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Target Vessel Revascularization (target + vessel_revascularization)
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] Real World, Long-Term Outcomes Comparison Between Paclitaxel-Eluting and Sirolimus-Eluting Stent PlatformsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010M.B.A., MANDEEP S. SIDHU M.D. We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio ,1.39 [95% CI 0.99,1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3,97.6] vs. 95.7% for PES [95% CI 94.1,96.9]) and two (95.0%[95% CI 93.0,96.4] for SES vs. 93.7% for PES [95% CI 91.6,95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7,97.3) and 95.3% for PES (95% CI 93.7,96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI. (J Interven Cardiol 2010;23:167-175) [source] Impact of Thienopyridine Administration Prior to Primary Stenting in Acute Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2009LEROY E. RABBANI M.D. The impact of thienopyridine administration prior to primary stenting in acute myocardial infarction (AMI) has not been well studied. We therefore examined the database from the prospective, multicenter, controlled CADILLAC trial in which 1,036 patients were randomized to bare metal stenting with or without abciximab to determine whether patients who received a thienopyridine prior to bare metal stenting in AMI had superior clinical outcomes. Per operator discretion, 659 patients (63.6%; Th+) received either a 500 mg ticlopidine loading dose (n = 623) or a 300 mg clopidogrel loading dose (n = 40), while 377 patients (36.4%; Th-) received no thienopyridine prior to stent implantation. Baseline and procedural characteristics of the two groups, including abciximab use (52.5% vs 52.8%, P = 0.93) were well matched. Th+ compared to Th- patients had lower rates of core lab assessed TIMI 0/1 flow postprocedure (0.8% vs 2.7%, P = 0.01). Th+ compared to Th- patients also had significantly reduced in-hospital and 30-day rates of ischemic target vessel revascularization (TVR) (1.1% vs 3.2%, P = 0.01 and 1.5% vs 3.8%, P = 0.02, respectively) and major adverse cardiovascular events (MACE) (2.7% vs 5.8%, P = 0.01 and 4.0% vs 6.9%, P = 0.03, respectively), results that remained significant after covariate adjustment. In conclusion, in this large prospective, controlled trial, patients receiving a thienopyridine prior to primary stenting in AMI were less likely to have TIMI 0/1 flow postprocedure and experienced reduced in-hospital and 30-day rates of ischemic TVR and MACE compared to those not administered a thienopyridine prior to stent implantation. [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] Initial and Follow-Up Results of the European SeaquenceÔ Coronary Stent RegistryJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2004MARTIAL HAMON M.D. The primary objective of the present study was to assess the feasibility and the safety of the SeaquenceÔ stent (CathNet-Science) deployment for the treatment of coronary artery disease and the event-free survival of patients treated with this coronary stent. The study was conducted as a multicenter, prospective, observational registry. Patients with stable or unstable angina pectoris who were candidates for percutaneous coronary intervention with elective stenting of one single de novo lesion in a native coronary artery ,3 mm in diameter were included in the study. Clinical follow-up was performed at 1 month and 9 months. Major adverse coronary events (MACE), that is, cardiac death, myocardial infarction, and target vessel revascularization (re-PTCA or CABG), were recorded over a period of 9 months. Using this stent, a 99% in-hospital success rate was achieved. A total of 17 patients presented MACE (8.7%) during the whole follow-up period and target lesion revascularization was needed for 14 (7.1%) patients. Using multivariate analysis only some clinical parameters (patients treated for unstable angina, with a history of CABG or of female gender) were found as independent predictors of MACE after coronary stenting. Procedural related factors, angiographic characteristics, or reference diameter were not found to influence clinical outcome. Because the study was performed in patients with a high proportion of complex lesions (relative high-risk nonselected population with nearly one third calcified lesions, many long and type B2 and C lesions) we can conclude that the coronary SeaquenceÔ stent can be considered as a stent of reference in routine practice. (J Interven Cardiol 2004;17:9,15) [source] Resource Utilization, Cost, and Health Status Impacts of Coronary Stent Versus "Optimal" Percutaneous Coronary Angioplasty: Results from the OPUS-I TrialJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2002NANCY NEIL Ph.D. In the OPUS-I trial, primary coronary stent implantation reduced 6-month composite incidence of death, myocardial infarction, cardiac surgery, or target vessel revascularization relative