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M H Prins

Publications and source records attributed to M H Prins.

At least 37 records · Page 2Linked to original sources
PubMed2005

Decision analysis for cancer screening in idiopathic venous thromboembolism.

BACKGROUND: The SOMIT trial randomized patients with idiopathic venous thromboembolism (IVTE) and without signs of cancer at routine medical examination, to extensive screening for cancer plus 2 years of follow-up or to just 2-year follow-up. METHODS: The data of the SOMIT-trial were used to perform a decision analysis. The screening tests were divided in several possible strategies. The number of detected cancer patients and the number of patients investigated further for an eventually benign condition were calculated for each strategy. The total costs for the screening strategy and for each detected cancer patient were determined. Based on the tumor type, stage, age and gender of the individual cancer patient, the difference in live years gained (LYG) was calculated between the two study groups. RESULTS: Computed tomography (CT) of the abdomen combined with sputum cytology and mammography detected 12 of the 14 patients with cancer and had one false-positive result. In general, screening strategies including abdominal/pelvic ultrasonography (US) or tumor markers yielded a higher number of patients needed to screen in comparison with those using abdominal/pelvic CT. Furthermore, the strategies which included colonoscopy, tumor markers, and abdominal/pelvic US were significantly more costly, had inferior LYG and higher costs per LYG, when compared with strategies using abdominal/pelvic CT. CONCLUSIONS: Despite the limitations of this analysis, the screening for cancer with a strategy including abdominal/pelvic CT with or without mammography and/or sputum cytology appears potentially useful for cancer screening in patients with IVTE. The cost-effectiveness analysis of this strategy needs confirmation in a large trial.

Cost-Benefit Analysis↗
PubMed2004

Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism.

BACKGROUND: Low molecular weight heparins (LMWH) have been shown to be effective and safe in preventing venous thromboembolism (VTE), and may also be effective for the initial treatment of VTE. OBJECTIVES: To determine the effect of LMWH compared with unfractionated heparin (UFH) for the initial treatment of VTE. SEARCH STRATEGY: Trials were identified from the Cochrane Peripheral Vascular Diseases Group's Specialised Register, CENTRAL and LILACS. Colleagues and pharmaceutical companies were contacted for additional information. SELECTION CRITERIA: Randomised controlled trials comparing fixed dose subcutaneous LMWH with adjusted dose intravenous or subcutaneous UFH in people with VTE. DATA COLLECTION AND ANALYSIS: At least two reviewers assessed trials for inclusion and quality, and extracted data independently. MAIN RESULTS: Twenty-two studies were included (n = 8867). Thrombotic complications occurred in 151/4181 (3.6%) participants treated with LMWH, compared with 211/3941 (5.4%) participants treated with UFH (odds ratio (OR) 0.68; 95% confidence intervals (CI) 0.55 to 0.84, 18 trials). Thrombus size was reduced in 53% of participants treated with LMWH and 45% treated with UFH (OR 0.69; 95% CI 0.59 to 0.81, 12 trials). Major haemorrhages occurred in 41/3500 (1.2%) participants treated with LMWH, compared with 73/3624 (2.0%) participants treated with UFH (OR 0.57; 95% CI 0.39 to 0.83, 19 trials). In eighteen trials, 187/4193 (4.5%) participants treated with LMWH died, compared with 233/3861 (6.0%) participants treated with UFH (OR 0.76; 95% CI 0.62 to 0.92). Nine studies (n = 4451) examined proximal thrombosis; 2192 participants treated with LMWH and 2259 with UFH. Subgroup analysis showed statistically significant reductions favouring LMWH in thrombotic complications and major haemorrhage. By the end of follow up, 80 (3.6%) participants treated with LMWH had thrombotic complications, compared with 143 (6.3%) treated with UFH (OR 0.57; 95% CI 0.44 to 0.75). Major haemorrhage occurred in 18 (1.0%) participants treated with LMWH, compared with 37 (2.1%) treated with UFH (OR 0.50; 95% CI 0.29 to 0.85). Nine studies (n = 4157) showed a statistically significant reduction favouring LMWH with respect to mortality. By the end of follow up, 3.3% (70/2094) of participants treated with LMWH had died, compared with 5.3% (110/2063) of participants treated with UFH (OR 0.62; 95% CI 0.46 to 0.84). REVIEWERS' CONCLUSIONS: LMWH is more effective than UFH for the initial treatment of VTE. LMWH significantly reduces the occurrence of major haemorrhage during initial treatment and overall mortality at follow up.

