Two-year Clinical Follow-up Research Articles

Two-year clinical follow-up of the unrestricted use of the paclitaxel-eluting stent compared to the sirolimus-eluting stent as part of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry.

To investigate the medium term (2 year) clinical outcome of the use of the paclitaxel-eluting stent (PES) compared to the sirolimus-eluting stent (SES). To date, there are no direct comparative data on the efficacy of these stents over medium term follow-up. Furthermore, a possible late restenotic phenomenon has not been excluded. The Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry compared 576 consecutive "all-comer" patients, exclusively treated with PES, with 508 patients who received SES from the RESEARCH registry in the preceding period. Patients were enrolled irrespective of clinical or angiographic features. At 2 years, major adverse cardiac event (death, myocardial infarction or target vessel revascularisation) rates were comparable in the two groups: 15.4% in the SES group versus 18.9% in the PES group (HR 1.26, 95% CI 0.94-1.69, p=0.12). Correcting for differences in both groups resulted in an adjusted HR of 1.11 (95% CI 0.82-1.50, p=0.51, using significant univariate variables). Target vessel revascularisation was 8.0% in the SES group compared with 9.6% in the PES group (HR 1.23, 95% CI 0.81-1.86, p=0.33). The unrestricted use of SES and PES was safe at two years of follow-up. No significant difference was found between the two devices in terms of death or MI, MACE, TVR or TLR. No late clinical restenotic phenomenon was observed.

Bone Augmentation with Bioactive Glass in Three Cases of Dental Implant Placement

This study reports the clinical use of a bioactive bone graft material, PerioGlas, in the treatment of dental extraction sites before dental implant placement, to effect bone regeneration and to give early fixation to the implant.PerioGlas, granules, ranging from 90 to 710 mm, are implanted after tooth extraction in three patients; after 6 months bone biopsies were performed in the site of the glass implantation and observed under Electron Scanning Microscopy. All the granules showed a biodegradation involving precipitation of calcium phosphate that worked as a scaffold for osteoblasts colonization. All cases examined showed the bioactivity of PerioGlas granules resulting in new bone formation and biodegradation of the glass. After a two-year clinical follow-up all the implants were successfully loaded and appeared stable.

Two-Year Clinical Follow-Up in 200 Patients Receiving Sirolimus-Eluting Stents in Lesions at a High Risk of Restenosis

Sirolimus-eluting stents (SESs) have been shown to reduce the rate of restenosis significantly in all types of coronary lesion. However, reports of late cases of thrombosis and restenosis have raised questions about long-term outcome in patients treated with these stents. Our aim was to evaluate long-term outcome in patients undergoing SES placement in lesions at a high risk of restenosis. Since SESs became available, we have used them to treat lesions at risk of restenosis. We studied clinical outcomes in consecutive patients treated with SESs who were followed up for more than 2 years. The study included 200 patients (age 60[11] years, 22% diabetics) who were treated between June 2002 and April 2003 for 309 lesions: 16% were total occlusions, 16.8% in-stent restenoses, 28% diffuse lesions, and 30% small-vessel lesions. The total stent length per patient was 29 (16) mm and the mean diameter was 2.78 (0.27) mm. In a mean clinical follow-up period of 29 (3.2) months (range 24-34 months), there were four deaths, two (1%) of which were cardiac, four (2%) non-fatal infarctions, four (2%) in-stent thromboses (all occurred late, at 3, 7, 26 and 31 months), four (2%) cases requiring target lesion revascularization (at 3, 5, 14 and 15 months), and six (3%) requiring revascularization of a new lesion. Long-term follow-up of patients undergoing SES placement in lesions at a high risk of restenosis revealed a very low restenosis rate. However, the incidence of late thrombosis appeared to be elevated and warrants further evaluation in larger studies.

