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Biomedical subjects

A Leizorovicz

Publications and source records attributed to A Leizorovicz.

At least 19 recordsLinked to original sources
PubMed2007

Influence of age on the prescription of vitamin K antagonists in outpatients with permanent atrial fibrillation in France.

PURPOSE: The aim of the study was to describe the current rate and determinants of the prescription of antithrombotics in outpatients with permanent atrial fibrillation, with a pre-specified emphasis on the influence of age on the prescription of vitamin K antagonists. METHODS: This was a prospective observational survey in France among 5893 consecutive outpatients with documented permanent atrial fibrillation being seen by 770 physicians from August to December 2002. We recruited physicians from two random lists of general practitioners and cardiologists, respectively, stratified according to their administrative region, from the list of all French private general practitioners and cardiologists. RESULTS: The mean age of patients was 75.8 years. Mean duration since diagnosis of atrial fibrillation was 5.0 years; 31.7% of patients had valvular heart disease and 60.3% hypertension. An antithrombotic was prescribed to 95.5% of patients at the time of consultation. The percentage of patients treated with vitamin K antagonists was 76.4%; it decreased from 86.0% in patients aged 60-70 years to 63.5% in patients aged 80 years or above. On multivariate analysis, high age was a significant predictor (p = 0.001) for the non-prescription of vitamin K antagonists. In patients above 70 years currently receiving an antithrombotic, the probability of prescription of vitamin K antagonists decreased on average by 9.6% per year. CONCLUSIONS: Vitamin K antagonists are administered to most outpatients with permanent atrial fibrillation at high thromboembolic risk seen by French physicians in private practice. However, their use decreases with age.

Age Factors↗
PubMed2006

Prevention of cardiovascular events in end-stage renal disease: results of a randomized trial of fosinopril and implications for future studies.

Cardiovascular events (CVEs) are the leading cause of death in chronic hemodialysis patients. Results of trials in non-end-stage renal disease (ESRD) patients cannot be extrapolated to patients with ESRD. It is critical to test cardiovascular therapies in these high-risk patients who are usually excluded from major cardiovascular trials. The study objective was to evaluate the effect of fosinopril on CVEs in patients with ESRD. Eligible patients were randomized to fosinopril 5 mg titrated to 20 mg daily (n=196) or placebo (n=201) plus conventional therapy for 24 months. The primary end point was combined fatal and nonfatal first major CVEs (cardiovascular death, resuscitated death, nonfatal stroke, heart failure, myocardial infarction, or revascularization). No significant benefit for fosinopril was observed in the intent to treat analysis (n=397) after adjusting for independent predictors of CVEs (RR=0.93, 95% confidence interval (CI) 0.68-1.26, P=0.35). The per protocol secondary supportive analysis (n=380) found a trend towards benefit for fosinopril (adjusted RR=0.79 (95% CI 0.59-1.1, P=0.099)). In the patients who were hypertensive at baseline, systolic and diastolic blood pressures were significantly decreased in the fosinopril as compared to the placebo group. After adjustment for risk factors, trends were observed suggesting fosinopril may be associated with a lower risk of CVEs. These trends may have become statistically significant had the sample size been larger, and these findings warrant further study.

Aged↗
PubMed2005

Epidemiology of venous thromboembolism in Asian patients undergoing major orthopedic surgery without thromboprophylaxis. The SMART study.

BACKGROUND: In Asian patients undergoing surgery, the incidence of venous thromboembolism (VTE) is thought to be low relative to Western patients, and the routine use of thromboprophylaxis is controversial. OBJECTIVES: The aim of this work was to study the epidemiology of VTE in Asian patients undergoing orthopedic surgery without thromboprophylaxis. PATIENTS AND METHODS: We performed a prospective observational study of a cohort of consecutive Asian patients hospitalized for total hip or knee replacement or hip fracture surgery without thromboprophylaxis. The primary study outcome was the incidence of the composite of symptomatic VTE or sudden death at hospital discharge. This outcome was also assessed at 1 month's follow-up. RESULTS: Between April 2001 and July 2002, 2420 patients were enrolled. Median age was 68 years and the median duration of hospital stay was 13 days. The rate of symptomatic VTE or sudden death as notified by investigators was 2.3%[55 patients, 99% confidence interval (CI) 1.6, 3.2] and 1.2% (28 patients, 99% CI 0.7, 1.8) after adjudication by an independent committee. Chronic heart failure, varicose veins and a history of VTE were independent risk factors (P < 0.05) for the occurrence of the primary endpoint. At 1 month's follow-up, the incidence of adjudicated symptomatic VTE or sudden death was 1.5% (35/2264 patients). CONCLUSION: In Asian patients, the incidence of symptomatic VTE after major orthopedic surgery is not low, consistent with the rates observed in Western countries. The use of thromboprophylaxis should be considered in Asian patients undergoing such high-risk surgical procedures.