Heparin↗
PubMed2004

Non-pharmaceutical measures for prevention of post-thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) characterised by chronic pain, swelling and skin changes in the affected limb. One in every three patients with DVT will develop post-thrombotic complications within five years. OBJECTIVES: To determine the relative effectiveness of, and the rate of complications using non-pharmaceutical interventions in patients with DVT in the prevention of PTS. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group Specialised Trials Register (last searched January 2003), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 4, 2002). In addition, hand searching of non-listed journals and personal communications with researchers was undertaken. SELECTION CRITERIA: Randomised controlled trials (RCTs) of non-pharmaceutical interventions, such as bandaging and elastic stockings in patients with clinically confirmed DVT. The primary outcome was the occurrence of PTS. There was no restriction on date or language. One reviewer (DNK) identified and assessed titles and abstracts for relevance. This was verified independently by a second reviewer (RS). DATA COLLECTION AND ANALYSIS: Data extraction was undertaken independently by two reviewers (DNK, RS), using data extraction sheets. MAIN RESULTS: Three RCTs that evaluated compression therapy were identified. Two studies compared elastic compression stockings with a pressure of 30-40 mm Hg at the ankle with no intervention applied directly after an episode of DVT. The other small study compared elastic compression stockings (pressure 20-30 mm Hg) with stockings that were one to two sizes too large in patients one year after DVT. Overall, in the treatment group at two years, the use of elastic compression stockings was associated with a highly statistically significant reduction in the incidence of PTS with odds ratio (OR) 0.31 (95% confidence interval (CI) 0.20 to 0.48). In addition, the incidence of severe PTS was reduced from OR 0.39 (95% CI 0.20 to 0.76). In another RCT that considered the first nine days post DVT, no difference in the incidence of pulmonary embolism and size of thrombus in the femoral vein was found. A statistically significant reduction (p <0.05) was found in pain, swelling and clinical scores, favouring the compression group. REVIEWER'S CONCLUSIONS: There is substantial evidence that elastic compression stockings reduce the occurrence of PTS after DVT. No serious adverse effects were mentioned in the studies. Hence, elastic compression stockings should be added to the treatment of DVT to prevent the development of post-thrombotic syndrome.

Bandages↗
PubMed2004

Peripheral arterial disease: public and patient awareness in The Netherlands.

OBJECTIVE: To determine critical issues for future awareness programmes on peripheral arterial disease (PAD). DESIGN: National Dutch survey. MATERIALS AND METHODS: A representative sample of 1294 members of the general population, and 281 patients with PAD from the Capi@home database were administered a questionnaire concerning awareness of PAD. RESULTS: The response rate was 81% for the general population and 78% for patients with PAD. The familiarity with PAD terminology and symptoms amongst the general population was low. Few patients (20%) were aware that PAD was a disease of arteries. Amongst both the general population and the patient populations, PAD risk factors identification was low: hypertension (4% versus 0%); hypercholesterolaemia (9% versus 12%), diabetes (2% versus 8%), and smoking (27% versus 52%). Knowledge was moderate in both populations about treatment with exercise, but low for smoking cessation. The general population was unaware of the central role of general practitioners in the treatment of PAD. CONCLUSIONS: The awareness of symptoms, risk factors, and treatment options for PAD is low. Both population and patients needed only minimal information to relate PAD to other atherosclerotic diseases. Based on the results of this survey the Dutch Platform of Peripheral Arterial Disease together with the Dutch Heart Foundation are initiating the first awareness campaign on atherosclerosis.

Adult↗
PubMed2004

Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial.

