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Eberhard Grube

Publications and source records attributed to Eberhard Grube.

At least 55 records · Page 3Linked to original sources
PubMed2004

Validation of a thermographic guidewire for endoluminal mapping of atherosclerotic disease: an in vitro study.

Temperature heterogeneity along the inner surface of an artery may be a surrogate marker of impending plaque rupture and has been associated with an increased likelihood of future coronary events. Initial studies using catheter-based thermographic devices have demonstrated that the changes in temperature are subtle, while the effects of coronary flow on measured temperature have not yet been examined. A novel guidewire-based system (ThermoCoil, Imetrx) designed to measure surface temperature in coronary arteries was used to study the effects of heat source intensity and flow on measured temperature. An in vitro model of a focal, eccentric, heat-generating lesion demonstrated that a guidewire-based system can detect changes in surface temperature with a precision of less than 0.08 degrees C. In this model, temperature measurements increased linearly with source temperature and decreased with increases in flow by an exponent of -0.33 (P < 0.001 for both). Flow rates and heat source properties can significantly influence the measurement and interpretation of thermographic data. The incorporation of 2D thermographic images may contribute further to the characterization of metabolically active plaques likely to cause acute coronary syndromes.

Artificial Intelligence↗
PubMed2004

Rapamycin analogs for stent-based local drug delivery. Everolimus- and tacrolimus-eluting stents.

The inhibitory action of the sirolimus-like agent everolimus on smooth muscle cell proliferation, evidenced in animal models, has triggered the interest in everolimus as stent coating for local inhibition of in-stent restenosis. For preclinical and clinical evaluation of safety and efficacy of an everolimus-eluting stent design, a new stent has recently been introduced by Biosensors International Inc, covered by a resorbable "composite" coating, that contains the immunosuppressive drug within a polyhydroxyacid biodegradable polymer matrix with roughly equal resorption rates. FUTURE I, the feasibility trial of this new stent concept, revealed a 30-day MACE (major adverse cardiac events) rate of 0% as well as a restenosis rate of 0% at 6-month follow-up in a total of 32 patients included. The more sensitive QCA (quantitative computerized analysis) and IVUS (intravascular ultrasound) parameters showed an 88% reduction of in-stent late loss and an 87% reduction of the neointimal volume. Adding a second feasibility trial including diabetics, the multicenter trial FUTURE II confirmed the initial beneficial findings of FUTURE I in a total of 64 patients in a 1 : 2 randomization to a bare metal control stent. Based on these results, the FUTURE program has now been expanded by Guidant with two large-scale multicenter studies, FUTURE III and IV, which evaluate this stent design in a larger patient population. Furthermore, FUTURE IV is addressed to demonstrate the non-inferiority of this stent concept in a head-to-head comparison to an approved drug-eluting stent (DES) concept. In contrast to everolimus, tacrolimus is a well-known potent antiproliferative agent, already used in various therapeutic areas. Preclinical studies on tacrolimus-eluting stents for treatment of native coronary artery lesions demonstrated safety and efficacy of this stent concept with significant reduction of neointimal proliferation within the implanted study stents. However, the clinical trial program of the first tacrolimus-eluting stent system in the treatment of native coronary lesions (PRESENT I, II) and saphenous vein graft lesions (EVIDENT) failed to prove the clinical benefit of the stent systems tested and demonstrated the impact of specific stent designs, especially the drug carrier characteristics, on the patient outcome. The progressive PRESET study, evaluating a directly coated tacrolimus-eluting stent, will provide important insights, that will clarify the potential of tacrolimus for prevention of neointimal proliferation in clinical practice without being affected by any additional artificial surface compounds.

Angioplasty, Balloon, Coronary↗
PubMed2004

ABT-578-eluting stents. The promising successor of sirolimus- and paclitaxel-eluting stent concepts?

ABT-578 is a new synthetic analog of rapamycin, designed to inhibit smooth muscle cell proliferation-a key contributor to restenosis-by blocking the function of the mTOR cell cycle regulatory protein. Given these pharmacodynamics, ABT-578 was considered beneficial for intracoronary delivery to arrest the process responsible for neointimal hyperplasia after angioplasty and stenting. Consequently, the ABT-578-eluting ENDEAVOR stent system has been created, representing a potential new alternative for treating patients with coronary heart disease. In order to evaluate safety, feasibility and efficacy of this stent design, the ENDEAVOR clinical program has been started, including three randomized clinical trials. ENDEAVOR I is the first-in-man trial including 100 patients with native de novo coronary lesions. The 4-month follow-up data, recently presented, demonstrated safety and feasibility of this new drug-eluting stent (DES) concept with a 4-month MACE (major adverse cardiac events) rate of 2.0%. In order to evaluate this stent system in a larger patient population as well as more complex lesion subsets, the multicenter study ENDEAVOR II has been started including a total of 1,200 patients. The enrollment of this study was completed in January 2004. The aim of the US multicenter study ENDEAVOR III is a head-to-head comparison of the ENDEAVOR ABT-578-eluting stent system with the already approved sirolimus-eluting Cypher stent in 369 patients. If the results of both pivotal studies ENDEAVOR II and III confirm the efficacy of the ENDEAVOR stent design observed so far, the ENDEAVOR stent will be established as a new and promising contender in the field of DES.

