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【ACC热点】比伐卢定vs低分子肝素：没有更多获益
30 March 2008
MedWire News: Anticoagulation treatment with the direct thrombin inhibitor (DTI) bivalirudin reduces bleeding rates but does not improve clinical outcomes in comparison with unfractionated heparin (UFH) in low-to-intermediate risk patients undergoing percutaneous coronary intervention (PCI) with optimal clopidogrel pretreatment, results of the ISAR-REACT-3 trial indicate.
Previous studies have shown that bivalirudin treatment during angioplasty and coronary stenting is associated with better outcomes compared with UFH and adjunctive glycoprotein (GP) IIb/IIIa inhibitors, but these were not done on a backdrop of optimal antiplatelet therapy.
To investigate further, Adnan Kastrati (Deutsches Herzzentrum and Technical University, Munich, Germany) and colleagues conducted the double-blind, controlled ISAR-REACT-3 trial, in which they randomly assigned 4570 coronary artery disease patients without troponin T elevation undergoing PCI to receive bivalirudin (n=1189) or unfractionated heparin (n=2281).
All patients received 600 mg clopidogrel and =325 mg aspirin at least 2 hours before the procedure. Bivalirudin was given as an intravenous (iv) bolus at 0.75 mg/kg prior to PCI, followed by continuous iv infusion during the procedure at 1.75 mg/kg/hour. Patients in the UFH arm received UFH as an iv bolus of 0.75 units/kg followed by a continuous infusion of placebo for the duration of the procedure.
The results were presented by Kastrati at the American College of Cardiology Scientific Sessions, being held in Chicago, Illinois. The primary composite endpoint comprising death, myocardial infarction (MI), urgent target vessel revascularization (UTVR), or in-hospital major bleeding at 30 days was similar between treatment groups, at 8.3% in the bivalirudin arm compared with 8.7% in the UFH arm, giving a relative risk of 0.94.
Rates of the primary endpoint components death, MI, and UTVR were 0.1 and 0.2%, 5.6 and 4.8%, and 0.8 and 0.7% among patients who received bivalirudin versus those given UFH, respectively.
The secondary composite endpoint of death, MI, and UTVR at 30 days was also similar between groups, at 5.9 and 5.0% among bivalirudin- versus UFH-treated patients, giving a relative risk of 1.16.
In contrast, rates of major and minor bleeding at 30 days were significantly lower among patients who received bivalirudin than among those given UFH, at 3.1 versus 4.6% (p=0.008) and 6.8 versus 9.9% (p=0.0001), respectively, for the prespecified trial definition of bleeding used in the earlier REPLACE trial. The difference in major bleeding translated into a 33% lower relative risk with bivalirudin. The reduction in both major and minor bleeding with bivalirudin held true when the results were analyzed according to Thombolysis in MI (TIMI) bleeding definitions.
Thrombocytopenia rates were similar between groups.
Kastrati cautioned that the dose of UFH used is higher than has been used in recent US PCI trials. He said: “Whether and to what degree this affected outcome cannot be determined.”
Commentator on the trial Harvey White (Green Lane Hospital, Auckland, New Zealand) emphasized that the reduction in bleeding with bivalirudin is clinically relevant.
He noted: “Interestingly and strikingly, in my view, TIMI major bleeding was reduced by 50%, with a marginal p value of 0.04.”
White noted that the bleeding rate with UFH was low in the trial, despite the relatively high dose. He compared it with the higher rate of major bleeding of 8.5% seen in STEEPLE, in which elective patients received the current US-recommended 70 units/kg UFH dose, guided by activated clotting time.
White said: “I think the real question in a low-risk ischemic group is: Does bivalirudin reduce bleeding? And I think this should have been the primary endpoint.”
He concluded that the composite results were numerically in favor of bivalirudin, with no increase in ischemic events but a marked reduction in major bleeding. “Importantly there was no signal of stent thrombosis,” he added.
American College of Cardiology Annual Scientific Sessions; Chicago, Illinois: 29 March – 1 April 2008
http://www.incirculation.net/NewsItem/Intensive-antiplatelet-therapy-reduces-ischemia-st.aspx 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 bivalirudin versus UFH ？？？
UFH or LMWH？？ ISAR-REACT 3: No clinical benefit but reduction in bleeding with bivalirudin versus UFH on optimal antiplatelet backdrop
ISAR-REACT 3：在优化抗血小板治疗基础上加用比伐卢定与加用普通肝素相比：没有临床获益，但减少出血的发生
30 March 2008
2008年3月30日
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作者:admin@医学,生命科学 2011-02-09 17:14
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