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Key Points: Question: Is treatment with a coronary paclitaxel-coated balloon superior to an uncoated balloon for 1-year target lesion failure in patients undergoing percutaneous coronary intervention for in-stent restenosis? Findings: In a multicenter randomized trial of 600 patients designed to support US regulatory approval, target lesion failure was significantly lower in the paclitaxel-coated balloon group (17.9%) compared with the uncoated balloon group (28.6%) (P =.003). Ischemia-driven target lesion revascularization and target vessel myocardial infarction were also lower after treatment with a paclitaxel-coated balloon. Meaning: Treatment with a paclitaxel-coated balloon offers an effective treatment strategy for the management of coronary in-stent restenosis. Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure—defined as the composite of ischemia-driven target lesion revascularization, target vessel–related myocardial infarction, or cardiac death—was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P =.003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P =.001) and target vessel–related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P =.02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P =.38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253 This clinical trial compares a paclitaxel-coated balloon vs an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

Background: There is a paucity of data on the burden of in-stent restenosis (ISR) in the United States as well as on its presentation and appropriate treatment strategies.Objectives: This study aims to provide an analysis of the temporal trends, clinical presentation, treatment strategies, and in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR in the United States.Methods: This study is a retrospective analysis of data collected in the Diagnostic Catheterization and Percutaneous Coronary Intervention (CathPCI) registry of the National Cardiovascular Data Registry (NCDR) between 2009 and 2017. Of the total patients undergoing PCI, we identified those undergoing PCI for ISR lesions. For comparison of in-hospital outcomes, propensity-score matching was employed.Results: Among the 5,100,394 patients undergoing PCI, 10.6% of patients underwent PCI for ISR lesions. Patients with bare-metal stent ISR declined from 2.6% in 2009 Q3 to 0.9% in 2017 Q2 (p < 0.001), and drug-eluting stent ISR rose from 5.4% in 2009 Q3 to 6.3% in 2017 Q2 (p < 0.001). Patients with ISR PCI were less likely to present with non-ST-segment elevation myocardial infarction (MI) (18.7% vs. 22.5%; p < 0.001) or ST-segment elevation MI (8.5% vs. 15.7%; p < 0.001). In the propensity-matched population of patients, there were no significant differences between patients with ISR and non-ISR PCI for in-hospital complications and hospital length of stay.Conclusions: ISR represents approximately 10% of all PCI and is treated most commonly with another stent. Approximately 25% of patients present with acute MI. In-hospital outcomes of patients with ISR PCI are comparable with those undergoing non-ISR PCI. [ABSTRACT FROM AUTHOR]

Background: BioFreedom is a polymer- and carrier-free drug-coated stent that delivers Biolimus A9 to the vessel wall. Our purpose was to evaluate the efficacy and safety of this DCS in patients with short-duration dual antiplatelet therapy.Methods: The BioFreedom US IDE feasibility trial was a single-arm, open-label, prospective study of patients requiring stenting of de novo lesions. Patients received 3 months of DAPT, repeat angiography at 9 months, and clinical follow-up at multiple intervals. A subgroup also underwent intravascular ultrasound (IVUS) interrogation. The primary safety end point was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, or stent thrombosis. The primary efficacy end point, in-stent late lumen loss at 9 months, was compared with a historical control from a first-generation paclitaxel-eluting stent.Results: A total of 72 patients from 10 sites received BioFreedom DCS implanted in 83 de novo lesions. At 9 months, the incidence of composite MACE was 8.4%, and TLR was 1.5%. Short DAPT was safe without occurrence of stent thrombosis. The primary end point of LLL was 0.32±0.53 mm. Paired IVUS analyses comparing postprocedural with 9-month measurements showed low in-stent neointimal volume obstruction (5.39±5.28%) and low neointimal hyperplasia (7.43±8.04 mm3).Conclusions: This study's angiography and IVUS assessments demonstrated that the BioFreedom DCS has anti-restenotic efficacy similar to first-generation DES. In the absence of concerning safety signals, this DCS should be considered effective and safe for patients who require a shorter duration of DAPT. [ABSTRACT FROM AUTHOR]

