[TCT2008]PROBI VIRI研究:延长比伐卢定的疗程可降低心肌损伤
发布于:2008-10-17 10:31
徐迎佳,硕士,副主任医师。新加坡进修三年。主要从事心内科常见病、多发病的诊治,尤其是冠心病的综合治疗,且在心内科重症的处理方面积累了丰富的经验。
Dr. Xu Yingjia Associate Consultant of Department of Cardiology,Shanghai Chest Hospital,Shanghai, PRC
PROBI VIRI研究:延长比伐卢定的疗程可降低心肌损伤
PROBI VIRI: Prolonged Bivalirudin Reduced Myocardial Injury
(上海市胸科医院 徐迎佳 翻译)
要点:对30天或6个月的MACE发生率无影响。
PROBI VIRI研究结果表明对接受复杂PCI术的患者延长比伐卢定的疗程可减少围术期心梗的发生率。
意大利医生Cortese和他的同事选取了178例因稳定或不稳定心绞痛行复杂PCI术的患者,术中给予比伐卢定静推,继以1.75mg/kg/hr静滴维持。术后患者分为二组,一组以0.25mg/kg/hr速度静滴比伐卢定4小时(n=88),另一组术后即停止滴注比伐卢定。
一级终点,围术期心梗在延长疗效组明显降低,二级终点,30天和6个月MACE发生率二组比较无显著差异。
Cortese进一步指出,6个月靶血管血运重建在延长疗程组有下降的趋势(8%和12.2%,P=0.33)。
两组均无支架内血栓形成。
住院期间出血发生率二组间无差别,同时,桡动脉介入的比例高达86.6%。
Cortese医生就此得出结论:对复杂PCI术,术后延长比伐卢定疗程有望减少心肌损伤,并可能起到预防支架内血栓形成的作用。
Duke大学医学中心的Ohman医生对此结果提出几点质疑,如小样本,一级终点的差异属于临界范围(P=0.041),过多的使用桡动脉介入途径以及稳定心绞痛患者的复杂病变处理等。
Ohman医生认为,比伐卢定疗程的延长对围术期心肌保护作用并不明确,而血小板活性对此过程的影响更应引起我们的关注。
(来源:www.tctmd.com)
PROBI VIRI: Prolonged Bivalirudin Reduced Myocardial Injury
Key Points:
-
No effect on MACE at 30 days or six months.
By TCT Daily Staff
Patients undergoing complex PCI who received a prolonged infusion of bivalirudin experienced significantly less periprocedural MI than those given a standard, shorter infusion, according to results from the PROBI VIRI study.
Bernardo Cortese, MD, Ospedale della Misericordia, Italy, and colleagues enrolled 178 patients with stable or unstable angina and complex disease undergoing PCI. Patients were treated in the cath lab with bolus and infusion bivalirudin 1.75 mg/kg per hour.
After angiography, each patient was then randomly assigned to prolonged bivalirudin infusion 0.25 mg/kg per hour for four hours (n=88) or to stop infusion (n=90) after angiography.
The primary endpoint, periprocedural MI, was significantly decreased in patients given prolonged bivalirudin (see Figure). The secondary outcome, MACE, was similar between patients assigned to prolonged bivalirudin infusion and patients who stopped infusion at both 30 days (1.1% vs. 3.3%; P=.43) and six months (10.2% vs. 16.7%; P=.18).
However, Cortese said data indicated a trend toward lower TVR at six months with prolonged infusion (8% vs. 12.2%; P=.33).
There was no stent thrombosis reported in either group.
In-hospital major and minor bleeding also did not differ between the two groups. In addition, Cortese reported a radial access rate of 86.6%.
"In a complex PCI setting, bivalirudin prolonged infusion after PCI seems a promising choice to reduce myocardial injury and might possibly prevent stent thrombosis," said Cortese.
E. Magnus Ohman, MD, of Duke Universty Medical Center, Durham, N.C., cited several concerns with the study, such as small sample size, borderline significance of the primary endpoint (P=.041), high use of radial artery access, and stable patients with complex lesions.
"The issue may not be prolonging infusion but rather focusing on platelet activation," Ohman said.
Disclosures:
-
Dr. Cortese reports that he is a consultant for The Medicines Company.
-
Dr. Ohman reports receiving research grants from Bristol-Myers Squibb, Daichii Sankyo, Datascope, Eli Lilly, Sanofi-Aventis, Schering-Plough, and The Medicines Company. He also reports serving as a consultant for AbioMed, CV Therapeutics, Invoise Medical, Liposcience, Northpoint Domain, Response Biomedical, Sanofi-Aventis, and The Medicines Company.