AIM: To evaluate whether angioplasty or above-knee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions, we performed a multicentre randomised trial. PATIENTS AND METHODS: Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related to a 5-15 cm long occlusive lesion of the superficial femoral artery. Thirty-one patients were randomly assigned to percutaneous transluminal angioplasty (PTA); 25 patients to bypass surgery. All patients were followed at 1, 6 and 12 months after the procedure. The primary outcome of our study was re-occlusion of the femoral artery. RESULTS: Thirty patients underwent the allocated PTA and 24 patients underwent bypass surgery. Cumulative 1-year primary patency after PTA was 43 and 82% after bypass surgery. After PTA more than half of the patients had a re-occlusion with an absolute risk reduction of 31% (CI: 6-56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.9-5.58). CONCLUSION: Despite 18 participating centres only 56 patients were randomised to PTA our bypass surgery. Based on our results, for every three patients treated with bypass surgery instead of PTA, one additional re-occlusion is prevented. Therefore, we conclude that with respect to patency, for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA.

Adult↗
PubMed2004

Severity of venous insufficiency is related to the density of microvascular deposition of PAI-1, uPA and von Willebrand factor.

BACKGROUND: Impaired microcirculation in chronic venous insufficiency leads to chronic inflammation and dystrophic changes of the skin, and finally to leg ulceration. The purpose of this study was to investigate in more detail coagulation and fibrinolytic protein response of the capillaries in skin biopsies of the lower extremity. PATIENTS AND METHODS: From eighteen ambulant patients with venous leg ulcer(s) (n = 8) and controls (n = 10) with various degrees of venous insufficiency according to the CEAP classification, we obtained 4 mm punch biopsies. Immunohistochemical staining with tissue derived plasminogen activator (tPA), urokinase derived plasminogen activator (uPA), plasminogen activator inhibitor (PAI-1) and von Willebrand Factor (vWF) was performed and analyzed with bright field microscopy. RESULTS: The amount of staining with vWF (p = 0.04) and uPA (p = 0.02) showed statistically significant differences, PAI-1 (p = 0.09) and tPA (p = 0.50) showed no difference between leg ulcer and control groups. A strong proliferation of capillaries with tortuous capillary loops in the papillary dermis was seen, but no statistically significant difference (M-W test, p = 0.10) was found between the groups. Comparison between CEAP classes 0-6 showed a statistically significant increased staining pattern of vWF (p = 0.06), uPA (p = 0.02) and PAI-1 (p = 0.02), but not from tPA (p = 0.30). CONCLUSIONS: In skin biopsies of the lower extremity of patients with severe venous insufficiency increased deposition of vWF, PAI-1 and uPA were found in the capillaries. These findings point to a local imbalance in coagulation and fibrinolytic status, which might contribute to impaired microcirculation and finally to the development of venous leg ulceration.

Adult↗
PubMed2004

Influence of SERTPR and STin2 in the serotonin transporter gene on the effect of selective serotonin reuptake inhibitors in depression: a systematic review.

Large differences in clinical response to selective serotonin reuptake inhibitors (SSRIs) are observed in depressive patients with different genotypes. Quantification of these differences is needed to decide if genetic testing prior to antidepressant treatment is useful. We conducted a systematic review of the literature on the influence of polymorphisms in the serotonin transporter gene (SERTPR (or 5-HTTLPR) and STin2) on SSRI response. Studies were identified by the use of MEDLINE, EmBase and PsycINFO, references of articles, reviews and information from pharmaceutical companies. Nine studies assessing the influence of SERTPR or STin2 on treatment response were included. Outcome was expressed as the percentage of decrease in depression score (HAM-D or MADRS) or as the percentage of responders (> or =50% reduction on the depression scale). Both study methodologies and study outcomes showed large heterogeneity. Weighted mean decreases in depression score for patients with the s/s, s/l and l/l genotypes were 35.4, 46.3 and 48.0% at week 4, respectively, and 53.9, 54.6 and 48.3% at week 6. Among Caucasian patients, both mean decrease in depression score and response rate were lowest in the s/s group, while among Asian patients, results were inconsistent. Weighted response rates were 36.1% for the 10/12 genotype of the STin2 polymorphism and 80.7% for the 12/12 genotype (chi2=27.8, P<0.001) (only Asians). The available evidence points to a less favourable response to SSRI treatment among Caucasian patients with the SERTPR s/s genotype and among (Asian) patients with the STin2 10/12 genotype. In view of the scarcity and heterogeneity of the studies, however, current information is insufficiently reliable as a basis for implementing genetic testing in the diagnostic work-up of the depressive patient.

Adult↗
PubMed2004

Extensive screening for occult malignant disease in idiopathic venous thromboembolism: a prospective randomized clinical trial.