Background: Drug-eluting stents (DES) reduce restenosis but require prolonged antiplatelet therapy, when compared with bare metal stents. Ideally, the patient should be involved in this risk:benefit assessment prior to selecting DES, to maximize the benefits and cost-effectiveness of care, and to improve medication adherence. However, accurate estimation of restenosis risk may require angiographic factors identified at cardiac catheterization.Methods: In a large PCI registry, we used logistic regression to identify clinical and angiographic predictors of clinically-driven target lesion revascularization (TLR) over the first year after stent placement. Discrimination c-statistic and integrated discrimination improvement (IDI) were used to calculate the incremental utility of angiographic variables when added to clinical predictors.Results: Of 8501 PCI patients, TLR occurred in 4.5%. After adjusting for DES use, clinical TLR predictors were younger age, female sex, diabetes, prior PCI, and prior bypass surgery (model c-statistic 0.630). Angiographic predictors were vein graft PCI, in-stent restenosis lesion, longer stent length, and smaller stent diameter (c-statistic 0.650). After adding angiographic factors to the clinical model, c-statistic improved to 0.680 and the average separation in TLR risk among patients with and without TLR improved by 1% (IDI=0.010, 95% CI 0.009-0.014), primarily driven by those experiencing TLR (from 5.9% to 6.9% absolute risk).Conclusions: Among unselected PCI patients, the incidence of clinically-indicated TLR is <5% at 1-year, and standard clinical variables only moderately discriminate who will and will not experience TLR. Angiographic variables significantly improve TLR risk assessment, suggesting that stent selection may be best performed after coronary anatomy has been delineated.Short Summary (for Annotated Table Of Contents): Although several recent studies have challenged traditional expectations regarding the duration of dual antiplatelet therapy, current guidelines recommend at least 6 to 12months of treatment after implantation of a drug eluting stent, with a shorter course for bare metal stents. Stent selection ideally should involve input from the patient receiving these stents, but multiple studies have suggested that angiographic factors - obtained after the patient has received sedation during the diagnostic catheterization - are important predictors of repeat revascularization. In this analysis from a large registry of patients receiving coronary stents, angiographic characteristics were found to significantly improve risk assessment for target lesion revascularization, when added to clinical variables alone. [ABSTRACT FROM AUTHOR]

Background/purpose: Drug-eluting stents (DES) reduce in-stent restenosis and repeat revascularization in comparison to bare metal stents. Individual DES vary, however, in regard to rates of restenosis and stent thrombosis; they also differ in regard to their platform and physical characteristics. The Promus Premier was designed to improve the performance of the Promus Element, with respect to conformability, trackability, and avoidance of longitudinal stent deformation; there is little published data, however, on clinical outcomes with Promus Premier.Methods: We performed a registry study that compared 952 patients who underwent percutaneous coronary intervention with Promus Premier to 595 patients who received Taxus Liberte and 600 patients who received Xience V for a variety of indications. The primary endpoint was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction, and target vessel revascularization (TVR-MACE). Kaplan-Meier analysis and Cox proportional hazards regression were performed in order to compare the three stents in regard to outcomes at 1year.Results: Procedural success was highest with Premier (99.4%) when compared to Xience V (98.0%) and Taxus Liberte (97.3%; p<0.001). Unadjusted survival analysis showed that TVR-MACE was less frequent with Premier in comparison to Taxus Liberte (p=0.003), and similar frequency in comparison to Xience V (p=0.16). Following multivariable adjustment, and using Xience V as the reference, there was only a borderline association of Promus Premier and lower rates of TVR-MACE (HR 0.69, 95% CI 0.45-1.04; p=0.075).Conclusion: Promus Premier demonstrates excellent procedural success rates and real-world outcomes that are similar to Xience V. [ABSTRACT FROM AUTHOR]

