Background American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC) guidelines gave fondaparinux a class I recommendation for use in patients with non-ST elevation acute coronary syndromes (NSTE-ACS) undergoing invasive or conservative strategy. Nadroparin is one of the common anticoagulants used in NSTE-ACS in China. Accordingly, this study compared the safety and efficacy between fondaparinux and nadroparin in patients with NSTE-ACS.
Methods In this prospective, randomized, open-label, and single center study, a total of 300 patients with NSTE-ACS were randomized to receive either fondaparinux (group F, n=150, 2.5 mg/d) or nadroparin (group N, n=150, 0.1 ml/10 kg q12 h) for a mean of 4 days. The primary safety endpoint was the incidence of major or minor bleeding at 9 days that was not related to coronary artery bypass grafting (CABG). The primary efficacy endpoints included death, myocardial infarction, or recurrent ischemia at 9 days. All patients underwent a 180-day follow-up.
Results Baseline characteristics were well matched between the two groups. There was a non-significant 28% relative risk reduction in the primary safety endpoint in group F compared with group N (4.7% vs. 6.7%, HR 0.72, 95% CI 0.42–1.65, P=0.38). The primary efficacy endpoint was 8.0% in group F and 10.0% in group N (HR, 0.82, 95% CI 0.54–1.71, P=0.49). The composite of the safety and efficacy endpoints at 9 days (10.0% vs. 16.0%, HR 0.61, 95% CI 0.31–1.10, P=0.10), 30 days (14.0% vs. 17.9%, HR 0.72, 95% CI 0.47–1.16, P=0.21), or 180 days (18.7% vs. 27.3%, HR 0.65, 95% CI 0.38–1.11, P=0.11) showed a non-significant trend toward a lower value in group F.
Conclusion Fondaparinux resulted in a nonsignificant risk reduction in patients with NSTE-ACS in both bleeding and ischaemic events during short- and long-term follow-up compared with nadroparin.
Since the recognition that any thrombosis overlying a ruptured atherosclerotic plaque is a central component of the pathogenesis of unstable coronary artery disease (CAD), a number of antithrombotic treatment strategies have been investigated in randomised clinical trials. Aspirin reduces the occurrence of symptomatic and silent ischaemia, myocardial infarction (MI) and death in patients with unstable CAD, both in the acute phase and during continued long-term treatment and is now considered routine therapy. The addition of unfractionated heparin infusion further reduces cardiac events during the treatment period, but is not associated with any sustained benefits during long-term follow-up. Low molecular weight heparins (LMWHs) are completely absorbed by the sc. route. A predictable anticoagulant effect is maintained by sc. injections every 12 - 24 h without laboratory monitoring. The FRISC trial demonstrated that, in conjunction with aspirin, the LMWH dalteparin reduced death and MI by more than 50% in the acute phase. Four similar trials have directly compared LMWH with unfractionated heparin and demonstrated at least the same efficacy in the acute phase, treated between three and eight days. The LMWH enoxaparin was more effective at reducing death or MI than unfractionated heparin infusion during the three days of treatment, an effect which lasted up to 12 months. Prolonged out-patient treatment beyond the acute phase has been evaluated in four trials. It was demonstrated, in two of these trials, that continuing twice-daily injections of dalteparin further reduced the risk of death, MI and need for revascularisation at least during the initial six weeks of treatment. This effect was confined, however, to patients with signs of myocardial damage, i.e., elevation of troponin, at admission. During prolonged out-patient treatment, there is an increased risk of severe bleeding due to the combination of LMWH with aspirin. Based on successful results, the LMWHs, having the convenience of treatment and the option for continuation in an out-patient setting, should replace unfractionated heparin as the routine treatment in unstable CAD. If an early invasive procedure is considered, the LMWH therapy should be continued until the intervention as a ‘bridge-to-revascularisation’. New antiplatelet agents are also emerging as additional useful tools for treating these patients, thus it is urgent to evaluate the comibination of these new therapies with the LMWHs. 相似文献
The plasma concentration of prothrombin fragment 1+2 (F1+2) is considered a very sensitive parameter for specific detection
of latent hypercoagulability. To evaluate the degree of hypercoagulation associated with chronic uremia, we measured F1+2
by ELISA in the plasma of 51 patients with severe or end-stage chronic renal failure (35 males, 16 females, aged 22–81 years):
24 on dietary treatment, 15 on combined dietary and once a week hemodialysis, and 12 on regular maintenance hemodialysis;
33 healthy subjects served as a control group. Plasma F1+2 showed a significant elevation in the group on dietary treatment;
it was further increased in the group on once a week hemodialysis, and even more markedly increased in the group on maintenance
hemodialysis. In patients on dietary treatment a positive correlation was found between plasma F1+2 and serum creatinine.
In patients on maintenance hemodialysis, no increase in the F1+2 plasma level was found during the course of a single hemodialysis
session. Low molecular weight heparin, administered to 7 patients on dietary treatment, caused a marked drop in the F1+2 plasma
level, providing evidence that the elevation in F1+2 indicates an accelerated in vivo thrombin generation rather than impaired
renal catabolism. The enhanced coagulation activation appears to be related to the reduction of residual renal function, i.e.,
to the severity of renal failure, and may contribute to the increased risk of vascular events in uremic patients. 相似文献