Two-year follow-up on joint stability and muscular function comparing rotating versus fixed bearing TKR

Mobile and fixed bearing in total knee replacement are still discussed controversially. In a retrospective, matched-pair study, we investigated 40 patients with computer-assisted (BrainLAB) primary total knee replacement (PFC Sigma, DePuy) performed two years before. Twenty patients each received a mobile bearing and a fixed bearing. We compared Womac Score, Knee Society Score, postoperative ROM, fluoroscopic measurement of knee stability in flexion and extension and isokinetic muscle strength using a Biodex-3 dynamometer. Both groups showed similar results concerning WOMAC Score (total rotating bearing: 23.05; fixed bearing: 22.57), KSS (rotating bearing: 174.89; fixed bearing: 176.1). Isokinetic muscle force demonstrated statistically significant superior results for knee flexion in the rotating bearing group. Medio-lateral stability revealed statistically significant superior results for the rotating bearing compared to fixed bearing in extension (P>0.05). In flexion only lateral stability was superior (P>0.05). Two-year clinical follow-up after computer-assisted total knee replacement resulted in good clinical outcome with high patient satisfaction. Statistically significant better values for the rotating platform group were found for the medio-lateral stability in extension and the peak flexion torque.

Two-year Clinical Follow-up of 90Sr/ 90 Y β-radiation Versus Placebo Control for the Treatment of In-stent Restenosis

Two-year Clinical Follow-up of 90Sr/ 90 Y β-radiation Versus Placebo Control for the Treatment of In-stent Restenosis

Endothelial Progenitor Cells, Neointimal Hyperplasia, and Hemodialysis Vascular Access Dysfunction

Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has an impact on multiple and diverse disciplines, including cardiology (coronary restenosis), cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and transplant medicine (chronic allograft rejection in hearts and kidneys). The traditional response to injury hypothesis on the pathogenesis of neointimal hyperplasia focuses on the migration of medial smooth muscle cells from the media into the intima.1 Recently, there has been a great deal of excitement about the role of circulating smooth muscle progenitor cells in the pathogenesis of neointimal hyperplasia. These cells have been identified in a variety of experimental models of vascular injury,2 and interventions that reduce the number of these cells can attenuate neointimal hyperplasia. In marked contrast to the deleterious effects of smooth muscle progenitor cells on neointimal hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an important role in vascular repair and in the inhibition of neointimal hyperplasia.3 See p 12 In this issue of Circulation , Rotmans and colleagues have attempted to achieve the “holy grail” for a vascular access procedure: rapid and complete endothelialization.4 Their experiments are based on a newly developed technique that can coat the surface of stent and graft material with antibodies against CD34 (Orbus Medical Technologies). CD34 is a marker for hematopoietic stem cells, and previous research has demonstrated that coronary stents coated with anti-CD34 have a significant increase in endothelialization as early as 1 hour after deployment because of the binding of circulating CD34+ cells, which then differentiate into endothelial cells.5 Placement of anti-CD34–coated grafts in an arteriovenous model of PTFE graft stenosis by Rotmans et al resulted in almost complete endothelialization of the grafts (both …

Two-year clinical follow-up of 90Sr/ 90 Y β-radiation versus placebo control for the treatment of in-stent restenosis

It is an ongoing concern that intracoronary brachytherapy may possibly just delay the problem of in-stent restenosis ("late catch up"). For gamma-radiation, 3 placebo-controlled studies have shown the maintenance of the initially positive effect after 2 years, but similar data do not exist for beta-radiation. STents And Restenosis Trial (START) was the first placebo-controlled randomized trial for in-stent restenosis with beta-radiation; herein, we report the 2-year clinical follow-up. Two hundred and forty-four patients were randomized to active treatment, 232 patients to placebo (nonactive source train) treatment. The primary end point of efficacy was target vessel revascularization (TVR); primary safety end point was any major adverse cardiac event (MACE) at 8 months and 2 years. Two-year clinical outcome in patients receiving brachytherapy was based on 195 of 244 original patients (79.9%) and in the placebo arm on 183 of 232 original patients (78.9%). TVR was significantly reduced by 25%; from 36.6% (placebo) to 27.5% (brachytherapy) remained significant after 2 years (RR .7 [.57-.98], 95% CI -9.2 [-17.5-0.8]). The Kaplan-Meier analysis for TVR and MACE showed improvement beginning approximately 90 days after radiation and remained almost constant for the 2 following years. Freedom from TVR was significantly increased from 62.4% +/- 3.8% to 71.6% +/- 3.3% (P = .027) and freedom from MACE from 58.9% +/- 3.7% to 68.0% +/- 3.4% (P = .035). The START trial shows for the first time that the initial beneficial effects of intracoronary brachytherapy with beta-radiation using 90 Sr/ 90 Y are maintained at 2-year clinical follow-up period.

