Is a Drug-Eluting Stent the Default Treatment Strategy for Drug-Eluting Stent Restenosis? | JACC: Journal of the American...
In 2001, when Morice et al. (1) presented the initial results of RAVEL (The Randomized Study With the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions), showing 0% angiographic restenosis 6 months after implantation of a sirolimus-eluting stent, very few people would have envisaged that more than 10 years later, there would be a need for a trial to evaluate the best treatment strategy for drug-eluting stent (DES) in-stent restenosis (ISR).. Although widespread use of DES (versus bare-metal stents [BMS]), advances in stent design, and greater operator experience have all significantly reduced the incidence of restenosis and resultant target vessel revascularization (2), a low rate of ISR continues to exist and it is not benign. Outcomes are even poorer for those with DES compared with individuals presenting with BMS-ISR (3).. There are several treatment options for ...http://www.onlinejacc.org/content/66/1/34
Abstract 15518: Restenosis Pattern of Drug-Eluting Stent: Impact of Stent Type | Circulation
Background: Differences in restenosis pattern and timing between bare-metal stent and drug-eluting stent (DES) have been reported. However, little is known about the effect of the type of DES on restenosis pattern and timing.. Methods: From November 2002 to August 2010, 6676 consecutive patients were treated with sirolimus-eluting stent (SES: 6321 lesions), paclitaxel-eluting stent (PES: 1520 lesions), zotarolimus-eluting stent (ZES: 599 lesions), everolimus-eluting stent (EES: 924 lesions), and biolimus-eluting stent (BES: 288 lesions), and underwent midterm follow-up coronary angiography (f/u CAG) at 8 months after implantation. Of these, patients without restenosis underwent late f/u CAG at 12 months after midterm f/u. We defined early restenosis as restenosis at midterm f/u and late restenosis as restenosis at late f/u without early restenosis. ...http://circ.ahajournals.org/content/126/Suppl_21/A15518
Randomized Trial of Paclitaxel- Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting...
The principal findings of the ISAR-DESIRE 2 study are that in cases of DES restenosis occurring within a SES: 1) the implantation of a second DES is feasible and safe; 2) a strategy of either repeat SES implantation or switch to a PES is associated with comparable anti-restenotic efficacy; and 3) the neointimal inhibition observed with repeat SES implantation is somewhat lower than expected, indicative perhaps of the existence of some degree of drug hyporesponsiveness at an individual patient level.. The widespread adoption of DES therapy coupled with an overall increase in the number of PCI procedures has generated significant absolute numbers of patients presenting with DES restenosis (2). Clinically, the treatment of these DES restenotic lesions seems to be associated with slightly higher rates of recurrent restenosis than that observed after treatment of bare-metal stent restenosis. For example, the use of DES to treat bare-metal stent ...http://www.onlinejacc.org/content/55/24/2710
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR) - Full Text View -...
1. The patient has an in-stent restenosis of , 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.. 2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;. 3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring , 2.75mm and 3.5mm in diameter and , 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary ...https://clinicaltrials.gov/ct2/show/NCT00231257
Abstract 14548: A Multicenter Randomized Comparison of Paclitaxel-Coated Balloon Catheter With Conventional Balloon Angioplasty...
Background: The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR).. Methods: This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR; 123 lesions, DES-ISR; 90 lesions) at 13 centers in Japan. Patients were randomly assigned to PCB group (PCB group, 137 patients with 142 lesions) or conventional balloon angioplasty group (BA group, 71 patients with 71 lesions). The primary endpoint was target vessel failure (TVF) at 6-month follow-up.. Results: Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). TVF was noted in 6.6% of PCB group and 31.0% of BA group (p,0.001). Recurrent restenosis occurred in 4.3% of PCB group and 31.9% of BA group ...http://circ.ahajournals.org/content/128/Suppl_22/A14548
Randomised Trial of Three Rapamycin-Eluting Stents with Different Coating Strategies for the Reduction of Coronary Restenosis -...
