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Bare Metal Stents (bare + metal_stent)
Selected AbstractsTwo-Year Clinical Registry Follow-up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010ERIC CHONG M.B.B.S., F.A.M.S., M.R.C.P. Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate-term efficacy and safety of EPC stent and compared that with sirolimus-eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single-center clinical registry. The study end-points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2-year follow-up, the EPC group showed favorable, single-digit TVR rate and stent thrombosis remained a low-event occurrence. (J Interven Cardiol 2010;23:101-108) [source] Long-Term Clinical Outcomes and Stent Thrombosis of Sirolimus-Eluting Versus Bare Metal Stents in Patients with End-Stage Renal Disease: Results of Korean Multicenter Angioplasty Team (KOMATE) RegistryJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2009BYEONG-KEUK KIM M.D., Ph.D. Background:There are still controversies about long-term clinical outcomes of sirolimus-eluting stents (SES) versus bare metal stents (BMS) implantation in patients with end-stage renal diseases (ESRD). Objective:To compare long-term outcomes in patients with (ESRD) following SES versus BMS implantation. Methods:Between March 2003 and July 2005, a total of 54 patients (80 lesions) with ESRD undergoing SES implantation [SES-ESRD] were enrolled and compared with 51 patients (54 lesions) with ESRD receiving BMS during the same periods [BMS-ESRD] in the Korean Multicenter Angioplasty Team Registry. The primary outcome was the composite of death, myocardial infarction (MI), or any stent thrombosis (ST) according to the Academic Research Consortium definition during a 3-year follow-up. Results:The cumulative 3-year rate of composite of death, MI, or ST of the SES-ESRD group (24%) was nearly similar with that of the BMS-ESRD group (24%, P = 1.000). The 3-year rates of death (26% vs. 24%, P = 0.824) or MACE (37% vs. 43%, P = 0.331) in the SES-ESRD did not differ significantly from those in the BMS-ESRD. However, the SES-ESRD showed a sustained lower 3-year TVR rate (9%), compared with BMS-ESRD (24%, P = 0.042). The rate of any ST in SES-ESRD was not significantly higher than that in the BMS-ESRD (17% vs. 14%, P = 0.788). There was no significant difference in the rate of late or very late ST between SES-ESRD (15%) versus BMS-ESRD group (10%, P = 0.557). Conclusions:SES did not increase the risks for death, MI, or any ST in patients with ESRD during the long-term follow-up, compared with BMS. [source] Drug-Eluting Stents Versus Bare Metal Stents Following Rotational Atherectomy for Heavily Calcified Coronary Lesions: Late Angiographic and Clinical Follow-Up ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2007AHMED A. KHATTAB M.D. Objectives: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. Background: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. Methods: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. Results: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 ± 0.7 mm in the DES group and 1.11 ± 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). Conclusion: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years. [source] Two-Year Clinical Registry Follow-up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010ERIC CHONG M.B.B.S., F.A.M.S., M.R.C.P. Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate-term efficacy and safety of EPC stent and compared that with sirolimus-eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single-center clinical registry. The study end-points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2-year follow-up, the EPC group showed favorable, single-digit TVR rate and stent thrombosis remained a low-event occurrence. (J Interven Cardiol 2010;23:101-108) [source] The Short-Term Effect on Restenosis and Thrombosis of a Cobalt-Chromium Stent Eluting Two Drugs in a Porcine Coronary Artery ModelJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2009YINGYING HUANG Ph.D. The aim of this article was to study the effect of dual drug-eluting stent (DES) on both restenosis and thrombosis in a porcine coronary artery model. This study reports on the use of two drugs coated on the stent to simultaneously minimize both restenosis and thrombosis. The DES was prepared by spray coating a bare metal stent with a biodegradable polymer loaded with sirolimus and triflusal, to treat against restenosis and thrombosis, respectively. The two-layered dual drug-coated stent was characterized in vitro for surface properties before and after expansion, as well as for possible delamination by cross-sectioning the stent in vitro. In vivo animal studies (in a pig model) were then performed for acute thrombosis, inflammation, and restenosis. The results show a significant reduction in restenosis with a stent coated with both drugs compared with the controls (a bare metal stent, a sirolimus-coated, and a pure polymer-coated