Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer

Purpose

A substantial clinical need exists for an alternative to vitamin K antagonists for treating deep-vein thrombosis in cancer patients who are at high risk of both recurrent venous thromboembolism and bleeding. Low-molecular-weight heparin, body-weight adjusted, avoids anticoagulant monitoring and has been shown to be more effective than vitamin-K-antagonist therapy.

Subjects and Methods

Subjects were patients with cancer and acute symptomatic proximal-vein thrombosis. We performed a multi-centre randomized, open-label clinical trial using objective outcome measures comparing long-term therapeutic tinzaparin subcutaneously once daily with usual-care long-term vitamin-K-antagonist therapy for 3 months. Outcomes were assessed at 3 and 12 months.

Results

Of 200 patients, 100 received tinzaparin and 100 received usual care. At 12 months, the usual-care group had an excess of recurrent venous thromboembolism; 16 of 100 (16%) versus 7 of 100 (7%) receiving low-molecular-weight heparin (P = .044; risk ratio = .44; absolute difference −9.0; 95% confidence interval [CI], −21.7 to −0.7). Bleeding, largely minor, occurred in 27 patients (27%) receiving tinzaparin and 24 patients (24%) receiving usual care (absolute difference −3.0; 95% CI, −9.1 to 15.1). In patients without additional risk factors for bleeding at the time of randomization, major bleeding occurred in 0 of 51 patients (0%) receiving tinzaparin and 1 of 48 patients (2.1%) receiving usual care. Mortality at 1 year was high, reflecting the severity of the cancers; 47% in each group died.

Conclusion

Our findings confirm the limited but benchmark data in the literature that long-term low-molecular-weight heparin is more effective than vitamin-K-antagonist therapy for preventing recurrent venous thromboembolism in patients with cancer and proximal venous thrombosis.     

Self-managed long-term low-molecular-weight heparin therapy: the balance of benefits and harms

Purpose

A substantial clinical need exists for an alternate to vitamin K antagonists for treating deep vein thrombosis in many patients. Long-term low-molecular-weight heparin (LMWH), body-weight adjusted, avoids anticoagulant monitoring and may be associated with less bleeding. We evaluated the effectiveness and safety of long-term LMWH compared with vitamin K antagonist therapy in a broad spectrum of patients with proximal vein thrombosis.

Methods

We performed a multicenter, randomized, open-label clinical trial using objective outcome measures comparing therapy for 3 months. Outcomes were assessed at 3 and 12 months.

Results

Of 737 patients, 18 of 369 receiving tinzaparin (4.9%) had recurrent venous thromboembolism at 3 months compared with 21 of 368 (5.7%) receiving usual care (absolute difference, −0.8%, 95% confidence interval −4.1-2.4). Hemorrhagic complications occurred less frequently in the LMWH group largely because of less minor bleeding: 48 of 369 patients (13.0%) versus 73 of 368 patients (19.8%) receiving usual-care anticoagulation (absolute difference −6.8%; P = .011; risk ratio = 0.66). New major bleeding events ceased early (by day 23, P = .034) for patients receiving LMWH but persisted throughout the study treatment interval for patients receiving vitamin K antagonist therapy. No mortality advantage was shown for LMWH.

Conclusion

Our study shows that LMWH is similar in effectiveness to the usual-care vitamin K antagonist treatment for preventing recurrent venous thromboembolism in a broad spectrum of patients. It causes less harm and enhances the clinicians’ therapeutic options for patients with proximal deep vein thrombosis. Our findings reported here suggest the possibility of a broader role for long-term LMWH in selected 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.     

Enoxaparin versus tinzaparin in non-ST-segment elevation acute coronary syndromes: the EVET trial

Background

Low-molecular weight heparins have different pharmacokinetic and pharmacodynamic characteristics and may vary in efficacy. We compared the efficacy of enoxaparin with that of tinzaparin in the management of non-ST-segment elevation acute coronary syndromes (NSTACS).

