新型生物可吸收聚合物涂层依维莫司洗脱冠状动脉支架的疗效与安全性：EVOLVE II随机试验
Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.
作者信息
Kereiakes Dean J, Meredith Ian T, Windecker Stephan, Lee Jobe R, Mehta Shamir R, Sarembock Ian J, Feldman Robert L, Stein Bernardo, Dubois Christophe, Grady Timothy, Saito Shigeru, Kimura Takeshi, Christen Thomas, Allocco Dominic J, Dawkins Keith D
机构信息
From the Heart and Vascular Center/The Lindner Research Center, Christ Hospital, Cincinnati, OH (D.J.K., I.J.S.); Department of Medicine, MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia (I.T.M.); Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Department of Invasive Cardiology, Wake Medical Center, Raleigh, NC (R.L.J.); Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada (S.R.M.); Invasive/Interventional Cardiology, Mediquest Research at Munroe Regional Medical Center, Ocala, FL (R.L.F.); Interventional Cardiology, Morton Plant Mease Healthcare System, Clearwater, FL (B.S.); Department of Cardiology, University Hospital Leuven, Leuven, Belgium (C.D.); Research and Education, Aspirus Heart and Vascular Institute-Research and Education, Wausau, WI (T.G.); Division of Cardiology and Catherization Laboratories Heart Center, Shonan Kamakura General Hospital, Kanagawa, Japan (S.S.); Department of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan (T.K.); and Clinical Sciences, Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A., K.D.D.).
出版信息
Circ Cardiovasc Interv. 2015 Apr;8(4). doi: 10.1161/CIRCINTERVENTIONS.114.002372.
BACKGROUND
Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent.
METHODS AND RESULTS
Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively.
CONCLUSIONS
In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.
背景
具有持久聚合物的药物洗脱支架可能与超敏反应、愈合延迟和内皮化不完全有关，这可能导致晚期/极晚期支架血栓形成以及需要延长双联抗血小板治疗。可生物吸收的聚合物可能有助于支架愈合，从而提高临床安全性。SYNERGY支架是一种薄支柱、铂铬金属合金平台，带有超薄的可生物吸收的聚（D，L-丙交酯-共-乙交酯）管腔外依维莫司洗脱聚合物。我们进行了一项多中心随机对照试验以获得监管批准，以确定SYNERGY支架相对于持久聚合物PROMUS Element Plus依维莫司洗脱支架的非劣效性。
方法与结果
计划对非ST段抬高急性冠状动脉综合征或稳定冠状动脉疾病进行经皮冠状动脉介入治疗的患者（n = 1684）被随机分配接受SYNERGY支架或PROMUS Element Plus支架。意向性治疗分析显示，接受SYNERGY支架治疗的患者中12个月靶病变失败的主要终点发生率为6.7%，接受PROMUS Element Plus支架治疗的患者为6.5%（差异P = 0.83；非劣效性P = 0.0005），按符合方案分析两组均为6.4%（非劣效性P = 0.0003）。SYNERGY支架治疗组和PROMUS Element Plus支架治疗组中，临床指征的靶病变血运重建或明确/可能的支架血栓形成发生率分别为2.6%对1.7%（P = 0.21）和0.4%对0.6%（P = 0.50）。
结论
在这项随机试验中，SYNERGY可生物吸收聚合物依维莫司洗脱支架在1年靶病变失败方面不劣于PROMUS Element Plus依维莫司洗脱支架。这些数据支持SYNERGY在广泛接受经皮冠状动脉介入治疗的患者中的相对安全性和有效性。
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