stent). The reduction in restenosis with a sirolimus/triflusal-eluting stent is associated with an inhibition of inflammation and thrombus formation, suggesting that such dual DES have a role to play for the treatment of coronary artery diseases. [source] Mechanisms of Late Stent Malapposition After Primary Stenting in ST-Elevation Myocardial Infarction: A Subanalysis of the Selection TrialJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2009TANIA CHECHI M.D. Background: One of the major predictors of late stent malapposition (LSM) is primary stenting in acute myocardial infarction. However, mechanisms of LSM are still under debate. Methods: Patients with ST-elevation myocardial infarction (STEMI) and enrolled in the SELECTION trial (38 patients in the paclitaxel-eluting stent, PES, and 35 in the bare metal stent, BMS, cohort) were retrospectively analyzed to evaluate LSM, by means of intravascular ultrasound (IVUS) data recorded at the index and 7-month follow-up procedures. Results: Stent malapposition was documented in 21 lesions in 21 patients (28.8%): in 8 of these 21 patients (38.1%) it was LSM. Although statistical significance was not reached, LSM was more frequent after PES than BMS implantation (15.8% vs. 5.7%). LSM was mainly located within the body of the stent (62.5% of the cases). At the LSM segment, a significant increase of vessel area (19.2 ± 3.3 mm2 vs. 21.9 ± 5.3 mm2, P = 0.04) and a reduction of plaque area (12.6 ± 4.6 mm2 vs. 9.1 ± 3.9 mm2, P = 0.04) were observed at IVUS between the index and follow-up procedure. Conclusions: After primary stenting for STEMI, LSM seems to be more frequent after PES rather than BMS implantation. In the STEMI setting, possible mechanisms leading to LSM include positive remodeling and plaque mass decrease. [source] Comparison of the Systemic Levels of Inflammatory Markers after Percutaneous Coronary Intervention with Bare Metal versus Sirolimus-Eluting StentsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2009ABDALLAH G. REBEIZ M.D., F.A.C.C. Background: Percutaneous coronary intervention (PCI) with bare metal stent (BMS) deployment causes plaque disruption and a rise in systemic levels of C-reactive protein (CRP), interleukin (IL)-6, and monocyte chemoattractant protein (MCP)-1. Our aim is to study whether PCI with sirolimus-eluting stent (SES) use attenuates this response. Methods: Patients with stable angina undergoing single-vessel PCI were enrolled in a randomized, open-label fashion into a BMS group or an SES group. Blood samples were drawn pre-PCI, 24 hours post-PCI, and 30 days post-PCI. Systemic concentrations of CRP, IL-6, and MCP-1 were measured at all time points. Results: In total, 41 patients were enrolled (21 in the BMS group and 20 in the SES group). The baseline plasma concentrations of all markers were comparable between groups. At 24 hours, the mean plasma CRP concentration in the SES group was 20.21 mg/dL versus 8.95 mg/dL in the BMS group (P = 0.15). The mean plasma IL-6 concentration at 24 hours was 25.41 pg/mL in the SES group versus 17.44 pg/mL in the BMS group (P = 0.17). The mean plasma MCP-1 concentration at 24 hours was 382.38 pg/mL in the SES group versus 329.04 pg/mL in the BMS group (P = 0.2). At 30 days, plasma concentrations of all three markers decreased to similar values between groups. Conclusions: The use of SES did not inhibit the rise in systemic concentrations of CRP, IL-6, and MCP-1 at 24 hours or 30 days post-PCI, compared with BMS. Moreover, at 24 hours, there was a trend for higher systemic levels of all proinflammatory markers in the SES group compared with the BMS cohort. [source] Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2010Neeraj Badhey MD Abstract Background: We sought to evaluate the contemporary use of embolic protection devices (EPDs) in saphenous vein graft (SVG) interventions. Methods: We examined EPD use in the stenting of saphenous vein grafts (SOS) trial, in which 80 patients with 112 lesions in 88 SVGs were randomized to a bare metal stent (39 patients, 43 grafts, and 55 lesions) or paclitaxel-eluting stent (41 patients, 45 grafts, and 57 lesions). Results: An EPD was used in 60 of 112 lesions (54%). A Filterwire (Boston Scientific) was used in 70% of EPD-treated lesions, Spider (ev3, Plymouth, Minnesota) in 12%, Proxis (St. Jude, Minneapolis, Minnesota) in 12%, and Guardwire (Medtronic, Santa Rosa, California) in 7%. Of the remaining 52 lesions, an EPD was not utilized in 13 lesions (25%) because the lesion was near the distal anastomosis, in 14 lesions (27%) because of an ostial location, in one lesion (2%) because of small SVG size, in two in-stent restenosis lesions (4%) because of low distal embolization risk, and in 22 lesions (42%) because of operator's preference even though use of an EPD was feasible. Procedural success was achieved in 77 patients (96%); in one patient a Filterwire was entrapped requiring emergency coronary bypass graft surgery and two patients had acute stent