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 language | English |
|---|---|
| Article number | i4935 |
| Journal | British Medical Journal |
| Volume | 354 |
| DOIs | |
| Publication status | Published - Sep 27 2016 |
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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 journal › Article
}
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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U2 - 10.1136/bmj.i4935
DO - 10.1136/bmj.i4935
M3 - Article
AN - SCOPUS:84995747091
VL - 354
JO - British Medical Journal
JF - British Medical Journal
SN - 0959-8146
M1 - i4935
ER -