Prevention of deep-vein thrombosis after total knee replacement. Randomised comparison between a low-molecular-weight heparin (nadroparin) and mechanical prophylaxis with a foot-pump system.
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The optimal regime of antithrombotic prophylaxis for patients undergoing total knee arthroplasty (TKA) has not been established. Many surgeons employ intermittent pneumatic compression while others use low-molecular-weight heparins (LMWH) which were primarily developed for total hip arthroplasty. We compared the efficacy and safety of these two techniques in a randomised study with blinded assessment of the endpoint by phlebography. We randomised 130 patients, scheduled for elective TKA, to receive one daily subcutaneous injection of nadroparin calcium (dosage adapted to body-weight) or continuous intermittent pneumatic compression of the foot by means of the arteriovenous impulse system. A total of 108 patients (60 in the LMWH group and 48 in the mechanical prophylaxis group) had phlebography eight to 12 days after surgery. Of the 47 with deep-vein thrombosis, 16 had received LMWH (26.7%, 95% CI 16.1 to 39.7) and 31, mechanical prophylaxis (64.6%, 95% CI 49.5 to 77.8). The difference between the two groups was highly significant (p < 0.001). Only one patient in the LMWH group had severe bleeding. We conclude that one daily subcutaneous injection of calcium nadroparin in a fixed, weight-adjusted dosage scheme is superior to intermittent pneumatic compression of the foot for thromboprophylaxis after TKA. The LMWH scheme was also safe. (+info)
Assessment of the treatment effect of enoxaparin for unstable angina/non-Q-wave myocardial infarction. TIMI 11B-ESSENCE meta-analysis.
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BACKGROUND: Two phase III trials of enoxaparin for unstable angina/non-Q-wave myocardial infarction have shown it to be superior to unfractionated heparin for preventing a composite of death and cardiac ischemic events. A prospectively planned meta-analysis was performed to provide a more precise estimate of the effects of enoxaparin on multiple end points. METHODS AND RESULTS: Event rates for death, the composite end points of death/nonfatal myocardial infarction and death/nonfatal myocardial infarction/urgent revascularization, and major hemorrhage were extracted from the TIMI 11B and ESSENCE databases. Treatment effects at days 2, 8, 14, and 43 were expressed as the OR (and 95% CI) for enoxaparin versus unfractionated heparin. All heterogeneity tests for efficacy end points were negative, which suggests comparability of the findings in TIMI 11B and ESSENCE. Enoxaparin was associated with a 20% reduction in death and serious cardiac ischemic events that appeared within the first few days of treatment, and this benefit was sustained through 43 days. Enoxaparin's treatment benefit was not associated with an increase in major hemorrhage during the acute phase of therapy, but there was an increase in the rate of minor hemorrhage. CONCLUSIONS: The accumulated evidence, coupled with the simplicity of subcutaneous administration and elimination of the need for anticoagulation monitoring, indicates that enoxaparin should be considered as a replacement for unfractionated heparin as the antithrombin for the acute phase of management of patients with high-risk unstable angina/non-Q-wave myocardial infarction. (+info)
Comparison of two treatment durations (6 days and 14 days) of a low molecular weight heparin with a 6-day treatment of unfractionated heparin in the initial management of unstable angina or non-Q wave myocardial infarction: FRAX.I.S. (FRAxiparine in Ischaemic Syndrome).
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AIM: To assess the benefit of short-term low molecular weight heparin nadroparin compared with unfractionated heparin in unstable angina or non-Q wave myocardial infarction patients and to determine whether a longer, 2-week low molecular weight heparin regimen would offer additional clinical benefit. PATIENTS, METHODS AND RESULTS: This was a multicentre, prospective, randomized, double-blind study in three parallel groups, involving 3468 patients. Patients received one of three treatment regimens: the unfractionated heparin group received an intravenous bolus of unfractionated heparin 5000 IU, followed by an activated partial thromboplastin time adjusted infusion of unfractionated heparin for 6+/-2 days; the nadroparin 6 group received an intravenous bolus of nadroparin 86 anti-Xa IU. kg(-1), followed by twice daily subcutaneous injections of nadroparin 86 anti-Xa IU. kg(-1)for 6+/-2 days, and the nadroparin 14 group received an intravenous bolus of nadroparin 86 anti-Xa IU. kg(-1), followed by twice daily subcutaneous injections of nadroparin 86 anti-Xa IU. kg(-1)for 14 days. No statistically significant differences were observed between the three treatment regimens with respect to the primary outcome (cardiac death, myocardial infarction, refractory angina, or recurrence of unstable angina at day 14). The absolute differences between the groups in the incidence of the primary outcome were: -0.3% (P=0.85) for the nadroparin 6 group vs the unfractionated heparin group and +1.9% (P=0.24) for the nadroparin 14 group vs the unfractionated heparin group. Furthermore, there were no significant intergroup differences regarding any of the secondary efficacy outcomes. However, there was an increased risk of major haemorrhages in the nadroparin 14 group compared with unfractionated heparin (3.5% vs 1.6%;P=0.0035). CONCLUSIONS: Treatment with nadroparin for 6+/-2 days provides similar efficacy and safety to treatment with unfractionated heparin, for the same period, in the therapeutic management of acute unstable angina or non-Q wave myocardial infarction, and may be easier to administer. A prolonged regimen of nadroparin (14 days) does not provide any additional clinical benefit. (+info)
Low molecular weight heparin in acute coronary syndrome: evidence for superior or equivalent efficacy compared with unfractionated heparin?