Administration, Topical↗
PubMed2004

Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation. A post hoc analysis of TAXUS II.

BACKGROUND AND METHOD: Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26). RESULTS: In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 +/- 0.36 vs. 0.33 +/- 0.30 mm) or intravascular ultrasound-(IVUS-)measured volume obstruction (7.95 +/- 9.84% vs. 5.61 +/- 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 +/- 0.30 vs. 0.80 +/- 0.62 mm) or IVUS-measured volume obstruction (5.61 +/- 7.91% vs. 22.50 +/- 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent. CONCLUSION: Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.

Angioplasty, Balloon, Coronary↗
PubMed2004

Treatment of in-stent restenosis using a paclitaxel-eluting stent: acute results and long-term follow-up of a matched-pair comparison with intracoronary beta-radiation therapy.

AIMS: Intracoronary radiation therapy (ICR) has significantly improved the long-term outcome after treatment of diffuse in-stent restenosis (ISR). The efficacy of drug eluting stents in this setting remains less well defined. This matched-pair analysis compared the procedural and long-term clinical and angiographic outcome after treatment of diffuse ISR using a paclitaxel-eluting stent (PES) with intracoronary beta-radiation therapy. METHODS AND RESULTS: Twenty-two patients receiving 25 PES (ACHIEVE, Cook, 3.1 microg paclitaxel per square millimeter, non-polymer based coating) for ISR underwent 6-month angiographic and 12-month clinical follow-up. From a database including 141 patients (174 lesions) undergoing intracoronary beta-radiation for ISR, 25 lesions (25 patients) were pair-matched with the former group for lesion length and vessel size. PES implantation and ICR were successful in all patients with a significantly lower postprocedural in-stent diameter stenosis in the PES group (8+/-12% vs. 18+/-8%, p < 0.01). Angiographic binary in-lesion restenosis at 6 month was 20% (5/25 lesions) in the PES group and 16% (4/25) in the ICR group (p = 1.0). PES implantation resulted in significantly higher in-stent MLD at FU (2.10+/-0.71 vs. 1.75+/-0.36, p = 0.03) and a higher in-stent net gain (PES: 1.19+/-0.69, ICR: 0.84+/-0.49, p = 0.04). Two patients in the PES group and 6 patients in the ICR group experienced a target lesion revascularisation at 12-month follow-up (p = 0.25). CONCLUSION: Implantation of a non-polymer based paclitaxel-elution stent and conventional ICR therapy for complex ISR lead to comparable acute and long-term clinical and angiographic follow-up results.

Coronary Angiography↗
PubMed2004

Initial and follow-up results of the European Seaquence coronary stent registry.

The primary objective of the present study was to assess the feasibility and the safety of the Seaquence 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 > or =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 Seaquence stent can be considered as a stent of reference in routine practice.

Adult↗
PubMed2004

Clinical experiences using everolimus-eluting stents in patients with coronary artery disease.

Despite the growing use of drug-eluting stents, restenosis remains to occur especially in high risk subgroups like patients with diffuse in-stent restenosis. This observation is supporting the search for new and potentially even more effective drug eluting stent systems. Everolimus has been used in conjunction with a new bioabsorbable polymer and gave promising results in initial clinical studies. In FUTURE I, a single-center, single-blinded randomized safety and feasibility study enrolling 15 patients with bare metal stents and 27 patients with everolimus-coated stents, 30-day MACE rate was 0% in both groups. In-stent late loss at six months was 0.83 mm in the control group and 0.10 mm in the everolimus group (p < 0.0001). In FUTURE II, a randomized multi-center study, a total of 64 patients were enrolled confirming safety and feasibility. After 6 months late loss was 0.85 mm in the control group and 0.12 mm in the everolimus group (p < 0.001).

Coronary Disease↗
PubMed2004

Paclitaxel-eluting stents: current clinical experience.

