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Biomedical subjects

Lutz Buellesfeld

Publications and source records attributed to Lutz Buellesfeld.

16 recordsLinked to original sources
PubMed2006

Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study.

BACKGROUND: The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). METHODS AND RESULTS: Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital. CONCLUSIONS: Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

Aged↗
PubMed2006

Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: results of clinical and angiographic follow-up at six months in a single-center registry.

OBJECTIVE: To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. METHODS: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. RESULTS: Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. CONCLUSIONS: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.

Aged↗
PubMed2006

[Percutaneous aortic valve replacement].

Surgical aortic valve replacement has been the gold standard for treatment of symptomatic aortic valve disease. However, the success of this approach depends on various patient- and situation-specific risk predictors; thus, the perioperative mortality can reach up to 50%. Percutaneous valve replacement might offer a new less invasive alternative. Since 2002, a balloon-expandable valve prosthesis is under evaluation in symptomatic high-risk patients with aortic valve stenosis. After modifications of both the implantation technique as well as the design of the prosthesis, procedural success rates of > 75% and adverse event rates of < 20% at 30-day follow-up have been reported. A new alternative to this approach is the self-expanding valve prosthesis. The recently reported First-in-Man Study demonstrated the feasibility of this technique. However, the strict inclusion criteria for both procedures limit the number of potential candidates. New devices are currently under development, which will allow for a broader use of percutaneous valve replacement in the near future.

Angiography↗
PubMed2006

High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional guidewires.

BACKGROUND: Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs. PATIENTS AND METHODS: A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness. RESULTS: The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred. CONCLUSIONS: The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.

Adult↗
PubMed2006

Evaluation of a new polymer-coated paclitaxel-eluting stent for treatment of de novo lesions: six-month clinical and angiographic follow-up results of the APPLAUSE trial.

BACKGROUND: This trial assesses the safety and efficacy of the PicoElite stent (amg International GmbH, Raesfeld-Erle, Germany), a new paclitaxel-eluting polymer-based stent. METHODS: This is a first-in-man, single-center pilot trial that randomized 30 patients with 35 de novo coronary lesions in a 2:1 proportion to either the paclitaxel-eluting PicoElite stent (PES group: 20 patients with 24 lesions) or the bare metal ArthosPico stent (BMS group: 10 patients with 11 lesions). RESULTS: Baseline characteristics were similar in both groups, apart from younger patients in the PES group (mean age 63.5 years vs. 71.7 years in the BMS group; p = 0.032) and shorter lesion length in the PES group (9.56 mm vs. 14.25 mm in the BMS group; p = 0.02). In both groups, there was no difference in the primary endpoint of major adverse cardiac events (MACE) at 30-day follow up. There was a nonsignificant trend towards lower 6-month MACE and target lesion revascularization (TLR) rates in the PES group (10.5% PES vs. 40.0% in the BMS group for both; p = 0.143), and no stent thrombosis in the PES group. At 6-month angiographic follow up, the PES group demonstrated a significantly reduced in-stent binary restenosis rate (5.0% vs. 40.0%; p = 0.031), in-stent late loss (0.47 mm vs. 1.10 mm; p = 0.004), and in-segment late loss (0.72 mm vs. 1.16 mm; p = 0.016) as compared to the BMS group. CONCLUSIONS: The 6-month results of the APPLAUSE study demonstrate the safety and efficacy of the paclitaxel-eluting PicoElite stent for de novo lesions, with a significant reduction in late loss and a trend towards less TLR compared to a bare metal control.

Adult↗
PubMed2005

Two-year-plus follow-up of a paclitaxel-eluting stent in de novo coronary narrowings (TAXUS I).

Early results with polymer-based paclitaxel-eluting stents have shown significant improvements in the clinical and angiographic parameters of restenosis, as well as excellent safety outcomes. However, the duration of these beneficial effects is unknown. Therefore, the clinical outcomes of the TAXUS I study population were evaluated at 2- and 3-year follow-up. In TAXUS I, 61 patients with single, focal coronary lesions were randomly assigned to receive either a paclitaxel-eluting TAXUS stent (n = 31) or a bare metal control stent (n = 30). Low rates of composite major adverse cardiac events (MACEs) reported at 1-year follow-up (3.2% TAXUS vs 10.0% control) were maintained at 2 and 3 years, with no additional MACEs in either treatment group 1 year after implantation. The single target vessel revascularization in the TAXUS group was remote from the target lesion in contrast to 3 target lesion revascularizations in the control group.

Aged↗
PubMed2005

Polymer-based paclitaxel-eluting stent for treatment of chronic total occlusions of native coronaries: results of a Taxus CTO registry.

The purpose of this prospective nonrandomized study was to evaluate both safety and efficacy of the polymer-based paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. Drug-eluting stents have been proven safe and efficacious in suppressing neointimal proliferation when used in simple native de novo coronary lesions. However, there are only limited data on safety and efficacy of these stents for treatment of more difficult lesion subsets, especially chronic total occlusions. Forty-five consecutive symptomatic patients with chronic total coronary occlusions were included in this observational single-arm study. Only patients with successfully crossed occlusions were enrolled. Primary endpoints were binary restenosis and late lumen loss at 6-month angiographic follow-up. Secondary endpoints were MACE at 30-day and 6-month follow-up. The 30-day MACE rate was 0%. At 6 months, the cumulative MACE-free survival was 84.4%. There were no deaths, myocardial infarctions, or stent thrombosis up to 6 months poststenting. At angiographic follow-up, the in-stent restenosis rate was 13.2% (5/38). There was a total of five in-stent restenoses, with three focal and two diffuse restenosis patterns. The in-segment late lumen loss was 0.13 +/- 0.58 mm. The stent edge analyses revealed a late loss of 0.21 +/- 0.66 proximally and a negative late loss of -0.10 +/- 0.67 at the distal edge segment. This study shows safety and indicators of efficacy of implantation of the paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. The quantitative angiographic analysis revealed beneficial results with respect to the efficacy surrogates binary restenosis rate and late loss.

