Preprocedural inflammatory markers do not predict restenosis after successful coronary stenting

Background

Levels of C-reactive protein (CRP), serum amyloid A protein (SAA), and interleukin-6 (IL-6) can predict coronary restenosis following angioplasty and stent deployment in patients with unstable angina. We investigated whether measurement of periprocedural inflammatory markers predicted the angiographic outcome at 6 months in stable angina patients undergoing coronary stenting.

Methods

We prospectively studied 182 patients; 152 patients underwent elective and successful stenting procedure for de novo lesions in native and nongrafted coronary arteries and 30 individuals in the control group underwent diagnostic angiography alone. CRP, SAA, and IL-6 were determined by high-sensitivity immunoassays.

Results

At 6 months, quantitative computer-assisted angiographic analysis in 133 patients with stents showed a binary restenosis rate of 33.8%. Statins were being taken by 80% of the patients. There were no significant differences between the pre- or postprocedure values of CRP, SAA, or IL-6 in patients with or without in-stent restenosis.

Conclusions

Preprocedural inflammatory markers in stable angina subjects undergoing coronary artery stent deployment did not correlate with the development of in-stent restenosis. Differences in pathobiology between stable and unstable coronary syndromes, the widespread use of statins with anti-inflammatory activity in our cohort of patients, along with different mechanisms underlying the early angiographic appearances of restenosis as compared to clinical end points, most likely explain our findings.     

A randomized,double-blinded,placebo-controlled,dose-ranging study measuring the effect of an adenosine agonist on infarct size reduction in patients undergoing primary percutaneous transluminal coronary angioplasty: the ADMIRE (AmP579 Delivery for Myocardial Infarction REduction) study

Background

Evidence suggests that myocardial ischemic preconditioning and reperfusion injury may be mediated by adenosine A1 and A2 receptors. AMP579 is a mixed adenosine agonist with both A1 and A2 effects. In animal models of acute myocardial infarction (MI), AMP579 reduced infarct size at serum levels of 15 to 24 ng/mL.

Methods

The AMP579 Delivery for Myocardial Infarction REduction study evaluated AMP579 in a double-blind, multicenter, placebo-controlled trial of 311 patients undergoing primary percutaneous transluminal coronary angioplasty (PTCA) after acute ST-segment elevation MI. Patients were randomly assigned to placebo or to 3 different doses of AMP579 continuously infused over 6 hours. The primary end point was final MI size measured by technetium Tc-99m sestamibi scanning at 120 to 216 hours after PTCA. Secondary end points included myocardial salvage and salvage index at the same time interval (in a subset of patients who underwent baseline technetium Tc-99m sestamibi scan), left ventricular ejection fraction and heart failure at 4 to 6 weeks, duration of hospitalization, and cardiac events at 4 weeks and 6 months.

Results

Final infarct size did not differ among the placebo group and the active treatment groups for either anterior MI or nonanterior MI. In patients with anterior MI, median myocardial salvage was increasingly higher in the groups receiving ascending dosages of AMP579 plus PTCA. Serum levels approaching levels shown to reduce infarct size in animal models were achieved only in the 60-mcg/kg treatment group.

Conclusion

AMP579 was safe at the doses tested, but it did not reduce infarct size. There was a trend toward greater myocardial salvage in treated patients with anterior MI.     

Evaluation of severe infection and survival after splenectomy

Purpose

Splenectomized patients are known to be at risk of severe infection, but the extent of risk is unclear. We evaluated the incidence of severe infection and survival in 1648 splenectomized patients.

Methods

Patients who underwent splenectomy between 1988 and 1999 in Scotland were identified through the Scottish hospital discharge records (SMR01) and then linked to the death certificate data recorded by the General Register Office in Scotland to obtain clinical and demographical information.

Results

The overall rate of first severe infection was 7.0 per 100 person-years (95% confidence interval, 6.30-7.78). The overall rate for a second infection per 100 person-years was 44.9 and 109.3 for a third infection after the first episode of infection. Among the repeated episodes of severe infection, 42% to 76% and 61% to 84% of total episodes of second and third severe infection, respectively, occurred within 6 months after the first severe infection. The susceptibility to severe infection was greatest in older age groups (5.5 per 100 person-years in those aged > 50 years) and in patients splenectomized for hematologic malignancy (9.2), and iatrogenic splenectomy for malignancy disease (7.4). Between 50% and 80% of all severe infections or deaths occurred within 1 to 3 years after splenectomy.