Methods

A total of 438 patients with NSTACS were randomized to receive subcutaneous treatment with enoxaparin, 100 IU/kg twice daily (equivalent to 1 mg/kg twice daily; n = 220), or tinzaparin, 175 IU/kg once daily, (n = 218) for as long as 7 days. The primary composite end point was recurrent angina, myocardial infarction (or reinfarction), or death at day 7. Secondary end points were the primary end point at day 30 and the occurrence of individual events at days 7 and 30.

Results

The incidence of the primary end point was 12.3% in the enoxaparin group and 21.1% in the tinzaparin group (P = .015). At day 7, the rate of recurrent angina was lower with enoxaparin than with tinzaparin (11.8% vs 19.3%). At day 30, the incidences of the composite end point, recurrent angina, and myocardial infarction were also lower with enoxaparin, 17.7% vs 28.0% (P = .012), 17.3% vs 26.1% and 0.5% vs 2.8%, respectively. The rate of revascularization was lower in the enoxaparin group, 8.6% vs 17.9% (P = .010) at day 7 and 16.4% vs 26.1% (P = .019) at day 30. Rates of bleeding complications were similar in the 2 treatment groups.

Conclusions

This study indicates a benefit of enoxaparin (100 IU/kg twice daily) as compared with tinzaparin (175 IU/kg once daily) in the treatment of patients with NSTACS, which is sustained for at least 30 days.     

Family history for venous thromboembolism and the risk for recurrence

Purpose

The relevance of a family history for venous thromboembolism with regard to the likelihood for recurrence is unknown.

Subjects and methods

We studied 826 patients for an average of 36 months after a first unprovoked venous thromboembolism and withdrawal of oral anticoagulation. Patients with cancer, lupus anticoagulant, or deficiency of antithrombin, protein C, or protein S were excluded. The study endpoint was objective evidence of recurrent symptomatic venous thromboembolism.

Results

Recurrence for venous thromboembolism was recorded in 23 of 190 patients (12.1%) with a family history (at least one affected first-degree family member) and in 79 of 636 patients (12.4%) without familial thrombosis (relative risk for recurrence 1.0; 95% confidence interval, 0.7-1.6; P = .9). At 5 years, the likelihood for recurrence was 20% among patients with a family history for venous thromboembolism and 18% among those without a family history for venous thromboembolism (P = .9). Risk determinants for venous thromboembolism including factor V Leiden, factor II G20210A, and high factor VIII were not statistically different between the 2 groups.

Conclusion

A family history for venous thromboembolism does not segregate patients into high- or low-risk categories and is not suitable to identify patients at increased risk for recurrent venous thromboembolism.     

Long-term low-molecular-weight heparin and the post-thrombotic syndrome: a systematic review

Objective

Post-thrombotic syndrome causes considerable morbidity. The Home-LITE study showed a lower incidence of post-thrombotic syndrome and venous ulcers after 3 months of treating deep vein thrombosis with the low-molecular-weight heparin tinzaparin versus oral anticoagulation. This systematic review examined whether long-term treatment of deep vein thrombosis using low-molecular-weight heparin, rather than oral anticoagulation, reduces development of post-thrombotic syndrome.

Methods

We identified 9 articles comparing treatment of deep vein thrombosis using long-term low-molecular-weight heparin with any comparator, which reported outcomes relevant to the post-thrombotic syndrome assessed ≥ 3 months post-deep vein thrombosis.

Results

Pooled analysis of 2 studies yielded an 87% risk reduction with low-molecular-weight heparin in the incidence of venous ulcers at ≥ 3 months (P = .019). One study showed an overall odds ratio of 0.77 (P = .001) favoring low-molecular-weight heparin for the presence of 8 patient-reported post-thrombotic syndrome signs and symptoms. Pooled analysis of 5 studies showed a risk ratio for low-molecular-weight heparin versus oral anticoagulation of 0.66 (P < .0001) for complete recanalization of thrombosed veins.

Conclusion

These results support the lower incidence of post-thrombotic syndrome and venous ulcers observed in Home-LITE. Long-term treatment with low-molecular-weight heparin rather than oral anticoagulation after a deep vein thrombosis may reduce or prevent development of signs and symptoms associated with post-thrombotic syndrome. Post-thrombotic syndrome and associated acute ulcers may develop more rapidly after deep vein thrombosis than previously recognized.     

