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PubMed2006

C-reactive protein and mortality in mild to moderate chronic obstructive pulmonary disease.

BACKGROUND: Although C-reactive protein (CRP) levels are increased in chronic obstructive pulmonary disease (COPD), it is not certain whether they are associated with adverse clinical outcomes. METHODS: Serum CRP levels were measured in 4803 participants in the Lung Health Study with mild to moderate COPD. The risk of all-cause and disease specific causes of mortality was determined as well as cardiovascular event rates, adjusting for important covariates such as age, sex, cigarette smoking, and lung function. Cardiovascular events were defined as death from coronary heart disease or stroke, or non-fatal myocardial infarction or stroke requiring admission to hospital. RESULTS: CRP levels were associated with all-cause, cardiovascular, and cancer specific causes of mortality. Individuals in the highest quintile of CRP had a relative risk (RR) for all-cause mortality of 1.79 (95% confidence interval (CI) 1.25 to 2.56) compared with those in the lowest quintile of CRP. For cardiovascular events and cancer deaths the corresponding RRs were 1.51 (95% CI 1.20 to 1.90) and 1.85 (95% CI 1.10 to 3.13), respectively. CRP levels were also associated with an accelerated decline in forced expiratory volume in 1 second (p < 0.001). The discriminative property of CRP was greatest during the first year of measurement and decayed over time. Comparing the highest and lowest CRP quintiles, the RR was 4.03 (95% CI 1.23 to 13.21) for 1 year mortality, 3.30 (95% CI 1.38 to 7.86) for 2 year mortality, and 1.82 (95% CI 1.22 to 2.68) for > or =5 year mortality. CONCLUSIONS: CRP measurements provide incremental prognostic information beyond that achieved by traditional markers of prognosis in patients with mild to moderate COPD, and may enable more accurate detection of patients at a high risk of mortality.

Adult↗

PubMed1996

Intermittent negative pressure ventilation in the treatment of hypoxic hypercapnic coma in chronic respiratory insufficiency.

BACKGROUND: In recent years non-invasive ventilatory techniques have been used successfully in the treatment of acute on chronic respiratory failure (ACRF), but careful selection of patients is essential and a comatose state may represent an exclusion criterion. The aim of this retrospective and uncontrolled study was to evaluate whether a non-invasive ventilatory technique such as the iron lung could also be used successfully in patients with hypoxic hypercapnic coma, thus widening the range for application of non-invasive ventilatory techniques. METHODS: A series of 150 consecutive patients with ACRF and hypoxic hypercapnic coma admitted to our respiratory intensive care unit were evaluated retrospectively. The most common underlying condition was chronic obstructive pulmonary disease (79%). On admission a severe hypoxaemia (Pao2 5.81 (3.01) kPa) and hypercapnia (Paco2 14.88 (2.78) kPa) associated with a decompensated acidosis (pH 7.13 (0.13)) were present, the Glasgow coma score ranged from 3 to 8, and the mean APACHE II score was 31.6 (5.3). All patients underwent intermittent negative pressure ventilation with the iron lung. The study end point was based on a dichotomous classification of treatment failure (defined as death or need for endotracheal intubation) versus therapeutic success. RESULTS: There were 45 treatment failures (30%) and 36 deaths (24%). Nine patients (6%) required intubation because of lack of airway control. The median total duration of ventilation was 27 hours per patient (range 2-274). The 105 successfully treated cases recovered consciousness after a median of four hours (range 1-90) of continuous ventilatory treatment and were discharged after 12.1 (9.0) days. CONCLUSIONS: These results show that, in patients with acute on chronic respiratory failure and hypoxic hypercapnic coma, the iron lung resulted in a high rate of success. As this study has the typical limitations of all retrospective and uncontrolled studies, the results need to be formally confirmed by controlled prospective studies. Confirmation of these results could widen the range of application of non-invasive ventilatory techniques.

Aged↗

PubMedDate not supplied

Prospective study on the complication rate of carotid surgery.

