经治血小板高反应性作为冠状动脉支架血运重建后二级预防的危险因素：ARCTIC 研究的里程碑分析。
High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: A landmark analysis of the ARCTIC study.
机构信息
From the ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Université Paris 6, Paris, France (G.M., J.S., O.B., P.S., S.A.O., M.K., J.-P.C.); Hôpital Louis Pasteur, Le Coudray, France (G.R.); Hôpital de la Timone, Marseille, France (J.-L.B., T.C.); CH de Bastia, Bastia, France (Z.B.); CHU Carémeau, Nîmes, France (G.C.); CH de la Région Annecienne, Annecy, France (L.B.); Hôpital Cardiologique, Lille, France (E.V.B.); CH de Lagny, Marne-la-Vallée, France (S.E.); Clinique Sainte-Clothilde, La Réunion, France (C.P.); Hôpital Lariboisière, Paris, France (P.H.); CHU Clermont-Ferrand, Clermont-Ferrand, France (P.M.); Hôpital de Rangueil, Toulouse, France (D.C.); Unite de Recherche Clinique, Hôpital Lariboisière, ACTION Study Group, Paris, France (H.R., E.V.); Hôpital Bichat, Paris, France (P.A.); HIA du Val-du-Grâce, Paris, France (J.M.); Hôpital Bichat, ACTION Study Group, Paris, France (J.A.); Hôpital Trousseau, Chambray-lès-Tours, ACTION Study Group, Paris, France (C.S.-E.); and CHU Côte de Nacre, Caen, ACTION Study Group, Caen, France (F.B.).
出版信息
Circulation. 2014 May 27;129(21):2136-43. doi: 10.1161/CIRCULATIONAHA.113.007524. Epub 2014 Apr 9.
BACKGROUND
Individualizing antiplatelet therapy after platelet function testing did not improve outcome after coronary stenting in the Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting (ARCTIC) study. Whether results are different during the phase of secondary prevention starting after hospital discharge, when periprocedural events have been excluded, is unknown.
METHODS AND RESULTS
In ARCTIC, 2440 patients were randomized before coronary stenting to a strategy of platelet function monitoring (VerifyNow P2Y12/aspirin point-of-care assay) with drug adjustment in suboptimal responders to antiplatelet therapy or to a conventional strategy without monitoring and without drug or dose changes. We performed a landmark analysis starting at the time of hospital discharge evaluating the primary end point of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization through 1 year. After discharge, the primary end point occurred in 8.6% of patients in the monitoring arm and 7.9% in the conventional arm (hazard ratio, 1.105; 95% confidence interval, 0.835-1.461; P=0.48). Stent thrombosis or urgent revascularization occurred in 4.4% and 4.5% in the monitoring and conventional arms, respectively (P=0.99). There was no difference for any of the other ischemic end points. Major bleeding event rates were 1.8% in the monitoring arm and 2.8% in the conventional arm (P=0.11), whereas major or minor bleeding event rates were 2.3% and 3.4%, respectively (P=0.10).
CONCLUSIONS
Detection of platelet hyper-reactivity by platelet function testing in patients undergoing coronary stenting with further therapeutic adjustment does not reduce ischemic recurrences after intervention. On-treatment platelet hyperreactivity cannot be considered as a risk factor requiring intervention for secondary prevention after percutaneous coronary revascularization.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT00827411.
背景
在血小板功能检测后进行个体化抗血小板治疗并未改善冠状动脉支架置入术后的结果，这在双重随机评估常规抗血小板策略与药物洗脱支架植入监测指导策略、支架置入术后一年停药与继续治疗（ARCTIC）研究中得到证实。在排除围手术期事件后开始的二级预防阶段，结果是否不同尚不清楚。
方法和结果
在 ARCTIC 研究中，2440 例患者在冠状动脉支架置入术前随机分为血小板功能监测策略组（VerifyNow P2Y12/阿司匹林即时检测）和常规策略组。在血小板功能监测策略组中，对接受抗血小板治疗效果不理想的患者进行药物调整，而在常规策略组中不进行监测，也不进行药物或剂量调整。我们进行了一项基于住院时间的里程碑分析，评估 1 年内死亡、心肌梗死、支架血栓形成、卒中和紧急血运重建的主要终点。出院后，监测组患者主要终点事件发生率为 8.6%，常规组为 7.9%（危险比，1.105；95%置信区间，0.835-1.461；P=0.48）。监测组和常规组分别有 4.4%和 4.5%的患者发生支架血栓形成或紧急血运重建（P=0.99）。其他缺血性终点无差异。监测组大出血发生率为 1.8%，常规组为 2.8%（P=0.11），而大出血或轻微出血发生率分别为 2.3%和 3.4%（P=0.10）。
结论
在接受冠状动脉支架置入术的患者中，通过血小板功能检测发现血小板高反应性，并进一步进行治疗调整，并不会降低介入治疗后的缺血性复发。在经皮冠状动脉血运重建后，治疗中血小板高反应性不能被视为需要干预的二级预防危险因素。
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