thrombosis. Conclusion: In spite of their proven efficacy, EPDs were utilized in approximately half of SVG interventions in the SOS trial. Availability of a proximal protection device could allow protection of ,25% of unprotected lesions, yet operator discretion appears to be the major determinant of EPD use. © 2010 Wiley-Liss, Inc. [source] Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-Year results of the PAINT trial,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2009Pedro A. Lemos MD Abstract Objectives: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54,0.44 mm, 0.32,0.43 mm, vs. 0.90,0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley-Liss, Inc. [source] Recalcitrant in-stent restenosis of the celiac trunk treated by drug-eluting stentCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008Gabriella Visconti MD Abstract Stent implantation is an alternative, safe, and reliable strategy for the treatment of chronic mesenteric ischemia, especially for patients at high surgical risk. However, in-stent restenosis (the Achille's hill of bare metal stent) may occur in up to 20% of cases at 6 months and 53% at 1 year. We describe a case of celiac trunk stenosis treated by bare metal stent complicated by recalcitrant in-stent restenosis and treated by paclitaxel-eluting stent implantation. © 2008 Wiley-Liss, Inc. [source] Late or very late stent thrombosis can also occur with bare metal stentsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007Andres Rosas Ramos MD Abstract The issue of late stent thrombosis (LAST) has become a subject of highly polemical debate over the past few months. Yet, both acute and LAST has always been a potential complication. The objective of this manuscript is to remind the readers, by means of two case reports, that thrombosis of bare metal stents may occur even very late after stent implantation. In the first case, stent thrombosis occurred after five years. In the second case, it occurred three years after the stenting procedure in a bare metal stent implanted in the circumflex artery of a patient who had also received two drug-eluting stents in the left anterior descending coronary artery. © 2007 Wiley-Liss, Inc. [source] Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunctionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2006FACC, Giuseppe Gioia MD Abstract OBJECTIVE: We examined the efficacy of drug-eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction and compared the outcome with a similar group of patients undergoing bare metal stent (BMS) implantation. BACKGROUND: Patients with severe LV dysfunction are a high risk group. DES may improve the long term outcomes compared with BMS. METHODS: One hundred and ninety one patients (23% women) with severe LV dysfunction (LV ejection fraction ,35%) underwent coronary stent implantation between May 2002 and May 2005 and were available for follow-up. One hundred and twenty eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 63 patients had BMS. Patients with acute S-T elevation myocardial infarction (STEMI) were excluded. The primary endpoint was cardiovascular mortality. A composite endpoint of major adverse cardiac events (MACE) including cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization (TVR) was the secondary endpoint. RESULTS: Mean follow-up was 420 ± 271 days. No differences were noted in age (69 ± 10 years vs. 70 ± 10 years, P = NS), number of vessel disease (2.3 ± 0.7 vs. 2.2 ± 0.8, P = NS), history of congestive heart failure (47% vs. 46%, P = NS), MI (60% vs. 61%, P = NS), or number of treated vessels (1.3 ± 0.5 vs. 1.3 ± 0.6, P = NS) for the DES and BMS group, respectively. Diabetes was more common among DES patients (45% vs. 25%, P = 0.01). The left ventricular ejection fraction (LVEF) was similar between the two groups (28% ± 6% vs. 26% ± 8%, P = NS for the DES and BMS, respectively). During the follow-up, there were a total of 25 deaths of which two were cancer related (2 in DES group). There were 23 cardiac deaths, 8/126 (6%) which occurred in the DES group and 15/63 (24%) in the BMS group (P = 0.05 by log-rank test). MACE rate was 10% for the DES group and 41% for the BMS group (P = 0.003). NYHA class improved in both groups (from 2.5 ± 0.8 to 1.7 ± 0.8 in DES and from 2 ± 0.8 to 1.4 ± 0.7 in the BMS, P = NS). CONCLUSION: Compared with bare-metal stents, DES implantation reduces mortality and MACE in high risk patients with severe left ventricular dysfunction. © 2006 Wiley-Liss, Inc. [source] Meta-analysis comparing clinical effectiveness of drug-eluting stents, bare metal stents and coronary artery bypass surgeryINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Eun-Hwan Oh PhD MPH MHA BA Abstract Objective, To compare clinical outcomes among patients receiving drug-eluting stents, bare metal stents, or coronary artery bypass grafting surgery (CABG) to treat coronary artery disease. Data sources, Randomised controlled trials were systematically selected from electronic database for