In the past few years, drug-eluting stents have emerged as one of the most promising technologies in the field of interventional cardiology. Loaded with antiproliferative and anti-inflammatory agents, these stents have the potential to reduce post-stent-implantation restenosis significantly. In particular, sirolimus- and paclitaxel-eluting stents (PES) have been shown to be remarkably effective and are now available commercially in many countries.However, several PES systems have been under clinical investigation and produced different outcomes because of differences in their stent platforms, their total drug load, and their drug delivery and release concepts. The multicenter studies ASPECT (Asian Paclitaxel-Eluting Stent Clinical Trial), ELUTES (European evaLUation of PacliTaxel-Eluting Stent), and DELIVER (the RX Achieve drug-eluting coronary stent system in the treatment of patients with de novo native coronary lesions) I and II have been conducted to evaluate a PES system with direct impregnation of the agent onto the stent surface without using any further coatings. ASPECT and ELUTES revealed a clear dose response with descending binary restenosis rates for ascending drug dosages. However, statistically significant reductions of neointimal proliferation were only observed in the high-dose groups. DELIVER I, a study including 1043 patients, demonstrated the safety of the directly paclitaxel-coated RX Achieve stent, but the late loss reduction did not translate into a sufficient reduction of the clinical endpoints. The TAXUS program has been conducted to explore safety and efficacy of the TAXUS polymer-based, PES system, which delivers polymer-controlled low-dose paclitaxel, in contrast to the stents with direct impregnation. TAXUS I, a randomized trial with 61 patients, revealed the first evidence of the potential of this concept with remarkable results in safety and reduction of in-stent restenosis. In a larger patient population, the following TAXUS II trial demonstrated the safety and superior performance of the TAXUS-slow and TAXUS-moderate release stents over uncoated control stents for the reduction of restenosis up to 12 months after implantation. TAXUS IV, the pivotal US multicenter study including 1314 patients, underlined the efficacy of this stent in a wide range of complex patient and lesion subsets, including small vessels, long lesions, and diabetes mellitus. The ongoing TAXUS V and VI trials are designed to show whether this benefit will be reproducible in even more complex lesion subsets. Beside these randomized studies, several 'real-world' registries have recently been started to evaluate the performance of the TAXUS stent in daily clinical practice. Programs like these are vital to sufficiently monitor patients who have received a drug-eluting stent, particularly because of the controversy regarding long-term effects.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Everolimus for stent-based intracoronary applications.

Everolimus, a novel proliferation signal inhibitor initially developed for the prevention of allograft rejection after organ transplantation, is a potent anti-proliferative and immunosuppressive agent. Compared to sirolimus, everolimus absorbs to local tissue more rapidly and possesses longer cellular residence time and activity. The stent-based intracoronary elution of everolimus was first investigated by BioSensors International using a bioabsorbable-PLA-polymer-coated S-Stent for drug delivery. Following preclinical animal studies that demonstrated excellent safety and efficacy of this device, the clinical FUTURE trial program was initiated. FUTURE I and II were designed to demonstrate safety and feasibility of the everolimus-eluting stent in a small patient population with focal de novo coronary lesions. At follow-up, an acceptable safety profile without evidence of stent thrombosis or late stent malapposition was observed. Moreover, these studies revealed a remarkable reduction of neointimal proliferation with everolimus-eluting stent implantation versus procedures utilizing bare-metal stents. Guidant Corporation licensed the exclusive rights to both the S-Stent and the bioabsorbable drug delivery platform. Guidant will conduct two pivotal trials (FUTURE III and IV) in order to demonstrate the efficacy of this stent design. FUTURE IV will make a non-inferiority comparison between everolimus and the already-approved drug eluting stent systems. Given the pooled results of FUTURE I and II, there is already some evidence suggesting that the everolimus-eluting stent is as potent a suppressor of reactive neointimal ingrowth as the sirolimus-eluting CYPHERTM stent. The everolimus-eluting coronary stent might shortly be established as a new and promising contender in the field of drug eluting stents for treatment of coronary heart disease.

Coronary Stenosis↗
PubMed2003

Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.

BACKGROUND: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA. CONCLUSIONS: Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.

Angioplasty↗
PubMed2003

A randomized trial of polytetrafluoroethylene-membrane-covered stents compared with conventional stents in aortocoronary saphenous vein grafts.

We compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft. The use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts. This prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography. Acute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93). This controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.

Aged↗
PubMed2003

Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.

BACKGROUND: Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. METHODS AND RESULTS: We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients. CONCLUSIONS: Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.

Coated Materials, Biocompatible↗
PubMed2003

Heparin-coated stent placement for the treatment of stenoses in small coronary arteries of symptomatic patients.