BACKGROUND: Randomized trials of carotid endarterectomy for high-grade stenosis have shown a benefit for surgery under the condition of low perioperative complication rates. Concerns have been expressed that the complication rates of carotid surgery are higher in everyday practice and may vary considerably between centers. We prospectively established the complication rate for carotid surgery in a single institution. DESIGN: Prospective 2-year study. All patients received pre- and postoperative neurological evaluation. Laboratory tests included pre- and postoperative brain imaging, intracranial and neck vessel sonography, conventional angiography, magnetic resonance angiography, and intraoperative monitoring. PARTICIPANTS: 108 consecutive patients: 54 symptomatic patients fulfilling the inclusion criteria of the European Carotid Surgery Trial (ECST) and 54 asymptomatic patients fulfilling the inclusion criteria of the North American Trial on Asymptomatic Stenoses (ACAS). SETTING: Single academic center with a high volume of carotid endarterectomies (>50 per year). Participating center in ECST. MAIN OUTCOME MEASURES: Stroke or death as defined in the randomized trials. RESULTS: The overall complication rate was 8.3% (95% CI 4.1-15.6%). Complications were more frequent in patients with symptomatic stenosis (11.1%, CI 4.6-23.3%) than in asymptomatic cases (5.6%, CI 1.5-16.4%). Three patients died (2 strokes, 1 myocardial infarction). Disabling strokes were found in 2 patients (Rankin scale scores 3 and 4). Nondisabling strokes (Rankin scale score 1 and 2) occurred in 4 patients. The complication rates for symptomatic and asymptomatic patients were higher than the ones reported in the randomized trials, but 95% confidence intervals showed that the differences were not statistically significant. The point estimates of complication rates still supported a benefit of surgery for patients with symptomatic stenosis, but denied a positive effect of endarterectomy for patients with asymptomatic stenosis. CONCLUSION: In this center, a beneficial effect of carotid surgery for asymptomatic stenoses cannot be safely assumed.

Adult↗

PubMed2002

Cognitive functions and depression as predictors of poor outcome 15 months after stroke.

The prognostic predictors of poor outcome, as defined by death between 3 and 15 months and dependent living at 15 months, were examined in the Helsinki Stroke Aging Memory (SAM) study cohort. Death between 3 and 15 months was registered from the whole study group of 486 consecutive patients aged 55-85 years. Altogether 286 of the 486 patients went through a detailed follow-up examination both 3 and 15 months after stroke, including structured measures of emotion (Beck's Depression Inventory, BDI), cognition (Mini-Mental State Examination, MMSE), dementia assessment according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-III), and handicap (Rankin scale, RS). The only independent correlate of death between 3 and 15 months was dependent living at 3 months (OR 2.6, 95% CI 1.2-5.8), which also had the most powerful association with dependent living at 15 months (OR 5.8, 95% CI 2.6-13.1). Also, both worsening in cognition (change in MMSE, OR for each point of worsening 1.2, 95% CI 1.1-1.3) and worsening of depression (change in BDI, OR for each point of worsening 1.1, 95% CI 1.02-1.12), between 3 and 15 months follow-up, had an independent effect on dependent living 15 months after ischemic stroke. This challenges the care and rehabilitation of these items even at the stable period after stroke.

Activities of Daily Living↗

PubMed2003

Early arterial lactate and prediction of outcome in preterm neonates admitted to a neonatal intensive care unit.

AIM: In the present study early arterial lactate samples were examined to predict adverse outcome in preterm neonates. SUBJECTS AND METHODS: 88 preterm neonates (mean gestational age 29.8 weeks, mean birth weight 1,225 g) had arterial lactate levels measured from indwelling arterial catheters within the first 3 h of life. An adverse outcome was defined as death or abnormal neurodevelopment. The positive (PPV) and negative predictive value (NPV) of early arterial lactate levels for an adverse outcome (death or neurodevelopmental abnormalities) were calculated using receiver operating characteristic analysis. RESULTS: PPV and NPV of arterial lactate within 3 h after birth were 0.47 and 0.92, respectively, with a cutoff value of 5.7 mmol/l. Umbilical blood gas values and 1 and 5 min Apgar scores had much lower PPVs. CONCLUSION: Arterial lactate levels within 3 h of life can be used to select preterm neonates who are at risk of an adverse outcome.

Apgar Score↗

PubMed2003

Treatment of secondary peritonitis: is a less expensive broad-spectrum antibiotic as effective as a carbapenem?