head-to-head comparisons. The results from these head-to-head comparisons were used for an adjusted indirect comparison. Methods, Published randomised controlled trials were reviewed for outcome data in patients treated for coronary artery disease with drug-eluting stents, bare metal stents, or CABG. Head-to-head comparisons were conducted for drug-eluting stents versus bare metal stents and for CABG versus bare metal stents. Adjusted indirect comparison was used to compare drug-eluting stents and CABG. Mid-term clinical outcomes (range: 6,12 months) were investigated and included rates of mortality, myocardial infarction, thrombosis, target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Results, Systematic literature search identified 23 randomised controlled trials (15 for drug-eluting stents vs. bare metal stents, 8 for CABG vs. bare metal stents). Head-to-head comparisons for both single and multiple vessel disease demonstrated that compared with bare metal stents, drug-eluting stents had better outcomes for target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Except target lesion revascularisation, data were similarly favourable for CABG when compared with bare metal stents. Adjusted indirect comparison between drug-eluting stents and CABG in single vessel disease failed to detect significant differences in any of the measured outcomes. Multiple vessel disease data analysis demonstrated that target vessel revascularisation (odds ratio 3.41 [95% CI 2.29,5.08]) and major adverse cardiac events (1.89 [1.28,2.79]) were superior to drug-eluting stents in patients undergoing CABG. Conclusions, Drug-eluting stents and CABG were superior to bare metal stents in terms of target lesion revascularisation (drug-eluting stents only), target vessel revascularisation, restenosis and major adverse cardiac events. There was no difference in clinical outcomes when comparing CABG and drug-eluting stents in patients with single vessel disease, and CABG may be superior to drug-eluting stents for target vessel revascularisation and major adverse cardiac events in patients with multiple vessel disease. However, results may vary between subpopulations with different clinical or socioeconomic differences. [source] Efficacy and Safety of Drug-Eluting Stents: Current Best Available EvidenceJOURNAL OF CARDIAC SURGERY, Issue 6 2006Shahzad G. Raja M.R.C.S. Drug-eluting coronary stents deliver effective local concentrations of antiproliferative drugs (thus avoiding systemic toxicities), without substantially modifying the technique of percutaneous coronary intervention. Studies involving several different stent platforms and antiproliferative drug coatings have recently demonstrated dramatic reductions in restenosis rates, compared to conventional bare metal stents. Although the clinical benefits of drug-eluting stents are increasingly evident, important concerns about their long-term safety and costs have been raised. Furthermore, drug-eluting stents are being claimed to replace coronary artery bypass surgery in the near future. This review article evaluates the current best available evidence on the efficacy and safety of drug-eluting stents with a focus on the impact of this "revolutionary" new technology on the practice of coronary artery bypass surgery. [source] Long-Term Clinical Outcomes and Stent Thrombosis of Sirolimus-Eluting Versus Bare Metal Stents in Patients with End-Stage Renal Disease: Results of Korean Multicenter Angioplasty Team (KOMATE) RegistryJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2009BYEONG-KEUK KIM M.D., Ph.D. Background:There are still controversies about long-term clinical outcomes of sirolimus-eluting stents (SES) versus bare metal stents (BMS) implantation in patients with end-stage renal diseases (ESRD). Objective:To compare long-term outcomes in patients with (ESRD) following SES versus BMS implantation. Methods:Between March 2003 and July 2005, a total of 54 patients (80 lesions) with ESRD undergoing SES implantation [SES-ESRD] were enrolled and compared with 51 patients (54 lesions) with ESRD receiving BMS during the same periods [BMS-ESRD] in the Korean Multicenter Angioplasty Team Registry. The primary outcome was the composite of death, myocardial infarction (MI), or any stent thrombosis (ST) according to the Academic Research Consortium definition during a 3-year follow-up. Results:The cumulative 3-year rate of composite of death, MI, or ST of the SES-ESRD group (24%) was nearly similar with that of the BMS-ESRD group (24%, P = 1.000). The 3-year rates of death (26% vs. 24%, P = 0.824) or MACE (37% vs. 43%, P = 0.331) in the SES-ESRD did not differ significantly from those in the BMS-ESRD. However, the SES-ESRD showed a sustained lower 3-year TVR rate (9%), compared with BMS-ESRD (24%, P = 0.042). The rate of any ST in SES-ESRD was not significantly higher than that in the BMS-ESRD (17% vs. 14%, P = 0.788). There was no significant difference in the rate of late or very late ST between SES-ESRD (15%) versus BMS-ESRD group (10%, P = 0.557). Conclusions:SES did not increase the risks for death, MI, or any ST in patients with ESRD during the long-term follow-up, compared with BMS. [source] Inflammatory Cytokine Imbalance after Coronary Angioplasty: Links with Coronary AtherosclerosisJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2007NATALE DANIELE BRUNETTI M.D., Ph.D. Aim:To investigate release of some inflammatory cytokines (Cys) after coronary angioplasty and its links with coronary atherosclerosis. Methods:Twenty-seven consecutive subjects with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) were enrolled in the study: serial blood samples were taken in order to evaluate plasma concentrations of Interleukin (IL)-2, IL-10, IL-18, TNF,, and IFN, just before PCI at 12 and 24 hours. Patients were then divided, considering balance between each inflammatory Cy and IL-10, an antiinflammatory Cy, into four groups, ranging from a prevalent antiinflammatory response (stable inflammatory Cy,increasing IL-10 values) to a marked inflammatory imbalance (increasing inflammatory Cy,stable IL-10 values). Results:All Cys showed significant increases in plasma concentrations if compared with baseline values. Release curves were not significantly different when comparing subjects with ST-elevation myocardial infarction (STEMI) versus unstable angina,non-STEMI (UA-NSTEMI), diabetics versus controls. Subjects with marked inflammatory response showed a higher incidence of stenosis on left anterior descending (LAD) coronary artery (IL-2 ,2 and IFN, P < 0.05); Cy release was higher in patients with multivessel coronary disease (IL-2 and IFN,, ANOVA P < 0.01). Correlations were also referable between Cys and myocardial enzyme release. Subjects treated with sirolimus-eluting stents (SES) showed significantly lower Cy periprocedure ratio if compared with those treated with bare metal stents. Conclusions:A significant Cy release is detectable after PCI: inflammatory response seems to correlate with both PCI due to plaque instabilization and coronary atherosclerosis. A blunted inflammatory response is detectable in subjects treated with SES. [source] The Costs and Quality-of-Life Outcomes of Drug-Eluting Coronary Stents: A Systematic ReviewJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2007M.S., PETER W. GROENEVELD M.D. Objectives: While the efficacy of drug-eluting coronary stents (DES) has been demonstrated by several clinical trials, the impact of DES on health-care costs and recipient quality of life (QOL) is controversial. We performed a systematic review of the published literature on DES costs and the QOL effects of restenosis and target vessel revascularization (TVR). Methods: Among 536 potential articles initially identified by a broad search, 12 publications ultimately met inclusion criteria. Data were independently abstracted, evaluated for quality and relevance, and summarized by two reviewers. Excessive heterogeneity among these studies prevented formal meta-analysis, thus a narrative synthesis of the literature was performed. Results: In four economic studies, DES recipients had $1,600,$3,200 higher up-front costs than recipients of bare metal stents, but the differences in total costs after 1 year were less pronounced ($200,$1,200), and estimates of the average cost of an avoided revascularization ranged widely ($1,800,$36,900). All eight QOL studies indicated that restenosis was associated with lower QOL, but only two studies quantified this in terms of quality-adjusted life years (QALYs), with estimates ranging from 0.06 to 0.08. An additional study estimated that the median willingness to pay to prevent restenosis was $2,400,$3,600. Conclusions: There is a lack of convergence in the literature on the cost of DES in avoiding TVR. There is more agreement that the average QALY benefit of an avoided revascularization is 0.04,0.08. This implies that use of DES in patients where the average cost per avoided revascularization exceeds $8,000 may be less likely to be cost-effective. [source] Clinical Use of Sirolimus-Eluting StentsCARDIOVASCULAR THERAPEUTICS, Issue 4 2007Ajay J. Kirtane ABSTRACT Drug-eluting stents, or intracoronary stents that combine the local delivery of antirestenotic pharmacologic therapies while maintaining the mechanical advantage of bare metal stents over balloon angioplasty alone, are a highly complex technology that have profoundly affected the practice of percutaneous coronary intervention over the last 5 years. These devices were designed specifically to treat the neointimal hyperplasia occurring after conventional bare metal stent placement, and have been remarkably successful in this regard. However, recent concerns have been raised regarding the long-term safety of these devices, particularly when used outside of the specific patient and lesion subsets studied in the pivotal randomized trials that led to device approval by regulatory bodies within the United States and abroad. This