Patients with symptomatic idiopathic venous thromboembolism and apparently cancer-free have an approximate 10% incidence of subsequent cancer. Apparently cancer-free patients with acute idiopathic venous thromboembolism were randomized to either the strategy of extensive screening for occult cancer or to no further testing. Patients had a 2-year follow-up period. Of the 201 patients, 99 were allocated to the extensive screening group and 102 to the control group. In 13 (13.1%) patients, the extensive screening identified occult cancer. In the extensive screening group, a single (1.0%) malignancy became apparent during follow-up, whereas in the control group a total of 10 (9.8%) malignancies became symptomatic [relative risk, 9.7 (95% CI, 1.3-36.8; P < 0.01]. Overall, malignancies identified in the extensive screening group were at an earlier stage and the mean delay to diagnosis was reduced from 11.6 to 1.0 months (P < 0.001). Cancer-related mortality during the 2 years follow-up period occurred in two (2.0%) of the 99 patients of the extensive screening group vs. four (3.9%) of the 102 control patients [absolute difference, 1.9% (95% CI, -5.5-10.9)]. Although early detection of occult cancers may be associated with improved treatment possibilities, it is uncertain whether this improves the prognosis.

Adult↗
PubMed2004

Screening for occult cancer in patients with acute deep vein thrombosis or pulmonary embolism.

Patients with acute venous thromboembolism have an increased risk for occult malignancy. Limited screening for these malignancies has become common practice but little is known about its usefulness. This is a prospective cohort follow-up study in consecutive patients with acute venous thromboembolism. All patients underwent a routine clinical evaluation for malignancy, if negative, followed by a limited diagnostic work-up consisting of abdominal and pelvic ultrasound and laboratory markers for malignancy. Clinical follow-up was conducted to detect screening failures. The routine clinical evaluation was performed in 864 patients and revealed malignancy in 34 (3.9%) of them. Among the remaining 830 patients the limited diagnostic work-up revealed 13 further malignancies. During follow-up, cancer became symptomatic in 14 patients who were negative for cancer at screening (sensitivity of limited diagnostic work-up, 48.1%). Malignancies that were identified by the limited diagnostic work-up were early stage in 61% of cases vs. 14% in cases occurring during follow-up. Most patients with occult cancer had idiopathic venous thromboembolism and were older than 70 years. A limited diagnostic work-up for occult cancer in patients with venous thromboembolism has the capacity to identify approximately one-half of the malignancies. Identified malignancies were predominantly in an early stage.

Acute Disease↗
PubMed2004

Non-invasive diagnostic work-up of patients with clinically suspected pulmonary embolism; results of a management study.

BACKGROUND: Clinicians often deviate from the recommended algorithm for the diagnosis of pulmonary embolism consisting of ventilation-perfusion scintigraphy and pulmonary angiography. OBJECTIVES: To assess the safety and feasibility of a diagnostic algorithm which reduces the need for lung scintigraphy and avoids the use of angiography. PATIENTS AND METHODS: Consecutive patients with a clinical suspicion of pulmonary embolism were prospectively investigated according to an algorithm in which the diagnosis of pulmonary embolism was excluded after a low clinical probability estimate and a normal d-dimer test result, a normal perfusion scintigraphy result, or a non-high probability scintigraphy result in combination with normal serial ultrasonography of the legs. In these patients anticoagulant treatment was withheld and they were followed up for 3 months to record possible thromboembolic events. During the study period, 923 consecutive patients were seen, of whom 292 were excluded because of predefined criteria. RESULTS: Of the 631 included patients, the diagnosis was refuted on the basis of a low clinical probability estimate and a normal d-dimer test result (95 patients), normal perfusion scintigraphy (161 patients) and non-high probability lung scintigraphy followed by normal serial ultrasonography (210 patients). Of these 466 patients, venous thromboembolic complications during follow-up occurred in six (complication rate 1.3%, 95% confidence interval 0.5, 2.8). The diagnostic protocol was completed in 92% of all included patients. CONCLUSION: The diagnosis of pulmonary embolism can be safely ruled out by a non-invasive algorithm consisting of d-dimer testing combined with a clinical probability estimate, lung scintigraphy, or serial ultrasonography of the legs (in case of non-diagnostic lung scintigraphy).