BACKGROUND: In this retrospective study, the possibility of using amoxicillin/clavulanate for empirical therapy of secondary peritonitis as an alternative to imipenem was explored. METHODS: All secondary peritonitis cases at our institution between 1998 and 2000 were included. Susceptibility to imipenem and amoxicillin/clavulanate of microorganisms isolated in peritoneal fluid and success rates were compared. Therapeutic failure was defined as death, necessity of repeated surgical intervention, or clinical deterioration with persistent positive cultures. RESULTS: Seventy-six cases of secondary peritonitis with 156 microorganisms were found. One hundred and forty-nine (98%) were susceptible to imipenem versus 124 (82%) to amoxicillin/clavulanate (p = 0.0001). Thirteen therapeutic failures occurred in 52 patients treated with amoxicillin/clavulanate (25%) versus 3 out of 8 (38%) with imipenem (p = 0.43). The proportion of organisms resistant to amoxicillin/clavulanate in therapeutic failures was greater in nosocomial versus community-acquired secondary peritonitis (p = 0.041). CONCLUSION: Despite its better in vitro bacteriological activity, clinical efficacy of imipenem was identical to amoxicillin/clavulanate. The use of amoxicillin/clavulanate instead of imipenem would save 889 Euro per case.

Amoxicillin-Potassium Clavulanate Combination↗

PubMed2004

Effects and safety of intracoronary thrombectomy using transradial application of the PercuSurge distal balloon protection system in patients with early or recent myocardial infarction.

BACKGROUND: Distal embolization and no reflow are likely during primary percutaneous coronary intervention (PCI) on the large infarct-related artery (IRA), which mostly contains high-burden thrombus formation (HBTF) and plaque burden. Mechanical devices to prevent distal atheroembolism may be of importance for preserving reperfusion and microvascular integrity in IRA. METHODS AND RESULTS: Between May 2002 and December 2002, transradial application (TRA) of the PercuSurge GuardWire device with 7-french arterial sheath was performed in 39 consecutive patients who experienced early (>12 h and </=7 days) or recent (>7 days and <14 days) myocardial infarction (MI) associated with large IRA (vessel size >/=3.5 mm with HBTF; group 1). Between January 2001 and April 2002, 64 consecutive patients who had early or recent MI associated with HBTF in IRA of a vessel size >/=3.5 mm received TRA of PCI with adjunctive tirofiban therapy but without using the adjunctive PercuSurge GuardWire device (group 2). The angiographic and clinical outcomes of both groups were compared in a chronologically consecutive manner. The procedural success rate and post-PCI myocardial blush grades were significantly higher in group 1 than in group 2 patients (all p values <0.05), whereas a combined incidence of vascular and bleeding complications and 30-day major adverse cardiac events (defined as death, reinfarction and repeated PCI of IRA) were significantly higher in group 2 than in group 1 patients (all p values <0.05). CONCLUSIONS: Our data suggested that TRA using the PercuSurge GuardWire device during PCI for patients with early or recent MI and HBTF in IRA was safe and feasible. This mechanical device provided more additional benefit to patients in this clinical setting than a combination of conventional PCI and tirofiban therapy.

Aged↗

PubMed2005

-455G/A polymorphism and preprocedural plasma levels of fibrinogen show no association with the risk of clinical restenosis in patients with coronary stent placement.

The effect of preprocedural fibrinogen levels on in-stent restenosis is largely unknown. The -455G/A polymorphism of the fibrinogen beta-gene is associated with baseline plasma level or acute phase increase of fibrinogen. Therefore, we hypothesized that there is a relationship between this polymorphism and preprocedural fibrinogen level and clinical restenosis at follow-up among patients with coronary stent placement. The GENetic DEterminants of Restenosis (GENDER) project is a multicenter follow-up study that enrolled 3,146 consecutive patients after successful percutaneous coronary intervention. A coronary stent was placed in 2,309 patients. Of these, 2,257 (97.7%) patients were successfully genotyped for the -455G/A polymorphism. Plasma fibrinogen levels were measured at baseline in a subpopulation of 623 stented patients with the von Clauss method and patients were grouped into tertiles according to fibrinogen levels. Primary endpoint was target vessel revascularization (TVR); secondary combined endpoint was defined as death presumably from cardiac causes, MI not attributable to another coronary artery than the target vessel, and TVR. No association was observed between the -455G/A polymorphism and TVR or combined endpoint (p=0.99, p=0.97, respectively). Multivariate regression analysis revealed that the risk of TVR and combined endpoint was not higher for patients in the highest tertile for fibrinogen versus the lowest tertile (RR=0.60, 95% CI: 0.26-1.37 for TVR, RR=0.64, 95% CI: 0.29-1.44 for combined endpoint). In conclusion, the presence of -455G/A polymorphism in the fibrinogen beta-gene and preprocedural fibrinogen level is not associated with an increased risk of TVR or combined endpoint in a patient population with coronary stent placement. Therefore, these parameters are not worthwhile for stratifying patients at risk for restenosis pre-stenting.

