急性心肌梗死患者和非急性心肌梗死患者PCI术后延长疗程双重抗血小板治疗的获益与风险
Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction.
作者信息
Yeh Robert W, Kereiakes Dean J, Steg Philippe Gabriel, Windecker Stephan, Rinaldi Michael J, Gershlick Anthony H, Cutlip Donald E, Cohen David J, Tanguay Jean-Francois, Jacobs Alice, Wiviott Stephen D, Massaro Joseph M, Iancu Adrian C, Mauri Laura
机构信息
Massachusetts General Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio.
出版信息
J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.
BACKGROUND
The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations.
OBJECTIVES
This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI.
METHODS
The Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding.
RESULTS
Of 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 30.7% presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group, 0.5% vs. 1.9%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21).
CONCLUSIONS
Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study]; NCT00977938).
背景
与病情更稳定的患者相比，急性心肌梗死（MI）患者长期双重抗血小板治疗的获益和风险可能有所不同。
目的
本研究旨在评估接受冠状动脉支架植入术的患者中，30个月与12个月双重抗血小板治疗的获益和风险，这些患者有的发生过MI，有的未发生过MI。
方法
双重抗血小板治疗研究是一项随机双盲、安慰剂对照试验，比较了冠状动脉支架置入术后30个月与12个月的双重抗血小板治疗。评估了继续使用噻吩吡啶对最初发生MI和未发生MI的患者缺血和出血事件的影响。共同主要终点为明确或可能的支架血栓形成以及主要不良心血管和脑血管事件（MACCE）。主要安全终点为GUSTO（全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞动脉）中度或重度出血。
结果
在11648例随机分组的患者中（9961例接受药物洗脱支架治疗，1687例接受裸金属支架治疗），30.7%的患者发生过MI。在12至30个月期间，与安慰剂相比，继续使用噻吩吡啶可降低最初发生MI和未发生MI的患者的支架血栓形成风险（MI组，0.5%对1.9%，p<0.001；未发生MI组，0.4%对1.1%，p<0.001；交互作用p=0.69）。与未发生MI的患者（4.4%对5.3%；p=0.08；交互作用p=0.03）相比，继续使用噻吩吡啶使发生MI的患者MACCE的降低幅度更大（3.9%对6.8%；p<0.001）。在两组中，继续使用噻吩吡啶均可降低MI发生率（MI组，2.2%对5.2%，p<0.001；未发生MI组，2.1%对3.5%，p<0.001；交互作用p=0.15），但会增加出血发生率（MI组，1.9%对0.8%，p=0.005；未发生MI组，2.6%对1.7%，p=0.007；交互作用p=0.21）。
结论
与12个月的治疗相比，30个月的双重抗血小板治疗可降低发生MI和未发生MI的患者的支架血栓形成风险和MI发生率，但会增加出血发生率。（双重抗血小板治疗研究[DAPT研究]；NCT00977938）
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