Biomedical subjects

Joachim Schofer

Publications and source records attributed to Joachim Schofer.

At least 19 recordsLinked to original sources

PubMed2006

Cause of death with bare metal and sirolimus-eluting stents.

AIMS: Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents. METHODS AND RESULTS: An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. CONCLUSION: At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.

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PubMed2006

Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials.

OBJECTIVES: The purpose of this research was to determine the relative safety and efficacy of multiple (> or =2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey). BACKGROUND: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents. METHODS: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent-treated patients were compared by stent type and with single-stent-treated patients for the same stent device. RESULTS: In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent-treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent-treated patients. Overlapped SES was not associated with an increase in myocardial infarction. CONCLUSIONS: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.

Angioplasty, Balloon, Coronary↗

PubMed2006

Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses.

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.

Coronary Artery Disease↗

PubMed2006

Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry.

BACKGROUND: The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. METHODS AND RESULTS: Between April 2002 and September 2005, data were collected on 15,157 patients who underwent implantation of > or =1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7+/-11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18,295 lesions were treated (20,503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. CONCLUSIONS: This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

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PubMed2006

[The femoral artery: the most complex peripheral vessel].

The superficial femoral artery (SFA) is a unique vessel in terms of its anatomy, its function and its interventional requirements; it has no comparison in any other arterial vascular bed. It is a long conduction vessel with a high flow resistance underlying several different hemodynamic conditions. In the past 15 years the unique characteristics of the SFA have resulted in poor interventional outcomes, with mid-term restenosis rates in the order of 50%--outcomes that are worse than in any other arterial vascular bed. In view of the clinical importance of SFA treatment, which comprises about 50% of all interventions at peripheral arterial lesions, considerable efforts have been made with a variety of interventional techniques to achieve progress. Only the use of self-expanding nitinol stents appears to improve the mid-term results of catheter-based interventional SFA treatment.

Alloys↗

PubMed2006

[Mitral valve reconstruction without cardiopulmonary bypass. Border zone between cardiac surgery and interventional cardiology].

Mitral regurgitation is a disease associated with major clinical impairment depending on its severity. Treatment is usually performed by surgical reconstruction or valve replacement. Initial attempts to perform the surgical procedure without extracorporeal circulation are currently being made. In parallel, new devices in interventional cardiology offer percutaneous treatment of the disease. At present, one surgical approach and several percutaneous ones exist, which are evaluated in phase I or phase II studies. In this article, the authors focus on the available data as well as on the advantages and disadvantages of the different approaches.

Angioplasty, Balloon↗

PubMed2006

European carotid PROCAR Trial: prospective multicenter trial to evaluate the safety and performance of the ev3 Protégé stent in the treatment of carotid artery stenosis--1- and 6-month follow-up.

BACKGROUND: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. METHOD: The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018'' (6-9 mm stent) or 7 Fr 0.035'' (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. RESULTS: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. CONCLUSIONS: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA).

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PubMed2006

Endovascular treatment of in-stent restenosis after carotid artery stenting: immediate and midterm results.

PURPOSE: To evaluate the immediate and midterm outcome and analyze the debris captured after repeat endovascular intervention for the treatment of in-stent restenosis after carotid artery stenting (CAS). METHODS: Thirty-one consecutive patients (27 men; mean age 63.7+/-13.0 years, range 53- 81) underwent repeat endovascular intervention (balloon angioplasty and provisional stenting) for the treatment of 32 in-stent restenoses following CAS. RESULTS: Procedural success was achieved in all patients. An additional stent was implanted in 10 (31%) cases. No procedural complication was observed. Filter analysis was performed in 17 (53%) procedures; on 12 (71%), macroscopically visible material was captured. The histomorphometric analysis performed on 6 (19%) filters showed fibrin nets entrapping erythrocytes, leucocytes, platelets, and in 2 cases, fibrous hypercellular tissue fragments. At 30 days and during follow-up (mean 17+/-5 months), no deaths, transient ischemic attacks, or strokes were observed. In 1 (3.1%) patient, asymptomatic recurrence of ISR was found on Doppler ultrasonography and successfully treated with balloon angioplasty. CONCLUSION: Repeat endovascular intervention using balloon angioplasty with provisional stenting and routine cerebral protection appears to be a feasible, safe, and clinically effective strategy for the treatment of in-stent restenosis after CAS.

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PubMed2005

Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents.