Two‐year clinical follow‐up results of intracoronary radiation therapy with rhenium‐188‐diethylene triamine penta‐acetic acid‐filled balloon

We investigated the 2-year clinical follow-up results as well as 6-month angiographic and clinical follow-up results of intracoronary radiation therapy using a rhenium-188-diethylene triamine penta-acetic acid ((188)Re-DTPA)-filled balloon system. The study comprised of 161 patients with significant de novo (83%) or in-stent restenosis (17%) lesions. Irradiation to deliver 17.6 Gy at a depth of 1.0 mm into the vessel wall was carried out after successful intervention. At 6-month follow-up, binary restenosis developed with significantly lower frequency in the radiation group than in the control group (24.3% vs. 46.3%; P = 0.009), although target lesion revascularization rate did not show significant benefit. At 2-year follow-up, cumulative target lesion revascularization rate was not significantly different between radiation group (n = 86) and control group (n = 75; 20.0% vs. 26.0%; P = 0.368). The rate of major adverse cardiac events including death, myocardial infarction, and target lesion revascularization did not show significant difference between two groups either (22.3% vs. 30.1%; P = 0.266). In conclusion, although significant reduction in restenosis rate was noted at 6-month angiographic follow-up, intracoronary radiation therapy mostly in patients with de novo lesion did not show significant clinical benefit in 6-month and 2-year follow-up results. The benefit was noted only in a small subgroup of patients with in-stent restenosis.

Two-year clinical follow-up of intracoronary radiation therapy using 188Re-DTPA-filled balloon system after coronary artery stenting

Two-year clinical follow-up of intracoronary radiation therapy using 188Re-DTPA-filled balloon system after coronary artery stenting

A randomized comparison of elective high-pressure stenting with balloon angioplasty: Six-month angiographic and two-year clinical follow-up

Background Previous randomized trials have shown beneficial effects of coronary stenting on restenosis and event–free survival rates. However, it has not yet been fully established if routine high–pressure stenting with an antiplatelet regimen can show similar results. Methods We compared the 6-month angiographic restenosis rate and 2-year event-free survival rate in 400 patients randomly assigned to stent or angioplasty. Aspirin and ticlopidine were prescribed in both groups. Results The procedural success rate did not significantly differ between the stent and angioplasty groups (97.92% vs 97.45%, P = not significant). No stent thrombosis was found. The 6-month restenosis rate was lower in the stent group (18.18% vs 24.87%, P =.055). At 2 years target lesion revascularization rate was 17.19% in the stent group and 25.51% in the angioplasty group (P =.02, 33% reduction). No significant differences with regard to death and myocardial infarction were observed. Event–free survival rate at 6, 12, and 24 months was 86.77% vs 78.84%, 84.13% vs 76.70%, and 83.07% vs 73.54% for stent and angioplasty groups, respectively (P =.0172). Conclusions The 6-month angiographic and 2-year clinical outcomes were better in patients who received stent than in those after balloon angioplasty. The difference in 2-year event–free survival rate was explained by a reduction in target lesion revascularization rate in the stent group. (Am Heart J 2000;140:264-71.)

