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Results for “Multivariate response regression”

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PubMed2002

Clinical and immunologic factors associated with the presence or absence of airways hyper-responsiveness in childhood asthma.

BACKGROUND: During the baseline period of a clinical trial comparing different dosage schedules of inhaled steroids, asthmatic children (aged 6-10 years) were expected to meet the inclusion criterion of airways hyper-responsiveness (PD(20) methacholine < 80 micro g) after withdrawal of inhaled corticosteroids for 2-8 weeks. However, many children failed to do so. OBJECTIVE: It has been shown that young wheezing children may outgrow their symptoms. We investigated if differences between children with and without airways hyper-responsiveness after withdrawal of inhaled corticosteroids were compatible with differences between transient and persistent wheezers found in other studies. METHODS: Seventy-eight children entered the study, of which 41 developed airways hyper- responsiveness after withdrawal of inhaled corticosteroids, and 37 did not. These two groups of children were compared with respect to differences in demographic, clinical, and immunological features (IL-4, IL-5, IL-10, and IFN-gamma produced by Con A stimulated peripheral mononuclear cells (PBMCs) and serum IL-4, IL-5 and soluble intercellular adhesion molecule-1 (sICAM-1)). RESULTS: Hyper-responsive children had more atopic features (positive RAST, high IgE, eczema), lower levels of FEV1 and lower concentrations of sICAM-1 than non-hyper-responsive children. Apart from a borderline significantly higher IL-4 production in the hyper-responsive group, other immunologic parameters were comparable. Multivariate logistic regression analysis showed that high serum IgE, low FEV1, and low sICAM-1 levels were independently associated with the presence of airways hyper-responsiveness after stopping inhaled corticosteroids. Atopy was associated with higher concentrations of IL-4 in the hyper-responsive group. CONCLUSION: After withdrawal of inhaled corticosteroids many children previously diagnosed with asthma did not develop airways hyper-responsiveness. We conclude that hyper-responsive children share features with persistent wheezers as found in previous studies, whereas the non-hyper- responsive children may represent transient wheezers.

Animals↗

PubMed2000

Human immunodeficiency virus-infected persons with mutations conferring resistance to zidovudine show reduced virologic responses to hydroxyurea and stavudine-lamivudine.

The baseline predictors of poor virologic response (<0.5 log decrease in plasma virus load) were examined in two 1996 pilot trials of combination nucleoside-analogue therapy. One trial examined the addition of hydroxyurea to didanosine therapy; the other examined stavudine-lamivudine in combination. In both, predictors of virologic response included the presence of mutations associated with zidovudine resistance. For hydroxyurea, the odds ratio (OR) of failure to achieve a short-term (4 weeks) virologic response in a bivariate logistic regression model was 30.8 (95% confidence interval [CI], 1.75-543; P=.02) for use of lower dose hydroxyurea (500 mg/day) and 14.7 (95% CI, 1.1-200; P=.04) for the presence of a zidovudine-related mutation. For the stavudine-lamivudine study, the OR of failure to achieve a virologic response at 4 weeks in a multivariate logistic regression model was 23 (95% CI, 2.7-199; P=.004) for the presence of a mutation at codon 215.

Anti-HIV Agents↗

PubMed2000

Predictive factors of response to cisplatin-based chemotherapy and the relation of response to survival in patients with metastatic urothelial cancer.

PURPOSE: To identify pretreatment variables predicting overall and complete response to cisplatin-based chemotherapy for metastatic urothelial cancer, and to study the relation between response and the duration of survival. PATIENTS AND METHODS: A total of 119 evaluable patients with recurrent locally advanced or metastatic urothelial cancer received cisplatin-based combination chemotherapy in four consecutive phase II studies from 1987 to 1997. The relationship of pretreatment variables and response was evaluated with logistic regression, and prognostic factors for survival were analyzed with Cox's multivariate model. RESULTS: Response was achieved in 49% of the patients with a complete response rate of 15%. Good performance status and absence of bone metastases were independently predictive of overall response. Good performance status and normal hemoglobin were independently predictive of complete response. Median survival was 8.9 months. Performance status, alkaline phosphatase, s-creatinine, liver and bone metastases were independent prognostic factors for survival. Median survival was 12.4 months in responding patients and 6.3 in nonresponding patients. Response to chemotherapy was included in the multivariate model and was the strongest prognostic factor for survival. CONCLUSION: The presence of bone metastases, low hemoglobin or poor performance status predicts decreased chance of response to chemotherapy. Response to chemotherapy is an independent prognostic factor for prolonged survival in patients with metastatic urothelial cancer.