BACKGROUND: Observed rates of restenosis after drug-eluting stenting are low (<10%). Identification of a reliable and powerful angiographic end point will be useful in future trials. METHODS AND RESULTS: Late loss (postprocedural minimum lumen diameter minus 8-month minimum lumen diameter) was measured in the angiographic cohorts of the SIRIUS (n=703) and E-SIRIUS (n=308) trials. Two techniques, the standard normal approximation and an optimized power transformation, were used to predict binary angiographic restenosis rates and compare them with observed restenosis rates. The mean in-stent late loss observed in the SIRIUS trial was 0.17+/-0.45 mm (sirolimus) versus 1.00+/-0.70 mm (control). If a normal distribution was assumed, late loss accurately estimated in-stent binary angiographic restenosis for the control arm (predicted 35.4% versus observed 35.4%) but underestimated it in the sirolimus arm (predicted 0.6% versus observed 3.2%). Power transformation improved the reliability of the estimate in the sirolimus arm (predicted 3.2% [CI 1.0% to 6.7%]) with similar improvements in the E-SIRIUS trial (predicted 4.0% [CI 1.2% to 7.0%] versus observed 3.9%). In the sirolimus-eluting stent arm, in-stent late loss correlated better with target-lesion revascularization than in-segment late loss (c-statistic=0.915 versus 0.665). CONCLUSIONS: Because distributions of late loss with a low mean are right-skewed, the use of a transformation improves the accuracy of predicting low binary restenosis rates. Late loss is monotonically correlated with the probability of restenosis and yields a more efficient estimate of the restenosis process in the era of lower binary restenosis rates.

Coronary Restenosis↗

PubMed2005

Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials.

OBJECTIVES: We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes. BACKGROUND: The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials. METHODS: A post hoc analysis was performed on 225 patients (158 men; 62 +/- 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients. RESULTS: Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p=0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p <0.001) in the DS subgroup. At eight months, in-lesion late loss (0.10 vs. 0.19 mm at predilation, p=0.14) and in-lesion binary restenosis (2.0% vs. 6.1% at predilation, p=0.46) tended to be lower after DS. Clinical follow-up at one year revealed non-significantly reduced incidences of target lesion revascularization (1.8% vs. 5.4% at predilation, p=0.46) and major adverse cardiac events (5.3% vs. 8.9% at predilation, p=0.57). CONCLUSIONS: Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.

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PubMed2005

Angiographic and clinical outcomes at 8 months of cutting balloon angioplasty and beta-brachytherapy for native vessel in-stent restenosis (BETACUT): results from a stopped randomized controlled trial.

The objective of this study was to assess angiographic and clinical outcomes of cutting balloon (CB) angioplasty and concomitant Sr/Y-90 beta-brachytherapy as a treatment modality for patients with native vessel in-stent restenosis (ISR). Procedural advantages over the standard balloon (SB) have been claimed for the CB. Intracoronary brachytherapy preceded by SB angioplasty is regarded as the treatment of choice in patients with ISR. In an interim analysis of a prospective randomized trial designed for 652 patients, 100 consecutive patients with ISR were assigned to treatment with SB angioplasty (n = 51) or CB angioplasty (n = 49), followed in either case by Sr/Y-90 beta-brachytherapy. Quantitative coronary angiography at baseline, postintervention, and at 8 months was performed by an independent central laboratory. More than 90% of target lesions in the overall patient population were diffuse, with 14% of stents totally occluded. Procedural parameters and immediate angiographic outcomes were essentially the same in either study arm. At 8 months, no statistically significant differences were observed in recurrent angiographic restenosis (SB = 26.1%; CB = 29.5%; P = 0.82), target lesion revascularizations (SB = 13.7%; CB = 8.2%; P = 0.53), and major adverse cardiac events (SB = 15.7%; CB = 8.2%; P = 0.36). In this interim analysis, there was no indication of a beneficial effect of CB use over SB use in terms of angiographic or clinical outcomes at 8-month follow-up. CB angioplasty appears to be as safe and efficacious as SB angioplasty in beta-radiation treatment of patients with predominantly diffuse native vessel ISR. It was decided to discontinue the trial.

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PubMed2005

Vascular response to sirolimus-eluting stents delivered with a nonaggressive implantation technique: comparison of intravascular ultrasound results from the multicenter, randomized E-SIRIUS, and SIRIUS trials.

