An update with the MATRIX study
Bivalirudin in 2015- An update with the MATRIX study Bernardo Cortese Intv Cardiology, A.O. Fatebenefratelli bernardocortese.com 30 Day and 1-Year All-Cause Mortality
HORIZONS AMI 30 Day and 1-Year All-Cause Mortality ' Cardiac Mortality (%) 2.9% 5.1% 12 15 18 21 24 27 30 33 36 Months 3 6 9 1 5 4 2 3.8% 2.1% Bivalirudin (n=1,800) Heparin + GP IIb/IIIa (n=1,802) 1-yr HR [95%CI]= 0.57 [0.38, 0.84] P = 0.005 30-d HR [95% CI]= 0.62; [0.40,0.96] P = 0.03 2.9% 3-yr HR [95%CI]= 0.56 [0.40, 0.80] P = 0.001 NNT=45 Stone 2008 Mehran Stone 2011 1.8% *3-year all cause mortality was also lower with bivalirudin (59% vs 77%),HR 075 [058097]; p=003 These time points were prespecified analyses.NNT=number needed to treat Stone GW NEJM. 2008;358: Mehran R Lancet. 2009;374: Stone GW Lancet. 2011;377: Three-Year Stent Thrombosis (ARC Definite/Probable)
Bivalirudin alone (n=1611) 6 Heparin + GPIIb/IIIa (n=1591) 5.1% 5 4.5% 3.5% 4 HR [95%CI]= Stent Thrombosis (%) 3 3.0% 0.89 [0.65, 1.23] p=0.49 2 HR [95%CI]= 1.16 [0.79, 1.71] 1 p=0.45 3 6 9 12 15 18 21 24 27 30 33 36 Months Number at risk Bivalirudin 1611 1509 1478 1453 1432 1398 971 Heparin+GPIIb/IIIa 1591 1484 1456 1401 1373 1335 906 HEAT PPCI: Design and enrollment
1917 STEMI pts scheduled for emergency angiography at a single center between Feb 2012Nov 2013* 29 (1.5%) already randomized in the trial 59 (3.0%) met one or more other exclusion criteria Exclusion Criteria Active bleeding at presentation Factors precluding oral DAPT Intolerance or contraindication totrial medications Previous enrolment in this trial 1829 eligible for recruitment were randomized 1:1 All of these patients were randomized to create an unselectedReal-Worldpopulation Heparin 70 IU/Kg(n=914) Bivalirudin (n=915) 17 (1%) refused post procedure consent and were withdrawn Heparin*(n=907) Assigned to Bivalirudin (n=905) Shahzad A et al. Lancet 2014 4 HEAT PPCI: MACE Outcomes
Bivalirudin (n=905) Heparin (n=907) Any MACE 79 (8.7%) 52 (5.7%) - Death 46 (5.1%) 39 (4.3%) - CVA 15 (1.6%) 11 (1.2%) - Reinfarction 24 (2.7%) 8 (0.9%) - TLR 6 (0.7%) -Acute ST 20 (2.9%) 6 (0.9%) Some patients experience more than one event.This table lists all the observed MACE events. Heparin advantage is seen in all elements of the composite I need to draw you attention to the reinfarction and TLR figures 697 pts Shahzad A et al. Lancet 2014 5 HEAT PPCI: Safety Outcomes
Bivalirudin (n=905) Heparin (n=907) P BARC 2-5 115 (12.7%) 126 (13.9%) 0.54 - BARC 3-5 32 (3.5%) 28 (3.1%) 0.59 - BARC 2 83 (9.2%) 98 (10.8%) 0.25 Thrombocytopenia (moderate/severe) 6 (0.8%) 0.99 Rates of minor bleeding and rate of combined major or minor bleeding were also similar Shahzad A et al. Lancet 2014 6 BRIGHT: Study flow 2,194 pts with AMI randomized at 82 centers in China Aspirin and clopidogrel 86.2 % STEMI 13.8% NSTEMI 79% radial Randomization (1:1:1) Bivalirudin alone N=735 Biv 0.75 mg/kg bolus mg /kg/h (0.3 mg/kg bolus if ACT< 225s). Biv infusion (0.2 mg/kg/h) continued for at least 30 min post PCI (mean 4h). 4.4% bailout tirofiban. UFH alone N=729 Heparin 100 U/kg bolus + additional dose if ACT