Aged↗

PubMed1994

Delayed-type hypersensitivity anergy in human immunodeficiency virus-infected persons screened for infection with Mycobacterium tuberculosis.

A total of 479 human immunodeficiency virus (HIV)-infected persons at an HIV clinic in Florida and a tuberculosis clinic in New Jersey were skin-tested with tuberculin, tetanus toxoid, mumps antigen, and Candida antigen in a study of the prevalence of delayed-type hypersensitivity (DTH) anergy and the usefulness of two-step tuberculin testing in this population. Of the patients tested, 12% had a positive (> or = 5-mm) response to tuberculin; 57%, 45%, and 35% had a positive (> or = 3-mm) response to Candida antigen, tetanus toxoid, and mumps antigen, respectively; and 31% were anergic (< 3 mm of induration in response to each antigen). In a multivariate logistic regression model, anergy was significantly associated with a history of Kaposi's sarcoma, Pneumocystis carinii pneumonia, or oral candidiasis and with White race. Anergy was four times and 15 times as likely for persons with CD4+ T-lymphocyte counts of 200-400/mm3 and < 200/mm3, respectively, as for persons with > 499 CD4+ T lymphocytes/mm3. Of 103 patients who were tuberculin-tested a second time after their initial test result was negative, seven had > or = 5 mm of induration in response to the second test; only one of these patients was anergic at the initial screening. The findings of this study indicate that DTH antigens should be used in conjunction with tuberculin testing and that two-step tuberculin testing is not an alternative to anergy testing but may be useful for the detection of infection with Mycobacterium tuberculosis in nonanergic HIV-infected patients.

AIDS-Related Opportunistic Infections↗

PubMed1995

High levels of constitutive WAF1/Cip1 protein are associated with chemoresistance in acute myelogenous leukemia.

The WAF1/Cip1 gene product is an important regulator at the G1 checkpoint in the cell cycle. WAF1/Cip1 expression can be activated through p53-dependent and p53-independent pathways. The WAF1/Cip1 protein binds to cyclin-dependent kinase complexes and inhibits the kinase activity that is required for cell cycle progression. In this preliminary study, we analyzed with Western blot assays the steady-state levels of the WAF1/Cip1 protein in the leukemia cells of 100 untreated acute myelogenous leukemia (AML) patients. Normal bone marrow cells from six donors were used as a control. The results of these analyses showed that the levels of the WAF1/Cip1 protein were very low in normal marrow cells and in the leukemia cells of 83 AML patients. High levels of WAF1/Cip1 were detected in 17 patients; these patients with high WAF1/Cip1 levels were significantly less likely to achieve complete remission (41% versus 69%, P = 0.03) and were four times as likely to be resistant to therapy (47% versus 12%, P = 0.003) as patients with very low levels of WAF1/Cip1. Median survival was 38 weeks for patients having very low expression levels versus 11 weeks for patients having high expression levels (P = 0.04). The WAF1/Cip1 level was an independent predictor for response but not survival in a stepwise multivariate regression analysis. Southern blotting analyses did not detect deletion of the WAF1/Cip1 gene in the 12 negative WAF1/Cip1 AML samples tested. Also, the level of WAF1/Cip1 protein expression was not correlated with overexpression of cyclin D1, cyclin E, proliferating cell nuclear antigen, cyclin-dependent kinase 4, or p53 in the leukemia cells. However, the levels of cyclin D1, cyclin E, and cyclin-dependent kinase 4 were elevated in most of the AML samples compared with that in normal marrow. We hypothesize that high-level constitutively expressed WAF1/Cip1 in tumor cells may result in an indolent state that is refractory to chemotherapy drugs. We conclude that the WAF1/Cip1 expression level may be an important prognostic factor for response to therapy and survival in AML patients.