We sought to examine the impact of previous failure on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We examined the clinical and angiographic characteristics and procedural outcomes of 1,213 consecutive patients who underwent 1,232 CTO PCIs from 2012 to 2015 at 12 US centers. Mean age was 65 ± 10 years, and 84.8% of patients were men. A previously failed attempt had been performed in 215 patients (17.5%). As compared with patients without previous CTO PCI failure, patients with previous failure had higher Multicenter CTO Registry in Japan CTO score (2.40 ± 1.13 vs 3.28 ± 1.29, p <0.0001) and were more likely to have in-stent restenosis (10.5% vs 28.4%, p <0.0001) and to undergo recanalization attempts using the retrograde approach (41% vs 50%, p = 0.011). Technical (90% vs 88%, p = 0.390) and procedural (89% vs 86%, p = 0.184) success were similar in the 2 study groups; however, median procedure time (125 vs 142 minutes, p = 0.026) and fluoroscopy time (45 vs 55 minutes, p = 0.015) were longer in the previous failure group. In conclusion, a previously failed CTO PCI attempt is associated with higher angiographic complexity, longer procedural duration, and fluoroscopy time, but not with the success and complication rates of subsequent CTO PCI attempts. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4 ± 13.1 cm. The primary effectiveness outcome was acute success (≤ 30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. Results: Treated length was 19.5 ± 12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Objective: To better characterize intrastent pathology using optical coherence tomography (OCT) in patients presenting with late and very late stent thrombosis (LST/VLST).Background: The contribution of specific intrastent pathologies to the development of LST/VLST is not well understood.Methods: In this single-center, retrospective, observational study of 796 consecutive patients treated for ST-segment elevation myocardial infarction (STEMI) with primary PCI we identified 57 patients (7.2%) in whom STEMI resulted from LST/VLST. Of the patients with LST/VLST, 21 patients (37%) had OCT performed at the discretion of the operator during PCI for LST/VLST. Independent reviewers performed qualitative offline analysis of OCT images to determine the cause of stent thrombosis defined as the specific intrastent pathology associated with thrombus deposition.Results: The principal intrastent pathology causing LST/VLST was determined to be stent malapposition in 11 patients (55%), of which 5 (25% of all LST/VLST patents) had findings suggestive of positive vessel remodeling. Neoatherosclerosis was determined to be the cause of LST/VLST in 7 patients (35%). LST/VLST resulted from uncovered stent struts in 2 patients (10%). Among all LST/VLST patients, in-hospital mortality (12.3%) and post-hospital target vessel failure (TVF) or cardiac death (21.7%, median follow-up 1.6 years) remained high. There was a trend towards decreased TVF or cardiac death (7.7% vs. 27.3% P = 0.24) in patients who underwent OCT-guided therapy.Conclusions: LST/VLST remains a significant cause of STEMI and is associated with considerable morbidity and mortality. OCT use at the time of PCI consistently identifies significant intrastent pathology with potentially meaningful clinical impact. [ABSTRACT FROM AUTHOR]

Abstract: Background: Drug eluting stents (DES) reduce the risk of restenosis but are associated with increase in the risk of very late stent thrombosis, especially when antiplatelet therapy is held. The trend in DES use across the US is not fully defined. Methods: Data from the 2001–2011 Nationwide Inpatient Sample for patients undergoing PCI were used. The trend in DES use was analyzed overall and in subgroups at risk of restenosis (those with diabetes, chronic kidney disease or prior PCI), stent thrombosis (those with acute coronary syndrome) or bleeding (those with history of bleeding peptic ulcer or atrial fibrillation). Results: Among the 8,150,763 PCI procedures performed, DES use peaked in 2005 at 89% in all patients including groups with a low risk of restenosis, high risk of stent thrombosis or bleeding. A steep drop to 66% was noted in 2007 followed by a progressive rise to 73% in 2011 (P<0.0001). The 2011 DES use patterns indicate increased DES use in subgroups at risk of restenosis, decreased use in subgroups at risk of thrombosis or bleeding but also lower use in groups at risk for discriminant care such as African Americans, the elderly and patients with Medicaid/self-pay. Conclusions: DES trends indicate rapid and broad initial use followed by a sharp decline in 2007 and a progressive rise in 2011. DES use in 2011 seemed based on risk category, but was lower in groups at risk for discriminant care. [Copyright &y& Elsevier]

The article discusses a study to assess variations in drug-eluting stents (DES) use among U.S. physicians participating in the National Cardiovascular Data Registry (NCDR), the association between predicted target vessel revascularization (TVR) risk with bare-metal stents (BMS) with DES use and the estimated clinical and economic consequences of lower DES use in patients with low TVR risk. It concludes that DES use is common even on those predicted to be at the lowest restenosis risk.