Aged↗

PubMed1997

The relationship of soluble fibrin and cross-linked fibrin degradation products to the clinical course of myocardial infarction.

Recently, increases in the plasma concentration of soluble fibrin (SF) have been suggested to be sensitive and specific for myocardial infarction (MI). However, the relationship between elevations in the SF concentration and the onset of symptoms and clinical course of MI is unknown. In addition, there are no data regarding the relationship between SF concentrations and concentrations of other markers of procoagulant (fibrinopeptide A [FPA]) and fibrinolytic (cross-linked fibrin degradation products [XL-FDPs]) activity in patients with MI. In this study, concentrations of SF were measured with a novel antigen-based assay for 93 MI patients and 29 control subjects, and the relationship between SF concentrations and those of XL-FDPs and FPA was determined. Increases in SF, FPA, and XL-FDP concentrations were documented in 55.9%, 45.2%, and 73.9%, respectively, of patients with MI, but there was no relationship between the concentrations of these markers. Increases in the concentration of SF or XL-FDPs did not show a relationship to increases in the concentration of FPA. Concentrations of XL-FDPs but not of SF were elevated to a greater extent in patients with MI complications (defined as death, ventricular arrhythmia, severe congestive heart failure, or mural thrombus). Increases in SF and XL-FDPs were not sensitive enough for the diagnosis of MI, but increased concentrations of XL-FDPs appear to predict those patients who are at higher risk for MI-related complications.

Adult↗

PubMed2000

Assessment of aortic valve stenosis severity: A new index based on the energy loss concept.

BACKGROUND: Fluid energy loss across stenotic aortic valves is influenced by factors other than the valve effective orifice area (EOA). We propose a new index that will provide a more accurate estimate of this energy loss. METHODS AND RESULTS: An experimental model was designed to measure EOA and energy loss in 2 fixed stenoses and 7 bioprosthetic valves for different flow rates and 2 different aortic sizes (25 and 38 mm). The results showed that the relationship between EOA and energy loss is influenced by both flow rate and aortic cross-sectional area (A(A)) and that the energy loss is systematically higher (15+/-2%) in the large aorta. The coefficient (EOAxA(A))/(A(A)-EOA) accurately predicted the energy loss in all situations (r(2)=0.98). This coefficient is more closely related to the increase in left ventricular workload than EOA. To account for varying flow rates, the coefficient was indexed for body surface area in a retrospective study of 138 patients with moderate or severe aortic stenosis. The energy loss index measured by Doppler echocardiography was superior to the EOA in predicting the end points, which were defined as death or aortic valve replacement. An energy loss index </=0.52 cm(2)/m(2) was the best predictor of adverse outcomes (positive predictive value of 67%). CONCLUSIONS: This new energy loss index has the potential to reflect the severity of aortic stenosis better than EOA. Further prospective studies are necessary to establish the relevance of this index in terms of clinical outcomes.

Adult↗

PubMed1994

Low molecular weight heparin in prevention of restenosis after angioplasty. Results of Enoxaparin Restenosis (ERA) Trial.