Background: Drug-eluting stent (DES) platforms devoid of durable polymer have potential to enhance long-term safety outcomes. The ISAR-TEST-3 study was a randomized trial comparing three rapamycin-eluting stents with different coating strategies. The present study examined 2-year outcomes of these patients and is the first large-scale study to report long-term outcomes with biodegradable polymer and polymer-free DES.. Methods: Patients with de novo coronary lesions in native vessels were randomly assigned to receive biodegradable polymer (BP; n=202), permanent polymer (PP; Cypher; n=202) and polymer-free (PF; n=201) stents. The 2-year endpoints of interest were target lesion revascularization (TLR), death/myocardial infarction (MI), stent thrombosis, and delayed angiographic late luminal loss (LLL) between 6-8 months and 2 years.. Results: There were no significant differences in TLR (8.4%, 10.4% and 13.4% for BP, PP and PF stents respectively; p=0.26), death/MI (5.9%, 6.4% and 6.5% with BP, ...http://heart.bmj.com/content/early/2009/07/13/hrt.2009.172379
Restenosis - Wikipedia
Restenosis is the recurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. Restenosis usually pertains to an artery or other large blood vessel that has become narrowed, received treatment to clear the blockage and subsequently become renarrowed. This is usually restenosis of an artery, or other blood vessel, or possibly a vessel within an organ. Restenosis is a common adverse event of endovascular procedures. Procedures frequently used to treat the vascular damage from atherosclerosis and related narrowing and renarrowing (restenosis) of blood vessels include vascular surgery, cardiac surgery, and angioplasty. When a stent is used and restenosis occurs, this is called in-stent restenosis or ISR. If it occurs following balloon angioplasty, this is called post-angioplasty restenosis or PARS. The diagnostic threshold for ...https://en.wikipedia.org/wiki/Restenosis
Paclitaxel-Coated Balloon for Recalcitrant In-Drug-Eluting Stent Restenosis | JACC: Cardiovascular Interventions
Complete percutaneous revascularization, including the treatment of complex lesions and chronic total occlusions, has become a frequent reality in interventional cardiology. Although the overall need for repeat revascularization due to drug-eluting stent (DES) restenosis remains in single-digit levels, in highly complex forms of coronary artery disease, it may significantly compromise the long-term outcomes (1). Use of a second layer of DES to treat in-DES-restenosis is feasible and efficacious, but safety concerns at very long-term follow-up have been raised (2). Paclitaxel-eluting balloons have been established as an equivalent alternative to repeat implantation of first-generation DES regarding the antirestenotic efficacy within the first year of treatment of in-DES restenosis (3,4).. In this issue of JACC: Cardiovascular Interventions, Rittger et al. (5) report 3-year results of the PEPCAD-DES (Treatment of Drug-Eluting Stent [DES] ...http://interventions.onlinejacc.org/content/8/13/1701
Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes | JACC: Journal of the American College of...
The major results of this analysis from the TAXUS-IV randomized trial are: 1) implantation of the polymer-based paclitaxel-eluting TAXUS stent in ACS was safe, without increased rates of cardiac death, MI, or stent thrombosis compared to bare-metal stent implantation; 2) TAXUS stent implantation in patients with both ACS and non-ACS was associated with a marked reduction in clinical restenosis (TLR), with enhanced event-free survival compared to patients receiving a bare-metal stent; and 3) the TAXUS stent resulted in significant reductions in neointimal tissue proliferation and restenosis regardless of clinical syndrome acuity.. The thrombogenic coronary milieu in patients with unstable angina (12,14), coupled with a theoretical propensity for hypercoagulability and delayed re-endothelialization with drug-eluting stents, has resulted in concerns of an increased risk of stent thrombosis after implantation of these devices in patients with ACS. In this ...http://www.onlinejacc.org/content/45/8/1165
The intron 6 G/T polymorphism of c-myb oncogene and the risk for coronary in-stent restenosis.