Adult↗

PubMed1999

Similarity as a risk factor in drug-name confusion errors: the look-alike (orthographic) and sound-alike (phonetic) model.

BACKGROUND: One of every four medication errors reported in the United States is a name-confusion error. The rate of name-confusion errors might be reduced if new and confusing names were not allowed on the market and if safeguards could be put in place to avoid confusion between existing names. OBJECTIVES: To evaluate several prognostic tests of drug-name confusion, alone and in combination, with respect to their sensitivity, specificity, and overall accuracy. RESEARCH DESIGN: Case-control study. Twenty-two different computerized measures of orthographic similarity, orthographic distance, and phonetic similarity were used to compute similarity/distance scores for n = 1,127 cases (ie, pairs of names that appeared in published error reports or national error databases) and n = 1,127 controls. MAIN OUTCOME MEASURES: Mean similarity/distance scores were compared across cases and controls. The performance of each measure at distinguishing between cases and controls was evaluated by tenfold crossvalidation. Dose-response relationships were examined. Univariate and multivariate logistic regression models were formed and evaluated by 10 fold crossvalidation. RESULTS: Cases had significantly higher similarity scores than controls. Every measure of similarity proved to be a significant risk factor for error. There was a significant increasing trend in the odds-ratio as a function of similarity. A three-predictor logistic regression model had crossvalidated sensitivity of 93.7%, specificity of 95.9% and accuracy of 94.8%. CONCLUSIONS: A sensitive and specific test of drug-name confusion potential can be formed using objective measures of orthographic similarity, orthographic distance, and phonetic distance.

Analysis of Variance↗

PubMed1998

Increased intestinal permeability is associated with the development of multiple organ dysfunction syndrome in critically ill ICU patients.

We conducted a prospective, observational cohort study designed to compare intestinal permeability (IP) and development of multiple organ dysfunction syndrome (MODS) in a subset of critically ill patients in an intensive care unit (ICU). All patients with an expected ICU stay of 72 h or more were entered into the study, and IP was determined on a daily basis whenever possible from the urinary fractional excretion of orally administered lactulose and mannitol (LMR). Forty-seven consecutive patients were studied, and 28 developed MODS either at the time of admission or during their ICU course. These patients, as a group, had significantly worse IP at admission than did a non-MODS cohort (LnLMR: -2.10 +/- 1.10 versus -3.26 +/- 0.83). Those patients who developed MODS following admission also had a significantly greater admission IP than did the non-MODS group (-2.51 +/- 0.85). Differences in IP between cohorts could not be explained by differences in the incidence of systemic inflammatory response syndrome (SIRS)/sepsis or shock. With multivariate regression analysis, the only parameter present on admission that was predictive of subsequent MODS was IP. Differences in IP and the severity of organ dysfunction were also present (MODS severity mild: -3.01 +/- 0.72; moderate: -1.97 +/- 0.69; and severe: -1.12 +/- 0.96). Patients who developed MODS had a persistently abnormal IP during their ICU stay, and a significantly delayed improvement in their IP compared with the non-MODS cohort. We conclude that the development of MODS is associated with an abnormal and severe derangement of IP that is detectable prior to the onset of the syndrome. This observation lends credence to the premise that gastrointestinal (GI) dysfunction may be causally associated with the development of MODS in the critically ill patient.

Adult↗

PubMed2001

A random-effects mixture model for classifying treatment response in longitudinal clinical trials.

A random-effects regression model that allows the random coefficients to have a multivariate normal mixture distribution is described for classifying treatment response in longitudinal clinical trials. The proposed model is capable of dealing with longitudinal data from unknown heterogeneous populations. As applied to longitudinal clinical trials, for example, the model can distinguish subgroups of treatment response. Use of the proposed model is illustrated by analyzing data from two psychiatric clinical trials. The first includes depressed patients assigned to drug treatment who are repeatedly measured in terms of their level of depression. The second trial examined schizophrenic patients longitudinally who were assigned to either a drug or placebo condition. For both, the random-effects mixture model allows an assessment of whether patients comprise distinct populations in terms of their treatment response. Based on parameter estimates of the mixture model, ample evidence for a mixture of response to treatment is observed for both datasets.