BACKGROUND: Heparin, an anticoagulant, possesses antiproliferative effects and has been shown to reduce neointimal proliferation and restenosis following vascular injury in experimental studies. METHODS AND RESULTS: The primary aim of this double-blind multicenter study was to determine if 40 mg Enoxaparin, a low molecular weight heparin, administered subcutaneously once daily for 1 month after successful angioplasty would reduce the incidence of restenosis. Four hundred fifty-eight patients were randomized at nine clinical centers (231 to placebo and 227 to Enoxaparin). The primary end point was angiographic or clinical restenosis. Angiographic restenosis was defined as a loss of 50% of the initial gain as measured by quantitative coronary angiography (QCA) at a core laboratory. In the absence of QCA, clinical evidence of restenosis was defined as death, myocardial infarction, repeat revascularization, or worsening angina. Using the intention-to-treat analysis for all patients, restenosis occurred in 51% of the placebo group and 52% of the Enoxaparin group (relative risk, 1.07, P = .625). Likewise, no difference in restenosis was evident when the change in minimal lumen diameter or other angiographic definitions of restenosis were used. Adverse clinical events were infrequent and did not differ between the groups with the exception of minor bleeding complications, which were more common in the Enoxaparin group. CONCLUSIONS: Enoxaparin (40 mg/d SC for 1 month) following successful angioplasty did not reduce the incidence of angiographic restenosis or the occurrence of clinical events over 6 months. The treatment was well tolerated, although in-hospital minor bleeding was more common with active treatment.

Angioplasty, Balloon, Coronary↗

PubMed1995

Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial.

BACKGROUND: Direct thrombin inhibitors are a new class of drugs that may offer a more effective and potentially simpler alternative to heparin. Hirulog is a synthetic peptide based on the leech-derived compound hirudin and, like hirudin, is a highly specific, direct inhibitor of free and clot-bound thrombin. METHODS AND RESULTS: TIMI 7 was a randomized, double-blind study of Hirulog, given with 325 mg/d aspirin to 410 patients with unstable angina. Patients received a constant infusion of Hirulog for 72 hours at one of four doses: 0.02 (n = 160), 0.25 (n = 81), 0.5 (n = 88), and 1.0 (n = 81) mg.kg-1.h-1. The primary efficacy end point was "unsatisfactory outcome," defined as death, nonfatal myocardial infarction (MI), rapid clinical deterioration, or recurrent ischemic pain at rest with ECG changes by 72 hours. Unsatisfactory outcome was not different among the four dose groups: 8.1%, 6.2%, 11.4%, and 6.2% (P = NS). However, the secondary end point of death or nonfatal MI through hospital discharge occurred in 10.0% of patients treated with 0.02 mg.kg-1.h-1 compared with 3.2% of patients treated with the three higher doses of Hirulog (0.25, 0.5, and 1.0 mg.kg-1.h-1, P = .008). Only 2 of 410 patients (0.5%) experienced a major hemorrhage attributed to Hirulog. CONCLUSIONS: The direct thrombin inhibitor Hirulog is a promising new antithrombotic agent that deserves further study. The results of TIMI 7 lend support to the use of an antithrombin agent with aspirin in patients with unstable angina.

Adult↗

PubMed1996

Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure. US Carvedilol Heart Failure Study Group.

BACKGROUND: We tested the hypothesis that carvedilol inhibits clinical progression in patients with mildly symptomatic heart failure due to left ventricular (LV) systolic dysfunction. METHODS AND RESULTS: Patients (n = 366) who had mildly symptomatic heart failure with an LV ejection fraction (LVEF) < or = 0.35, had minimal functional impairment (defined as the ability to walk 450 to 550 m on a 6-minute walk test), and were receiving optimal standard therapy, including ACE inhibitors, were randomized double-blind to carvedilol (n = 232) or placebo (n = 134) and followed up for 12 months. The primary end point was clinical progression, defined as death due to heart failure, hospitalization for heart failure, or a sustained increase in heart failure medications. Clinical progression of heart failure occurred in 21% of placebo patients and 11% of carvedilol patients, reflecting a 48% (P = .008) reduction in the primary end point of heart failure progression (relative risk, 0.52; CI, 0.32 to 0.85). This effect of carvedilol was not influenced by sex, age, race, cause of heart failure, or baseline LVEF. Carvedilol also significantly improved several secondary end points, including LVEF, heart failure score, NYHA functional class, and the physician and patient global assessments. Carvedilol reduced all-cause mortality but had no effects on the Minnesota Living With Heart Failure scale, the distance walked in 9 minutes on a self-powered treadmill, or cardiothoracic index. The drug was well tolerated. CONCLUSIONS: Carvedilol, when added to standard therapy, including an ACE inhibitor, reduces clinical progression in patients who are only mildly symptomatic with well-compensated heart failure.

Adolescent↗

PubMed1997

Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome.

