Impact of Sex on Comparative Outcomes of Bivalirudin versus Unfractionated Heparin in Patients with Acute Coronary Syndromes Undergoing Invasive Management A pre-specified analysis of the MATRIX trial.

AIMS To assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in male and female patients with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS In the MATRIX program,7213 patients were randomized to bivalirudin or UFH.Patients in bivalirudin group were subsequently assigned to receive or not to receive a post-PCI infusion.The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE),defined as death,myocardial infarction,or stroke,and net adverse clinical events (NACE),defined as MACE or major bleeding.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 (TVR),definite stent thrombosis (ST),or NACE.The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio,0.90;95% confidence interval [CI], 0.75-1.07; P=0.22) and female patients (rate ratio, 1.06; 95%CI,0.80-1.40;P=0.67) without significant interaction (Pint=0.31), nor was the rate of NACE (males: rate ratio, 0.85; 95% CI, 0.72-1.01; P=0.07; females: rate ratio, 0.98; 95% CI, 0.76-1.28; P=0.91; Pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: rate ratio, 0.84; 95% CI, 0.66-1.07; P=0.15; females: rate ratio, 1.06; 95% CI, 0.74-1.53; P=0.74;Pint=0.28). CONCLUSIONS In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes.The rate of the composite of urgent TVR,definite ST,or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.