Algorithms↗

PubMed1991

Hyperthermia and radiation therapy of local-regional recurrent breast cancer: prognostic factors for response and local control of diffuse or nodular tumors.

Over the past decade, hyperthermia has been extensively studied as an adjuvant to radiation therapy in the management of local-regional metastases from adenocarcinoma of the breast. A retrospective review of our experience from July 1982 to January 1990 identified 241 fields in 89 patients which satisfied the following criteria: biopsy confirmation of recurrent or metastatic adenocarcinoma of the breast; involvement of the chest wall and/or regional lymph nodes with diffuse or nodular metastases; treatment which included radiation therapy and externally administered hyperthermia during which mechanically-mapped and/or multipoint normal tissue and intratumoral temperatures were monitored; and at least one follow-up evaluation at 3 weeks or more after completion of treatment. The majority of fields were in patients who had extensive prior treatment including radiation therapy (68%), chemotherapy (86%), and hormonal therapy (58%). Treatment consisted of radiation therapy (average dose: 39.88 Gy) and hyperthermia (1-12 treatments; average 3.12); concurrent chemotherapy or hormonal therapy were also administered in 3% and 32% of the fields, respectively. Parameters characterizing the initial breast cancer, the patient and tumor at the time of hyperthermia, and the treatment were studied in univariate and multivariate analyses with complete response rate at the time of maximum tumor regression and duration of local control as endpoints. The treatments were well tolerated with no life-threatening complications noted. The means for all fields of the mean minimum, mean maximum, and mean average measured intratumoral temperatures were 40.3 degrees C, 44.6 degrees C, and 42.4 degrees C, respectively. At 3 weeks following completion of radiation therapy, response rates were: complete response (52%), partial response (8%), no response (17%), and continuing regression (monotonic regression to less than 50% of initial volume) was noted in 22% of the fields. At the time of maximum tumor regression local control was noted in 72% of the fields. Five parameters correlated with higher complete response in univariate and multivariate analysis: lower T-stage of the initial breast cancer; at the time of hyperthermia age less than 50 years, Karnofsky status greater than 95%, and the absence of distant metastases; and the use of concurrent hormonal therapy. The absence of a family history of breast cancer and concurrent radiation dose greater than or equal to 25 Gy significantly correlated with higher complete response in the univariate but not in the best multivariate models.(ABSTRACT TRUNCATED AT 400 WORDS)

Breast Neoplasms↗

PubMed1999

High-dose natural interferon-alpha therapy for chronic hepatitis C with a high viral load: predictors of efficacy. The Aomori, Akita and Iwate Areas Viral Hepatitis Research Group.

BACKGROUND: The effectiveness of interferon against hepatitis C has been found to be greatly affected by viral factors. However, few controlled interferon trials have involved seemingly intractable cases of chronic hepatitis C. METHODS: In 44 patients with high hepatitis C virus RNA levels (> or = 10(5) copies/mL), we carried out a prospective, controlled study of two natural interferon-alpha regimens, seeking predictors of therapeutic efficacy. Total natural interferon-alpha doses over 6 months in two groups were 780 and 840 million units, respectively. RESULTS: High therapeutic efficacy was achieved with no significant outcome difference between the regimens. The virus eradication rate was 35% and the rate of sustained biochemical response was 45% for both regimens. Multivariate logistic regression analysis identified viral genotype as the only significant predictor of success in viral eradication. CONCLUSIONS: Hepatitis C virus genotype 2 showed high sensitivity to interferon-alpha and this therapy can be recommended even for patients with a high viral load of this genotype. In contrast, with genotype 1b, cure was extremely difficult in cases with 10(7) or more copies/mL with a single 6-month course of interferon-alpha.

Adult↗

PubMed2002

A randomized and controlled pilot trial of beta-blockers for the treatment of recurrent syncope in patients with a positive or negative response to head-up tilt test.