Objectives: This study sought to evaluate the long-term safety of the zotarolimus-eluting stent (ZES) using a pooled analysis of pivotal trials. Background: Drug-eluting stents, compared with bare-metal stents (BMS), have reduced restenosis; however, individual trials of these stents have not had sufficient power to ascertain long-term safety. Methods: We combined patient level data from 6 prospective randomized single-arm multicenter trials involving 2,132 patients treated with ZES and 596 patients treated with a BMS control. The median follow-up was 4.1 years, with 5-year follow-up completed in 1,256 patients (97% of those eligible). The recommended minimum duration of dual antiplatelet therapy in these studies was 3 to 6 months regardless of stent type. An independent events committee adjudicated all events. The 2 treatment groups were compared after adjustment for between trial variation and for individual patient clinical and angiographic characteristics by propensity score. Results: The cumulative incidence of adverse events at 5 years for ZES and BMS were: death: 5.9% versus 7.6% (adjusted hazard ratio: 0.81, p = 0.34), cardiac death: 2.4 versus 3.7% (0.83, p = 0.57), myocardial infarction: 3.4 versus 4.8% (0.77, p = 0.37), target lesion revascularization: 7.0% vs. 16.5% (0.42, p < 0.001), stent thrombosis (definite or probable): 0.8 versus 1.7% (0.50, p = 0.21). After adjustment for variation in study and patient characteristics, there were no significant differences in stent thrombosis or the clinical safety event rates at 5 years between ZES and BMS. Conclusions: Over 5 years, there was no increased risk of death, myocardial infarction, or stent thrombosis, and there was a benefit of prevention of repeat revascularization procedures in ZES compared with BMS. (The ENDEAVOR Pharmacokinetic [PK] Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System [ENDEAVOR PK]; NCT00314275) (The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions [ENDEAVOR II]; NCT00614848) (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256) (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions [ENDEAVOR IV]; NCT00217269) [Copyright &y& Elsevier]

Over the past decade, the advent of drug-eluting stents (DES) has revolutionised the field of interventional cardiology by having a major impact on patient care through their efficacy in reducing the need for repeat revascularisation. A number of stents capable of delivering an anti-proliferative agent designed to prevent neointimal hyperplasia, the principal mechanism of restenosis after stenting, have been evaluated; four of these devices are currently approved by the U.S. Food andDrug Administration (FDA). Bare metal stent (BMS) and first-generation DES, such as sirolimuseluting (SES-Cypher® ) and paclitaxel-eluting stents (PES-Taxus® ), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. However, there is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis (LST), especially after discontinuation of dual anti platelet therapy. Second-generation DES, such as zotarolimus-eluting (ZES-Endeavor®) and everolimus-eluting stents (EES-Xience v®), are become available in the USA and/or Europe. Recently, long-term resu lts comparing DES with BMS in patients with ST-segment-elevation Ml (STEMI) have raised some questions about the long-term risks of the drug-eluting devices. It may be useful to pause, reflect for a moment, and consider some recent pertinent results regarding their wider use. This systematic review tries to provide a concise and critical appraisal of the data available to compare first and second generation stents especially to assess risk of stent thrombosis (ST) with secondgeneration DES. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use. Background: DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations. Methods: The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics. Results: There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications. Conclusions: In contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS. [Copyright &y& Elsevier]