Algorithms↗
PubMed2003

Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.

BACKGROUND: The standard initial treatment of hemodynamically stable patients with pulmonary embolism is intravenous unfractionated heparin, requiring laboratory monitoring and hospitalization. METHODS: We conducted a randomized, open-label trial involving 2213 patients with acute symptomatic pulmonary embolism to compare the efficacy and safety of the synthetic antithrombotic agent fondaparinux with those of unfractionated heparin and to document noninferiority in terms of efficacy. Patients received either fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily or a continuous intravenous infusion of unfractionated heparin (ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), both given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0. The primary efficacy outcome was the three-month incidence of the composite end point of symptomatic, recurrent pulmonary embolism (nonfatal or fatal) and new or recurrent deep-vein thrombosis. RESULTS: Forty-two of the 1103 patients randomly assigned to receive fondaparinux (3.8 percent) had recurrent thromboembolic events, as compared with 56 of the 1110 patients randomly assigned to receive unfractionated heparin (5.0 percent), for an absolute difference of -1.2 percent in favor of fondaparinux (95 percent confidence interval, -3.0 to 0.5). Major bleeding occurred in 1.3 percent of the patients treated with fondaparinux and 1.1 percent of those treated with unfractionated heparin. Mortality rates at three months were similar in the two groups. Of the patients in the fondaparinux group, 14.5 percent received the drug in part on an outpatient basis. CONCLUSIONS: Once-daily, subcutaneous administration of fondaparinux without monitoring is at least as effective and is as safe as adjusted-dose, intravenous administration of unfractionated heparin in the initial treatment of hemodynamically stable patients with pulmonary embolism.

Aged↗
PubMed2003

Antiplatelet agents for preventing thrombosis after peripheral arterial bypass surgery.

BACKGROUND: Peripheral arterial disease (PAD) may cause occlusions (blockages) in the main arteries of the lower limbs. It is frequently treated by implantation of either an infrainguinal autologous (using the patient's own tissue) venous or artificial graft. A number of factors influence occlusion rates, including the material used. To prevent graft occlusion, patients are usually treated with either an antiplatelet or antithrombotic drug, or a combination of both. OBJECTIVES: To evaluate whether antiplatelet treatment in patients with symptomatic PAD undergoing infrainguinal bypass surgery improves graft patency, limb salvage and survival. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group Specialised Register, (last searched April 2003), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 1, 2003). Additional trials were sought through reference lists of papers and by reviewing proceedings from the vascular surgical society meetings. SELECTION CRITERIA: The methodological quality of each trial was assessed independently by two reviewers (JD, MMK), with emphasis on concealment of randomisation. DATA COLLECTION AND ANALYSIS: Details of the studies selected were extracted independently by two reviewers (JD, MMK), and an 'intention-to-treat' analysis performed. The treatment and control groups were compared for important prognostic factors and differences described. If any data were not available, further information was sought from the author. Data were synthesized by comparing group results. MAIN RESULTS: The administration of a variety of platelet-inhibitors resulted in improved venous and artificial graft patency compared to no treatment. However, analysing patients for graft-type indicated that patients receiving a prosthetic graft were more likely to profit from administration of platelet-inhibitors than those treated with a venous graft. REVIEWER'S CONCLUSIONS: Antiplatelet therapy with aspirin had a slight beneficial effect on the patency of peripheral bypasses, but seemed to have an inferior effect on venous graft patency compared with artificial grafts. The effect of aspirin on cardiovascular outcomes and survival was mild and not statistically significant; this might be due to the fact that the majority of patients receiving a peripheral graft have an advanced stage of PAD with critical ischemia. These patients are usually seriously ill with respect to cardiovascular diseases with high mortality rates of 20% per year. Additionally, the number of patients included in this analysis might still be too small to reach a statistically significant effect for mortality and cardiovascular morbidity.

Arteriosclerosis↗
PubMed2003

Antithrombotic agents for preventing thrombosis after infrainguinal arterial bypass surgery.