Antineoplastic Agents, Phytogenic↗
PubMed2005

First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis.

BACKGROUND: Percutaneous aortic valve replacement is a new technology for the treatment of patients with significant aortic valve stenosis. We present the first report on a human implantation of a self-expanding aortic valve prosthesis, which is composed of three bovine pericardial leaflets inserted within a self-expanding nitinol stent. The 73-year-old woman presented with severe symptomatic aortic valve stenosis (mean transvalvular gradient of 45 mmHg; valve area of 0.7 cm2). Surgical valve replacement had been declined for the patient because of comorbidities, including previous bypass surgery. METHOD AND RESULTS: A retrograde approach via the common iliac artery was used for valve deployment. The contralateral femoral vessels were used for a temporary extracorporal circulation, unloading the left ventricle during the actual stent expansion. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially during the procedure. Clinical and echocardiographic follow-up at day 1, 2, and 14 post procedure was performed to evaluate the short-term outcome. The prosthesis was successfully deployed within the native aortic valve, with accurate and stable positioning and with no impairment of the coronary artery or vein graft blood flow. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient (from 45 to 8 mmHg) without evidence of aortic or mitral valve insufficiency. The clinical status has then significantly improved. These results remained unchanged up to the day 14 follow-up. CONCLUSION: This case report demonstrates a successful percutaneous implantation of a self-expanding aortic valve prosthesis with remarkable functional and clinical improvements in the acute and short-term outcome.

Aged↗
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

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

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

Optical Coherence Tomography (OCT). Potential of a new high-resolution intracoronary imaging technique.

BACKGROUND: It is believed that most myocardial infarctions result from the rupture of "vulnerable plaques", that share certain common characteristics. These plaques typically consist of a lipid-rich core in the central portion of the thickened intima, covered by a thin friable fibrous cap. Today, one of the important challenges in the field of interventional cardiology is how to identify minor or silent plaques that carry the risk of thrombosis resulting in severe cardiac events. Current imaging technologies lack the resolution to reliably identify these lesions. OCT: Optical Coherence Tomography (OCT) might have the potential to fill this role. OCT is a new non-contact, light-based imaging modality providing in situ images of tissues at near histologic resolution. As shown in various preclinical and clinical reports, OCT allows the identification of mural as well as luminal morphologies including lumen dimensions, plaques, thrombi, dissections, tissue flaps as well as information on stent geometries including apposition and symmetry. Trials comparing intravascular ultrasound (IVUS) and OCT demonstrated that OCT provided additional morphologic information, which could be used to improve plaque characterization. CONCLUSION: OCT has the potential to provide a new and more detailed look into the vessel wall, which might help to identify plaques that are at risk of rupture, and furthermore, which will influence and guide the appropriate patient-specific therapeutic approach.

Coronary Artery Disease↗
PubMed2002

Results of the Jostent coronary stent graft implantation in various clinical settings: procedural and follow-up results.

The Jostent coronary stent graft (CSG) is composed of a PTFE layer sandwiched between two stainless steel stents, initially introduced for the treatment of coronary perforations and aneurysms with excellent results. By providing a mechanical barrier, this stent design also may be beneficial in the treatment of complex ulcerated lesions and in-stent restenosis by preventing debris protrusion and neointimal proliferation through the stent struts. To evaluate the safety and efficacy of this stent graft, we implanted 78 CSGs in 70 patients for a broad range of indications, including coronary perforations, aneurysms, degenerated saphenous vein grafts, complex lesions, and in-stent restenosis. The primary angiographic success rate (95.9%) was high, and using intravascular ultrasound (IVUS) guidance during stent implantation and high inflation pressures (19.3 +/- 3.2 atm), stent expansion with optimal symmetry was achieved in 94.7%. One limitation of the Jostent CSG was the side-branch occlusion rate (18.6%) and the resulting non-Q-wave infarction rate in seven cases (mean CK elevation, 238 U/l), acute Q-wave MI in two cases, and transient ventricular fibrillation in one patient after occlusion of the proximal RCA side branch without further complications. Subacute stent thrombosis occurred in four cases (5.7%) 7 to 70 days after stent implantation, despite using combined antiplatelet therapy with aspirin (ASA), ticlopidine, and/or clopidogrel for 30 days. Angiographic follow-up was available in 56 patients (80.0%) after a mean of 159 +/- 49 days, and follow-up IVUS was available in 38 cases. The overall restenosis rate (> 50% diameter stenosis) was 31.6% manifest primarily as edge restenosis (29.8% stent edge vs. 8.8% stent center; P < 0.001). IVUS examinations showed a minimal late lumen loss of 0.4 +/- 2.2 mm(2) within the center of the stent graft vs. 3.2 +/- 2.3 mm(2) at the stent edges (P < 0.001). The restenosis rate in the prespecified subgroups was 33.3% for saphenous vein grafts (2/6 lesions), 30.0% in complex lesions (6/20 lesions), and 38.5% (10/26 lesions) for the treatment of in-stent restenosis. Implantation of the Jostent CSG is feasible and safe, even in complex lesion subsets, and is associated with high primary success rates provided major side branches are avoided. The use of this stent may require an extended time course of antiplatelet therapy. Frequent focal stent edge renarrowing influences the overall restenosis rate. However, in treatment of complex in-stent restenosis and vein graft lesions, stent grafts may offer benefit over conventional therapies. Covered stents such as the JoMed coronary stent graft may become essential for bailout treatment of coronary perforations.

Adult↗