Zhonghua nei ke za zhi · 2013
[The clinical efficacy and safety of fondaparinux combined with tirofiban hydrochloride in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention].
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Li Mu-wei, Zhao Xiang-mei, Rao Li-xin, Chen Yan, Zhu Zhong-yu, Gao Chuan-yu
Аннотация
OBJECTIVE: To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina (UA) undergoing complex percutaneous coronary intervention (PCI) .
METHODS: A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban. Bleeding, thrombosis and main adverse cardiovascular events (MACE) were compared between the two groups during hospitalization, at week 2 and week 4 after discharge.
RESULTS: No severe bleeding was observed during hospitalization in the both groups, while lower rate of mild and minor bleeding was shown in the fondaparinux group (0 vs 1.5% and 18.2% vs 34.5%, P = 0.04 and P < 0.001 respectively). No difference was found between the two groups in the rate of MACE during hospitalization, at week 2 and week 4 weeks after discharge. The rates of death, recurrent myocardial infarction, refractory myocardial ischemia and target vessel revascularization were 0.5% vs 1.0%, 0.5% vs 1.0%, 1.6% vs 1.0% and 2.1% vs 1.5% during hospitalization; 0 vs 0, 1.0% vs 0.5%, 1.0% vs 1.5%, 0.5% vs 1.0% at week 2 after discharge; 0.5% vs 0.5%, 0.5% vs 0.5%, 2.6% vs 2.0%, 0 vs 0.5% at week 4 after discharge (all P values>0.05).
CONCLUSION: The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI.
METHODS: A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban. Bleeding, thrombosis and main adverse cardiovascular events (MACE) were compared between the two groups during hospitalization, at week 2 and week 4 after discharge.
RESULTS: No severe bleeding was observed during hospitalization in the both groups, while lower rate of mild and minor bleeding was shown in the fondaparinux group (0 vs 1.5% and 18.2% vs 34.5%, P = 0.04 and P < 0.001 respectively). No difference was found between the two groups in the rate of MACE during hospitalization, at week 2 and week 4 weeks after discharge. The rates of death, recurrent myocardial infarction, refractory myocardial ischemia and target vessel revascularization were 0.5% vs 1.0%, 0.5% vs 1.0%, 1.6% vs 1.0% and 2.1% vs 1.5% during hospitalization; 0 vs 0, 1.0% vs 0.5%, 1.0% vs 1.5%, 0.5% vs 1.0% at week 2 after discharge; 0.5% vs 0.5%, 0.5% vs 0.5%, 2.6% vs 2.0%, 0 vs 0.5% at week 4 after discharge (all P values>0.05).
CONCLUSION: The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI.