of Genous EPC capturing stent (ECS) relative to DES regarding target lesion failure (TLF); the composite of cardiac death, myocardial infarction (MI) and any target lesion revascularisation (TLR) within 5 years. Methods We undertook an international, clinical trial in 26 centres planning to randomise 1300 patients with stable coronary artery disease and with a high risk of restenosis between treatment with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was substantially higher and treatment of new patients with an ECS would be unreasonable. The trial was terminated for safety reasons. Results A total of 622 were randomly assigned to receive either Genous ECS (304 patients, 367 lesions) or DES (318 patients, 388 lesions). Five year follow-up data was obtained in 95.5% of patients. TLF occurred in 29.1% of the ECS-treated patients and in 16.0% of the DES-treated patients (p<0.001) (Figure 1). This difference was driven by higher rates of TLR (22.9% vs. 10.7%, p<0.001), but not by cardiac death (6.5% vs. 4.5%, p=0.268), or MI (5.8% vs. 3.6%, p=0.175). Definite or probable stent thrombosis was seen in 8 ECS-treated patients (2.7%) and in 3 DES-treated patients (1%), p=0.11. Figure 1. KM curves of TLF at 5year fu. Conclusion The Genous ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. If the addition of a EPCs capturing layer on a DES, like the COMBO stent, provides a lower risk of restenosis compared to DES will be tested in the ongoing SORT-OUT X trial. Acknowledgement/Funding OrbusNeich

scholarly journals Six-month clinical outcomes of drug eluting stents in patients with coronary artery disease: an experience in real-world Indian patients

2021 ◽  
Vol 9 (12) ◽  
pp. 3590
Author(s):  
Gaurav Sardarilal Verma
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Real World ◽  
Clinical Performance ◽  
Drug Eluting Stents ◽  
Angiographic Restenosis ◽  
Indian Patients ◽  
Drug Eluting ◽  
Artery Disease

Background: Treatment of patients with coronary artery disease using drug eluting stents (DES) remains a challenge due to stent thrombosis and in-stent restenosis. The present study sought to investigate the safety and clinical performance of DES in real-world Indian patients with coronary artery disease.Methods: This prospective, non-randomized, single-center study enrolled 114 patients with coronary artery disease who were implanted with DES from January-2005 to September-2007. Clinical and angiographic follow-up were performed at 6 months after the index procedure. The primary endpoints of the study were: (major adverse cardiac events (MACE) defined as a composite of any episode of rest angina, myocardial infarctions (MI), repeat percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), or (angiographic restenosis defined as ≥50% diameter stenosis at the treated site at 6-month follow-up. The secondary endpoints of the study were occurrence of any MACE events and stent vessel occlusion during the first 30 postprocedural days.Results: A total of 125 lesions were treated by implantation of 130 DES. Only one patient (0.9%) developed minor bleeding during hospitalization. At the 6-month follow-up, MACE was 10%, including 1 (1.3%) MI, 2 (2.5%) unstable angina, 3 (3.8%) stable angina, 1 (1.3%) repeat PCI, and 1 (1.3%) CABG. Angiographic restenosis was found in 7 (8.8%) patients. Comparison of characteristics between patients with and without angiographic restenosis revealed significant effects of presence of diabetes (p<0.012), hyperlipidaemia (p<0.028), and stent length>20 mm (p<0.05).Conclusions: The study results demonstrated excellent safety and clinical performance of DES in real-world Indian patients with coronary artery disease.

scholarly journals Ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Second Generation ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Durable Polymer ◽  
Drug Eluting

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.

Long-term efficacy and safety of newer generation ultrathin strut drug-eluting stents: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Lattuca ◽  
X Odorico ◽  
B.V Occean ◽  
L Cornillet ◽  
L Schmutz ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Efficacy And Safety ◽  
Short Term ◽  
Term Efficacy ◽  
Drug Eluting

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None

Abstract 2520: Drug-Eluting Stents for the Treatment of Chronic Total Occlusion: A Comparison with Sirolimus, Paclitaxel, Zotarolimus, EPC Capture and Everolimus-Eluting Stent: Multicenter Registry in Asia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sunao Nakamura ◽  
Shotaro Nakamura ◽  
Hisao Ogawa ◽  
Jang-Ho Bae ◽  
Yeo Hans Cahyadi ◽  
...  
Keyword(s):  
Chronic Total Occlusion ◽  
High Volume ◽  
Clinical Results ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Cardiac Events ◽  
Total Occlusion ◽  
Angiographic Restenosis ◽  
Adverse Cardiac Events ◽  
Drug Eluting

The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), Zotarolimus (ZES), EPC capture (ECS) and Everolimus-eluting stent (EES) on the outcome of patients with chronic total occlusion (CTO). A prospective analysis of 1149 patients with 1183 CTOs (396 SES, 526 PES, 177 ZES, 41 ECS, 43 EES) in five high volume Asian centers after successful recanalization of CTO was performed. The study endpoints were 30 days and 9 months major adverse cardiac events (MACE), 9 months angiographic restenosis and target lesion revascularization (TLR). See table for clinical results. The use of drug-eluting stents in patients with CTO was safe with low acute complication. Patients treated with SES and EES showed lesser rate of restenosis compared with other drug-eluting stents.

Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 207-217 ◽  
Author(s):  
Liefke C. van der Heijden ◽  
Marlies M. Kok ◽  
Marije M. Löwik ◽  
Peter W. Danse ◽  
Gillian A.J. Jessurun ◽  
...  
Keyword(s):  
High Risk ◽  
Left Ventricular Ejection ◽  
Drug Eluting Stents ◽  
Intermediate Risk ◽  
Target Vessel ◽  
High Risk Patients ◽  
Event Risk ◽  
Risk Patients ◽  
Drug Eluting

Objective: Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). Methods: We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). Results: At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00). Conclusions: The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

scholarly journals Angiographic Restenosis in Coronary Bifurcations Treatment with Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents: Analysis Based on Randomized POLBOS I and POLBOS II Studies

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Robert J. Gil ◽  
Jacek Bil ◽  
Adam Kern ◽  
Luis A. Iñigo-Garcia ◽  
Radoslaw Formuszewicz ◽  
...  
Keyword(s):  
Stable Coronary Artery Disease ◽  
Optimization Technique ◽  
Drug Eluting Stents ◽  
Coronary Bifurcation ◽  
Coronary Syndrome ◽  
Angiographic Restenosis ◽  
Coronary Bifurcation Lesions ◽  
Drug Eluting ◽  
Bifurcation Lesions

Aim. The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II. Methods. Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands). Results. In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group—17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up—90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES—0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06–0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48–11.44). Conclusions. The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions.

Sign in / Sign up

Export Citation Format

Share Document