BACKGROUND: Chronic peripheral arterial disease (PAD) is frequently treated by implantation of either an infrainguinal autologous venous or artificial graft. One-year occlusion rates for infrainguinal bypasses vary between 15 and 75%, depending on the site of distal anastomosis, length, quality, and material of the graft, but also on other factors such as proximal inflow and distal outflow conditions. To prevent graft occlusion, patients are usually treated with either an antiplatelet or antithrombotic drug, or a combination of both. Little is known about which drug is optimal to prevent infrainguinal graft occlusion. OBJECTIVES: To evaluate whether antithrombotic treatment in patients with chronic PAD undergoing infrainguinal bypass surgery improves graft patency, limb salvage and survival by performing a meta-analysis of performed RCTs. SEARCH STRATEGY: The search strategy was that adopted by the Cochrane Review Group on Peripheral Vascular Diseases. Additional data bases were reviewed (Reference lists of papers resulting from this search, MEDLINE from 1966-onwards and EMBASE from 1980-onwards using the terms 'anticoagulant' and 'arterial surgery'. SELECTION CRITERIA: The methodological quality of each trial was assessed independently by at least two reviewers using the checklist provided by the Peripheral Vascular Diseases Collaborative Review Group, with emphasis on concealment of randomisation. Each trial was given an allocation score of A (clearly concealed), B (unclear if concealed), or C (clearly not concealed) and a summary score of A (low risk of bias), B (moderate risk), or C (high risk). Trials scoring A were included and those scoring C were excluded. For a trial scoring B, an attempt was made to obtain more information by contacting the author. DATA COLLECTION AND ANALYSIS: For each trial, the number of patients originally allocated to each treatment group was extracted from the data and an 'intention to treat' analysis performed. Data collection on each trial included inclusion and exclusion criteria, patient details, type of graft, type and dose of antithrombotic therapy used, outcome, and side effects. The treatment and control groups were compared for important prognostic factors and differences described. If any of the above data was not available, further information was sought from the author. However, the heterogeneity between trials could not be tested due to inaccessible data. Data were synthesized by comparing group results. MAIN RESULTS: The analysis including four trials which evaluated vitamin K antagonists (VKA) versus no VKA indicate, that oral anticoagulation tendentially favours venous but not artificial graft patency as well as limb salvage and survival. Two other studies comparing VKA with aspirin or aspirin/dipyridamole supported evidence for a positive effect of VKA on the patency of venous but not artificial grafts. Subgroup analysis for artificial grafts as performed in one trial showed a favourable effect of antiplatelet agents on synthetic bypasses. In two trials with a relatively small number of patients low molecular weight heparin treatment was associated with a lower incidence of early postoperative graft thrombosis compared to treatment with unfractionated heparin. In one trial infusion of antithrombin concentrate was reported to have a negative effect on intraoperative graft thrombosis necessitating the study to be stopped before termination. Perioperative administration of ancrod was compared to unfractionated heparin showing no benefit of one drug compared to the other. REVIEWER'S CONCLUSIONS: Patients operated for an infrainguinal venous graft might benefit from treatment with VKA, whereas patients receiving an artificial graft might profit more from platelet inhibitors (aspirin). However, the evidence is not conclusive. Randomised controlled trials with larger patient numbers comparing antithrombotic therapies with either placebo or antiplatelet therapies are called for in the future.

Arteriosclerosis↗
PubMed2003

Once versus twice daily LMWH for the initial treatment of venous thromboembolism.

BACKGROUND: In the initial treatment of venous thromboembolism (VTE) low molecular weight heparin (LMWH) is administered once or twice daily. A once daily treatment regimen is more convenient for the patient and may optimise home treatment. However it is not clear whether a once daily treatment regimen is as safe and effective as a twice daily treatment regimen. OBJECTIVES: The objective of this review was to compare the efficacy and safety of once daily administration to a twice daily administration of LMWH. SEARCH STRATEGY: Trials were identified through the Specialised Register of the Cochrane Peripheral Vascular Diseases Group (last searched May 2001), the Cochrane Controlled Trials Register (CCTR/CENTRAL) (last searched Issue 1, 2002), by hand-searching other relevant journals, by checking cross-references and through personal communication with experts. SELECTION CRITERIA: Randomised clinical trials in which a once daily treatment regimen with LMWH is compared to a twice daily regimen in the initial treatment of patients with venous thromboembolism. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trials on criteria for inclusion and extracted the data independently. MAIN RESULTS: Five studies were included with a total of 1508 patients. The pooled data showed a statistically non-significant difference in recurrent venous thromboembolism between the two treatment regimens (OR 0.82; 0.49 - 1.39). A comparison of major haemorrhagic events (OR 0.77; 0.40 - 1.45) and mortality (OR 1.14; 0.62 - 2.08) also showed a statistically non-significant difference between the two treatment regimens. REVIEWER'S CONCLUSIONS: Once daily treatment with LMWH is as effective and safe as twice daily treatment with LMWH. However, the 95% confidence interval implies that there is a possibility that the risk of recurrent VTE might be higher when patients are treated once daily. Hence the decision to treat the patient with a once daily regimen will depend on the evaluated balance between increased convenience and the potential for a lower efficacy.

