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

Sergio Leonardi, Enrico Frigoli, Martina Rothenbühler, Eliano Navarese, Paolo Calabró, Paolo Bellotti, Carlo Briguori, Marco Ferlini, Bernardo Cortese, Alessandro Lupi, Salvatore Lerna, Dennis Zavallonito-Parenti, Giovanni Esposito, Simone Tresoldi, Antonio Zingarelli, Stefano Rigattieri, Cataldo Palmieri, Armando Liso, Fabio Abate, Marco ZimarinoMarco Comeglio, Gabriele Gabrielli, Alaide Chieffo, Salvatore Brugaletta, Ciro Mauro, Nicolas M. Van Mieghem, Dik Heg, Peter Jüni, Stephan Windecker, Marco Valgimigli

Research output: Contribution to journalArticle

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Abstract

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01433627.

Original languageEnglish
Article numberi4935
JournalBritish Medical Journal
Volume354
DOIs
Publication statusPublished - Sep 27 2016

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Acute Coronary Syndrome
Heparin
Randomized Controlled Trials
Platelet Glycoprotein GPIIb-IIIa Complex
bivalirudin
Percutaneous Coronary Intervention
Sweden
Netherlands
Spain
Italy
Stroke
Myocardial Infarction
Confidence Intervals
Hemorrhage

ASJC Scopus subject areas

  • Medicine(all)

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Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX) : Randomised controlled trial. / Leonardi, Sergio; Frigoli, Enrico; Rothenbühler, Martina; Navarese, Eliano; Calabró, Paolo; Bellotti, Paolo; Briguori, Carlo; Ferlini, Marco; Cortese, Bernardo; Lupi, Alessandro; Lerna, Salvatore; Zavallonito-Parenti, Dennis; Esposito, Giovanni; Tresoldi, Simone; Zingarelli, Antonio; Rigattieri, Stefano; Palmieri, Cataldo; Liso, Armando; Abate, Fabio; Zimarino, Marco; Comeglio, Marco; Gabrielli, Gabriele; Chieffo, Alaide; Brugaletta, Salvatore; Mauro, Ciro; Van Mieghem, Nicolas M.; Heg, Dik; Jüni, Peter; Windecker, Stephan; Valgimigli, Marco.

In: British Medical Journal, Vol. 354, i4935, 27.09.2016.

Research output: Contribution to journalArticle

Leonardi, S, Frigoli, E, Rothenbühler, M, Navarese, E, Calabró, P, Bellotti, P, Briguori, C, Ferlini, M, Cortese, B, Lupi, A, Lerna, S, Zavallonito-Parenti, D, Esposito, G, Tresoldi, S, Zingarelli, A, Rigattieri, S, Palmieri, C, Liso, A, Abate, F, Zimarino, M, Comeglio, M, Gabrielli, G, Chieffo, A, Brugaletta, S, Mauro, C, Van Mieghem, NM, Heg, D, Jüni, P, Windecker, S & Valgimigli, M 2016, 'Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): Randomised controlled trial', British Medical Journal, vol. 354, i4935. https://doi.org/10.1136/bmj.i4935
Leonardi, Sergio ; Frigoli, Enrico ; Rothenbühler, Martina ; Navarese, Eliano ; Calabró, Paolo ; Bellotti, Paolo ; Briguori, Carlo ; Ferlini, Marco ; Cortese, Bernardo ; Lupi, Alessandro ; Lerna, Salvatore ; Zavallonito-Parenti, Dennis ; Esposito, Giovanni ; Tresoldi, Simone ; Zingarelli, Antonio ; Rigattieri, Stefano ; Palmieri, Cataldo ; Liso, Armando ; Abate, Fabio ; Zimarino, Marco ; Comeglio, Marco ; Gabrielli, Gabriele ; Chieffo, Alaide ; Brugaletta, Salvatore ; Mauro, Ciro ; Van Mieghem, Nicolas M. ; Heg, Dik ; Jüni, Peter ; Windecker, Stephan ; Valgimigli, Marco. / Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX) : Randomised controlled trial. In: British Medical Journal. 2016 ; Vol. 354.
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abstract = "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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01433627.",
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TY - JOUR

T1 - Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX)

T2 - Randomised controlled trial

AU - Leonardi, Sergio

AU - Frigoli, Enrico

AU - Rothenbühler, Martina

AU - Navarese, Eliano

AU - Calabró, Paolo

AU - Bellotti, Paolo

AU - Briguori, Carlo

AU - Ferlini, Marco

AU - Cortese, Bernardo

AU - Lupi, Alessandro

AU - Lerna, Salvatore

AU - Zavallonito-Parenti, Dennis

AU - Esposito, Giovanni

AU - Tresoldi, Simone

AU - Zingarelli, Antonio

AU - Rigattieri, Stefano

AU - Palmieri, Cataldo

AU - Liso, Armando

AU - Abate, Fabio

AU - Zimarino, Marco

AU - Comeglio, Marco

AU - Gabrielli, Gabriele

AU - Chieffo, Alaide

AU - Brugaletta, Salvatore

AU - Mauro, Ciro

AU - Van Mieghem, Nicolas M.

AU - Heg, Dik

AU - Jüni, Peter

AU - Windecker, Stephan

AU - Valgimigli, Marco

PY - 2016/9/27

Y1 - 2016/9/27

N2 - 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01433627.

AB - 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01433627.

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