to a strategy of initial PTCA with provisional s tenting inpatients undergoing single vessel coronary angioplasty. The purpose of this research was to compare the economic and health status impacts of each treatment strategy. Resource utilization data were collected for the 479 patients randomized in OPUS-I. Itemized cost estimates were derived from primary hospital charge data gathered in previous multicenter trials evaluating coronary stents, and adjusted to approximate 1997 Medicare-based costs for a cardiac population. Health status at 6 months was assessed using the Seattle Angina Questionnaire (SAQ). Initial procedure related costs for patients treated with a primary stent strategy were higher than those treated with optimal PTCA/provisional stent ($5,389 vs $4,339, P<0.001). Costs of initial hospitalization were also higher for patients in the primary stent group ($9,234 vs $8,434, P<0.01) chiefly because of the cost differences in the index revascularization. Mean 6-month costs were similar in the two groups; however, there was a slight cost advantage associated with primary stenting. Bootstrap replication of 6-month cost data sustained the economic attractiveness of the primary stent strategy. There were no differences in SAQ scores between treatment groups. In patients undergoing single vessel coronary angioplasty, routine stent implantation improves important clinical outcomes at comparable, or even reduced cost, compared to a strategy of initial balloon angioplasty with provisional stenting. [source] Immediate and Long-Term Outcome of Recanalization of Chronic Total Coronary OcclusionsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2002FEDERICO PISCIONE M.D. Eighty-three consecutive patients with 85 coronary total occlusions undergoing coronary angioplasty were retrospectively studied. Patients were divided into two groups according to the occlusion age that was<30 days (subacute total occlusion [STO]: 25 patients; range 1,30 days) or>30 days (chronic total occlusion [CTO]: 58 patients; range 3,144 months). All procedures were carried out using a hydrophilic guidewire. Clinical success, consisting of crossing the lesion, balloon dilatation, stent deployment without complication, was 96% in STO and 81% in CTO. Multiple stepwise logistic regression analysis identified a family history of coronary artery disease (CAD), left anterior descending and right coronary artery occlusions as independent predictors of a successful procedure. No major events occurred during or immediately after the angioplasty. After a mean follow-up of 24 ± 2 months, no difference was found in survival or freedom from myocardial infarction or target vessel revascularization among the STO and CTO patients. Successful recanalization by using a hydrophilic guidewire was achieved in a high percentage of chronic total occlusions with a low incidence of complications and a satisfactory late clinical outcome. Family history of CAD and occlusion of left anterior descending or right coronary arteries are independent predictors of procedural success. [source] Stenting of Bifurcation Lesions: A Rational ApproachJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2001FSCAI, THIERRY LEFÈVRE M.D. The occurrence of stenosis in or next to coronary bifurcations is relatively frequent and generally underestimated. In our experience, such lesions account for 15%,18% of all percutaneous coronary intervention > (PCI). The main reasons for this are (1) the coronary arteries are like the branches of a tree with many ramifications and (2) because of axial plaque redistribution, especially after stent implantation, PCI of lesions located next to a coronary bifurcation almost inevitably cause plaque shifting in the side branches. PCI treatment of coronary bifurcation lesions remains challenging. Balloon dilatation treatment used to be associated with less than satisfactory immediate results, a high complication rate, and an unacceptable restenosis rate. The kissing balloon technique resulted in improved, though suboptimal, outcomes. Several approaches were then suggested, like rotative or directional atherectomy, but these techniques did not translate into significantly enhanced results. With the advent of second generation stents, in 1996, the authors decided to set up an observational study on coronary bifurcation stenting combined with a bench test of the various stents available. Over the last 5 years, techniques, strategies, and stent design have improved. As a result, the authors have been able to define a rational approach to coronary bifurcation stenting. This bench study analyzed the behavior of stents and allowed stents to be discarded that are not compatible with the treatment of coronary bifurcations. Most importantly, this study revealed that stent deformation due to the opening of a strut is a constant phenomenon that must be corrected by kissing balloon inflation. Moreover, it was observed that the opening of