Conclusions

The risk of severe infection is an important health problem in splenectomized patients, especially in those who underwent surgery for malignancies. Antibiotic prophylaxis could offer the most benefits in the first 3 years postsplenectomy or the first 6 months after the occurrence of a first severe infection.     

Phase II study of pharmacogenetic-tailored therapy in elderly colorectal cancer patients

Background

Retrospective analyses suggested that a pharmacogenetic approach may allow a tailored selection of chemotherapy for metastatic colorectal cancer.

Aim

We conducted a phase II study of pharmacogenetic-selected first-line chemotherapy in elderly patients with advanced colorectal cancer, with the aim to improve efficacy and to reduce toxicity in this group of patients.

Methods

24 patients were enrolled in this study. Chemotherapy regimen was prospectively assigned based on TS, DPD, ERCC-1 and UGT1A1 genotyping results. Twelve patients (50%) were treated with modified FOLFIRI, 11 patients (46%) with modified FOLFOX6 and 1 (4%) with De Gramont regimen.

Results

A partial remission was obtained in 4 cases (17%), stable disease in 8 cases (33%) and progressive disease in 12 cases (50%). Grade 3-4 neutropenia was observed in 7 patients (29%) and diarrhoea in 3 cases (12%). The trial was then interrupted according to study design requiring 13 partial remissions out of the first 24 patients enrolled as the necessary response rate level in order to continue.

Conclusion

Prospective selection of chemotherapy based on TS, DPD, ERCC-1 and UGT1A1 expression in elderly advanced colorectal cancer patients failed to confirm previous results. A more accurate validation of retrospective findings is warranted before these molecular markers can be used for treatment selection in the clinical practice.     

Adult intensive care patients' perception of endotracheal tube-related discomforts: A prospective evaluation

Objective

This study was designed to investigate adult patients' perceptions of endotracheal tube (ETT)-related discomfort at 5 days and 2 months after discharge from the intensive care unit (ICU).

Methods

This prospective cohort study in 2 general ICUs included 250 intubated, mechanically ventilated adults admitted for more than 24 hours. Patients were interviewed 5 days and 2 months after discharge from the ICU about their ETT-related discomfort, using a modified Swedish ETT version of the ICU Stressful Experience Questionnaire that comprises 14 items.

Results

Of 116 patients describing their ETT experience during their ICU stay, 88% rated their discomfort as moderately to extremely stressful. At 2 months after discharge from the ICU, 23% (51/226) reported bothersome discomfort, vs. 46% (104/226) 5 days after discharge from the ICU, and 10 patients suffered from severe, persistent hoarseness.

Conclusion

The incidence of bothersome subjective complaints after tracheal intubation in the intensive-care setting is high, and severe ETT-related problems may persist several months after extubation.     

Transient left ventricular dysfunction under severe stress: brain-heart relationship revisited

Purpose

Transient left ventricular dysfunction in patients under emotional or physical stress, also known as tako-tsubo-like left ventricular dysfunction, has been recently been recognized as a distinct clinical entity. The aims of this review are to define this phenomenon and to explore its similarities to the left ventricular dysfunction seen in patients with acute brain injury.

Methods

MEDLINE database, bibliographies of each citation for relevant articles, and consultation with clinical experts were used to examine the clinical picture of tako-tsubo-like left ventricular dysfunction.

Results

We identified case series and a systematic review that report on patients with this syndrome. This phenomenon occurs predominantly in female patients, presenting with a variety of ST-T segment changes and mildly elevated cardiac enzymes that mimic an acute coronary syndrome. The left ventricular dysfunction, typically showing a hyperkinetic basal region and an akinetic apical half of the ventricle, occurs in the absence of obstructed epicardial coronary arteries. The ventricular dysfunction usually resolves within weeks with a generally favorable prognosis. This phenomenon has similarities to that seen in patients with acute brain injury with regard to clinical presentation, pathology, and its reversible nature.