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This article will review the results of recent clinical trials evaluating low molecular weight heparins (LMWHs) in the management of patients with acute coronary syndromes of unstable angina and non-ST segment elevation MI. Low molecular weight heparins are a new class of anticoagulants that have a number of advantages over unfractionated heparin (UFH) leading to their increasing use for thrombotic vascular disorders. There is convincing evidence that LMWH is more effective than placebo and at least as effective as UFH in reducing the hard end points of death and recurrent myocardial infarction. Convincing evidence for a superior efficacy is mostly limited to the least robust but most prevalent end point of recurrent angina, and benefits appear to be confined predominantly to high-risk patients. The benefits are sustained long-term, but there appears to be no incremental benefit with prolonged treatment. The risk for major bleeding is approximately equivalent to UFH, but minor hemorrhage is clearly increased, especially with vascular instrumentation. The increased bleeding risk together with its long half-life and absence of specific antidote warrants exercising caution when using LMWH with coronary intervention. Low molecular weight heparins have the potential of being cost-neutral or even cost-saving by reducing resource utilization, especially in the setting of aggressive interventional practice pattern. Last, the issue of whether one LMWH preparation is more effective and cost-effective than others remains an open question that can be answered only by direct head-to-head comparison of different LMWH preparations in randomized trials. In conclusion, subcutaneous weight-adjusted LMWH is as effective and safe as intravenous UFH in the management of patients with acute coronary syndromes. The logistic ease of administration without the need for monitoring anticoagulation appears to be the major advantage over UFH. (+info)
Local delivery of nadroparin for the prevention of neointimal hyperplasia following stent implantation: results of the IMPRESS trial. A multicentre, randomized, clinical, angiographic and intravascular ultrasound study.
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BACKGROUND: We hypothesized that intramural delivery of nadroparin, a low molecular weight heparin, would prevent in-stent restenosis by inhibiting neointimal hyperplasia in an angioplasty model free of arterial remodelling. METHODS AND RESULTS: In a prospective randomized multicentre trial, 250 patients submitted to balloon angioplasty followed by stent implantation were randomized into control group (no local drug delivery) or intramural delivery of nadroparin (2 ml of 2500 anti-Xa-units/ml with a microporous catheter). An ancillary intravascular ultrasound substudy was performed to supplement angiographic data with specific measurements of in-stent neointimal hyperplasia. The primary end-point was the late loss in minimal luminal diameter on the 6 month follow-up angiogram. Secondary end-points included feasibility and safety of local nadroparin delivery, and major adverse cardiac events at 8 weeks and 6 months follow-up. Local delivery of nadroparin was successful in 124 patients (99.2% success rate) and was not associated with an increase in stent thrombosis, coronary artery dissection, side branch occlusion, distal embolization or abrupt arterial closure. At angiographic follow-up, the late loss in lumen diameter was 0.84 +/- 0.62 mm in the control group compared to 0.88 +/- 0.63 mm in the nadroparin group (P=0.56). Angiographic restenosis rate (defined as a >50% diameter stenosis) did not differ in the control group (20%) compared to the nadroparin group (24%). The average area of neointimal tissue within the stent was 2.86 +/- 0.64 mm(2) vs 2.90 +/- 0.53 mm(2) (P=0.57), control vs nadroparin groups. There was no difference in major adverse cardiac events at any time (88.8% vs 89.6% event free survival at 6 months, control vs nadroparin). CONCLUSION: Intramural delivery of nadroparin with a microporous catheter after stent deployment was feasible and safe but had no effect in reducing restenosis or the occurrence of major adverse clinical events over 6 months. (+info)
No effect of nadroparin prophylaxis in the prevention of central venous catheter (CVC)-associated thrombosis in bone marrow transplant recipients.