The aim of this study was to assess the efficacy of lipophilic beta-blockers in preventing recurrent neurocardiogenic syncope and the value of head-up tilt test (HUT) in predicting response to therapy. The efficacy of beta-blockers in recurrent syncope is controversial. The value of HUT in predicting efficacy of therapy has not been investigated. Fifty-six patients (44+/-18 years, 36 women) with recurrent syncope (> 1 event in the last 6 months) of suspected neurocardiogenic origin were included in the study. Independent of the response to HUT, patients were randomized to receive metoprolol or propanolol at the maximal tolerated dose (28 patients, group A, 86+/-23 vs 98+/-29 mg/d) or no pharmacological therapy (28 patients, group B). The primary endpoint was the first recurrence of syncope. During the 1-year of follow-up, 20 patients of group A and 8 of group B had no recurrence. In group A, of 20 patients without recurrences 12 had a positive and 8 a negative HUT result while of 8 patients with recurrences 5 had a positive and 3 a negative response to HUT. In the group B, of 20 patients with recurrences 10 had a positive and 10 a negative HUT result while of 8 patients without recurrences 4 had a positive and 4 a negative response to HUT. In a multivariate Cox-regression analysis, medical therapy was the only independent factor for predicting recurrence of syncope (P = 0.004); HUT had no influence in this regard (P = 0.773). In conclusion, lipophilic beta-blockers appear efficacious in preventing recurrent syncope of suspected neurocardiogenic origin. The efficacy of therapy seems to be not predicted by HUT.

Adrenergic beta-Antagonists↗

PubMed1999

Work-related eye injuries among union carpenters.

Union administrative records were combined with workers' compensation data to identify a cohort of 12,958 active union carpenters, their person-time at risk, and their documented work-related eye injuries between 1989 and 1995 in the state of Washington. The injuries were described using ANSI codes for injury nature, type (mechanism), and source or object associated with the event. Injuries which resulted in paid lost time from work were also described based on the ICD-9 codes attached to claims for their medical treatment. Overall rates of filing compensation claims for eye injuries as well as age, gender, and union local specific rates were calculated. To identify high risk subgroups and explore incident and recurrent events, the person-time and events were stratified by age, gender, time in the union, claim status, and predominant type of work of the union local with which each carpenter was affiliated for multivariate analyses with Poisson regression. Eye injuries were responsible for 12 percent (n = 1730) of workers' compensation claims during this time period, exceeded only by back and finger injuries. Thirty-one claims resulted in paid lost time from work and these cases accounted for one-third of all costs for medical care for eye injuries. At least 10 percent of all medical costs for eye injuries and 35.5 percent of medical costs for eye injuries which resulted in paid lost time were associated with injuries sustained while hammering--a very common carpenter exposure. Claims were filed at an estimated rate of 6.1 per 200,000 hours worked. Individuals with previous compensation claims for eye injuries had rates of injury 1.6 times higher than individuals without previous eye injuries. Rates decreased significantly with age and time in the union. Eye injuries among these union carpenters were very common, but the rate of injuries severe enough to require paid time off work was quite low. These findings raise questions about factors which might influence the failure to use appropriate protection including availability and acceptability of eye protection, use by peers, and perception of risk.

Adult↗

PubMed1999

Physicians' attitudes toward reclassifying drugs as over-the-counter.

OBJECTIVES: Releasing prescription drugs over-the-counter (OTC) has been a trend in many Western countries. The purpose of this study was to find out about Finnish physicians' attitudes towards OTC switches and to find out whether transfer of drugs that are used in a doctor's own area of specialty increases negative attitudes toward release. For the latter purpose, gynecologists' perceptions about the availability of vaginal antifungal OTC drugs was studied. METHODS: Postal questionnaire to a representative random sample of gynecologists (n = 169) and general practitioners (GPs) (n = 288) in six counties in Finland in 1996. After a reminder, the response rate was 77% (n = 341). Multivariate logistic regression models were used to explore the relationship of factors to attitudes toward OTC drugs. RESULTS: The overall attitude toward the availability of OTC drugs was moderately positive but was more reserved toward those drugs only recently given OTC status. However, physicians were judged in many cases to be the most suitable source of information on OTC drugs. GPs working in health centers, more often than other physicians, found drugs suitable for self medication. Our hypothesis about gynecologists being against the release of vaginal antifungal drugs was not supported. CONCLUSIONS: Physicians' views about OTC drugs are influenced by the current OTC status of the drug and by public discussion. The place of work has an important influence on these opinions, most likely reflecting the effect of case mix and patient load.

