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比伐卢定和肝素单药治疗心肌梗死的比较研究
Bivalirudin versus Heparin Monotherapy in Myocardial Infarction


David Erlinge ... 心脑血管疾病 • 2017.09.21
相关阅读
• 用于接受经皮冠状动脉介入的急性冠脉综合征患者的两种抗血栓策略之间的选择 • 瞬时无波形比值或血流储备分数用于PCI的比较研究 • 急性心肌梗死

对于行PCI的急性冠脉综合征,比伐卢定与肝素单一抗凝孰优孰劣

 

何国伟

中国医学科学院/北京协和医学院,泰达国际心血管病医院(天津)心血管外科

 

经皮冠状动脉介入(PCI)是急性冠脉综合征的重要治疗手段之一。使用肝素或比伐卢定(bivalirudin)抗凝,并合并使用抗血小板药物如阿司匹林、P2Y12抑制剂及糖蛋白Ⅱb/Ⅲa抑制剂,以期在冠脉造影及临床效果两方面得到改善,已成为常规。更有效的P2Y12抑制剂(普拉格雷[prasugrel]、替格瑞洛[ticagrelor]、坎格雷洛[cangrelor])的使用更进一步提高了急性冠脉综合征治疗的临床效果。抗凝药使用的目的是防止血栓形成(如再梗死及支架内栓塞),但是要充分权衡出血并发症风险来决定抗凝强度。

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摘要


背景

根据目前实践,急性心肌梗死患者接受经皮冠状动脉介入治疗(PCI)时采用桡动脉路径、给予强效P2Y12抑制剂、治疗计划中没有糖蛋白Ⅱb/Ⅲa抑制剂。然而,各种抗凝策略在这些患者中的相对效果尚不明确

 

方法

在这项多中心、随机、基于登记系统的开放标签临床试验中,我们纳入了ST段抬高型心肌梗死(STEMI)或非ST段抬高型心肌梗死(NSTEMI)患者,他们接受了PCI治疗,使用了强效P2Y12抑制剂(替格瑞洛、普拉格雷或坎格瑞洛),治疗计划中没有糖蛋白Ⅱb/Ⅲa抑制剂。这些患者在行PCI术时被随机分配接受比伐卢定或肝素治疗,PCI主要采用桡动脉路径。主要终点是180日随访期间任何原因死亡、心肌梗死或大出血构成的复合终点。

 

结果

本试验共纳入了6,006例患者(3,005例STEMI和3,001例NSTEMI)。在第180日时,比伐卢定组和肝素组分别有12.3%的患者(369/3,004)和12.8%的患者(383/3,002)发生了主要终点事件(风险比,0.96;95%置信区间[CI],0.83~1.10;P=0.54)。STEMI患者和NSTEMI患者之间,以及其他主要亚组的结果一致。心肌梗死在比伐卢定组的发生率是2.0%,在肝素组是2.4%(风险比,0.84;95% CI,0.60~1.19;P=0.33),大出血的发生率分别是8.6%和8.6%(风险比,1.00;95% CI,0.84~1.19;P=0.98),明确的支架内血栓形成的发生率分别是0.4%和0.7%(风险比,0.54;95% CI,0.27~1.10;P=0.09),死亡率分别是2.9%和2.8%(风险比,1.05;95% CI,0.78~1.41;P=0.76)。

 

结论

在接受PCI的心肌梗死患者中,任何原因死亡、心肌梗死或大出血这一复合终点的发生率在比伐卢定组不低于肝素单药治疗组(由瑞典心肺基金会[Swedish Heart-Lung Foundation]等资助;在VALIDATE-SWEDEHEART Clinical-TrialsRegister.eu注册号为2012-005260-10;在ClinicalTrials.gov注册号为NCT02311231)。





作者信息

David Erlinge, M.D., Ph.D., Elmir Omerovic, M.D., Ph.D., Ole Fröbert, M.D., Ph.D., Rikard Linder, M.D., Ph.D., Mikael Danielewicz, M.D., Mehmet Hamid, M.D., Eva Swahn, M.D., Ph.D., Loghman Henareh, M.D., Ph.D., Henrik Wagner, M.D., Ph.D., Peter Hårdhammar, M.D., Iwar Sjögren, M.D., Jason Stewart, M.D., Per Grimfjärd, M.D., Jens Jensen, M.D., Ph.D., Mikael Aasa, M.D., Ph.D., Lotta Robertsson, M.D., Pontus Lindroos, M.D., Jan Haupt, M.D., Helena Wikström, M.D., Anders Ulvenstam, M.D., Pallonji Bhiladvala, M.D., Bo Lindvall, M.D., Anders Lundin, M.D., Tim Tödt, M.D., Ph.D., Dan Ioanes, M.D., Truls Råmunddal, M.D., Ph.D., Thomas Kellerth, M.D., Leszek Zagozdzon, M.D., Matthias Götberg, M.D., Ph.D., Jonas Andersson, M.D., Ph.D., Oskar Angerås, M.D., Ph.D., Ollie Östlund, Ph.D., Bo Lagerqvist, M.D., Ph.D., Claes Held, M.D., Ph.D., Lars Wallentin, M.D., Ph.D., Fredrik Scherstén, M.D., Ph.D., Peter Eriksson, M.D., Ph.D., Sasha Koul, M.D., Ph.D., and Stefan James, M.D., Ph.D.
From the Department of Cardiology, Clinical Sciences, Lund University, Lund (D.E., P.B., A.L., T.T., M.G., F.S., S.K.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (E.O., D.I., T.R., O.A.), the Department of Cardiology, Faculty of Health, Örebro University, Örebro (O.F., T.K., L.Z.), the Department of Cardiology, Danderyd Hospital (R.L.), and the Department of Cardiology, Karolinska University Hospital (L.H.), Karolinska Institutet, the Department of Cardiology, Capio St. Görans Hospital (J.J., P.L.), and the Department of Cardiology, Södersjukhuset AB (M.A.), Stockholm, PCI-Unit at Karlstad Hospital, Karlstad (M.D.), the Department of Cardiology, Mälarsjukhuset, Eskilstuna (M.H.), the Department of Cardiology, Linköping University Hospital, Linköping (E.S.), the Department of Cardiology, Helsingborg Lasarett, Helsingborg (H. Wagner), the Department of Cardiology, Halmstad Hospital, Halmstad (P.H.), the Department of Cardiology, Falun Hospital, Falun (I.S.), the Department of Cardiology, Skaraborgs Hospital, Skövde (J.S.), the Department of Internal Medicine, Västmanlands Sjukhus, Västerås (P.G.), the Department of Cardiology, Södra Älvsborgs Sjukhus, Borås (L.R.), the Department of Cardiology, Sunderby Sjukhus, Luleå (J.H.), the Department of Cardiology, Kristianstad Hospital, Kristianstad (H. Wikström), the Department of Cardiology, Östersund Hospital, Östersund (A.U.), the Department of Cardiology, Sundsvall Hospital, Sundsvall (B. Lindvall), the Department of Cardiology, Umeå University, Umeå (J.A., P.E.), and the Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala (O.Ö., B. Lagerqvist, C.H., L.W., S.J.) — all in Sweden. Address reprint requests to Dr. Erlinge at the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, S-221 85 Lund, Sweden, or at david.erlinge@med.lu.se.

 

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