C1.7 Antigen Expression on CD8+ T Cells Is Activation Dependent: Increased Proportion of C1.7+CD8+ T Cells in HIV-1-Infected Patients with Progressing Disease

The C1.7 Ag is a surface marker previously shown to be expressed on all NK cells and on a subset of CD8+ T cells. We report in this study that C1.7 Ag expression on peripheral blood-derived CD8+ T cells overlaps with activation markers S6F1high and CD29high and is reciprocally expressed with CD62L. C1.7 Ag expression can be induced in vitro on CD8+ T cells by anti-CD3 cross-linking, suggesting that C1.7 Ag is activation dependent. In contrast to NK cells, C1.7 Ag does not signal on CD8+ T cells, nor does it induce redirected lysis upon ligation. The proportion of C1.7 Ag+CD8+ T cells is increased in HIV-infected patients compared with healthy donors. In 69 HIV-infected patients, we observed a significant inverse correlation between the percentage of C1.7 Ag-expressing CD8+ T cells and the absolute CD4+ T cell count. Two-year clinical follow-up of patients with initial CD4+ T cell count of >400 cells/mm3 and a normal proportion of C1.7 Ag+CD8+ T cells revealed that these patients were clinically stable with minimal HIV-associated symptoms. In contrast, 10 of 12 patients with CD4+ T cell counts of >400 cells/mm3 and an elevated proportion of C1.7 Ag+CD8+ T cells were symptomatic. ANOVA analysis of patients indicates that C1.7 Ag is a better predictor of disease progression than CD4 count. Overall, our findings indicate that C1.7 Ag is the first described marker for activated/memory CD8+ T cells and a useful parameter for evaluating the level of CD8+ T cell activation in vivo.

Triple Test Approach to Inadequate Fine Needle Aspiration Biopsies of Palpable Breast Lesions

To perform a retrospective study evaluating the triple test for inadequate fine needle aspiration (FNA) biopsies of palpable breast lesions with a two-year clinical follow-up. All aspirates were reviewed and assessed for cellular adequacy in a one-year period. Specimen adequacy was based on the most stringent criteria, the presence of six or more epithelial cell clusters composed of at least six cells each. In all cases, clinical and radiologic results were reviewed and compared with the histologic outcome. Aspirates from 61 of 263 (23%) patients with palpable breast lesions that yielded nondiagnostic results were examined. The study showed a misdirected FNA rate of 21% and a misinterpreted rate of 1.6%. The other 77% of cases had benign surgical biopsies and/or clinical follow-up. Three of 61 (4.9%) cases with nondiagnostic smears were found to have cancer; two were inadequate due to misdirected aspirates, and one was misinterpreted microscopically. All cancer cases underwent surgical removal of the mass as a result of clinical or radiologic suspicion. We recommend utilizing the three diagnostic parameters of cytology, clinical findings and radiology, the "triple test," to achieve the best diagnostic accuracy in breast FNAs and to enhance patient management.

Inferior epigastric artery as a conduit for myocardial revascularization: a two-year clinical and angiographic follow-up

The inferior epigastric artery has been proposed as a suitable conduit for myocardial revascularization but its mid-term patency rate has not been assessed. A prospective clinical and angiographic study on the use of the inferior epigastric artery as an additional arterial conduit together with bilateral internal thoracic artery grafting was conducted in 38 patients. No deaths or major postoperative complications occurred. Twenty-three patients underwent repeat angiography after an average of 21.2 months. The left and right internal thoracic artery grafts patency rate was 95.6% (44/46), while inferior epigastric artery patency rate was 52.2% (12/23). By relating patency to the grafted coronary branch, the following results were obtained: 100% for the left anterior descending (3/3), right coronary (1/1) and ramus medianus (1/1); 40% (4/10) and 37.5% (3/8) for diagonals and obtuse marginals respectively. The low patency rates observed when the inferior epigastric artery is used on diagonals and obtuse marginals indicate that this vessel cannot be considered a suitable conduit for extensive application of arterial revascularization. We suggest that the inferior epigastric artery should only be used in patients presenting with contraindications to bilateral internal thoracic artery or right gastroepiploic artery grafting, or exhibiting unsuitable saphenous veins.