BACKGROUND: Only limited data on the rate of hemodynamic progression and predictors of outcome in asymptomatic patients with valvular aortic stenosis (AS) are available. METHODS AND RESULTS: In 123 adults (mean age, 63 +/- 16 years) with asymptomatic AS, annual clinical, echocardiographic, and exercise data were obtained prospectively (mean follow-up of 2.5 +/- 1.4 years). Aortic jet velocity increased by 0.32 +/- 0.34 m/s per year and mean gradient by 7 +/- 7 mm Hg per year; valve area decreased by 0.12 +/- 0.19 cm2 per year. Kaplan-Meier event-free survival, with end points defined as death (n = 8) or aortic valve surgery (n = 48), was 93 +/- 5% at 1 year, 62 +/- 8% at 3 years, and 26 +/- 10% at 5 years. Univariate predictors of outcome included baseline jet velocity, mean gradient, valve area, and the rate of increase in jet velocity (all P < or = .001) but not age, sex, or cause of AS. Those with an end point had a smaller exercise increase in valve area, blood pressure, and cardiac output and a greater exercise decrease in stroke volume. Multivariate predictors of outcome were jet velocity at baseline (P < .0001), the rate of change in jet velocity (P < .0001), and functional status score (P = .002). The likelihood of remaining alive without valve replacement at 2 years was only 21 +/- 18% for a jet velocity at entry > 4.0 m/s, compared with 66 +/- 13% for a velocity of 3.0 to 4.0 m/s and 84 +/- 16% for a jet velocity < 3.0 m/s (P < .0001). CONCLUSIONS: In adults with asymptomatic AS, the rate of hemodynamic progression and clinical outcome are predicted by jet velocity, the rate of change in jet velocity, and functional status.

Aged↗

PubMed1998

Patent foramen ovale is an important predictor of adverse outcome in patients with major pulmonary embolism.

BACKGROUND: Right-to-left shunt through a patent foramen ovale is frequently diagnosed by contrast echocardiography and can be particularly prominent in the presence of elevated pressures in the right side of the heart. Its prognostic significance in patients with pulmonary thromboembolism, however, is unknown. METHODS AND RESULTS: The present prospective study included 139 consecutive patients with major pulmonary embolism diagnosed on the basis of clinical, echocardiographic, and cardiac catheterization criteria. All patients underwent contrast echocardiography at presentation. The end points of the study were overall mortality and complicated clinical course during the hospital stay defined as death, cerebral or peripheral arterial thromboembolism, major bleeding, or need for endotracheal intubation or cardiopulmonary resuscitation. Patent foramen ovale was diagnosed in 48 patients (35%). These patients had a death rate of 33% as opposed to 14% in patients with a negative echo-contrast examination (P=.015). Logistic regression analysis demonstrated that the only independent predictors of mortality in the study population were a patent foramen ovale (odds ratio [OR], 11.4; P<.001) and arterial hypotension at presentation (OR, 26.3; P<.001). Patients with a patent foramen ovale also had a significantly higher incidence of ischemic stroke (13% versus 2.2%; P=.02) and peripheral arterial embolism (15 versus 0%; P<.001). Overall, the risk of a complicated in-hospital course was 5.2 times higher in this patient group (P<.001). CONCLUSIONS: In patients with major pulmonary embolism, echocardiographic detection of a patent foramen ovale signifies a particularly high risk of death and arterial thromboembolic complications.

Adolescent↗

PubMed2006

Are there patients with acute ischemic stroke and atrial fibrillation that benefit from low molecular weight heparin?

