比伐卢定或普通肝素治疗急性冠脉综合征。

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

机构信息

From the Swiss Cardiovascular Center Bern, Bern University Hospital (M.V.), Clinical Trials Unit and Institute of Social and Preventive Medicine (M.R., D.H.), and Institute of Primary Health Care (P.J.), University of Bern, Bern, Switzerland; Thoraxcenter, Erasmus Medical Center, Rotterdam (M.V.), and Isala Klinieken, Zwolle (A.H.) - both in the Netherlands; EUSTRATEGY Association, Forli (E.F.), Unità Operativa Complessa Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L., A.R.), Cardiology Unit, Ospedali Riuniti di Rivoli (A.G., F.V.), and San Giovanni Bosco Hospital (R.G., G.B.), Turin, Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples (P.C.), Department of Advanced Biomedical Sciences, Division of Cardiology, Federico II University of Naples (G.E.), and Clinica Mediterranea (C.B.), Naples, Azienda Ospedaliera Ospedale Civile di Vimercate, Desio (S.G.), Department of Cardiology, ASL3 Ospedale Villa Scassi (P.R.), and IRCCS Azienda Ospedaliera Universitaria San Martino (A.Z.), Genoa, Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, University of Messina, Messina (G.A.), Unità Operativa Cardiologia, ASL 9 Grosseto, Grosseto (U.L.), Azienda Ospedaliera Ospedale Treviglio-Caravaggio, Treviglio (P.S.), Azienda Ospedaliera Sant'Anna, Como (F.R.), University Hospital Maggiore della Carita, Novara (A.L.), Ospedale Fatebenefratelli, Milan (B.C.), Casa di Cura Villa Verde, Taranto (A.A.), Ospedale Sirai-Carbonia, Carbonia (S.I.), IRCCS Humanitas, Rozzano (P.P.), Cardiovascular Department, Infermi Hospital, Rimini (A.S.), Policlinico Umberto I, Sapienza University of Rome (G.S.), and Interventional Cardiology Unit, Sandro Pertini Hospital Rome (S.R.), Rome, Azienda Ospedaliera Ospedale di Desio, Desio (S.T.), Policlinico San Marco, Zingonia (N.C.), and Mater Salutis Hospital, Legnago (P.T.) - all in Italy; Sahlgrenska University Hospital, Göteborg, Sweden (E.O.); Hospi

出版信息

N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1.

DOI:10.1056/NEJMoa1507854

PMID:26324049

Abstract

BACKGROUND

Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome.

METHODS

We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events.

RESULTS

The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34).

CONCLUSIONS

In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

摘要

背景

在接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征患者中，使用比伐卢定的疗效和安全性存在相互矛盾的证据。

方法

我们将 7213 例预计接受 PCI 的急性冠状动脉综合征患者随机分为比伐卢定组或普通肝素组。比伐卢定组患者随后被随机分为接受或不接受 PCI 后比伐卢定输注。比伐卢定与肝素比较的主要终点为主要不良心血管事件（死亡、心肌梗死或卒中等复合终点）和净不良临床事件（主要出血或主要不良心血管事件复合终点）的发生。PCI 后比伐卢定输注与无 PCI 后输注比较的主要终点为紧急靶血管血运重建、确定的支架血栓形成或净不良临床事件的复合终点。

结果

比伐卢定组的主要不良心血管事件发生率并不低于肝素组（分别为 10.3%和 10.9%；相对风险，0.94；95%置信区间[CI]，0.81 至 1.09；P=0.44），净不良临床事件发生率也无差异（分别为 11.2%和 12.4%；相对风险，0.89；95%CI，0.78 至 1.03；P=0.12）。与无输注相比，PCI 后比伐卢定输注并未显著降低紧急靶血管血运重建、确定的支架血栓形成或净不良临床事件的发生率（分别为 11.0%和 11.9%；相对风险，0.91；95%CI，0.74 至 1.11；P=0.34）。

结论

在急性冠状动脉综合征患者中，比伐卢定的主要不良心血管事件和净不良临床事件发生率并不低于普通肝素。与无 PCI 后输注相比，PCI 后比伐卢定输注并未显著降低紧急靶血管血运重建、确定的支架血栓形成或净不良临床事件的复合终点发生率。（由美纳里尼医药公司和泰尔茂医疗公司资助；MATRIX ClinicalTrials.gov 注册号：NCT01433627。）