a stent strut into a side branch could permit the stenting, at least partly, of the side branch ostium. This resulted in the provocative concept of "stenting both branches with a single stent." Therefore, a simple approach is currently implemented in the majority of cases: stenting of the main branch with provisional stenting of the side branch, The technique consists of inserting a guidewire in each coronary branch. A stent is then positioned in the main branch with a wire being "jailed" in the side branch. The wires are then exchanged, starting with the main branch wire that is passed through the stent struts into the side branch. After opening the stent struts in the side branch, kissing balloon inflation is performed. A second stent is deployed in the side branch in the presence of suboptimal results only. Over the last 2 years, this technique has been associated with a 98% angiographic success rate in both branches. Two stents are used in 30%,35% of cases and final kissing balloon inflation is performed in > 95% of cases. The in-hospital major adverse cardiac events (MACE) rate is around 5% and 7-month target vessel revascularization (TVR) is 13%. Several stents specifically designed for coronary bifurcation lesions are currently being investigated. The objective is to simplify the approach for all users. In the near future, the use of drug-eluting stents should reduce the risk of restenosis. [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] 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] 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] High-frequency vibration for the recanalization of guidewire refractory chronic total coronary occlusions,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008Klaus Tiroch MD Abstract Background: Recanalization of coronary chronic total occlusions (CTOs) remains a clinical challenge, particularly when standard guidewire attempts fail. Objectives: We sought to determine the safety and efficacy of a novel method that used high-frequency (20 kHz) vibration to fragment occlusive fibrous tissue and facilitate guidewire crossing into the distal vessel. Methods: A total of 125 patients with CTO, who failed at attempts of conventional guidewire recanalization after more than 5 min of fluoroscopy time, were enrolled in the study. The primary efficacy endpoint was the advancement of the CROSSERÔ catheter through the occlusion and attainment of coronary guidewire positioning in the distal coronary lumen. The primary safety endpoint was the occurrence of death, myocardial infarction, clinical perforation, or target vessel revascularization within the first 30 days. Results: The average fluoroscopy time while delivering the CROSSER catheter was 12.4 min. CROSSER-assisted guidewire recanalization was achieved in 76 (60.8%) procedures and a final diameter stenosis <50% was obtained in 68 (54.4%) of cases. Major adverse events occurred in 11 (8.8%) patients, lower than the predefined objective performance criteria. Angina frequency and quality of life were improved in patients with successful guidewire recanalization. Conclusions: We conclude that high-frequency vibration using the CROSSER catheter is a safe and effective therapy for patients with CTO, which are refractory to standard guidewire recanalization. © 2008 Wiley-Liss, Inc. [source] Usage patterns and 2-year outcomes with the TAXUS express stent: Results of the US ARRIVE 1 registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2008FACC, John M. Lasala MD Abstract Background: It is unclear how well the long-term safety and effectiveness of drug-eluting stents observed in tightly defined randomized controlled trials (RCT) translates to expanded use in routine practice. Methods: The FDA-mandated TAXUS® Express2Ô ARRIVE 1 postmarket registry was designed to consecutively enroll patients receiving ,1 TAXUS stent in low-, medium-, and high-volume US sites (n = 50). All cardiac events plus an additional 20% sample of records were monitored and all endpoints were independently adjudicated. Results: Detailed follow-up data through 2 years were compiled for 2,487 patients (95%). Simple-use (on-label) ARRIVE 1 patients (35%) had outcomes similar to 4 pooled TAXUS RCTs for death (3.5% vs. 3.4%, respectively, P = 0.78), Q-wave myocardial infarction (QWMI, 0.7% vs. 0.9%, P = 0.72), and stent thrombosis (ST, 2.2% vs. 1.2%, P = 0.12), but lower target vessel revascularization (7.8% vs. 13.4%, P < 0.0001). Compared with simple-use, cases representing expanded use to treat broader patient/lesion characteristics showed higher 2-year rates for death (7.4% vs. 3.5%, respectively, P = 0.0003), target lesion revascularization (9.4% vs. 5.8%, P = 0.0031), and ST (3.4% vs. 2.2%, P = 0.061, concentrated early in the first year). Conclusions: By including methods usually found in RCT, ARRIVE 1 captured a broad spectrum of disease treated in standard practice with high levels of ascertainment of clinical outcomes. In