Treatment of diabetic foot ulcers: a comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy

Objective

This study compared the effectiveness of extracorporeal shockwave therapy (ESWT) and hyperbaric oxygen therapy (HBOT) in chronic diabetic foot ulcers.

Patients and methods

The ESWT group (39 patients/44 feet) received shockwave therapy twice per week for total six treatments. The HBOT group (38 patients/40 feet) received hyperbaric oxygen therapy daily for total 20 treatments. Evaluations included clinical assessment, blood flow perfusion scan and histopathological examination.

Results

The overall clinical results showed completely healed ulcers in 57% and 25% (P = 0.003); ≥50% improved ulcers in 32% and 15% (P = 0.071); unchanged ulcers in 11% and 60% (P < 0.001) and none worsened for the ESWT and the HBOT group respectively. The blood flow perfusion rates were comparable between the two groups before treatment (P = 0.245), however, significant differences were noted after treatment favoring the ESWT group (P = 0.002). Histopathological examination revealed considerable increases in cell proliferation and decreases in cell apoptosis in the ESWT group as compared to the HBOT group.

Conclusion

ESWT is more effective than HBOT in chronic diabetic foot ulcers. ESWT-treated ulcers showed significant improvement in blood flow perfusion rate and cell activity leading to better healing of the ulcers relative to HBOT in chronic diabetic foot ulcers.     

Effects of a home walking exercise program on functional status and symptoms in heart failure

Background

Hospital-based exercise programs using a bicycle ergometer or a combination of exercise modalities have shown positive benefits in heart failure, but may not be readily accessible to many patients. Thus, we sought to evaluate the effects of a 12-week home walking exercise program on functional status and symptoms in patients with heart failure.

Methods

A randomized controlled trial comparing a 12-week progressive home walking exercise program (n = 42) to a “usual activity” control group (n = 37) was conducted in patients with heart failure (78 [99%] male; mean age 62.6 ± 10.6 years; ejection fraction 27% ± 8.8%; 63 [80%] New York Heart Association class II; 15[20%] New York Heart Association class III-IV) from a Veterans Affairs medical center and a university-affiliated medical center. Functional status (peak oxygen consumption via cardiopulmonary exercise testing, 6-minute walk test, the Heart Failure Functional Status Inventory), and symptoms (Dyspnea-Fatigue Index score with a postglobal rating of symptoms) were measured at baseline and 12 weeks.

Results

No adverse events related to exercise training occurred. Overall mean compliance to training was 74 ± 37%. Peak oxygen consumption and the Heart Failure Functional Status Inventory were unchanged with training. Compared to the usual activity group, the training group had significantly longer walking distances measured by the 6-minute walk test (1264 ± 255 vs 1337 ± 272 feet, P = .001), and improved postglobal rating of symptoms (P = .03).

Conclusion

In patients with heart failure, a progressive home walking exercise program is acceptable, increases walking distance, and decreases global rating of symptoms.     

Peroxisome proliferator-activated receptor-γ agonist rosiglitazone reduces circulating platelet activity in patients without diabetes mellitus who have coronary artery disease

Background

Rosiglitazone, a peroxisome proliferator-activated receptor-γ (PPAR-γ) agonist, is used in the treatment of type 2 diabetes mellitus, and in vitro data has shown that it may have anti-platelet effects independent of its hypoglycemic effects. The aim of this study was to assess the effect of rosiglitazone on circulating platelet activity in patients without diabetes mellitus who had coronary artery disease.

Methods

Ninety-two patients with stable, documented coronary artery disease without diabetes mellitus were studied. Patients were randomized (double-blind) to receive placebo or rosiglitazone for 12 weeks. Circulating platelet activity was measured at baseline and after 12 weeks of therapy with whole blood flow cytometry to quantify platelet P-selectin expression.

Results

The percentage of P-selectin positive platelets was significantly reduced by rosiglitazone treatment compared with placebo (P = .04). In the rosiglitazone group, the percentage of P-selectin positive platelets (median with interquartile range) decreased from 0.1 % (0.05-0.24) to 0.05 % (0.01-0.15). Rosiglitazone treatment significantly reduced the insulin resistance index (HOMA-R) compared with placebo (P = .02). No significant correlation was observed between change in platelet activity and change in HOMA-R.