Background: First-generation drug-eluting stents (DES) still have significant rates of restenosis and stent thrombosis, especially in complex lesions. A second- generation stent eluting everolimus from a thin, non-adhesive, non-inflammatory durable polymer coated onto a low-profile, cobalt- chromium stent has been developed and evaluated in patients with coronary artery disease. Methods: Following the SPIRIT First proof-of-concept trial, the everolimus-eluting stent (EES) was compared to a widely used paclitaxel-eluting stent (PES) in patients with non-complex coronary artery disease in 2 successive randomized trials in Europe and Asia (SPIRIT II) and the United States (SPIRIT III). The databases from these trials were pooled for a patient-level meta-analysis. Results: Collectively, the SPIRIT II and SPIRIT III trials randomized 1,302 patients to either EES (n = 892) or PES (n = 410), with a total of 1,501 randomized lesions treated. EES compared to PES resulted in reduced mean in-segment late loss (0.11 ± 0.37 vs. 0.22 ± 0.44 mm, P = 0.0004) and binary angiographic restenosis (4.1% vs. 7.8%, P = 0.039) at 6–8 months. The 30-day rates of myocardial infarction (MI) were lower with EES than PES (1.0% vs. 2.9%, P = 0.02). At 1-year, EES compared to PES resulted in reduced rates of target lesion revascularization (TLR; 3.1% vs. 5.8%, P = 0.02), a trend toward less MI (2.3% vs. 4.0%, P = 0.08), and comparable rates of cardiac death (0.6% vs. 1.0%, P = 0.39) and stent thrombosis (0.7% vs. 0.8%, P = 0.90). As a result, patients treated with EES compared to PES had significantly reduced rates of major adverse cardiac events (cardiac death, MI, or TLR) at 1 year (5.2% vs. 10.0%, P = 0.002). Conclusions: The EES stent is a second-generation DES which results in improved clinical and angiographic outcomes compared to PES at 1 year. Longer-term follow-up from these trials and larger comparative trials are under way to evaluate the durability and utility of this device in more complex patients and lesions. [ABSTRACT FROM AUTHOR]

The article focuses on the effectiveness of sirolimus-eluting stents (SES) in decreasing the rate of restenosis and repeated revascularization procedures among patients with lesions in native coronary arteries in the U.S. The Reduction of Restenosis in Saphenous Vein Grafts with Cypher Stent (RRISC) trial was the first study to evaluate the use of SES in saphenous vein graft lesions. It showed that the rate of restenosis and repeated revascularization was decreased.

The article reflects on which drug-eluting stent (DES) is more preferred in the U.S. Since Food and Drug Administration approved the Cypher stent in 2003 and the Taxus stent in 2004, DES have captured the marketplace and are now used in most of the coronary interventional procedures. Direct stenting may possibly reduce the incidence of focal edge restenosis. But still, it appears that nobody can provide the answer as to which drug-eluting stent is preferred for treating restenosis.

Discusses the in-stent restenosis, thrombosis, cost-effectiveness, stent-related inflammation at the annual meeting of the American College of Cardiology in the U.S. Complication of in-stent restenosis following drug-eluting stents implantation; Determination of the frequency of in-stent restenosis following drug eluting stent; Efficacy of vascular brachytherapy for in-stent restenosis.

Approximately 12 million Americans have coronary artery disease, and almost one in five deaths in the United States can be attributed to this disease. In addition, 1.2 million Americans undergo cardiac catheterization and over one-half million receive a percutaneous coronary intervention such as balloon angioplasty, atherectomy, or stent implantation annually. This article will provide an overview of (1) atherosclerosis, the progressive disease which can lead to thrombotic events and/or the development of hemodynamically significant coronary artery lesions; (2) restenosis, the reappearance of significant lesions after coronary interventions such as stent placement; and (3) drug-eluting stents, the devices which, by using appropriate polymers to elute the appropriate drug with the appropriate pharmacokinetics, have almost completely eliminated restenosis. [ABSTRACT FROM AUTHOR]

Coronary artery disease is the largest killer of men and women in the United States and costs the health care system billions of dollars annually. Several advances in both mechanical and pharmacologic treatment of coronary artery disease have occurred in recent decades. Mechanically, percutaneous coronary intervention is commonly used to treat coronary atherosclerosis. This approach has dramatically reduced both morbidity and mortality for patients with different Levels of severity of coronary artery disease. However, percutaneous coronary intervention is limited by restenosis, which is an increase in growth of the intimal layer of the vessel wall. Despite the introduction of intracoronary sterns and the addition of systemic pharmacotherapy, restenosis still affects a significant number of patients. The new technology of drug-eluting stents combines mechanical and pharmacologic approaches to prevent restenosis. Various types of these stents exist in different stages of development; several have been shown to prevent or reduce intimal growth after stent deployment. An understanding of how this combined mechanical and pharmacologic approach reduces restenosis requires consideration of complex issues in pathophysiology and pharmacology. [ABSTRACT FROM AUTHOR]