Conclusions

Transient left ventricular dysfunction occurs in the absence of obstructive epicardial coronary artery disease. In its broadest sense, this phenomenon may encompass a range of disorders including left ventricular dysfunction after central nervous system injury.     

Color of culprit lesion at 6 months after plain old balloon angioplasty versus stenting in patients with acute myocardial infarction

Background

Although the healing process of disrupted yellow plaques at myocardial infarction (MI) culprit lesions has been reported, the effect of stenting on this process has not been clarified. Stenting has been reported to deteriorate the endothelial function after percutaneous coronary intervention (PCI). Therefore, we compared the angioscopic morphology of culprit lesions at 6 months after plain old balloon angioplasty (POBA) and stenting to clarify the effect of stenting on the healing of disrupted culprit plaques of acute MI.

Methods

Patients with acute MI who had yellow culprit plaque, successful reperfusion therapy with POBA (n = 21) or stenting (n = 22), and a successful 6-month follow-up angioscopic examination were included in this study. Oral ticlopidine (200mg/day) was administered for 3 to 6 months after stenting.

Results

At 6 months after reperfusion therapy, the color of the culprit lesion became white in significantly more patients treated with stenting than treated with POBA (50% vs 14%; P = .01). However, the prevalence of thrombus appeared to be higher in patients treated with stenting than in patients treated with POBA (27% vs 5%; P = .04). Although there was some difference in the patients' characteristics in the groups, logistic regression analysis revealed no significant influence of those factors on the color of or on the prevalence of thrombus at the culprit lesion.

Conclusions

Coronary stenting in patients with acute MI leads to the disappearance of yellow color at a significantly higher rate than POBA; however, whether it stabilizes the plaque requires further investigation.     

A randomized, double-blind, placebo-controlled trial of nutritional supplementation during acute illness

Purpose

The study tested whether nutritional support of older patients during acute illness leads to a clinical benefit.

Methods

In this randomized, double-blind, placebo-controlled study, we randomly assigned 445 hospitalized patients aged 65 to 92 years to receive either a normal hospital diet plus 400 mL oral nutritional supplements (223 subjects) or a normal hospital diet plus a placebo (222 subjects) daily for 6 weeks. The composition of the supplement was such as to provide 995 kcal of energy and 100% of the Reference Nutrient Intakes for vitamins and minerals for a healthy older person. Patients had three assessments: at baseline, at 6 weeks, and at 6 months post-randomization. Outcome measures were 6 months of disability, non-elective readmission and length of hospital stay, discharge destination, morbidity, and mortality.

Results

Randomization to the supplement group led to a significant improvement in nutritional status. Over 6 months, 65 patients (29%) in the supplements group were readmitted to the hospital compared with 89 patients (40%) in the placebo group (adjusted hazard ratio 0.68 [95% confidence interval 0.49-0.94]). The mean length of hospital stay was 9.4 days in the supplements group compared with 10.1 days in the placebo group. Thirty-two people (14%) died in the supplement group compared with 19 people (9%) in the placebo group at 6 months (adjusted hazard ratio 1.65 [95% confidence interval, 0.93-2.92]).

Conclusion

Oral nutritional supplementation of acutely ill patients improved nutritional status and led to a statistically significant reduction in the number of non-elective readmissions.     

Clinical and angiographic efficacy of a self-expanding nitinol stent in saphenous vein graft atherosclerotic disease: the Stent Comparative Restenosis (SCORES) Saphenous Vein Graft Registry

Background

The Stent Comparative Restenosis (SCORES) Saphenous Vein Graft (SVG) Registry was a multicenter, prospective registry designed to evaluate the safety and efficacy of a self-expanding, nickel-titanium (nitinol) stent for de novo SVG lesions.

Methods

In all, 159 patients with de novo vein graft lesions ≥2.75 and ≤4.25 mm in diameter and <30 mm in length underwent stenting with the Radius self-expanding stent. The primary end point was target vessel failure (TVF) at 9 months, which was defined as a composite of procedural failure, death, myocardial infarction, or target vessel revascularization.