BACKGROUND: The effectiveness of SES to reduce the risk of restenosis was initially demonstrated in short lesions using stent implantation with routine pre-dilatation and post-dilatation. This intravascular ultrasound (IVUS) substudy of the E-SIRIUS trial sought to evaluate local arterial responses to sirolimus-eluting stents (SES) delivered with a stent implantation technique allowing direct stenting and only selectively applying high-pressure post-dilatation. METHODS AND RESULTS: IVUS was performed immediately after intervention and at 8-month follow-up in 51 patients randomised to either bare-metal stents (BMS; Bx-Velocitytrade mark; N=20) or SES (Cyphertrade mark N=31). Direct stenting was allowed (24%) and post-dilation was performed only selectively (32%). Lumen dimensions, intimal hyperplasia and vessel remodeling were compared between SES and BMS. Subsequently, results of SES in the E-SIRIUS IVUS substudy (N=31) were compared to those of SES in the IVUS substudy of the SIRIUS trial (N=137). SES in SIRIUS IVUS substudy were delivered with 100% pre-dilatation and 77% post-dilatation. Baseline stent and reference segment measurements were similar between BMS and SES in E-SIRIUS IVUS patients. Using SES there was a 96% reduction in intimal hyperplasia volume within the stented segment (1.8+/-4.9 vs 50.6+/-39.7 mm3, P<0.001) and a significantly larger minimal lumen cross sectional area at 8-month follow-up (4.5+/-1.1 vs 2.3+/-0.9 mm2, P<0.001). No vessel remodeling was observed with the use of SES. The applied stent implantation technique resulted in a minimal stent/reference vessel area ratio of 0.75+/-0.17 in E-SIRIUS SES as compared to 0.84+/-0.23 in SIRIUS SES (P=0.046). Mean intimal hyperplasia cross-sectional area at follow-up was 0.1+/-0.2 mm2 in the SES group of E-SIRIUS and 0.5+/-0.8 mm2 in the SES group of SIRIUS (P=0.003). CONCLUSIONS: An implantation technique of SES which includes direct stenting and minimizes the use of high-pressure post-dilatation results in less optimal stent expansion. However, follow-up results compare very favourable to those of BMS and are characterised by even less intimal hyperplasia than after a more forceful implantation of SES.

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PubMed2005

Direct stenting with sirolimus-eluting stents.

The sirolimus-eluting stent has been studied extensively in randomized controlled trials of patients with native de novo coronary lesions. Lesion predilation before stent placement has been the predominant implantation strategy in these trials. Direct implantation of the sirolimus-eluting stent without lesion predilation has been undertaken at the investigators' discretion in certain trials as well as in patients enrolled in a post-marketing surveillance registry, and was the intended implantation strategy in the DIRECT trial. Comparisons with patients receiving sirolimus-eluting stents after lesion predilation in the trials and the registry were all confounded by imbalances in patient, lesion, and/or procedural characteristics and point to the highly selective nature of the direct-stenting strategy. At present, direct implantation of the sirolimus-eluting stent appears to be safe and as effective as conventional (predilated) stenting, provided that the targeted coronary lesion is amenable to the direct approach. Since a randomized trial of implantation strategies is lacking, there is no conclusive evidence as to the hypothesized superiority of direct over predilated stenting in suitable coronary lesions.

Cell Proliferation↗

PubMed2005

Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.

PURPOSE: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries. METHODS: In 14 European centers, 157 patients (121 men; mean age 68.0+/-8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure. RESULTS: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%+/-7.8% to 6.7%+/-5.1%. The mean duration of flow blockage was 7.6+/-5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%. CONCLUSIONS: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.

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PubMed2004

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol. METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups. CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

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PubMed2004

Embolic protection with filtering or occlusion balloons during saphenous vein graft stenting retrieves identical volumes and sizes of particulate debris.

BACKGROUND: Distal embolization of plaque particulate liberated during stenting may cause periprocedural complications. The number, size, and volume of debris released during stenting, however, have not been quantified, rendering embolic protection approaches empiric. We used a novel method of microparticle size assessment to measure volume and characterize individual sizes of particles captured by the PercuSurge GuardWire balloon or a vascular filter during saphenous vein graft stenting. METHODS AND RESULTS: Braided nitinol filters (average distal pore size 100 microns) were used in 47 saphenous vein grafts in 44 patients. The PercuSurge GuardWire was used in 17 saphenous vein grafts in 16 patients. Particulate debris was subjected to microparticle size analysis (RapidVue, Beckman Coulter). All samples contained particulate debris. For both filter and GuardWire populations, most particles were <100 microm in longest dimension (87% and 90% of particles, respectively), and the distribution of particle sizes was identical. Total embolic load per lesion for both filters and GuardWire aspirates was also similar: median embolic load per filter was 16 mm3 (range 2 to 84 mm3). Median embolic load per GuardWire was also 16 mm3 (range 7 to 42 mm3). Histopathologic analysis demonstrated that most samples contained plaque elements and platelet-rich thrombus. CONCLUSIONS: During saphenous vein graft interventions, particulate retrieved with a vascular filtering device or an occlusion balloon was similar in amount and character. This supports the notion that unless soluble mediators play an important role in adverse acute clinical events after stenting, the clinical efficacy of filtering devices may be equal to that of occlusion devices.

Alloys↗

PubMed2004

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT).

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.

Angioplasty, Balloon↗

PubMed2004

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients.

PURPOSE: To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. METHODS: In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [+/- SD] age, 70 +/- 8 years). Cerebral protection involved distal filter devices (n=640), occlusive distal balloons (n=144), or proximal balloon protection (n=24). RESULTS: The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions (P=0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged > or =80 years (P=0.81). Protection device-related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). CONCLUSION: In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.

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