BACKGROUND: The role of stents, especially of heparin-coated stents for the treatment of stenoses in small coronary arteries, is still unclear. Therefore, we performed this prospective, randomized trial to evaluate the angiographic and clinical outcome after treatment of stenoses in small coronary arteries (2.0 to 2.6 mm) of symptomatic patients. METHODS AND RESULTS: We randomly assigned 588 patients to angioplasty (n=195), bare stenting (n=196), or heparin-coated stenting (n=197). The primary end point was minimal lumen diameter (MLD) at 6 months. With comparable baseline parameters, the two stent arms showed a larger postinterventional MLD, larger acute gain, and smaller residual percent diameter stenosis, although a residual stenosis of 12+/-16% was achieved in the angioplasty arm, including a 27% crossover rate to stenting. Eighty percent of patients had follow-up angiography, which documented a borderline significantly larger MLD and smaller percent diameter stenosis for the two stent groups (1.34+/-0.48 mm and 42+/-20% after angioplasty, 1.47+/-0.48 mm and 36+/-20% after bare stenting, and 1.45+/-0.54 mm and 38+/-23% after heparin-coated stenting; P=0.049 and P=0.038, respectively), but restenosis rates were not different (32%, 25%, and 30%). Thrombotic events occurred in 1.0% after angioplasty and 0.5% after bare or heparin-coated stenting. Survival without myocardial infarction or target vessel revascularization at 250 days was 84.6% (angioplasty), 88.3% (bare stenting), and 88.3% (heparin-coated stenting; log-rank P=0.39). CONCLUSION: Compared with angioplasty with provisional stenting, bare and heparin-coated stenting confer superior angiographic results and a nonsignificant 24% reduction in clinical events, with no difference between bare and heparin-coated stenting in the treatment of stenoses in small coronary arteries.

Angioplasty, Balloon, Coronary↗
PubMed2003

TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation.

BACKGROUND: The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR). METHODS AND RESULTS: The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length < or =30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization [TLR]). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent). CONCLUSIONS: Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.

Antineoplastic Agents, Phytogenic↗
PubMed2003

TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.

BACKGROUND: The TAXUS NIRx stent (Boston Scientific Corp) provides local delivery of paclitaxel via a slow-release polymer coating. The TAXUS I trial was the first in-human experience evaluating safety and feasibility of the TAXUS NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of coronary lesions. METHODS AND RESULTS METHODS AND RESULTS: The TAXUS I trial was a prospective, double-blind, three-center study randomizing 61 patients with de novo or restenotic lesions (< or =12 mm) to receive a TAXUS (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). Demographics, lesion characteristics, clinical outcomes were comparable between the groups. The 30-day major adverse cardiac event (MACE) rate was 0% in both groups (P=NS). No stent thromboses were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate was 3% (1 event) in the TAXUS group and 10% (4 events in 3 patients) in the control group (P=NS). Six-month angiographic restenosis rates were 0% for TAXUS versus 10% for control (P=NS) patients. There were significant improvements in minimal lumen diameter (2.60+/-0.49 versus 2.19+/-0.65 mm), diameter stenosis (13.56+/-11.77 versus 27.23+/-16.69), and late lumen loss (0.36+/-0.48 versus 0.71+/-0.48 mm) in the TAXUS group (all P<0.01). No evidence of edge restenosis was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal hyperplasia in the TAXUS (14.8 mm3) group compared with the control group (21.6 mm3) (P<0.05). CONCLUSIONS: In this feasibility trial, the TAXUS slow-release stent was well tolerated and showed promise for treatment of coronary lesions, with significant reductions in angiographic and intravascular ultrasound measures of restenosis.

Aged↗
PubMed2003

Initial multicenter experience with a novel distal protection filter during carotid artery stent implantation.

Atheroembolization resulting in transient or permanent neurologic impairment is the most common complication of catheter-based percutaneous carotid artery intervention. Protection of the distal cerebral vasculature during carotid stent implantation may enhance procedural safety. Carotid stent implantation with distal cerebral protection using the FilterWire EX was performed in 35 consecutive patients undergoing 36 procedures at six centers. The FilterWire was delivered and deployed successfully in all 36 cases, and embolic material was retrieved from 74% of procedures. The 30-day rate of major adverse events (death, major or minor stroke) was 0%. Transient ipsilateral periprocedural neurologic ischemia developed in two patients (5.7%), both resolving within 30 min. Distal cerebral protection with the FilterWire during carotid stenting is feasible and safe, results in capture and extraction of atheroembolic debris in the majority of patients while affording uninterrupted cerebral perfusion, and in this initial multicenter experience was associated with a high rate of procedural success without major complications.

Aged↗