Aged↗
PubMed2005

[Risk factors management in 5708 ambulatory patients suffering from peripheral vascular disease followed in urban practices].

STUDY OBJECTIVE: we examined the management of risk factors in patients suffering from obliterating peripheral arterial disease (OPAD), in urban medical practice. METHODS: PRISMA, ECLAT1 and APRES are surveys based on urban medicine in France. These 3 studies have allowed a compilation of data pertaining to the control of risk factors in patients suffering from one or more clinical manifestations of atherothrombosis, including cerebral vascular accident, coronary insufficiency or OPAD. The study population was divided among patients with isolated OPAD, versus OPAD associated with coronary artery disease (CAD), versus OPAD associated with cerebral vascular disease. RESULTS: a total of 5 708 patients with stable OPAD were included among the 3 studies. Risk factors were not managed in the majority of patients, including 62.6% of hypercholesterolemic patients, 71.1% of diabetics, and 77.4% of hypertensive patients. Overall, the control of risk factors was less satisfactory in patients with OPAD than in patients with CAD. Smoking (70.6% current or past smokers) remains a major risk factor in OPAD. The proportion of current smokers was significantly higher is the group with isolated OPAD than in the other 2 groups of patients (p < 0.0001). CONCLUSIONS: The control of risk factors in patients with OPAD is suboptimal, mainly because of failure to reach the therapeutic goals, rather than because of poor medical management. It is important that recent recommendations be implemented in medical practice. Awareness of the primary physicians will be key in the optimisation of treatment prescriptions and, above all, in the achievement of a higher level of clinical performance.

Adult↗
PubMed2004

[Management of the cardiology patient with polyvascular disease: PRISMA study].

INTRODUCTION: Myocardial infarction (MI), peripheral vascular disease and ischaemic cerebral vascular accident (CVA) are three manifestations of the same disease, atherothrombosis, and they share the same pathophysiology and prognosis. OBJECTIVE: The aim of this work was to describe the clinical characteristics and the medical management of polyvascular patients in cardiology. METHOD: Cardiologists from all over the country participated in a consultation register for 3 weeks. The clinical characteristics and medical management for the first 3 patients on the register for each cardiologist were studied in a national multicentre study and then compared according to whether the atherothrombotic disease was isolated or polyvascular. RESULTS: In total, 100,429 patients were examined during the period of the register and 2,780 were included in the study. Polyvascular patients represented 7% of the register and 22% of the vascular patients. These patients with multiple manifestations were frequently diabetics. A lipid profile was available less often in the cardiac patients when they had another disorder (72.4%) than in the case of an isolated disorder (78.9%). Whatever the initial disorder, dyslipidaemia was less often controlled in the case of polyvascular disease (63% of LDL-C > or = 1.3g/l in polyvascular cardiac patients vs 52% in cardiac patients with isolated disease). In cardiac patients, the presence of peripheral vascular disease was associated with less prescription of beta blockers (OR=0.4 [0.3-0.6]), the presence of CVA was associated with less prescription of statins (OR=0.7 [0.5-0.9]). Eight out of 10 polyvascular patients received anti-platelet aggregation treatment. The presence of multiple atherothrombotic manifestations was associated with greater prescription of ACEI, except in cardiac patients. CONCLUSION: These results improve our understanding of the specific management of polyvascular patients, for whom secondary prevention is paramount due to the higher risk of recurrence. They should prompt the reinforcement of measures which have been shown to be effective, such as managing major risk factors, and in particular the dislipidaemias.

Adrenergic beta-Antagonists↗
PubMed2003

[Factors influencing secondary prevention of atherothrombotic disease in the private outpatient cardiology setting: results of the Prisma survey].