BACKGROUND: The principle mechanisms leading to the development of atherosclerosis are long-term accumulation of lipids and cell proliferation. We have recently shown that a single nucleotide polymorphism in the c-myb gene is associated with the devehttp://www.biomedsearch.com/nih/intron-6-polymorphism-c-myb/15221349.html
Superiority of sirolimus eluting stent compared with intracoronary β radiation for treatment of in-stent restenosis: a matched...
The use of SES has been shown in randomised clinical trials to result in an in-stent lumen loss of −0.01 to 0.20 mm for de novo coronary lesions.6,7,8,9,10 Slightly higher lumen loss ranging from 0.12 (0.41) to 0.21 (0.62) mm has been reported in small registries with the use of SES for ISR lesions.21,22 In this study in-stent lumen loss in the SES group was 0.30 (0.49) mm if patients with failed IRT were included and 0.23 (0.41) mm if only patients with SES used for first time ISR were analysed. Thus, the results are comparable with those of previous studies on the use of SES for ISR.. It is important to note that not all ISR lesions have a similar risk of recurrence.13 This has to be considered if angiographic and clinical follow up results for different treatment modalities for ISR are compared. Most studies analysing the procedural and follow up results of different treatment strategies for ISR were not randomised or matched comparisons.23 In this study ISR lesions treated with SES were ...http://heart.bmj.com/content/91/12/1584
Treatment of in-stent restenosis. - MyScienceWork
Treatment of in-stent restenosis.: Although in-stent restenosis is the result of neointimal hyperplasia, mechanical problems (e.g. stent underexpansion) that ochttps://www.mysciencework.com/publication/show/treatment-stent-restenosis-b83aaeaa
Prospective, Randomized Trial of Paclitaxel- versus Sirolimus- Eluting Stents for Treatment of Coronary Restenosis in Sirolimus...
ISAR DESIRE 2 Background The optimal treatment strategy for in- stent restenosis is based on the axiom: maximize acute gain minimize late loss ISAR-DESIRE JAMA 2005; RIBS-II JACC 2006 TAXUS-V-ISR JAMA 2006; SISR JAMA 2006 In BMS-restenosis this has most effectively been accomplished by DEShttp://slideplayer.com/slide/679278/
restenosis - Symptoms, Treatments and Resources for restenosis
restenosis - MedHelp's restenosis Center for Information, Symptoms, Resources, Treatments and Tools for restenosis. Find restenosis information, treatments for restenosis and restenosis symptoms.http://www.medhelp.org/tags/show/36548/restenosis
Site-Specific Targeting of Nanoparticle Prednisolone Reduces In-Stent Restenosis in a Rabbit Model of Established Atheroma |...
The concept of systemic pharmacological treatment to reduce inflammation after stenting has been applied in many preclinical and clinical studies with varying success.3,4,18,19 Because of a lack of drug specificity requires high dosages to achieve sustained effects on neointimal growth, systemic side-effects are of major concern and have hindered the general acceptance of systemic pharmacological approaches to prevent restenosis. Steroids have been proven to be effective in reducing neointimal growth in preclinical and clinical settings2-4,20 but, nonetheless, systemic administration of glucocorticoids to prevent in-stent restenosis could not gain acceptance in routine clinical practice because of a lack of efficacy at concentrations low enough to avoid the hazard of steroid side-effects.. The targeted use of pharmacologically modified steroids with high affinity for sites of arterial injury, as demonstrated by our study, might be a valuable approach to effectively prevent ...http://atvb.ahajournals.org/content/28/11/1960
mediaTUM - Medien- und Publikationsserver
Objective: Drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal stents. P27 and P53 play important roles in the signal transduction leading to neointimal growth inhibition and induction of apoptosis of smooth muscle cells due to rapamycin and paclitaxel. We hypothesized that genetic variants of P27 and P53 influence the development of restenosis and the clinical outcome of patients receiving DES. Methods: Polymorphisms in the genes encoding for P27 and P53 were tested for their association with restenosis and major adverse cardiac events. P27 C-79T and P53 G72C polymorphism genotypes were determined in a series of 433 consecutive patients receiving DES. Follow-up angiography after 6 months was performed in 87% of the patients. Genotyping was performed with PCR-based methods. Results: For patients with the respective P27 C-79T and P53 G72C genotypes, the angiographic restenosis rates were between 5.0 and 22.0%, and ...http://mediatum.ub.tum.de/1218603
Restenosis Following Angioplasty in the Swine Coronary Artery Is Inhibited By an Orally Active PDGF-Receptor Tyrosine Kinase...