Results

Procedural success was achieved in 96.8% of patients, and the 30-day incidence of major adverse cardiac events was 2.5%. The binary rate of restenosis at 6 months was 28.6%. By 9 months, the rate of TVF was 24.5%, and the rate of major adverse cardiac events was 23.1%. The 9-month Kaplan-Meier survival rates for freedom from TVF and target lesion revascularization were 76.0% and 87.9%, respectively. No clinical or angiographic characteristic was predictive of restenosis.

Conclusions

In de novo atherosclerotic SVG disease, the use of a self-expanding, nitinol stent was associated with high initial procedural success and favorable early and intermediate outcomes. Because few studies have examined the influence of stent composition and design in SVG disease, these findings not only show the safety and efficacy of this self-expanding stent in de novo SVG disease, but also merit further comparison with balloon-expandable stents.     

Outcomes of uncomplicated aortic valve stenosis presenting in infants

Background

The management of uncomplicated aortic valve stenosis presenting with critical obstruction in infants continues to be associated with significant morbidity and mortality. However, not all infants have critical obstruction, and outcomes spanning the broader spectrum of disease severity are less well defined.

Methods

In a 12-year period, 55 infants (<3 months of age) were seen with aortic valve stenosis and with anatomy suitable for biventricular repair. Clinical, echocardiographic, angiographic, management, and outcome data were reviewed.

Results

Status at presentation (median age 6 days) included signs of congestive heart failure in 20 patients, cardiovascular collapse in 5 patients, and an asymptomatic heart murmur in 30 patients. The initial echocardiogram showed reduced left ventricular function in 26% of patients, with a mean peak instantaneous gradient of 69 ± 30 mm Hg in patients with normal function. There were 5 deaths (9%), all in patients with poor ventricular function. The initial intervention was balloon valvotomy in 24 patients and surgical valvotomy in 20 patients, with 11 patients having no intervention to date. The freedom-from-intervention rate was 69% at age 1 week, 58% at 1 month, 36% at 3 months, and 28% at 1 year. Patients without cardiovascular collapse, normal left ventricular function, and gradients <60 mm Hg at presentation (n =1 9) had better survival and longer freedom from intervention than patients with poor ventricular function or gradients ≥60 mm Hg (n = 36, P = .0001).

Conclusion

Most infants with aortic valve stenosis receive intervention, although this may be safely delayed in selected patients with lower initial gradients and good left ventricular function.     

Acute reperfusion therapy in ST-elevation myocardial infarction from 1994-2003

Background

Appropriate utilization of acute reperfusion therapy is not a national performance measure for ST-elevation myocardial infarction at this time, and the extent of its contemporary use among ideal patients is unknown.

Methods

From the National Registry of Myocardial Infarction, we identified 238,291 patients enrolled from June 1994 to May 2003 who were ideally suited for acute reperfusion therapy with fibrinolytic therapy or primary percutaneous coronary intervention. We determined rates of not receiving therapy across 3 time periods (June 1994-May 1997, June 1997-May 2000, June 2000-May 2003) and evaluated factors associated with underutilization.

Results

The proportion of ideal patients not receiving acute reperfusion therapy decreased by one half throughout the past decade (time period 1: 20.6%; time period 2: 11.4%; time period 3: 11.6%; P <.001). Utilization remained significantly lower in key subgroups in the most recent time period: those without chest pain (odds ratio [OR] 0.29; 95% confidence interval [CI], 0.27-0.32); those presenting 6 to 12 hours after symptom onset (OR 0.57; 95% CI, 0.52-0.61); those 75 years or older (OR 0.63 compared with patients <55 years old; 95% CI, 0.58-0.68); women (OR 0.88; 95% CI, 0.84-0.93); and non-whites (OR 0.90; 95% CI, 0.83-0.97).

Conclusions

Utilization of acute reperfusion therapy in ideal patients has improved over the last decade, but more than 10% remain untreated. Measuring and improving its use in this cohort represents an important opportunity to improve care.     

Expectations and outcomes of gastric feeding tubes

Purpose

To compare expected outcomes with actual outcomes from tube feeding in adult patients.