BACKGROUND AND PURPOSE: Treatment doses of heparins are not recommended for acute ischemic stroke. Despite this, their use in this setting is widespread. We investigated whether subgroups of patients with acute ischemic stroke and atrial fibrillation, identified by clinical, hemostatic (d-dimer, prothombin fragments(1+2) [F(1+2)], soluble fibrin monomer), or inflammatory (C-reactive protein [CRP]) variables might have a differential response to low molecular weight heparin (LMWH) over aspirin. In addition, we sought to identify factors associated with a poor clinical outcome at 3 months. METHODS: We conducted a post hoc subgroup analysis of a randomized, placebo-controlled, double-blind trial (Heparin in Acute Embolic Stroke Trial) designed to test the hypothesis that treatment doses of LMWH (dalteparin; 100 IU/kg BID) would be superior to aspirin (160 mg per day) in patients with acute ischemic stroke and atrial fibrillation. For the current analysis, 431 participants were included. The primary outcome measure was a poor outcome at 3 months, defined as death or dependency in activities of daily living. Using regression analysis, we determined whether any of the chosen variables were associated with a differential response to dalteparin (treatment interaction) or with poor outcome. RESULTS: In the multivariable logistic regression model, none of the clinical, hemostatic, or inflammatory variables were associated with a significant treatment interaction. Stroke severity (odds ratio [OR], 1.09 [95% CI, 1.07 to 1.12]), increasing age (OR, 1.09 [CI, 1.05 to 1.14]), CRP level (OR, 1.32 [CI, 1.04 to 1.66]), and F(1+2) level (OR, 1.77 [CI, 1.07 to 2.91]) were independently associated with a poor outcome at 3 months. CONCLUSIONS: Our study does not support the use of treatment doses of LMWH in any of the studied subgroups of patients with acute ischemic stroke and atrial fibrillation. Age, stroke severity, CRP, and F(1+2) were predictive of poor outcome at 3 months.

Adult↗

PubMed2001

Very Early Nimodipine Use in Stroke (VENUS): a randomized, double-blind, placebo-controlled trial.

BACKGROUND AND PURPOSE: The Very Early Nimodipine Use in Stroke (VENUS) trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on survival and functional outcome after stroke. This was suggested in a previous meta-analysis on the use of nimodipine in stroke. However, in a recent Cochrane review we were unable to reproduce these positive results. This led to the early termination of VENUS after an interim analysis. METHODS: In this randomized, double-blind, placebo-controlled trial, treatment was started by general practitioners or neurologists within 6 hours after stroke onset (oral nimodipine 30 mg QID or identical placebo, for 10 days). Main analyses included comparisons of the primary end point (poor outcome, defined as death or dependency after 3 months) and secondary end points (neurological status and blood pressure 24 hours after inclusion, mortality after 10 days, and adverse events) between treatment groups. Subgroup analyses (on final diagnosis and based on the per-protocol data set) were performed. RESULTS: At trial termination, after inclusion of 454 patients (225 nimodipine, 229 placebo), no effect of nimodipine was found. After 3 months of follow-up, 32% (n=71) of patients in the nimodipine group had a poor outcome compared with 27% (n=62) in the placebo group (relative risk, 1.2; 95% CI, 0.9 to 1.6). A treatment effect was not found for secondary outcomes and in the subgroup analyses. CONCLUSIONS: The results of VENUS do not support the hypothesis of a beneficial effect of early nimodipine in stroke patients.

Acute Disease↗

PubMed2006

Extending the horizon in chronic heart failure: effects of multidisciplinary, home-based intervention relative to usual care.

BACKGROUND: The long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown. METHODS AND RESULTS: The effects of a nurse-led, multidisciplinary, home-based intervention (HBI) in a typically elderly cohort of patients with chronic heart failure initially randomized to either HBI (n=149) or usual postdischarge care (UC) (n=148) after a short-term hospitalization were studied for up to 10 years of follow-up (minimum 7.5 years of follow-up). Study end points were all-cause mortality, event-free survival (event was defined as death or unplanned hospitalization), recurrent hospital stay, and cost per life-year gained. Median survival in the HBI cohort was almost twice that of UC (40 versus 22 months; P<0.001), with fewer deaths overall (HBI, 77% versus 89%; adjusted relative risk, 0.74; 95% CI, 0.53 to 0.80; P<0.001). HBI was associated with prolonged event-free survival (median, 7 versus 4 months; P<0.01). HBI patients had more unplanned readmissions (560 versus 550) but took 7 years to overtake UC; the rates of readmission (2.04+/-3.23 versus 3.66+/-7.62 admissions; P<0.05) and related hospital stay (14.8+/-23.0 versus 28.4+/-53.4 days per patient per year; P<0.05) were significantly lower in the HBI group. HBI was associated with 120 more life-years per 100 patients treated compared with UC (405 versus 285 years) at a cost of 1729 dollars per additional life-year gained when we accounted for healthcare costs including the HBI. CONCLUSIONS: In altering the natural history of chronic heart failure relative to UC (via prolonged survival and reduced frequency of recurrent hospitalization), HBI is a remarkably cost- and time-effective strategy over the longer term.

Aged↗