From March to July 1999, 940 private cardiologists in France recruited 100,429 patients of whom 30,430 (30%) had a previous history of atherothrombotic disease. The prevalence of patients with a previous history of Myocardial Infarction (MI), Ischemic Stroke (IS) or Peripheral Arterial Disease (PAD) was 19.7%, 7.2% and 10.7% respectively. Among patients with a history of atherothrombotic disease, myocardial infarction was the most frequent diagnosis responsible for 65% of all consultations. Each cardiologist described the secondary prevention treatment for 3 consecutive patients among whom 1 corresponded to each of the 3 atherothrombotic territories. The most frequent cardiovascular risk factors were hypercholesterolemia for myocardial infarction (77.9%), smoking for PAD (32.5%) and hypertension for IS (73.2%). Diabetes mellitus (1/4 patients), obesity (1/3) and sedentary way of life (1/3) were equally prevalent for each of the atherothrombotic territories. More than 90% of the patients received an antithrombotic drug. Antiplatelet agents were largely prescribed, anticoagulants being more frequently used for patients with atrial fibrillation, symptomatic cardiac heart failure or stroke of embolic origin. Thienopyridines represent 17.9% of the prescriptions. The prescription rate of statins after MI (58.9%) is lower than in published studies in secondary prevention. The lack of lipid measurement and the delay since last measurement are non-prescription factors. The rates of prescription are even lower in case of PAD (44.6%) or IS history (33.3%). More than half of the patients (56.6%) are treated with beta-blockers and 40.1% with ACE inhibitors. These rates are similar to what has been published. Atherothrombotic disease represents a large part of the daily activity of private cardiologists and is not limited to coronary heart disease. Despite their proven efficacy, drugs for secondary prevention for MI, except antithrombotic drugs, are insufficiently prescribed. This under-prescription is even higher in patients with PAD or IS history and may be related to the lack of clinical trials in these specific territories.

Adrenergic beta-Antagonists↗
PubMed2002

Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study).

The utility of low-molecular-weight heparin (LMWH) in the prophylaxis of venous thromboembolic disease has been examined using the surrogate endpoint of venographically identified thrombi. The largest portion of these thrombi were asymptomatic calf-vein thrombi. The clinical relevance of this observation is a matter of debate. The present study is designed to evaluate the impact of an LMWH on clinically important endpoints. The current study is a randomized, prospective, double-blinded, multicenter, multinational, controlled clinical trial comparing dalteparin with placebo in moderately high-risk hospitalized medical patients. A total of 3300 patients will be randomized to receive either 5,000 IU per day of dalteparin or placebo for 14 days. Patients will undergo appropriate evaluation for any symptomatic episodes and all patients will undergo a bilateral compression ultrasound (CUS) on day 21 to search for asymptomatic proximal thrombi. The primary endpoint is the combination of objectively confirmed symptomatic deep vein thrombi (DVT), fatal or non-fatal pulmonary emboli, all proximal DVT, and sudden death. This study will be the first study to examine clinically important endpoints in evaluating the effect of a LMWH in hospitalized medical patients. This study also is the first study to use CUS rather than venography in concordance with contemporary medical practice. This trial is thus designed to address this important question in a clinically relevant manner.

Adult↗
PubMed2001

Heart rate and cardiac rhythm relationships with bisoprolol benefit in chronic heart failure in CIBIS II Trial.

BACKGROUND: beta-Blockade-induced benefit in heart failure (HF) could be related to baseline heart rate and treatment-induced heart rate reduction, but no such relationships have been demonstrated. METHODS AND RESULTS: In CIBIS II, we studied the relationships between baseline heart rate (BHR), heart rate changes at 2 months (HRC), nature of cardiac rhythm (sinus rhythm or atrial fibrillation), and outcomes (mortality and hospitalization for HF). Multivariate analysis of CIBIS II showed that in addition to beta-blocker treatment, BHR and HRC were both significantly related to survival and hospitalization for worsening HF, the lowest BHR and the greatest HRC being associated with best survival and reduction of hospital admissions. No interaction between the 3 variables was observed, meaning that on one hand, HRC-related improvement in survival was similar at all levels of BHR, and on the other hand, bisoprolol-induced benefit over placebo for survival was observed to a similar extent at any level of both BHR and HRC. Bisoprolol reduced mortality in patients with sinus rhythm (relative risk 0.58, P:<0.001) but not in patients with atrial fibrillation (relative risk 1.16, P:=NS). A similar result was observed for cardiovascular mortality and hospitalization for HF worsening. CONCLUSIONS: BHR and HRC are significantly related to prognosis in heart failure. beta-Blockade with bisoprolol further improves survival at any level of BHR and HRC and to a similar extent. The benefit of bisoprolol is questionable, however, in patients with atrial fibrillation.