Conclusions

Rosiglitazone significantly reduces circulating platelet activity in patients without diabetes mellitus who have coronary artery disease. This effect appears to be independent of any insulin-sensitising effect.     

Biomechanical and echocardiographic characterization of flail mitral leaflet due to myxomatous disease: further evidence for early surgical intervention

Background

Flail mitral leaflet (FML) is a common complication of mitral valve prolapse, often leading to severe mitral regurgitation (MR) and left ventricular dysfunction. In the absence of timely surgical correction, survival is significantly impaired. Early recognition of FML and identification of risk factors is important because early intervention increases the chances of survival.

Methods

We studied 123 patients undergoing mitral valve surgery for severe MR caused by myxomatous disease. Chart review, echocardiography, and tensile testing were performed.

Results

Thirty-eight patients had FML, and 85 patients had non-flail mitral leaflet (non-FML). Patients with FML were younger (53.7 ± 1.8 vs 59.3 ± 1.4 years, P = .02), had more severe MR (3.89 ± 0.04 vs 3.76 ± 0.04, P = .02), were less likely to be in New York Heart Association class III or IV heart failure (5% vs 20%, P = .037), and were less likely to have bileaflet mitral valve prolapse (5% vs 38%, P <.001) than non-FML patients. Valve tissue from patients with FML had less stiff chordae (23.5 ± 3.6 vs 59.1 ± 11.7 Mpa, P = .006) that tended to have a lower failure stress (3.8 ± 0.9 vs 9.6 ± 2.2 Mpa, P = .07) and had more extensible leaflets (56.4% ± 7.9% vs 42.9% ± 2.7% strain, P = .04) compared with that of non-FML patients.

Conclusions

The development of FML may result from intrinsic tissue abnormalities and is associated with a distinct subset of the myxomatous population. Identification of such clinical characteristics in this population and knowledge of an implicit mechanical abnormality of valve tissue may further the argument for early surgical correction.     

Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS Study

Introduction and objectives

The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up.

Methods

The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome.

Results

Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100 mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A_1c <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003).

Conclusions

Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up.Full English text available from: www.revespcardiol.org     

Neutrophil gelatinase-associated lipocalin levels in isolated coronary artery ectasia

Background

The pathophysiology of coronary artery ectasia (CAE) is still unknown. Inflammation and degradation of connective tissue may have a role in the development of coronary ectasia. In the present study, the authors examined neutrophil gelatinase-associated lipocalin (NGAL) levels in isolated CAE patients.

Methods

Thirty-five patients with isolated CAE (25 males; mean age, 59 ± 10 years) and 35 age- and sex-matched healty volunteers (22 males; mean age, 57 ± 11 years) who had been shown to have normal coronary arteries were included in the study. Basal characteristics were recorded. Serum NGAL levels were determined with an enzyme-linked immunosorbent assay kit.

Results

NGAL levels were significantly higher in the isolated CAE group than in the control group (65.1 ± 13 vs 53.7 ± 19 ng/mL; P = 0.006). There were also significant difference in NGAL levels according to the number of ectatic coronary arteries (58.1 ± 13, 70.9 ± 9, and 71.1 ± 11 ng/mL for 1, 2, and 3 arteries, respectively; P = 0.015). Level of NGAL was lowest in patients who have only 1 ectatic coronary artery.

Conclusion

Serum NGAL levels increased in patients with isolated CAE, and NGAL may play a crucial role in the development and/or progression of coronary artery ectasia.     

Association of the PURSUIT risk score with predischarge ejection fraction, angiographic severity of coronary artery disease, and mortality in a nonselected, community-based population with non-ST-elevation acute myocardial infarction

Background

The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) risk score was derived from the PURSUIT trial population for 30-day mortality prediction.

