Kaul Sanjay, Shah Prediman K, Diamond George A
Division of Cardiology, Cedars-Sinai Medical Center, and the David Geffen School of Medicine, University of California, Los Angeles, California 90048, USA.
J Am Coll Cardiol. 2007 Jul 10;50(2):128-37. doi: 10.1016/j.jacc.2007.04.030. Epub 2007 May 22.
Drug-eluting stents (DES) have dramatically transformed the landscape of interventional cardiology largely on the basis of empirical evidence showing profound reduction in angiographic and clinical restenosis without any significant increase in adverse events. Recent data, however, raise questions regarding the increased risk of late stent thrombosis associated with DES in more complex lesions and higher-risk patients than those evaluated in the initial clinical trials or Food and Drug Administration-approved indications, the challenge of continuing long-term antiplatelet therapy, and the danger of early discontinuation of antiplatelet therapy. We herein review the current status of this controversy, describe the additional evidence needed for its resolution, and offer recommendations for regulatory reform and 3 specific recommendations to encourage evidence-based patient management: 1) an emphasis on medical therapies with proven long-term benefit; 2) the use of kinetic modeling to estimate long-term outcomes of therapies based on the available near-term data; and 3) the restructuring of reimbursement incentives to encourage the use of evidence-based clinical management strategies.
药物洗脱支架(DES)在很大程度上显著改变了介入心脏病学的格局,这主要基于经验证据,即血管造影和临床再狭窄显著降低,且不良事件无任何显著增加。然而,最近的数据引发了一些问题,即在比最初临床试验或美国食品药品监督管理局批准的适应症所评估的更复杂病变和更高风险患者中,DES相关的晚期支架血栓形成风险增加、持续长期抗血小板治疗的挑战以及早期停用抗血小板治疗的危险。我们在此回顾这一争议的现状,描述解决该争议所需的额外证据,并为监管改革提供建议以及为鼓励基于证据的患者管理提供3条具体建议:1)强调具有已证实长期益处的药物治疗;2)使用动力学模型根据现有的近期数据估计治疗的长期结果;3)调整报销激励措施以鼓励使用基于证据的临床管理策略。