the more complicated cases, expectedly higher adverse event rates were seen compared to that found in the simple-use cases or pivotal RCT. These results have now been included in the Directions for Use, to aid in physician and patient decision-making. © 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] Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 20081-Year results in the CABERNET trial Abstract Objective: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent® plus FilterWire EX®/EZÔ Emboli Protection System. Background: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). Methods: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography ,50% for symptomatic patients and ,60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31,365 days) ipsilateral stroke. Results: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. Conclusions: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls. © 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] The AST petal dedicated bifurcation stent: First-in-human experienceCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2007John Ormiston MBChB Abstract The aim of this first-in-human study was to evaluate the feasibility and safety of the novel AST petal side-access bifurcation stent. Outcomes following percutaneous coronary intervention for bifurcations remain inferior to those of nonbifurcated lesions. Even with drug-eluting stents, restenosis occurs especially at the side-branch (SB) ostium. The petal stent uniquely deploys strut elements into the SB, supporting the ostium and carina. The primary endpoint of this 13-patient prospective registry was in-hospital major adverse cardiac events (MACE). Secondary end points included acute minimum lumen diameter (MLD) at the SB ostium, lesion success, device success, procedural success, 30-day MACE, and 4-month SB ostial MLD. The study lesion was successfully treated in 13 patients with the study stent being successfully implanted in 12. Target lesions were left anterior descending coronary artery in nine subjects, left circumflex in three, and right coronary artery in one. In-hospital MACE were limited to two non-Q-wave myocardial infarctions. In-stent main branch MLD increased from a mean of 0.63 ± 0.45 mm to 2.61 ± 0.47 mm at the index procedure and for this initial bare metal version of the stent, 4-month mean MLD measured 1.02 ± 0.42mm and there was target vessel revascularization on two patients. The feasibility of safely deploying this first-generation petal stent was demonstrated in selected patients with challenging coronary bifurcation lesions. It is a promising platform for drug delivery, with unique scaffolding of the side-branch ostium. © 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] Outcome in the real-world of coronary high-risk intervention with drug-eluting stents (ORCHID),A single-center study comparing CypherÔ sirolimus-eluting with TaxusÔ paclitaxel-eluting stentsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2006S. Kumar MRCP Abstract Objective: We present real world experience from a single center registry comparing the 6-month outcome of percutaneous coronary intervention (PCI) in unselected high-risk individuals using either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES). Methods/Results: We compared clinical outcome at 6 months follow-up in two cohorts of 156 consecutive patients(total n = 312) who underwent SES (June 2002,Februrary 2003) and PES(march 2003,July 2003) implantation. The primary endpoint was a composite of major adverse cardiac events (MACE). Baseline clinical characteristics were well matched. The 6-month target vessel revascularization (TVR) rates were 1.9% (SES) and 2.6% (PES) and MACE rates were similar in the two groups (SES 4.5% vs. PES 3.2%, P = NS). In the PES group, intervention for multivessel disease, bifurcation lesions and in small vessels was more common, and for in-stent restenosis less common, reflecting the impact of drug eluting stents on indications for PCI. The incidence of sub-acute stent thrombosis, related to inadequate antiplatelet therapy in 3 of the 6 cases, was 0.95% with no difference between the two groups. Conclusion: This study confirms the safety and efficacy of SES and PES in unselected high risk patients undergoing PCI. Clinical outcomes of both stents are equivalent at 6 months with low rates of MACE and TVR. These data provide important complementary information to forthcoming randomized studies. © 2006 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] Single-digit target vessel revascularization in multivessel coronary interventions with sirolimus-eluting stents: Goodbye to coronary bypass graftingCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2004Antonio Colombo MD No abstract is available for this article. [source] Effect of stents in reducing restenosis in small coronary arteries: A meta-analysisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2004FSCAI, Paul