Drug-eluting stents have altered the practice of interventional cardiology by dramatically reducing the risk of angiographic and clinical restenosis following percutaneous coronary intervention. Based on extensive preclinical study and clinical trial data, the polymer-based, slow rate-release paclitaxel-eluting TAXUS stent has recently received Food and Drug Administration approval for sale in the United States. In the current article, we review the available data from the TAXUS trials that have demonstrated that implantation of the slow rate-release TAXUS stent is safe and, in terms of restenosis, markedly superior to bare metal stenting for the treatment of de novo lesions<28 mm in length in arteries 2.5–3.75 mm in diameter. Additional trials in the TAXUS program are currently examining the role of slow and moderate rate-release polymer-based, paclitaxel-eluting stents in a broader range of clinical settings and lesion subsets.(J Interven Cardiol 2004;17:271–282) [ABSTRACT FROM AUTHOR]

The article focuses on the establishment of percutaneous coronary intervention (PCI) in the U.S. The PCI is performed each year in patients whose coronary arteries are constricted by plaque formation. The Food and Drug Administration approved another PCI technique, known as coronary stenting, in 1994. The development of drug-coated stent that can reduce the risk of restenosis was discussed.

Examines the use of patch angioplasty after carotid endarterectomy with primary closure in the United States. Reduction of postoperative recurrent stenosis and ipsilateral stroke; Conduction of carotid duplex ultrasound and magnetic resonance angiography; Application of operative technique and surveillance protocol.

Percutaneous coronary interventions (PCIs) play an increasingly important role in the management of patients with coronary artery disease. However, these important procedures are complicated by restenosis in a sizeable number of patients. The pathobiology of atherosclerosis comprises a complex interaction among lipids, the endothelium, circulating and tissue inflammatory cells, platelets, and vascular smooth muscle cells. The superimposition of the mechanical and cellular consequences of PCIs on the abnormal substrate of atherosclerosis leads to a characteristic and distinct pathobiology that initiates and perpetuates restenosis. A clear understanding of the significant differences between atherosclerosis and restenosis will provide a rational basis for developing treatment plans that always address both problems. This article reviews and contrasts the pathobiology of atherosclerosis and restenosis and compares the mechanisms and time-course of these distinct entities. [ABSTRACT FROM AUTHOR]

The article focuses on the new guidelines to be set for cardiologists to forbid drug-eluting stent (DES). As stated, stents are used to prevent restenosis and reformation of epithelial cells, however, it was found that the implantable devices are connected with increased danger of thrombosis at the stent area. A Food and Drugs Administration Academic Research Consortium will meet on December 7-8, 2006 to discuss new guidelines related to this issue.

The article focuses on the results of the surrogate end points overcast drug-eluting stents (DES) trials in the U.S. To predict clinical outcomes, most biologists used percentage diameter stenosis, minimal lumen diameter, restenosis rate, and late lumen loss, but it has been deliberated in several recent trials. The Food and Drug Administration treats angiographic measures cautiously as primary end points, especially in new DES products which assess two primary end points, one clinical and one angiographic.

Reports developments related to nursing in the U.S. as of June 2002. Introduction of double-blood donation procedure; Development of coronary artery stents coated with drugs to prevent restenosis; Association of maternal obesity to birth defects.

Amin and colleagues have attempted to estimate the cost savings to the US health-care system if drug-eluting coronary stents were more selectively used in patients at low risk of restenosis. Their results and conclusions raise statistical, societal, and ethical issues that need to be considered before this approach should be widely embraced. [ABSTRACT FROM AUTHOR]

The author reflects on the disadvantages of percutaneous coronary intervention (PCI) process in the U.S. He mentions the need for repeat procedures due to restenosis as one of the drawbacks of PCI as a method of revascularization. He claims that PCI leads to symptoms such as worsening angina, reduced quality of life and significant expense for evaluation. He explains the use of traditional cost-effective analysis or a cost-benefit analysis in determining value of eliminating restenosis.