(source:www.tctmd.com)
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PROBI VIRI研究:延长比伐卢定的疗程可降低心肌损伤
PROBI VIRI: Prolonged Bivalirudin Reduced Myocardial Injury
(上海市胸科医院 徐迎佳 翻译)
要点:对30天或6个月的MACE发生率无影响。
PROBI VIRI研究结果表明对接受复杂PCI术的患者延长比伐卢定的疗程可减少围术期心梗的发生率。
意大利医生Cortese和他的同事选取了178例因稳定或不稳定心绞痛行复杂PCI术的患者,术中给予比伐卢定静推,继以1.75mg/kg/hr静滴维持。术后患者分为二组,一组以0.25mg/kg/hr速度静滴比伐卢定4小时(n=88),另一组术后即停止滴注比伐卢定。
一级终点,围术期心梗在延长疗效组明显降低,二级终点,30天和6个月MACE发生率二组比较无显著差异。
Cortese进一步指出,6个月靶血管血运重建在延长疗程组有下降的趋势(8%和12.2%,P=0.33)。
两组均无支架内血栓形成。
住院期间出血发生率二组间无差别,同时,桡动脉介入的比例高达86.6%。
Cortese医生就此得出结论:对复杂PCI术,术后延长比伐卢定疗程有望减少心肌损伤,并可能起到预防支架内血栓形成的作用。
Duke大学医学中心的Ohman医生对此结果提出几点质疑,如小样本,一级终点的差异属于临界范围(P=0.041),过多的使用桡动脉介入途径以及稳定心绞痛患者的复杂病变处理等。
Ohman医生认为,比伐卢定疗程的延长对围术期心肌保护作用并不明确,而血小板活性对此过程的影响更应引起我们的关注。
(来源:www.tctmd.com)
PROBI VIRI: Prolonged Bivalirudin Reduced Myocardial Injury
Key Points:
- No effect on MACE at 30 days or six months.
By TCT Daily Staff
Patients undergoing complex PCI who received a prolonged infusion of bivalirudin experienced significantly less periprocedural MI than those given a standard, shorter infusion, according to results from the PROBI VIRI study.
Bernardo Cortese, MD, Ospedale della Misericordia, Italy, and colleagues enrolled 178 patients with stable or unstable angina and complex disease undergoing PCI. Patients were treated in the cath lab with bolus and infusion bivalirudin 1.75 mg/kg per hour.
After angiography, each patient was then randomly assigned to prolonged bivalirudin infusion 0.25 mg/kg per hour for four hours (n=88) or to stop infusion (n=90) after angiography.
The primary endpoint, periprocedural MI, was significantly decreased in patients given prolonged bivalirudin (see Figure). The secondary outcome, MACE, was similar between patients assigned to prolonged bivalirudin infusion and patients who stopped infusion at both 30 days (1.1% vs. 3.3%; P=.43) and six months (10.2% vs. 16.7%; P=.18).
However, Cortese said data indicated a trend toward lower TVR at six months with prolonged infusion (8% vs. 12.2%; P=.33).
There was no stent thrombosis reported in either group.
In-hospital major and minor bleeding also did not differ between the two groups. In addition, Cortese reported a radial access rate of 86.6%.
"In a complex PCI setting, bivalirudin prolonged infusion after PCI seems a promising choice to reduce myocardial injury and might possibly prevent stent thrombosis," said Cortese.
E. Magnus Ohman, MD, of Duke Universty Medical Center, Durham, N.C., cited several concerns with the study, such as small sample size, borderline significance of the primary endpoint (P=.041), high use of radial artery access, and stable patients with complex lesions.
"The issue may not be prolonging infusion but rather focusing on platelet activation," Ohman said.
Disclosures:
-
Dr. Cortese reports that he is a consultant for The Medicines Company.
-
Dr. Ohman reports receiving research grants from Bristol-Myers Squibb, Daichii Sankyo, Datascope, Eli Lilly, Sanofi-Aventis, Schering-Plough, and The Medicines Company. He also reports serving as a consultant for AbioMed, CV Therapeutics, Invoise Medical, Liposcience, Northpoint Domain, Response Biomedical, Sanofi-Aventis, and The Medicines Company.
(source:www.tctmd.com)
来源: 医心网



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