Adrenergic beta-Antagonists↗
PubMed2000

Valsartan in acute myocardial infarction trial (VALIANT): rationale and design.

BACKGROUND: Survivors of acute myocardial infarction (MI) complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete pharmacologic mode to inhibit the adverse influence of angiotensin II. METHODS: Valsartan in Acute Myocardial Infarction (VALIANT) is a multicenter, double-blind, randomized, active controlled parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designed with 3 arms, giving equal statistical consideration to survival comparisons of captopril versus the angiotensin II receptor blocker valsartan, as well as the combination of captopril plus valsartan, compared with a proven effective dose of captopril. This 14,500-patient trial is designed with an 86% power to detect a 15% reduction in mortality rate with either use of valsartan compared with captopril. The trial encourages optimal individualization of other proven therapies in acute and chronic infarction, and the international patient body ensures good representation of multiple practice patterns. CONCLUSION: VALIANT is a large international investigative effort that will evaluate the role of valsartan in the management of patients with MI associated with heart failure and/or left ventricular dysfunction. The use of a proven dose of captopril and the comparator arms with valsartan alone or in combination with captopril provides a unique test of whether the angiotensin II receptor blocker can make an additional improvement in clinical outcomes beyond angiotensin-converting enzyme inhibitors.

Angiotensin II↗
PubMed1999

A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group.

BACKGROUND: The efficacy and safety of thromboprophylaxis in patients with acute medical illnesses who may be at risk for venous thromboembolism have not been determined in adequately designed trials. METHODS: In a double-blind study, we randomly assigned 1102 hospitalized patients older than 40 years to receive 40 mg of enoxaparin, 20 mg of enoxaparin, or placebo subcutaneously once daily for 6 to 14 days. Most patients were not in an intensive care unit. The primary outcome was venous thromboembolism between days 1 and 14, defined as deep-vein thrombosis detected by bilateral venography (or duplex ultrasonography) between days 6 and 14 (or earlier if clinically indicated) or documented pulmonary embolism. The duration of follow-up was three months. RESULTS: The primary outcome could be assessed in 866 patients. The incidence of venous thromboembolism was significantly lower in the group that received 40 mg of enoxaparin (5.5 percent [16 of 291 patients]) than in the group that received placebo (14.9 percent [43 of 288 patients]) (relative risk, 0.37; 97.6 percent confidence interval, 0.22 to 0.63; P< 0.001). The benefit observed with 40 mg of enoxaparin was maintained at three months. There was no significant difference in the incidence of venous thromboembolism between the group that received 20 mg of enoxaparin (43 of 287 patients [15.0 percent]) and the placebo group. The incidence of adverse effects did not differ significantly between the placebo group and either enoxaparin group. By day 110, 50 patients had died in the placebo group (13.9 percent), 51 had died in the 20-mg group (14.7 percent), and 41 had died in the 40-mg group (11.4 percent); the differences were not significant. CONCLUSIONS: Prophylactic treatment with 40 mg of enoxaparin subcutaneously per day safely and effectively reduces the risk of venous thromboembolism in patients with acute medical illnesses.

Acute Disease↗
PubMed1998

A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group.

BACKGROUND: The efficacy and safety of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis is still a matter of debate. METHODS: Using a two-by-two factorial design, we randomly assigned 400 patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism to receive a vena caval filter (200 patients) or no filter (200 patients), and to receive low-molecular-weight heparin (enoxaparin, 195 patients) or unfractionated heparin (205 patients). The rates of recurrent venous thromboembolism, death, and major bleeding were analyzed at day 12 and at two years. RESULTS: At day 12, two patients assigned to receive filters (1.1 percent), as compared with nine patients assigned to receive no filters (4.8 percent), had had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.22; 95 percent confidence interval, 0.05 to 0.90). At two years, 37 patients assigned to the filter group (20.8 percent), as compared with 21 patients assigned to the no-filter group (11.6 percent), had had recurrent deep-vein thrombosis (odds ratio, 1.87; 95 percent confidence interval, 1.10 to 3.20). There were no significant differences in mortality or the other outcomes. At day 12, three patients assigned to low-molecular-weight heparin (1.6 percent), as compared with eight patients assigned to unfractionated heparin (4.2 percent), had had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.38; 95 percent confidence interval, 0.10 to 1.38). CONCLUSIONS: In high-risk patients with proximal deep-vein thrombosis, the initial beneficial effect of vena caval filters for the prevention of pulmonary embolism was counterbalanced by an excess of recurrent deep-vein thrombosis, without any difference in mortality. Our data also confirmed that low-molecular-weight heparin was as effective and safe as unfractionated heparin for the prevention of pulmonary embolism.