Adult↗

PubMedDate not supplied

Factors that influence emergency department visits for asthma.

BACKGROUND: Asthma can usually be controlled through allergen avoidance and/or appropriate medication. An emergency department visit for an acute exacerbation of asthma often represents a breakdown in asthma management. Emergency department treatment results in significant health care expenditures and reflects a compromised quality of life. OBJECTIVES: To identify risk factors associated with an emergency department visit for asthma. METHODS: This case-control study compared 299 people (76% of 390 cases contacted) who attended one of two emergency departments in Alberta in 1992 and 1993 for an acute exacerbation of asthma (cases) with 212 unmatched community controls with asthma who were located by random digit dialing. Cases and controls were asked to complete a mailed questionnaire to obtain data regarding severity, visits to doctors and emergency departments, medication use, allergies and other triggers, and smoking history. Data analysis included bivariate analysis of risk factors and multivariate model development using logistic regression. RESULTS: The response rate was similar between cases and controls. Cases were younger than controls (odds ratio [OR] 2.16, 95% CI 1.34 to 3.48) and more often reported their asthma to be severe (OR 4.25, 95% CI 2.24 to 8.06), and had experienced nocturnal symptoms (stratified OR range 1.36 to 6.82). Cases used more health care services in the previous year, had been admitted to hospital at some time for asthma (OR 1.62, 95% CI 1.10 to 2.38) and used more medication than controls. CONCLUSIONS: Physicians and other health care workers should be sensitive to the risk factors and target interventions to high risk individuals.

Acute Disease↗

PubMed1999

Use of complementary therapies by patients attending musculoskeletal clinics.

Patients with musculoskeletal disorders commonly seek treatment outside orthodox medicine (complementary therapy). In patients attending hospital clinics we investigated the prevalence of such behaviour and the reasons for it. Patients attending rheumatology and orthopaedic clinics who agreed to participate were interviewed on the same day by means of a structured questionnaire in three sections: the first section about demographic characteristics; the second about the nature and duration of the complaint, the length of any treatment and whether the patient was satisfied with conventional treatment; and the third about the use of complementary medicine, the types of therapy that had been considered and the reasoning behind these decisions. The data were examined by univariate and bivariate analysis as well as logistic regression multivariate analysis. 166 patients were interviewed (99% response rate) and the predominant diagnosis was rheumatoid arthritis (22.3%). 109 patients (63%) were satisfied with conventional medical treatment; 63 (38%) had considered the use of complementary therapies, and 47 (28%) had tried such a therapy. 26 of the 47 who had used complementary therapy said they had gained some benefit. Acupuncture, homoeopathy, osteopathy and herbal medicine were the most popular types of treatment to be considered. Patients of female gender (P = 0.009) and patients who had expressed dissatisfaction with current therapies (P = 0.01) were most likely to have considered complementary medicine. These results indicate substantial use of complementary therapy in patients attending musculoskeletal disease clinics. The reasons for dissatisfaction with orthodox treatment deserve further investigation, as does the effectiveness of complementary treatments, which must be demonstrated before they are integrated with orthodox medical practice.

Adolescent↗

PubMed2003

Homicide in children and adolescents: a case-control study in Recife, Brazil.