Over the past 10 years, the number of percutaneous coronary intervention procedures performed in the United States increased by 33%; however, restenosis, which inhibits complete functional recovery of the vessel wall, complicates this procedure. A wide range of anti-restenotic therapeutics have been developed, although many elicit non-specific effects that compromise vessel healing. Drawing inspiration from biologically-relevant molecules, our lab developed a mimic of the natural proteoglycan decorin, termed DS-SILY, which can mask exposed collagen and thereby effectively decrease platelet activation, thus contributing to suppression of vascular intimal hyperplasia. Here, we characterize the effects of DS-SILY on both proliferative and quiescent human SMCs to evaluate the potential impact of DS-SILY-SMC interaction on restenosis, and further characterize in vivo platelet interactions. DS-SILY decreased proliferative SMC proliferation and pro-inflammatory cytokine secretion in vitro in a concentration dependent manner as compared to untreated controls. The addition of DS-SILY to in vitro SMC cultures decreased SMC migration and protein synthesis by 95% and 37%, respectively. Furthermore, DS-SILY decreased platelet activation, as well as reduced neointimal hyperplasia by 60%, in vivo using Ossabaw swine. These results indicate that DS-SILY demonstrates multiple biological activities that may all synergistically contribute to an improved treatment paradigm for balloon angioplasty. [ABSTRACT FROM AUTHOR]

Coronary artery stents revolutionized the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, there have been significant developments in their design, the most notable of which has been the introduction of drug-eluting stents. This paper reviews the benefits, risks, and current status of Food and Drug Administration-approved drug-eluting stents. [ABSTRACT FROM AUTHOR]

The article reports on the approval of Natick, Massachusetts-based Boston Scientific Corporation's TAXUS Express2 Atom Paclitaxel-Eluting Coronary Stent System for treating small coronary vessels. Boston Scientific received the U.S. Food and Drug Administration (FDA) approval for its TAXUS Express2 Paclitaxel-Eluting Coronary Stent System for the treatment of in-stent restenosis in bare metal stents.

The article presents a research on the benefits of drug-eluting stents (DES) by researchers in the U.S. They concluded that DES are effective at reducing restenosis and the need for repeat revascularization in all patients subgroups and lesion types, without an increase in late MI or excess mortality. However, there are few overall safety data from adequately controlled trials on the use of DES for off-label indications.

This article focuses on the outcome of a 2005 study on the benefits of the paclitaxel-eluting Taxus stent for women with blocked heart arteries in the U.S. The gradual release of paclitaxel is intended to slow tissue growth around the hollow stent that might re-block the artery, a process called restenosis. The trial involved 1,314 patients who underwent elective catheter procedures to open narrowed coronary arteries.

Presents medical news briefs. How stents are being widely used in medicine without much evaluation; Suggestions to prevent restenosis of a stent inserted during coronary angioplasty; Innovation known as the catheter thrombectomy which is used to prevent massive pulmonary embolism mortality; Thoughts on an advertisement for early and aggressive cancer screening from the American Cancer Society; Call for more women to get mammograms following the results of a study by researchers at Harvard; Exercise induced purpura which is thought to be an acute failure of the calf muscle pump; The use of telecounselling in Australia; Rise in the number of new cases of tuberculosis in Israel and possible causes for it; More.

Provides information on the Cypher stent intended to reduce the rate of in-stent restenosis in percutaneous coronary interventions. Mechanism of action of the sirolimus-eluting coronary stent; Warnings and contraindications; Dosage and administration.

Discusses the use of intracoronary beta and gamma radiotherapy for restenosis, which has been approved by the United States Food and Drug Administration (FDA). Delivery by the implantation of a radioactive stent and by radioactive seeds secreted from a catheter; Studies on this treatment, including two which appear in this issue; Questions related to safety, effectiveness, and delivery which need to be answered before this technique receives widespread acceptance.