Subjects and methods

This prospective cohort study was conducted in two North Carolina hospitals. Surrogates were interviewed shortly after feeding tube insertion and at 3- and 6-month follow-up; chart abstraction and death certificate review also were carried out. Participants were surrogate decision-makers for consecutive adult patients who received new feeding tubes.

Results

There were 288 patients with surrogate decision-makers enrolled. Mean age was 65 years; 30% had a primary diagnosis of stroke, 16% neurodegenerative disorder, 20% head and neck cancer, and 30% other diagnoses. At 3 months, 21% of patients had died, and 6-month mortality was 30%. At 3 months, 38% of survivors were residing in a nursing home, and 27% had the feeding tube removed. Patients were impaired in most activities of daily living (ADLs) with little change over time. Medical complications were common: 25% of patients had decubitus ulcers at 3 months, and 24% had at least one episode of pneumonia. Perceived global quality of life was poor at 4.6 (on a 0-10 scale) at baseline, and surrogates anticipated this would improve to 8.0 with tube feeding. Family surrogates’ expectations for improvement from the feeding tube were very high at baseline and remained so at 3 and 6 months.

Conclusions

Families’ high expectations of benefit from tube feeding are in contrast to clinical outcomes. Providers and families need better information about the outcomes of this common procedure.     

Survey of general practitioners management of erysipelas

Purpose

A few studies only have focused on ambulatory management of erysipelas.

Methods

To assess the diagnostic and therapeutic management of erysipelas by general practitioners, and their adherence to the French Society of Infectious Diseases and Dermatology joint 2000 recommendations, we surveyed 114 general practitioners during a 1 year period (from May 1st, 2005 to April 30th, 2006).

Results

Seventy-three general practitioners accepted to participate to the study and 54 cases of erysipelas were reported. Median age of patients was 63 years (range, 18-94) and sex ratio was 0.77. Lower limbs were affected in 83% out of the cases. A skin lesion was reported in 65% of the cases. None of the 15 doppler ultrasonography that were performed identified deep vein thrombosis. Five patients (9%) were initially hospitalized. Only 18% out of the patients were treated by amoxicillin. Most prescribed antimicrobial agents were pristinamycin (31%) and amoxicillin-clavulanate (27%). Median duration of treatment was 10 days. Six patients received an anti-inflammatory drug. Among the 44 patients who had a follow-up visit, 37 patients (84%) recovered and two patients were hospitalized after this follow-up assessment. Two patients experienced a recurrence of erysipelas during the study.

Conclusion

As previously reported in the literature, outcome of erysipelas after ambulatory management remains excellent, although recommendations are poorly followed.     

Autologous skeletal myoblast transplantation for the treatment of postinfarction myocardial injury: phase I clinical study with 12 months of follow-up

Background

Experimental studies have shown that skeletal myoblast transplantation into an area of postinfarction left ventricular injury results in an increase of segmental contractile performance that could be related to transplanted myoblasts. Initial experience with autologous skeletal myoblast transplantation in patients with postinfarction myocardial injury has also been obtained.

Methods

Patients who survived an acute myocardial infarction and were scheduled to undergo coronary artery bypass grafting were screened by means of dobutamine stress echocardiography and included into the study when no contractility changes within akinetic/dyskinetic segments were observed. Ten patients who gave informed consent were enrolled, and autologous myoblasts (satellite cells) were isolated from the skeletal muscle biopsy. Myoblast injections into the akinetic/dyskinetic area were performed after constriction of the anastomoses during the coronary artery bypass grafting procedure.

Results

Myoblast transplantations were performed after 3 weeks of in vitro culture in all patients. One patient died of a recent infarction at day 7 postoperatively because of a recent infarction in a remote area of the left ventricle. The left ventricular ejection fraction increased from 25% to 40% (mean, 35.2%) before the procedure to 29% to 47% (mean, 42.0%) during the 4-month visit (P <.05), and the effect was maintained throughout 12 months of follow-up. Sustained ventricular tachycardia was observed in 2 patients in the early postoperative period and in the other 2 patients after 2 weeks of follow-up. Prophylactic amiodarone infusion was used in the remaining 8 patients and prevented sustained ventricular tachycardia episodes.