Methods

The PURSUIT risk score was calculated for 337 consecutive Olmsted County residents with non-ST-elevation acute myocardial infarction admitted to the coronary care unit of our institution from 1988 through 1998. Predischarge ejection fraction (EF) measurement was available for 246 patients (73%). After excluding patients with prior coronary artery bypass graft surgery (n = 42), 219 patients (65%) had coronary angiography within 30 days of admission. Mortality at 30 days was 8.9%. Among 30-day survivors, mortality at 1 year was 7.9%.

Results

Mean age was 70 ± 13 years, and 37% of patients were women. Mean predischarge EF was 52% ± 16%. Patients with higher PURSUIT risk score had lower EF (P < .001). Three-vessel (≥70% stenosis in all 3 coronary arteries) or left main (≥50% stenosis) coronary artery disease was present in 60 of 219 patients (27%) who had coronary angiography. Higher PURSUIT risk score was associated with greater likelihood of 3-vessel or left main disease (P < .001). The PURSUIT risk score had very good predictive accuracy for both early (30-day, C-statistic = 0.78) and late (30-day to 1-year, C-statistic = 0.77) mortality.

Conclusions

The PURSUIT risk score correlates with EF, angiographic severity of coronary artery disease, and short- and long-term mortality of nonselected patients with non-ST-elevation acute myocardial infarction.     

Lack of relationship between Doppler indices of diastolic function and left ventricular pressure transients in patients with definite diastolic heart failure

Objectives

The purpose of this study was to compare invasive with noninvasive indices of diastolic function in a well-defined group of patients with diastolic dysfunction and a history of diastolic heart failure.

Background

Patients with heart failure and a normal left ventricular (LV) ejection fraction comprise a very large portion of the heart failure population and most are thought to have diastolic heart failure. While clinical and Doppler criteria for diastolic dysfunction and diastolic heart failure have been developed, there remains some controversy about the need for invasive cardiac catheterization and/or echo-Doppler evaluation of LV diastolic function. To date, there is no consensus as to the utility of these 2 methods in the diagnosis of diastolic heart failure.

Methods

Forty-seven patients (mean age 58 ± 11 years) with a history of congestive heart failure and preserved ejection fraction (≥50%) by echocardiography underwent a combined hemodynamic/echo-Doppler study. Patients with coronary disease were excluded. Invasive parameters of LV diastolic function (tau, LV diastolic pressures) and Doppler parameters (peak E, peak A, E/A ratio, isovolumic relaxation time, and E deceleration time) were measured using standard techniques.

Results

There was a close correlation between invasively-determined parameters (tau vs end diastolic pressure: r = 0.62, P < .001). The relationships between standard Doppler parameters and LV diastolic pressures were uniformly poor. However, the relationship between Doppler isovolumic relaxation time and tau improved considerably when patients were subgrouped by hemodynamic load.

Conclusions

Standard echo-Doppler indices of diastolic function correlate poorly with LV diastolic pressure transients. The diagnosis of diastolic heart failure cannot be made on the basis of a single echo-Doppler parameter but, rather, all parameters must be examined in concert and used in combination with clinical observations.     

Changing epidemiology of native valve infective endocarditis

Introduction and objectives

The aim of our study is to assess changes in the epidemiologic features of patients with native valve infective endocarditis.

Methods

We analyzed a prospective series of 228 cases of native valve infective endocarditis in non-intravenous drug users attending our center between 1987 and 2009. We compared three subperiods: 1987-1994 (67 cases), 1995-2002 (74 cases) and 2003-2009 (87 cases).

Results

The mean age of patients has progressively increased (38±22 years in the first subperiod vs 60±16 years in the third; P<.001), as has the proportion of cases without predisposing heart disease (25%, 46% and 67%; P<.001). Incidence of mitral valve prolapse remained stable (12%, 18% and 11%). Percentages of patients with predisposing heart disease and who were aware of their condition have fallen in recent years (45%, 27% and 21%; P<.001). A portal of entry for the infection could not be identified in 64%. Overall, Staphylococcus aureus is the most frequent causative organism (26%) whereas the percentage of cases caused by Streptococcus viridans remains unaltered (22%, 20% and 24%).