review aims to present a brief description of the sirolimus-eluting stent device platform and its mechanism of action, followed by an overview of current data regarding efficacy and safety regarding the clinical use of sirolimus-eluting stent technology. [source] Scanning electron microscopic analysis of different drug eluting stents after failed implantation: From nearly undamaged to major damaged polymers,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2010Marcus Wiemer MD Abstract Background: Implantation of drug eluting stents (DES) in tortuous and/or calcified vessels is much more demanding compared with implantation of bare metal stents (BMS) due to their larger diameters. It is unknown whether drug eluting stent coatings get damaged while crossing these lesions. Methods: In 42 patients (34 male, 68.1 ± 10 years) with 45 calcified lesions (15.9 mm ± 7.9 mm), DES could not be implanted, even after predilatation. Diabetes was present in 19 patients (45 %). Sixty-one stents were used; 19 Cypher selectÔ, 18 Taxus LibertéÔ, 10 CoStarÔ, 5 Endeavor RXÔ, 4 Xience VÔ. 3 Janus CarbostentÔ, 1 Yukon Choice SÔ, and 1 AxxionÔ DES. The entire accessible surface area of these stents, in either the unexpanded and expanded state, were examined with an environmental scanning electron microscope (XL30 ESEM, Philips) to evaluate polymer or surface damage. Results: The polymers of Taxus Liberte, Cypher Select, Xience V, CoStar, and Janus DES were only slightly damaged (less than 3% of surface area), whereas the Endeavor RX Stents showed up to 20% damaged surface area. In DES without a polymer (Yukon and Axxion), it could be shown that most of the stent surface (up to 40%) were without any layer of drug. Conclusion: Placement of drug eluting stents in tortuous vessels and/or calcified lesions could cause major surface damage by scratching and scraping of the polymer or drug by the arterial wall, even before implantation. There were remarkable differences among the stents examined, only minor damage with the Cypher, Taxus Costar, Janus, and Xience V, whereas the Endeavor, the Yukon, and the Janus DES showed large areas of surface injury. © 2009 Wiley-Liss, Inc. [source] Five-year clinical outcomes after coronary stenting of chronic total occlusion using sirolimus-eluting stents: Insights from the rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital,(Research) Registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2009Zhu Jun Shen MD Abstract Background: The use of drug eluting stents (DES) in patients with a successfully recanalized chronic total occlusion (CTO) has been associated with a significant decrease in the need for repeat revascularization, and a favorable short-term clinical outcome when compared with the use of bare metal stents (BMS). Our group, however, has previously reported similar rates of target lesion revascularisation (TLR) and major adverse cardiovascular events (MACE) at 3 years follow-up in patients with a successfully opened CTO who were treated with either a sirolimus eluting stent (SES) or a BMS. The objective of this report was to evaluate the outcomes of these patients at 5-years clinical follow-up. Methods and Results: A total of 140 (BMS 64, SES 76) patients with successfully opened CTOs were included. Seven patients died in the BMS group whilst nine patients died in the SES group (P = 0.90). Noncardiac death was the major component of all-cause mortality (11 noncardiac deaths vs. 5 cardiac). There were two and three myocardial infarctions (MI) in the BMS and SES group, respectively (P = 1.0). The composite of death and MI occurred in seven (10.9%) and eleven (14.5%) patients in the BMS and SES group, respectively (P = 0.53). Clinically driven TLR was performed in eight patients (12.5%) in the BMS group, and five (6.6%) in the SES group (P = 0.26). Non-TLR target vessel revascularization was performed in one patient in the BMS group, and four in the SES group (P = 0.37). The 5-year device-oriented cumulative MACE rate was 15.6% and 11.8% in the BMS and SES group, respectively (P = 0.56). Conclusion: In patients with a successfully treated CTO, clinical outcome after 5 years was similar between SES and BMS, however, clinically driven TLR was slightly higher in the BMS group. © 2009 Wiley-Liss, Inc. [source] Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008Bruce R. Brodie MD Abstract Objectives: This study compares outcomes with drug-eluting stents (DES) versus bare metal stents (BMS) in patients with ST-elevation myocardial infarction (STEMI). Background: DESs have been effective in elective percutaneous coronary intervention (PCI), but their safety and efficacy in patients with STEMI have not been well studied. Methods: The STENT Registry is a multicenter United States registry evaluating outcomes of DES. Our study population includes patients with STEMI treated with either a DES or BMS who completed 9-month or 2-year follow-up. Outcomes were adjusted using propensity score analysis. Results: