Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial

被引：31

作者：

Leonardi, Sergio ^{[1
]}

Frigoli, Enrico ^{[2
]}

Rothenbuhler, Martina ^{[3
,4
]}

Navarese, Eliano ^{[5
]}

Calabro, Paolo ^{[6
]}

Bellotti, Paolo ^{[7
]}

Briguori, Carlo ^{[8
]}

Ferlini, Marco ^{[1
]}

Cortese, Bernardo ^{[9
]}

Lupi, Alessandro ^{[10
]}

Lerna, Salvatore ^{[11
]}

Zavallonito-Parenti, Dennis ^{[12
]}

Esposito, Giovanni ^{[13
]}

Tresoldi, Simone ^{[14
]}

Zingarelli, Antonio ^{[15
]}

Rigattieri, Stefano ^{[16
]}

Palmieri, Cataldo ^{[17
]}

Liso, Armando ^{[18
]}

Abate, Fabio ^{[19
]}

Zimarino, Marco ^{[20
]}

Comeglio, Marco ^{[21
]}

Gabrielli, Gabriele ^{[22
]}

Chieffo, Alaide ^{[23
]}

Brugaletta, Salvatore ^{[24
]}

Mauro, Ciro ^{[25
]}

Van Mieghem, Nicolas M. ^{[26
]}

Heg, Dik ^{[3
,4
]}

Juni, Peter ^{[27
,28
]}

Windecker, Stephan ^{[29
]}

Valgimigli, Marco ^{[29
]}

机构：

[1] Fdn IRCCS Policlin San Matteo, Pavia, Italy

[2] EUSTRATEGY Assoc, Forli, Italy

[3] Univ Bern, CTU Bern, CH-3012 Bern, Switzerland

[4] Univ Bern, ISPM, CH-3012 Bern, Switzerland

[5] Univ Milan, Policlin Multimed IRCSS, Milan, Italy

[6] Univ Naples 2, Dept Cardiothorac Sci, Div Cardiol, Naples, Italy

[7] ASL3 Osped Villa Scassi, Dept Cardiol, Genoa, Italy

[8] Clin Mediterranea, Naples, Italy

[9] Osped Fatebene Fratelli, Milan, Italy

[10] Univ Hosp Maggiore Carita, Novara, Italy

[11] Osped Sirai Carbonia, Carbonia, Italy

[12] IRCCS, Humanitas Res Hosp, Rozzano, Italy

[13] Univ Naples Federico II, Dept Adv Biomed Sci, Div Cardiol, Naples, Italy

[14] AO Osped Desio, Lombardia, Italy

[15] IRCCS San Martino IST, Genoa, Italy

[16] Intervent Cardiol Sandro Pertini Hosp Rome, Rome, Italy

[17] Osped Pasquinucci, Massa, Italy

[18] Citta Lecce Hosp, Lecce, Italy

[19] Osped Giovanni Paolo II, Sciacca, Italy

[20] Univ G dAnnunzio Chieti & Pescara, Chieti, Italy

[21] Osped San Jacopo, Pistoia, Italy

[22] Azienda Osped Riuniti Presidio GM Lancisi, Ancona, Italy

[23] Osped San Raffaele IRCCS, Milan, Italy

[24] IDIBAPS, Cardiovasc Inst, Hosp Clin, Barcelona, Spain

[25] AORN Cardarelli, Naples, Italy

[26] Erasmus MC, Rotterdam, Netherlands

[27] Univ Toronto, Appl Hlth Res Ctr, Li Ka Shing Knowledge Inst, St Michaels Hosp, Toronto, ON M5S 1A1, Canada

[28] Univ Toronto, Dept Med, Toronto, ON M5S 1A1, Canada

[29] Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2016年 / 354卷

关键词：

INTERVENTION; METAANALYSIS; ANGIOPLASTY;

D O I：

10.1136/bmj.i4935

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE To test the optimal antithrombotic regimen in patients with acute coronary syndrome. DESIGN andomised controlled trial. SETTING Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden. PARTICIPANTS 7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously. INTERVENTIONS Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors. MAIN OUTCOME MEASURES Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat. RESULTS Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43). CONCLUSIONS A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation.

引用

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