T. Vaitkus MD Abstract The ability of stents to reduce restenosis was established in larger coronary arteries. Clinical trials of stenting in smaller vessels have yielded conflicting results due in part to their sample sizes. The aim of this meta-analysis was to increase the statistical power by pooling data from these clinical trials. Trials were identified from Medline search, review of recent cardiology meetings' abstracts, and manual review of bibliographies. Studies were included if they were prospective randomized controlled trials. Endpoints examined included a dichotomized definition of angiographic restenosis, target lesion revascularization (TLR), target vessel revascularization (TVR), or any repeat revascularization. Pooling of data was performed by calculating a Mantel-Haenszel odds ratio (OR). The analysis included 2,598 patients enrolled in eight clinical trials. Stenting significantly reduced restenosis (OR = 0.62; 95% CI = 0.61,0.63). Concordantly, stenting reduced TLR (OR = 0.49), TVR (OR = 0.90), and any revascularization (OR = 0.48). This meta-analysis supports the hypothesis that stenting reduces restenosis in small coronary arteries as well as in larger coronary arteries. The apparent discordant result of individual clinical trials was due in part to underpowering related to small sample sizes. Catheter Cardiovasc Interv 2004;62:425,429. © 2004 Wiley-Liss, Inc. [source] Sequential vs. kissing balloon angioplasty for stenting of bifurcation coronary lesionsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2002Martin Brueck Abstract Coronary angioplasty of bifurcation lesions remains a technical challenge and is believed to result in low procedural success associated with the risk of side-branch occlusion. Furthermore, long-term results are associated with a high rate of reintervention. The aim of the study was to evaluate the immediate and long-term clinical and angiographic results of sequential vs. simultaneous balloon angioplasty (kissing balloon technique) for stenting of bifurcation coronary lesions. Between December 1999 and January 2001, 59 patients underwent coronary angioplasty because of symptomatic bifurcation lesions type III (i.e., side branch originates from within the target lesion of the main vessel, and both main and side branch are angiographically narrowed more than 50%). Twenty-six patients were treated with simultaneous and 33 patients with sequential balloon angioplasty. Main-vessel stent placement was mandatory; side-branch stenting and platelet IIb/IIIa antagonists were allowed at the discretion of the operator. Kissing balloon technique offered no advantage in terms of procedural success or need for repeat target vessel revascularization due to restenosis at 6-month follow-up. Using sequential balloon angioplasty, permanent or transient side-branch compromise rate (TIMI flow < 3) was significantly higher than after kissing balloon technique (33% vs. 0%, respectively; P = 0.003). Major clinical events in-hospital or at 6-month follow-up, however, showed no significant differences. Kissing balloon angioplasty reduces the rate of transient side-branch occlusion compared to sequential PTCA but does not improve immediate or long-term outcome compared to sequential PTCA for stenting of bifurcation lesions. Cathet Cardiovasc Intervent 2002;55:461,466. © 2002 Wiley-Liss, Inc. [source] Outcome of patients with acute coronary syndromes and moderate coronary lesions undergoing deferral of revascularization based on fractional flow reserve assessmentCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2006Joshua J. Fischer MD Abstract Objectives: To determine the outcome of consecutive patients with and without acute coronary syndromes (ACS) in whom revascularization was deferred on the basis of fractional flow reserve (FFR). Background: FFR < 0.75 correlates with ischemia on noninvasive tests and deferral of treatment on the basis of FFR is associated with low event rates in selected populations. Whether these low event rates apply to patients undergoing assessment of moderate stenoses in association with an ACS is not known and is an important clinical question. Methods: Retrospective analysis and 12 month follow-up of consecutive, moderate (50,70%) de novo coronary lesions assessed with FFR. Results: Revascularization was deferred in 120 lesions (111 patients) with FFR , 0.75. ACS was present in 35 patients (40 lesions). The clinical, angiographic and coronary hemodynamic characteristics of patients with and without ACS were similar. Among the 35 patients with ACS, there were 3 deaths, 1 MI, and 6 target vessel revascularizations (TVRs) (15% of lesions). Among the 76 patients without ACS, there were 5 deaths, 1 MI, and 7 TVR's (9% of lesions). Conclusions: Deferral of revascularization based on FFR in patients with ACS and moderate coronary stenoses is associated with acceptable and low event rates at 1 year. © 2006 Wiley-Liss, Inc. [source] | ||||||||||