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Complications of CVCs in 382 consecutive patients receiving a stem cell transplantation (SCT) were analysed. Early complications were pneumothorax (3.6%), haematothorax (0.5%), dislocation (3%) and dysfunction (3.6%). Eighty-seven-associated infections (22%) were observed, leading to removal of the CVC in 26 patients. More bacteraemias were associated with double- or triple-lumen CVCs, 19% vs 5% in single lumen CVCs (P < 0.0001). Coagulase-negative staphylococci were the predominant microorganisms in 72%. A special point of investigation was CVC-associated thrombosis and the prophylactic value of nadroparin. Two consecutive regimens with nadroparin were used and compared; 7 days 2850 IE nadroparin and 10 days 5700 IE nadroparin. The incidence of CVC-associated thrombosis was 6.9% in 382 patients with 390 catheters. The incidence was 8% in patients receiving one of the prophylactic nadroparin regimens compared to 6% in a comparable control group without prophylaxis. A short course of nadroparin was unable to prevent thrombotic complications after discontinuation. (+info)
Low molecular weight heparin versus oral anticoagulants in the long-term treatment of deep venous thrombosis.
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PURPOSE: The purpose of this study was to evaluate whether low molecular weight heparin (LMWH) could be equal or more effective than conventional oral anticoagulants (OAs) in the long-term treatment of deep venous thrombosis (DVT). METHODS: One hundred fifty-eight patients with symptomatic DVT of the lower limbs confirmed by means of duplex ultrasound scan were randomized to receive 3 to 6 months' treatment with nadroparine calcium or acenocoumarol. Quantitative and qualitative duplex scan scoring systems were used to study the evolution of thrombosis in both groups at 1, 3, 6, and 12 months. RESULTS: During the 12-month surveillance period, two (2.5%) of the 81 patients who received LMWH and seven (9%) of the 77 patients who received OAs had recurrence of venous thrombosis (not significant). In the LMWH group no cases of major bleeding were found, and four cases (5.2%) occurred in the OA group (not significant). The mortality rate was nine (11.1%) in the LMWH group and 7.8% in the OA group (not significant). The quantitative mean duplex scan score decreased in both groups during the follow-up and had statistical significance after long-term LMWH treatment on iliofemoral DVT (1, 3, 6, and 12 months), femoropopliteal DVT (1-3 months), and infrapopliteal DVT (first month). Duplex scan evaluation showed that the rate of venous recanalization significantly increased in the common femoral vein at 6 and at 12 months and during each point of follow-up in the superficial and popliteal veins in the LMWH group. Reflux was significantly less frequent in communicating veins after LMWH treatment (17.9% vs 32.2% in the OA group). The reflux rates in the superficial (22.4% in the LMWH group, 30.6% in OA group) and deep (13.4% vs 17.7%) venous system showed no significant differences between groups. CONCLUSIONS: The unmonitored subcutaneous administration of nadroparine in fixed daily doses was more effective than oral acenocoumarol with laboratory control adjustment in achieving recanalization of leg thrombi. With nadroparine, there was less late valvular communicating vein insufficiency, and it was at least as efficacious and safe as oral anticoagulants after long-term administration. These results suggest that LMWHs may therefore represent a real therapeutic advance in the long-term management of DVT. (+info)
Eligibility for home treatment of deep vein thrombosis: a prospective study in 202 consecutive patients.
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PURPOSE: Home treatment of deep vein thrombosis (DVT) has been shown to be safe and effective. However, this conclusion has been drawn from studies with predefined patient selection criteria. Eligibility for home treatment has never been properly assessed. METHODS: In a 9-month period, we prospectively evaluated the possible reasons for hospital treatment in consecutive patients with acute DVT by using a check list that included medical reasons, home care situation, preferences, and hospital service logistics. Treatment consisted of low-molecular-weight heparin and concomitant oral vitamin K antagonists and compression therapy. A 3-month follow-up examination included assessment of recurrent venous thromboembolism (VTE), bleeding events, and mortality. RESULTS: A total of 202 patients were included in the study; 117 patients (58%) were outpatients and 85 patients (42%) were hospitalized before DVT diagnosis. Of the 117 outpatients, 95 (81%) were considered eligible for home treatment. Only two patients (1.7%) were admitted to the hospital for DVT-related morbidity, one (0.85%) because of comorbidity, 11 (9.4%) for home care reasons, and eight (6.83%) because of hospital service logistics. Of the hospitalized patients, 79 (92.94%) remained inpatients, and six (7.05%) could be discharged within 48 hours. The only reason for hospitalization was pre-existing comorbidity. In outpatients, the outcome after 3 months showed a 4% rate of recurrent VTE, no major bleeding, and an 8% mortality rate; 75% of deaths were caused by cancer. No patient died of VTE. In inpatients, a statistically significant higher mortality rate was found (8% vs 19%; P < .02). CONCLUSION: Less than 3% of patients with DVT who were outpatients had to be hospitalized because of DVT morbidity. For the entire DVT population, the main reason for hospital treatment is comorbidity, rather than management issues or DVT morbidity. (+info)