The oral efficacy of the selective PDGFr-TKI, RPR101511A, was evaluated in a porcine model of coronary artery restenosis following PTCA. This model shares similarities with human restenosis in several ways: PTCA was performed on a preestablished coronary lesion in the presence of elevated plasma cholesterol, surgical protocols were similar to those used clinically, lumen diameters were measured before and after PTCA and again 1 month later by angiography (Figure 4⇑) and at termination, the restenotic lesion contained smooth muscle cells, matrix, and lipids (Figure 5⇑) comparable to human restenotic lesions.20 21 This model differs significantly from previously described models in which naïve coronary arteries of normocholesterolemic pigs were subjected to a single catheter-induced injury.22 23 24 RPR101511A is a novel, low molecular weight inhibitor (Figure 1⇑) of PDGF-rTK autophosphorylation (Figures 2⇑ and 3A⇑) and an ...http://circ.ahajournals.org/content/99/25/3292
Is there any place for oral anti-restenotic treatment in the era of drug eluting stents? | Heart
While the reported data from ORAR are limited in being derived from a small observational uncontrolled study, there are a number of messages that emerge. It is clear that that administration of diltiazem can indeed increase oral rapamycin blood concentrations. The drug appears relatively well tolerated (31% side effects in phase II, but with only two patients needing to discontinue the drug) and that at blood concentrations of around 8 ng/ml or above, in-stent restenosis was only 6.2%, with TVR rates of 12%. There does appear to be an inverse discrepancy ("clinical" restenosis is usually lower than angiographic restenosis) and is likely to be caused by the combination of reporting TVR rather than TLR, together with this being reported at one year in a small number of subjects, as well as failure in the paper to correlate adequately the angiographic outcomes fully with the clinical outcomes.. The overall impression gained from this report is that oral ...http://heart.bmj.com/content/91/11/1377
Arterial Versus Venous Bypass Grafts in Patients With In-Stent Restenosis | Circulation
Patients who develop in-stent restenosis constitute a peculiar technical challenge for both interventional cardiologists and cardiac surgeons. Indeed, once anatomical and technical factors have been ruled out, the occurrence of stent failure can identify a subset of patients with particularly aggressive coronary atherosclerosis in whom successful revascularization can be difficult to achieve using either percutaneous or surgical methods. In fact, in the cardiology literature, there is consistent evidence that the percutaneous retreatment of these cases leads to suboptimal clinical results and is associated with an high risk of additional restenosis or occlusion.1-4 Although this issue has not been specifically investigated in surgical series, it is at least likely that even coronary bypass conduits can be damaged by the aggressive atherosclerotic process and develop accelerated graft disease and failure.. The present protocol was conceived ...http://circ.ahajournals.org/content/112/9_suppl/I-265
The Effects of Bindarit in Preventing Stent Restenosis - Full Text View - ClinicalTrials.gov
Coronary artery disease is caused by the gradual build-up of fatty deposits in coronary arteries (atherosclerosis). A diminished blood flow may cause chest pain (angina), shortness of breath or other symptoms. A complete blockage can cause a heart attack. Angioplasty and stenting techniques are safe and effective procedures performed to unblock coronary arteries. However, a recurrent problem after angioplasty is the occurrence of a new blockage, usually within 6 to 9 months after the initial procedure. This phenomenon, called 'restenosis', is a body's response to the injury of the angioplasty and does not mean a progression of coronary artery disease.The pathophysiology of restenosis is complex and has as yet not been fully clarified.. Serial studies have shown that in-stent restenosis is almost exclusively caused by neointimal hyperplasia and tissue proliferation occurring in site or ...https://clinicaltrials.gov/ct2/show/NCT01269242
Plaque Modification with Scoring Balloon Improves Angiographic Outcomes in Patients Treated with a Drug-Coated Balloon for Drug...