Conclusions

We found significant changes in the epidemiology of native valve infective endocarditis. The incidence of patients without predisposing heart disease has increased significantly and staphylococci are the most frequent causative organisms.Full English text available from: www.revespcardiol.org     

Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications

Purpose

Selective cyclooxygenase-2 (COX-2) inhibitors cause significantly fewer peptic ulcers than conventional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at low risk or high risk for peptic ulcers. On the other hand, proton pump inhibitor co-therapy has also been shown to be effective in preventing relapse of peptic ulcers in high-risk patients using nonselective NSAIDs. We compared the efficacy of a selective COX-2 inhibitor with that of proton pump inhibitor co-therapy in the reduction in the incidence of ulcer relapse in patients with a history of NSAID-related peptic ulcers.

Materials and methods

For this study, we recruited 224 patients who developed ulcer complications after NSAID use. We excluded patients who required concomitant aspirin treatment and who had renal impairment. After healing of ulcers and eradication of Helicobacter pylori, patients were randomly assigned to treatment with celecoxib 200 mg daily (n = 120) or naproxen 750 mg daily and lansoprazole 30 mg daily (n = 122) for 24 weeks. The primary endpoint was recurrent ulcer complications.

Results

During a median follow-up of 24 weeks, 4 (3.7%, 95% confidence interval [CI] 0.0%-7.3%) patients in the celecoxib group, compared with 7 patients (6.3%, 95% CI 1.6%-11.1%) in the lansoprazole group, developed recurrent ulcer complications (absolute difference −2.6%; 95% CI for the difference −9.1%-3.7%). Celecoxib was statistically non-inferior to lansoprazole co-therapy in the prevention of recurrent ulcer complications. Concomitant illness (hazard ratio 4.72, 95% CI 1.24-18.18) and age 65 years or more (hazard ratio 18.52, 95% CI 2.26-142.86) were independent risk factors for ulcer recurrences. Significantly more patients receiving celecoxib (15.0%, 95% CI 9.7-22.5) developed dyspepsia than patients receiving lansoprazole (5.7%, 95% CI 2.8-11.4. P = .02).

Conclusions

Celecoxib was as effective as lansoprazole co-therapy in the prevention of recurrences of ulcer complications in subjects with a history of NSAID-related complicated peptic ulcers. However, celecoxib, similar to lansoprazole co-therapy, was still associated with a significant proportion of ulcer complication recurrences. In addition, more patients receiving celecoxib developed dyspepsia than patients receiving lansoprazole and naproxen.     

Safety of fine-needle aspiration in patients with small hepatocellular carcinoma

Objective.

This study was to clarify the safety of fine-needle aspiration of small hepatocellular carcinoma (HCC).

Methods.

Ninety consecutive patients with small hepatocellular carcinoma (46 with single nodule, 44 with multiple nodules, all ≤3 cm) who had a comparative angiography performed within 50 days (median 16 days) after aspiration were included.

Results.

The angiographic detection of hepatocellular carcinoma was not influenced by the procedure of aspiration except in one (1.1%) with small arterioportal shunt. The newly developed nodules of hepatocellular carcinoma were not localized in the segment of aspirated nodule located. None of the new nodules was located along the needle tract. Patients with single nodule caused by hepatitis C had a significantly higher incidence of appearance of new nodule than those caused by hepatitis B (38.46% versus 4.35%, p = 0.0159). Patients with multiple nodules had a significantly higher incidence of appearance of new nodule than patients with single nodule (60% versus 18.18%, p < 0.005). These results indicated that the newly developed nodules were related to the disease process rather than the procedure of aspiration.

Conclusions.

Fine-needle aspiration is a safe procedure in the collection of specimens for the diagnosis of small hepatocellular carcinoma.     

Accuracy of electrocardiogram interpretation by cardiologists in the setting of incorrect computer analysis

Background

Overreading of 12 lead electrocardiograms (ECGs) is required to circumvent errors of computerized ECG interpretation. The accuracy of the overreading physician's interpretation of ECGs that were incorrectly read as atrial fibrillation by a computer algorithm has not been systematically examined.

