An update with the MATRIX study
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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consent and were withdrawn Heparin*(n=907) Assigned to Bivalirudin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