Aged↗
PubMed1998

A cost-minimization of heart failure therapy with bisoprolol in the French setting: an analysis from CIBIS trial data. Cardiac Insufficiency Bisoprolol Study.

Beta-blocker-induced benefit in heart failure is under intense evaluation. Several large-scale mortality trials are currently being performed, with CIBIS II evaluating bisoprolol. The economic impact of beta-blocker therapy in heart failure has not been previously determined. The present study is a cost-effectiveness evaluation of bisoprolol treatment based on CIBIS I data. It considers direct costs, that is, the bisoprolol medication cost and the cost of hospitalization related to heart failure and its complications. Hospitalization costs were calculated from the French system of classification (PMSI), which provides costs according to homogeneous groups of patients (GHM). The cost difference between bisoprolol and placebo in the entire CIBIS population and the trial duration result from an increase in cost caused by bisoprolol treatment (+ 2018 Frs/patient) and a decrease in cost related to reduced hospitalization (6349 Frs/patient). A total savings per patient of about 4330 Frs was produced by bisoprolol. Cost reduction is still more pronounced in patients not having a history of myocardial infarction. We conclude that heart failure therapy with bisoprolol lowers medical healthcare costs, mainly due to the reduced rate of hospital admissions for heart failure.

Adrenergic beta-Antagonists↗
PubMed1998

Long-term consequences of deep vein thrombosis.

Following an overt episode of deep vein thrombosis (DVT), the long-term prognosis of the patient is predominantly obscured by three natural complications: recurrence of venous thromboembolism (VTE), post-thrombotic syndrome and death. Antithrombotic treatments have been proven effective in preventing recurrence of VTE but carry the risk of major bleeding. A high mortality rate persists during the first year following an acute VTE, with a small but continuing risk beyond the first year. Recurrences of VTE account for the minority of causes of deaths. With effective initial anticoagulant treatment, the early (within approximately 3 months) risk of recurrence is 3-6%. Long-term follow-up studies have shown that although the risk of recurrence of VTE beyond the first 6 months is lower, the risk persists over several years. Approximately 25% of DVT patients remain asymptomatic in the long term but severe signs of post-thrombotic syndrome (ulceration) are observed in 2-10% of patients 10 years after DVT. Major advances have been made in the management of acute VTE but the excess risks of death, recurrence of VTE and post-thrombotic syndrome persist for several years following the initial event. Appropriate therapeutic strategies for these events are still being developed and future study should be directed towards finding the optimal regimen for patients who require prolonged treatment.

Anticoagulants↗
PubMed1997

Persistent reduction of mortality for five years after one year of acebutolol treatment initiated during acute myocardial infarction. The APSI Investigators. Acebutolol et Prévention Secondaire de l'Infarctus.

The APSI trial was a randomized placebo-controlled trial designed to assess the efficacy of 1 year of treatment by acebutolol in high-risk patients who had survived an acute myocardial infarction. At 1 year there was a statistically significant 48% relative reduction in total mortality (p = 0.019) in favor of acebutolol. In 1995 a long-term mortality survey was undertaken through an administrative inquiry and contacts with investigators. The vital status of 586 of the 607 (96.5%) patients enrolled was known at the cutoff date and all these patients were followed up for at least 5 years. During follow-up (in-trial and post-trial period), 74 deaths (24.8%) occurred in the acebutolol group and 96 (31.1%) in the placebo group (p = 0.10). No difference between the 2 groups was observed for the number of deaths that occurred after the end of the trial: 55 deaths (19.6%) among the 281 survivors in the acebutolol group and 59 deaths (21.7%) (p = 0.70) among the 272 survivors in the placebo group. The annual hazard rate (annual death rate), calculated year by year using the actuarial method, was significantly different (p < 0.01) only for the first year and was not significantly different thereafter. Thus, the initial benefit obtained in 1 year of treatment by acebutolol lasts for 5 years.

Acebutolol↗