Methods

A total of 2298 ECGs with the computerized interpretation of atrial fibrillation from 1085 patients were analyzed by 2 electrophysiologists, who identified 442 ECGs (19%) from 382 patients (35%) that were incorrectly interpreted as atrial fibrillation. Charts were reviewed to determine the interpretation of the ECG by the ordering physician (primary reader) and the overreading cardiologist.

Results

Cardiologists as primary readers more often corrected the misinterpreted ECGs as compared with internists, emergency physicians, or other specialists (94% vs 71%, P < .001). Surprisingly, interpretations by cardiologists as primary readers were more accurate than the interpretation provided by overreading cardiologists (94% vs 72%, P < .001).

Conclusion

Knowledge of an individual patient on whom an ECG is ordered may result in a more critical rhythm assessment and might account for the higher accuracy of rhythm interpretation by the cardiologist as compared with the interpretation by the overreading cardiologist who is lacking relevant clinical information.     

Clinical trial of an educational intervention to achieve recommended cholesterol levels in patients with coronary artery disease

Background

Despite national efforts to improve cholesterol management for patients with coronary artery disease, many patients are not reaching recommended cholesterol target levels. We sought to determine whether a nurse-based educational intervention, designed to educate patients with confirmed coronary artery disease about personal low-density lipoprotein (LDL) cholesterol target levels and encourage partnership with physicians, could increase adherence with National Cholesterol Education Program target levels (LDL cholesterol level ≤100 mg/dL).

Methods

Patients hospitalized with confirmed coronary artery disease were randomized to undergo a nurse-based educational intervention (375 patients) or usual care (381 patients) for a 12-month period after hospitalization. The primary outcome was the proportion of patients at the LDL cholesterol target level 1 year after hospitalization. The secondary outcome was the proportion of patients with accurate knowledge of LDL cholesterol target levels.

Results

The groups were similar at baseline in demographic and clinical characteristics, percent at LDL cholesterol target level (43.9% and 41.1%, respectively), and percent with knowledge of LDL cholesterol target levels (both 5%). The proportion of patients at LDL cholesterol target levels at 1 year did not differ between the intervention (70.2%) and usual care group (67.4%, P = .46). At the conclusion of the trial, patient knowledge about LDL cholesterol target level was higher for the intervention group than the usual care group (19.6% and 6.7%, respectively, P = .001), but this was not associated with improved cholesterol management.

Conclusions

Our nurse-based educational intervention did not result in a significant increase in the proportion of patients who reached target LDL cholesterol levels 1 year after hospitalization. Although the intervention improved patient knowledge of LDL cholesterol target levels, overall rates of LDL cholesterol knowledge remained low, and it was not associated with improved cholesterol management.     

Comparison of infusion or low-dose proton pump inhibitor treatments in upper gastrointestinal system bleeding

Background

The most effective schedule of proton pump inhibitor (PPI) administration following endoscopic hemostasis of bleeding ulcers remains uncertain.

Aim

To compare the treatment effects of continuous infusion and low-dose esomeprazole therapies in patients with non-variceal upper gastrointestinal (GI) bleeding.

Methods

This prospective clinical study compared continuous infusion of esomeprazole (80 mg bolus followed by 8 mg∕h continuous infusion for 72 h) and low-dose esomeprazole (40 mg twice daily IV) treatments in GI bleeding patients with peptic ulcer presenting a high risk of re-bleeding, who were administered a successful endoscopic homeostasis. The primary end point was the occurrence of re-bleeding during hospitalization and within one month of discharge. Secondary outcomes were defined as duration of hospitalization, need of transfusion, surgical treatment, and mortality rate. After 72 h, both groups were switched to oral esomeprazole therapy for one-month.

Results

A hundred thirty-two subjects were enrolled. Re-bleeding occurred in 11 (16.7%) patients in the infusion therapy group and in 12 (18.2%) patients in the low-dose group (P = 0.819) within the first 72 h. No patient experienced re-bleeding in the first month following discharge. There was no statistical significant difference between the two groups in terms of transfusion need, durations of hospitalization, need for surgery and mortality rate.

Conclusion

PPI infusion therapy following endoscopic hemostasis treatment was not found superior to low-dose PPI therapy in the terms of re-bleeding, need of surgery and mortality.