OBJECTIVE: The homicide rate for children and adolescents in Recife, Brazil, mostly caused by firearms, is one of the highest that has been reported. The present case-control study was designed to identify factors that were potentially modifiable through preventive interventions. METHODS: Cases were 255 homicide victims under 20 years of age, who had died in 1997 and been identified at the Institute of Forensic Medicine, Police Department, Recife, and whose relatives were interviewed by two community health workers when they claimed the corpse. The 255 controls were neighbours of the cases, paired by age and sex to them, and identified within one week of identification of each case, and whose relatives were interviewed by a third community health worker. FINDINGS: The overall homicide rate in Recife for under-20-year-olds in 1997 was 49 per 100,000; among males aged 15-19 years it was 324 per 100,000. Firearms were responsible for 97% of deaths. After multivariate logistic regression, history of personal police records (odds ratio (OR) = 18.65; 95% confidence interval (CI) = 1.91-182.50), use of illicit drugs (OR = 7.48; 95% CI = 1.86-30.17), tap water at home (OR = 7.30; 95% CI = 1.80-29.59), and maternal age at birth over 26 years (OR = 3.98; 95% CI = 1.79-8.84) were identified as risk factors, while higher education (OR = 0.22; 95% CI = 0.11-0.43), religious practice (OR = 0.25; 95% CI = 0.10-0.65), and presence of the father in the household (OR = 0.28; 95% CI = 0.09-0.81) were protective factors. CONCLUSION: Public health authorities should plan preventive interventions based on the findings of this study and should control the acquisition, possession and carrying of firearms.

Adolescent↗

PubMed1996

Risk factors for bleeding during treatment of acute venous thromboembolism.

OBJECTIVE: Identification of risk factors for bleeding and prospective evaluation of two bleeding risk scores in the treatment of acute venous thromboembolism. DESIGN: Secondary analysis of a prospective, randomized, assessorblind, multicenter clinical trial. SETTING: One university and 2 regional teaching hospitals. PATIENTS: 188 patients treated with heparin or danaparoid for acute venous thromboembolism. MEASUREMENTS: The presenting clinical features, the doses of the drugs, and the anticoagulant responses were analyzed using univariate and multivariate logistic regression analysis in order to evaluate prognostic factors for bleeding. In addition, the recently developed Utrecht bleeding risk score and Landefeld bleeding risk index were evaluated prospectively. RESULTS: Major bleeding occurred in 4 patients (2.1%) and minor bleeding in 101 patients (53.7%). For all (major and minor combined) bleeding, body surface area < or = 2 m2 (odds ratio 2.3, 95% CI 1.2-4.4; p = 0.01), and malignancy (odds ratio 2.4, 95% CI 1.1-4.9; p = 0.02) were confirmed to be independent risk factors. An increased treatment-related risk of bleeding was observed in patients treated with high doses of heparin, independent of the concomitant activated partial thromboplastin time ratios. Both bleeding risk scores had low diagnostic value for bleeding in this sample of mainly minor bleeders. CONCLUSIONS: A small body surface area and malignancy were associated with a higher frequency of bleeding. The bleeding risk scores merely offer the clinician a general estimation of the risk of bleeding. In patients with a small body surface area or in patients with malignancy, it may be of interest to study whether limited dose reduction of the anticoagulant drug may cause less bleeding without affecting efficacy.

Acenocoumarol↗

PubMed1995

The changing profile of patient selection, procedural techniques, and outcomes in excimer laser coronary angioplasty. Participating Investigators of the Percutaneous Excimer Laser Coronary Angioplasty Registry.

During the course of development of excimer laser angioplasty, several changes in patient selection and technique have occurred. It is uncertain, however, whether these changes have been associated with improved procedural outcome. In this study, multivariable regression methods were used to identify the factors responsible for clinical success, major complications, and vessel perforation in 2,041 consecutive patients treated with excimer laser coronary angioplasty. The overall rates of clinical success were 89%, major complications 7.5%, and vessel perforation 2.1%. Clinical success was 86% in patients treated with prototype catheters, 89% with flexible catheters, 92% with extremely flexible catheters, and 95% in patients treated with directional eccentric catheters (P < 0.001). By multivariable analysis, clinical success increased with each subsequent catheter design (odds ratio [OR] = 1.4 per iteration [95% confidence interval 1.2, 1.6]), and with improved lesion selection. Major complications were reduced when operators had performed more than 25 cases (rate = 6.5%, OR = 0.7 [0.5, 0.9]), and the incidence of vessel perforation was decreased when the size of the target vessel was > 1.0 mm larger than the diameter of the laser catheter (rate = 1.1%, OR = 0.3 [0.2, 0.5]). In conclusion, during the course of clinical investigation with excimer laser angioplasty, procedural outcome has improved. These results emphasize the importance of careful patient selection and procedural technique to enhance the success of excimer laser angioplasty.

Aged↗