Results of the ISAR-DESIRE 4 Trial Presented at TCT 2015 SAN FRANCISCO - October 14, 2015 - Results from the ISAR-DESIRE 4 trial indicate that use of a scoring balloon plus a paclitaxel-coated balloon (PCB) was angiographically superior to a paclitaxel-coated balloon alone for the treatment of restenosis within limus-eluting stents.. Findings from study were presented today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.. Restenosis after drug-eluting stent implantation (DES) in patients with coronary artery disease occurs in up to 5 to 10% of cases and the most appropriate treatment strategy remains unclear. Drug-coated balloons (DCB) are novel devices that can effectively treat in-stent restenosis. Scoring balloon (SCB) devices prevent ...http://www.crf.org/crf/news-and-events/news/news/1647-plaque-modification-with-scoring-balloon-improves-angiographic-outcomes-in-patients-treated-with-a-drug-coated-balloon-for-drug-eluting-stent-restenosis
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...https://clinicaltrials.gov/ct2/show/NCT01204320
Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials...
Results Five studies and a total of 801 patients were included in this analysis. Follow-up duration ranged from 12 to 60months. Most endpoints were significantly reduced for DEB compared with the control groups. For MACE, the relative risk RR was 0.46 (0.31 to 0.70), p,0.001, for TLR it was 0.34 (0.16 to 0.73); p=0.006, for angiographic in-segment restenosis it was 0.28 (0.14 to 0.58); p,0.001. There was a lower mortality for DEB (RR 0.48 (0.24 to 0.95); p=0.034). The incidence of MI was numerically lower, but the differences were not statistically significant (RR 0.68 (0.32 to 1.48); p=0.337). There was no difference in the risk of ST (RR 1.12 (0.23 to 5.50), p=0.891).. ...http://heart.bmj.com/content/early/2013/01/17/heartjnl-2012-302945.full
Editor's Corner | Should We Applaud the DIVA Trial... or Not? - American College of Cardiology
The argument went that the same would likely be true for reversed saphenous veins. Randomized trials in the past supported this notion. RRISC (2006) showed that angiographic restenosis occurred more frequently with BMS (33 percent vs. 14 percent with DES), but there were only 75 patients in the trial. Notably, there was no difference in major adverse cardiovascular events (MACE) at 32 months. The SOS trial (2009 with 80 patients) supported this finding with a 51 percent vs. 9 percent angiographic restenosis rate at 12 months with BMS and DES respectively. Target vessel failure also occurred more frequently with BMS at 35 months.. More recent trials, ISAR CABG and BASKET-SAVAGE (2011 and 2016 respectively) also found DES to be superior. These trials used composite endpoints of death or cardiac death, target lesion or target vessel revascularization and myocardial infarction as endpoints. That makes comparison of actual restenosis rates difficult. Nonetheless, ...http://www.acc.org/latest-in-cardiology/articles/2017/10/04/10/42/should-we-applaud-the-diva-trial-or-not
Intracoronary radiation for in-stent restenosis | Springer for Research & Development
At three-year follow-up target lesion revascularisation was significantly less in the 192Ir group (15.4% vs 48.3%; P ,0.01). The dichotomous restenosis rate at 3 years was also significantly less in 192Ir patients (33% vs 64%; P ,0.05). No events occurred at either the 6 months or 3 year follow-up to suggest an adverse effect of vascular radiotherapy. ...https://rd.springer.com/article/10.1186/cvm-2001-71900