DES patients were younger, had less prior infarction and prior bypass surgery, but had smaller vessels and longer lesions. After adjusting for differences in baseline variables, there were no significant differences between DES and BMS in death, reinfarction, or major adverse cardiac events (MACE). DES had lower rates of stent thrombosis at 9 months (1.0% vs. 2.7%, HR 0.40 [0.17,0.95]) and lower rates of target vessel revascularization (TVR) at 9 months (4.0% vs. 7.5%, HR 0.55 [0.34,0.88]) and 2 years (8.0% vs. 11.3%, HR 0.57 [0.35,0.92]). There was a nonsignificant increase in stent thrombosis with DES versus BMS from 1 to 2 years (1.1% vs. 0.3%, P = 0.28). Conclusions: Our data suggest that DES used with primary PCI for STEMI are more effective than BMS in reducing TVR and are safe for up to 2 years. Whether DES are safe beyond 2 years and whether the reduction in TVR is enough to justify their use in STEMI will have to wait for the results of large randomized trials. 2008 Wiley-Liss, Inc. [source] A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: The DECODE study,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008Charles Chan MD Abstract Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions. Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few. Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months. Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006). Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS. © 2008 Wiley-Liss, Inc. [source] Late outcomes of drug-eluting versus bare metal stents in saphenous vein grafts: Propensity score analysisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2008Robert J. Applegate MD Abstract Objective: To compare late outcomes with the routine use of drug-eluting stents (DES) compared with bare-metal stents (BMS) during percutaneous intervention (PCI) of saphenous vein grafts (SVGs). Background: Safety concerns >1 year from stent implantation have been raised about DES used for PCI of SVGs in a small randomized clinical trial. However, there are few studies comparing late outcomes of DES and BMS in routine clinical practice. Methods: Clinical outcomes (nonfatal MI, cardiac mortality) were assessed in 74 consecutive patients who received BMS and 74 consecutive propensity score matched patients that received DES for PCI of SVGs. Clinical follow-up was censored at 2 years ± 30 days for both stent groups. Results: At 2 years, the hazard ratio for DES compared with BMS for PCI of SVGs for target vessel revascularization was 0.54 (0.21,1.36), nonfatal MI or cardiac death was 0.68 (0.27,1.68), cardiac mortality 1.19 (0.32,4.45), and stent thrombosis 0.49 (0.09,2.66). Similar outcomes were observed stratified by propensity score quintile. Conclusions: The routine clinical use of DES for PCI of SVGs was associated with a safety profile that was similar to that of bare metal stents with a clear trend toward a less frequent need for reinterventions. © 2008 Wiley-Liss, Inc. [source] The effect of drug eluting stents on cardiovascular events in patients with intermediate lesions and borderline fractional flow reserve,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2007Shahar Lavi MD Abstract Objective: To assess the role of fractional flow reserve (FFR) in guiding therapy in the drug eluting stent (DES) era. Background: FFR is a useful index for evaluation of the physiological significance of angiographically indeterminate coronary artery lesions. However, its role in the DES era is unknown. Methods: Long term outcome of 281 patients with angiographically indeterminate coronary lesions and borderline FFR (0.75 , FFR < 0.9) was obtained. The outcome of patients who had a DES placed (n = 58), was compared with that of consecutive patients with borderline FFR that were treated by PCI with bare metal stents (BMS, n = 58), or were deferred from revascularization (n = 165). Results: FFR was significantly higher in the deferred group (median and IQR); 0.85 (0.82 to 0.88) compared with the BMS (0.78; 0.76 to 0.82) and the DES (0.79; 0.77 to 0.82), P < 0.001. Pretreatment FFR was a significant determinant of long term event rates in the deferred patients (P = 0.002) but had no effect in patients treated by PCI. In the deferred group, there were fewer events (death, myocardial infarction, target vessel revascularization) compared with the BMS group; but no significant difference was observed between the DES and the deferred groups. Conclusions: In borderline FFR, long term outcome after PCI with BMS is inferior to conservative therapy or PCI with DES. While conservative management is preferable in these patients, PCI with DES may be considered in specific circumstances. © 2007 Wiley-Liss, Inc. [source] Late or very late stent thrombosis can also occur with bare metal stentsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007Andres Rosas Ramos MD Abstract The issue of late stent thrombosis (LAST) has become a subject of highly polemical debate over the past few months. Yet, both