Inferior Epigastric Artery as a Conduit for Myocardial Revascularization: A Two-Year Clinical and Angiographic Follow-Up

Inferior Epigastric Artery as a Conduit for Myocardial Revascularization: A Two-Year Clinical and Angiographic Follow-Up

Two-year clinical follow-up of children and adolescents after percutaneous transluminal angioplasty for renovascular hypertension.

Two percent of children have hypertension. For those younger than 10 years of age, there is a high probability that hypertension is secondary. The purpose of this study was to evaluate the merits of percutaneous transluminal angioplasty (PTA) in the treatment of childhood renovascular hypertension (RVH) in light of the results previously obtained by the authors and to evaluate their stability at 2-year follow-up. The positive response of peripheral renin plasma levels to a single dose of captopril was used as a criterion for selecting 36 patients between 4 and 15 years of age with renovascular hypertension. All underwent angiography; in most patients, PTA was performed in the same session. A 2-year follow-up study was conducted. In the 36 patients considered for RVH screening, PTA was successful in 34 of 36 patients (94%). Four of these patients had neurofibromatosis. The high success rate was confirmed in the 2-year follow-up study: 34 patients continue to be normotensive. Percutaneous transluminal angioplasty treatment of pediatric patients with hypertension has proved to be an effective and valuable method when the cause of renal artery stenosis is fibromuscular dysplasia, and the long-term results were sufficient to suggest the use of this technique in patients with neurofibromatosis as well.

The timing of brain morphological changes in schizophrenia and their relationship to clinical outcome

The present study is an examination of ventricular and temporal lobe size in 50 DSM-III-R first-episode schizophreniform or schizoaffective patients who were ill for less than 6 months. Two-year clinical follow-up and magnetic resonance imaging (MRI) scan analyses are also reported from data collected on an initial group of 30 first-episode schizophrenic patients and controls. Left ventricular enlargement, which was present in our previously published report of first-episode cases of schizophrenia, is not present to the same extent in this larger group of schizophreniform patients closer to the onset of their illness, and no temporal lobe volume reduction was detected. However, lateral ventricular size at the time of the first-episode was generally correlated with outcome—the larger the ventricles, the poorer the outcome. No mean change in ventricular or temporal lobe size was found at rescanning 2 years later, but the degree of ventricular change was inversely correlated with the number of hospitalizations and the amount of time spent in hospital; it did not correlate with temporal lobe size. When rescanned, some patients showed change greater than 20% in ventricular size and 10% in temporal lobe size. Thus, these findings need further evaluation by serial scans over a longer time period before it can be determined that no progression of brain structural abnormalities is occurring as part of the pathology of schizophrenia, even in a subgroup of patients.

A Two-Year Clinical and Economic Follow-Up of Patients on Clozapine

The long-term efficacy of clozapine therapy and its effect on health care costs were examined over a two-year period. Patients on clozapine showed marked clinical improvement as measured by the Brief Psychiatric Rating Scale. They also had significantly lower rates of rehospitalization and hospitalization costs than a comparison group of schizophrenic patients who received standard neuroleptic treatment and who were considerably less psychotic at hospital admission. By the second year of the study, savings on mental health care costs averaged $20,000 for each patient on clozapine therapy. The savings were due largely to the patients' change in residence from costly inpatient facilities to less expensive settings in the community.

CHEMOTHERAPY IN ACUTE AND CHRONIC PYELONEPHRITIS: A Two-year Clinical, Bacteriological, and Functional Follow-up

CHEMOTHERAPY IN ACUTE AND CHRONIC PYELONEPHRITIS: A Two-year Clinical, Bacteriological, and Functional Follow-up