Anticoagulants↗
PubMed2003

Compression therapy for treating stage I and II (Widmer) post-thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis characterised by chronic complaints, swelling, and skin changes in the affected limb. One in every three patients with deep vein thrombosis develops post-thrombotic complications within five years. OBJECTIVES: To assess the effectiveness of compression therapy in patients with stage I and II post-thrombotic syndrome according to the classification of Widmer. Interventions of interest included elastic compression stockings and mechanical devices, compared with no intervention and with each other. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Specialised Trials Register (last searched April 2003), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 1, 2003). In addition, journals, conference proceedings and bibliographies were hand searched. Personal contact with other investigators involved in the clinical area was sought to get information about missed or unpublished studies. SELECTION CRITERIA: Trials that evaluated compression therapy for stage I and II (Widmer) post-thrombotic syndrome. Primary outcomes were leg ulceration, or deterioration of post-thrombotic syndrome. There were no restrictions on date or language. One reviewer (DNK) assessed titles and abstracts for relevance. This was verified independently by a second reviewer (MWCS). DATA COLLECTION AND ANALYSIS: Details of eligible studies were extracted and summarised using data extraction sheets. Data extraction was undertaken by one reviewer (DNK) and verified by a second reviewer (MHP). MAIN RESULTS: Only two trials were identified that addressed physical treatment of post-thrombotic syndrome. Both trials were initiated by the same group of investigators. A cross-over study lasting two months compared low and high pressure with intermittent compression units for severe post-thrombotic syndrome. This showed a beneficial effect of higher pressures. The second study, in patients with mild to moderate post-thrombotic symptoms, showed no effect of elastic compression stockings (30-40 mm Hg at the ankle region) when compared to 'placebo' stockings that were one to two sizes too large. REVIEWER'S CONCLUSIONS: There is some evidence of a beneficial effect of intermittent pneumatic compression units, but the study was too small and of too short a duration to draw strong conclusions. Further research is needed in order to assess whether intermittent pneumatic compression units give long term reduction and relief of the symptoms caused by post-thrombotic syndrome, and prevent deterioration and leg ulceration. The use of elastic compression stockings to treat post-thrombotic syndrome cannot be supported on the basis of the currently available data.

Bandages↗
PubMed2003

The use of specific antidotes as a response to bleeding complications during anticoagulant therapy for venous thromboembolism.

When a bleeding complication occurs during therapy with heparin or vitamin K antagonists, there is an option to give a specific antidote. Several new anticoagulants have been developed that are likely to have some risk of bleeding complications, for which no specific antidotes are available. Interestingly, it is unknown how often the use of an antidote is necessary in clinical practice. We investigated 1877 patients treated for venous thromboembolism included in three large clinical trials, of which 181 (9.6%) had a total of 225 adjudicated bleeding episodes; 46 hemorrhages being designated as major. Some form of antidote was given to 26 (14.4%) patients with a hemorrhage. Of the patients with at least one major hemorrhage, 19 (41.3%) received an antidote. Vitamin K was given to 23 (1.2%) patients, one (0.05%) patient received protamin sulfate and seven (0.4%) patients received fresh frozen plasma. The use of antidotes was comparable for initial and long-term treatment. Antidotes were statistically significantly more frequently given in Canada as compared to other participating countries. Vitamin K was more frequently given in case of a higher international normalized ratio value. Although antidotes against anticoagulant treatment are widely available, our analysis shows that in only a very small number of patients a direct, or slow-acting antidote to reverse the anticoagulant effect was used.

Aged↗