Conclusions

Autologous skeletal myoblast transplantation for the treatment of postinfarction heart failure is feasible. Our initial observations justify further research to validate this method in a clinical practice.     

High levels of circulating endothelial microparticles in patients with acute coronary syndromes

Background

Endothelial injury plays a critical role in coronary artery disease (CAD), but the assessment of this injury has been problematical. Recently, it has been shown in vitro that endothelial cells (ECs) release endothelial microparticles (EMPs) on activation or apoptosis and that an assay of EMPs can provide useful information on EC status in patients with thrombotic disorders. This study is aimed at assessing possible correlations between EMPs, which are markers of endothelial injury, and clinical subgroups of patients with CAD.

Methods

A prospective, case-controlled study was conducted on 84 patients with CAD and 42 control subjects to investigate EMP profiles. Included were 64 patients with acute coronary syndromes ([ACS], 38 with myocardial infarction [MI] and 26 with unstable angina [UA]) and 20 patients with stable angina (SA). EMPs in platelet-poor plasma were measured flow cytometrically with combinations of fluorescent antibodies (anti-CD31, -51, -42), allowing distinction of EMPs from platelet microparticles (PMPs). Clinical subgroups of patients were correlated with EMP and PMP levels in blood.

Results

Two species of EMPs (CD31+ and CD51+) were evaluated. Both were significantly higher in patients with CAD than in control subjects. CD31+ EMP was higher in ACS than SA. Among patients with first MI, CD31+ EMP was higher in patients with MI than in patients with UA and was significantly higher than in patients with recurring MI. CD51+ EMP did not discriminate ACS from SA. A simultaneous assay of PMP showed correlation between EMPs and PMPs. However, PMPs did not discriminate patients with SA from control subjects.

Conclusions

EMP assay appears promising for assessing EC injury in CAD.     

Short-term metabolic changes achieved by weight loss in hypertensive patients

Introduction

Glucose and lipid metabolism abnormalities of hypertensive patients are highly relevant due to its increase in cardiovascular risk; moreover, impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) have a high risk of new-onset diabetes mellitus (DM) development. The objective of the study was to describe glucose metabolism abnormalities and the impact of mid-term weight loss.

Methods

A six-month prospective, observational and multicentre study of patients with hypertension was conducted. Clinical antecedents, physical examination, blood test and treatments were collected in two separated visits; conventional advice was the only intervention planned.

Results

A total of 1957 patients were included, mean age 66.3 (10.9) years and 59.9% males. A previous diagnosis of glucose metabolism alteration was present in 43.9% (25.5% type-2 DM, 14.8% IFG, 1.6% IFG and IGT, 1.0% IGT and 1.0% type-1 DM). An increasing pattern of cardiovascular risk and target organ damage was observed according to the categories of fasting glucose. Oral glucose tolerance test (OGTT) was carried out in 234 patients (11.9%) patients and yielded the diagnosis of IGT in 44.7% or DM in 22.4% of patients with fasting glucose > 100 mg/dl. Six months follow-up was achieved in 85.9% patients. A slight reduction in fasting glucose was observed in the whole cohort and patients who achieved ≥ 5% weight loss experienced the highest reduction in fasting glucose, LDL-c and triglycerides; moreover, 15.8% normalized their IFG.

Conclusions

Glucose and lipid metabolism abnormalities are highly prevalent in hypertensive patients and improve with 5% of weight lost at 6 months follow-up. OGTT is not currently extended in daily clinical practise.     

Significance of Cardiac Computed Tomography Incidental Findings in Acute Chest Pain

Background

Coronary computed tomography angiography might improve the management of patients presenting to the emergency department with acute chest pain; however, noncoronary incidental findings are frequently detected. The prevalence and clinical significance of these findings have not been well described.

Methods

Consecutive patients presenting to the emergency department with acute chest pain and inconclusive initial evaluation between May 2005 and May 2007 underwent 64-slice coronary computed tomography angiography before hospital admission with noncoronary incidental findings immediately reported. An expert panel adjudicated which incidental findings changed in-hospital patient management, and projections for additional testing were based on standard medical practice.