acute and LAST has always been a potential complication. The objective of this manuscript is to remind the readers, by means of two case reports, that thrombosis of bare metal stents may occur even very late after stent implantation. In the first case, stent thrombosis occurred after five years. In the second case, it occurred three years after the stenting procedure in a bare metal stent implanted in the circumflex artery of a patient who had also received two drug-eluting stents in the left anterior descending coronary artery. © 2007 Wiley-Liss, Inc. [source] Comparison of drug-eluting stents with bare metal stents in unselected patients with acute myocardial infarctionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2007L. Iri Kupferwasser MD Abstract Objectives: The aim of this study was to compare the procedural characteristics and outcomes of patients with acute myocardial infarction treated with drug-eluting stents (DES) vs. bare metal stents (BMS). Background: DES have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with BMS in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction. Methods: Two hundred and sixty-one consecutive patients who presented with myocardial infarction between 7/2001 and 8/2005 were studied. The procedural characteristics, 30-day and 12-month outcomes of 131 patients treated with DES were compared with 130 patients treated with BMS. Results: At 12-months follow-up DES therapy was associated with a substantial decrease in major adverse cardiovascular events (MACE) (HR 0.33; P =0.002), TVR (HR 0.19; P =0.002), and recurrent myocardial infarction (HR 0.23; P =0.051) vs. BMS therapy. Coronary interventions utilizing DES were characterized by a marked increase in the number of stent per target vessel (DES: 1.9 ± 0.9 vs. BMS: 1.38 ± 0.6, P < 0.0001), treatment of bifurcation (DES: 21% vs. BMS: 5%, P =0.0004), and multivessel intervention (DES: 22% vs. BMS: 8%, P =0.003). Conclusion: The routine use of DES in acute myocardial infarction is associated with reduced rates of MACE at 12 months vs BMS, despite a higher rate of complex procedures in the DES treated patients. In addition to its anti-restenosis effect, the improved outcome of patients treated with DES may be linked to a more complete revascularization in association with prolonged clopidogrel therapy. © 2007 Wiley-Liss, Inc. [source] Impact of sirolimus-eluting stents on outcomes of patients treated for acute myocardial infarction by primary angioplastyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2005Edouard Cheneau MD Abstract Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization. © 2005 Wiley-Liss, Inc. [source] Real-world bare metal stenting: Identification of patients at low or very low risk of 9-month coronary revascularizationCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2004Stephen G. Ellis MD Abstract The high cost of drug-eluting stents (DESs) has made identification of patients who are at low risk for subsequent revascularization after treatment with bare metal stents (BMSs) highly desirable. Previous reports from randomized trials suffer from biases induced by restricted entry criteria and protocol-mandated angiographic follow-up. Between 1994 and 2001, 5,239 consecutive BMS patients, excluding those with coil stents, technical failure, brachytherapy, staged procedure, or stent thrombosis within 30 days, were prospectively identified from a large single-center tertiary-referral-center prospective registry for long-term follow-up. We sought to identify characteristics of patients with very low (, 4%) or low (4,10%) likelihood of coronary revascularization 9 months after BMS. Nine-month clinical follow-up was obtained in 98.2% of patients. Coronary revascularization was required in 13.4% and did not differ significantly by stent type. On the basis of multivariate analysis identifying 11 independent correlates and previous reports, 20 potential low-risk patient and lesion groups (228 ± 356 patients/groups) were identified (e.g, patients with all of the following: native vessel, de novo, reference diameter , 3.5 mm, lesion length < 5 mm, no diabetes, not ostial in location). Actual and model-based outcomes were analyzed. No group had both predicted and observed 9-month revascularization , 4% (very low risk). Conversely, 19 of 20 groups had a predicted and observed revascularization rate of 4,10% (low risk). In the real-world setting, the need for intermediate-term revascularization after BMS may be lower than expected, but it may be very difficult to identify patients at very low risk. Conversely, if the benefits of DESs are attenuated in routine practice, many groups of patients treated with BMSs may have nearly comparable results. Catheter Cardiovasc Interv 2004;63:135,140. © 2004 Wiley-Liss, Inc. [source] Drug-eluting stents versus bare metal stentsCLINICAL CARDIOLOGY, Issue 11 2003C. Richard Conti M.D., M.A.C.C. Editor-in-Chief No abstract is available for this article. [source] | ||||||||||