Results

Among 395 patients (37.0% were female, mean age 53 ± 12 years), incidental findings were detected in 44.8% (n = 177): noncalcified pulmonary nodules (n = 94, 23.8%), simple liver cysts (n = 26, 6.6%), calcified pulmonary nodules (n = 16, 4.1%), and contrast-enhancing liver lesions (n = 9, 2.3%). In-hospital management was changed because of incidental finding reporting in 5 patients (1.3%), and a potential alternative diagnosis was offered in another 16 patients (4.1%). Subsequent diagnostic imaging tests were recommended in 81 patients (20.5%), including 74 chest computed tomography scans. After 6 months, biopsy was performed in 3 patients, revealing cancer in 2 (0.5%) who underwent successful tumor resection.

Conclusion

Clinically important findings are detected in up to 5% of patients with a lead symptom of acute chest pain and low to intermediate likelihood of acute coronary syndrome, but only few directly change patient management; 21% are recommended for further imaging tests, resulting in invasive procedures and detection of cancer in few patients.     

Enoxaparin versus tinzaparin in non-ST-segment elevation acute coronary syndromes: results of the enoxaparin versus tinzaparin (EVET) trial at 6 months

Background

We have previously reported significant benefits of using enoxaparin, compared to tinzaparin, in the 7- and 30-day incidence of the composite triple end point of death, myocardial infarction (MI), or recurrent angina in patients with non-ST-segment elevation acute coronary syndromes (NSTACS). In the present study, we aimed to determine whether the observed benefits of enoxaparin were maintained beyond the early phase and report the results of the 6-m follow-up of patients in the EVET study.

Methods

We recruited 438 patients with NSTACS. All patients received oral aspirin and were randomized to also receive enoxaparin, 100 IU/kg subcutaneously twice daily (equivalent to 1 mg/kg twice daily; n = 220), or tinzaparin, 175 IU/kg subcutaneously once daily (n = 218), for up to 7 days.

Results

At 6 m, the incidence of the composite triple end point of death, MI, or recurrent angina was lower among patients receiving enoxaparin compared to those receiving tinzaparin (25.5% vs 44.0%, P < .001). A lower incidence of the secondary composite end point of death or MI was also found in the enoxaparin group compared to tinzaparin group (2.7% vs 6.9%, P = .046). The need for revascularization procedures was also lower in the enoxaparin group compared to tinzaparin group (23.2% vs 37.2%, P = .002).

Conclusions

In patients with NSTACS, enoxaparin significantly reduced the rates of recurrent ischemic events and therapeutic procedures in the short term, with sustained benefit at 6 m compared to tinzaparin.     

Hereditary Angioedema: Increased Number of Attacks after Frequent Treatments with C1 Inhibitor Concentrate

Objective

C1 inhibitor concentrate is regarded as effective and safe in treating acute attacks of hereditary angioedema caused by C1 inhibitor deficiency. This study investigated the course of disease in 3 women treated frequently with C1 inhibitor concentrate.

Methods

Three women are described who received C1 inhibitor concentrate for the treatment of acute attacks of hereditary angioedema and experienced an increase in the frequency of attacks during that treatment period. In a control group of 24 patients aged more than 60 years with hereditary angioedema, the natural course of disease was determined.

Results

The 3 women (ages 50, 69, and 72 years) had received C1 inhibitor concentrate for 27, 18, and 22 years, respectively, for acute abdominal and skin attacks. Before this treatment, all attacks were severe. The treatment was always effective: The attacks were mild, and the duration of the attacks was shortened. During the treatment period, the number of attacks increased slowly but continuously, starting at the onset of treatment and paralleling the course of treatment. At the end of the observation period, the number of attacks increased by 4-fold, 12-fold, and 5-fold in the 3 women, respectively. No factors known to increase the frequency of attacks in hereditary angioedema were found in these patients. The control group did not show a similar increase in attacks during a comparable period of time.

Conclusion

A possible explanation for the increase in the frequency of attacks may lie in the large number of injections of C1 inhibitor concentrate.