Bivalirudin should be indicated for all patients with STEMI. Adnan Kastrati Deutsches Herzzentrum, Munich, Germany

Transcription

1 Bivalirudin should be indicated for all patients with STEMI Adnan Kastrati Deutsches Herzzentrum, Munich, Germany 1

2 Heparin+IIb/IIIa, heparin alone or bivalirudin in STEMI: Do we have the answer? 2

3 Heparin+IIb/IIIa, heparin alone or bivalirudin in STEMI: Do we have the answer? Why we do not need IIb/IIIa inhibitors? Why is bivalirudin the preferred drug? 3

4 Why we do not need IIb/IIIa inhibitors? Effect of GPIIb/IIIa in PPCI: Drug specific or class effect? De Luca et et al. JACC

5 Why we do not need IIb/IIIa inhibitors? Effect of GPIIb/IIIa in PPCI: Drug specific or class effect? De Luca et et al. JACC 2009 No significant differences in efficacy and safety are seen among different IIb/IIIa inhibitors during PCI for MI 5

6 Why we do not need IIb/IIIa inhibitors? Upstream vs. Downstream Abciximab: FINESSE Trial 6

7 Why we do not need IIb/IIIa inhibitors? Upstream vs. Downstream Abciximab: FINESSE Trial All cause death or recurrent MI There is no reason for upstream use of IIb/IIIa inhibitors Ellis et al, NEJM

8 Why we do not need IIb/IIIa inhibitors? BRAVE patients with STEMI Clopidogrel 600 mg oral Abciximab n=401 Double-blind Placebo n=399 Bolus: 0.25 mg/kg Unfractionated Heparin Infusion: μg/kg/min/12h / i / h Placebo infusion i for 12h Aspirin 200mg/day indefinitely Clopidogrel 2 x 75mg/day for 3 days Clopidogrel l 75mg/day for at least 4 weeks BRAVE 3, Circ

9 Why we do not need IIb/IIIa inhibitors? BRAVE 3 Primary endpoint: Final infarct size SPECT study (5 7days after randomization) (% of the left ventricle) Myocardial perfusion % 0% 50% 100% BRAVE 3, Circ

10 Why we do not need IIb/IIIa inhibitors? BRAVE Year MACCE Death, rec current MI, IRA Revas sc. and stro oke (%) 40 Abciximab Placebo 30 RR 0.89 (95% CI, ), p= % 23.0% Schulz et al, CRC 2010 Months after randomization 10

11 Is intracoronary administration the solution? i.c. Abciximab AIDA STEMI Trial 2,065 STEMI Patients i.v. Abciximab 1 EP: 90-day death, reinfarction, new congestive e heart failure 8 % EP 2 P= AIDA STEMI, Lancet 2012 ic Abciximab iv Abciximab 11

12 Is local intracoronary administration the solution? INFUSE AMI trial 100 % PNS P=NS Local I.C. I.V P= Infarct size TIMI III flow Complete ST Res 30d MACE 30d Death INFUSE AMI, JAMA

13 Need for IIb/IIIa inhibitors? Recent evidence is not in support of the routine use of IIb/IIIa inhibitors during PCI in STEMI patients 13

14 Why bivalirudin is the preferred drug? Bivalirudin in NSTEMI 3,798 Pts (ACUITY >2,081 pts + ISAR REACT 4 >1,717 pts) 1,870 pts 1,928 pts IIb/IIIa inhibitors Bivalirudin (abciximab, eptifibatide, tirofiban) heparins UFH or LMWH 30 day results 14

15 Why bivalirudin is the preferred drug? Bivalirudin in NSTEMI HR 1.04 [ ] 15

16 Why bivalirudin is the preferred drug? Bivalirudin in NSTEMI Major bleeding (%) 20 P<0.001 Heparin plus GPI Bivalirudin 15 HR 0.54 [ ] Days after randomization 16

17 Why bivalirudin is the preferred drug? Bivalirudin in STEMI 3602 pts with STEMI Randomized UFH + GP IIb/IIIa N=1802 R 1:1 Bivalirudin Monotherapy N= Withdrew Lost to FU day FU* ITT population p N=1778 N=1777 (98.7%) (98.7%) N=1802 N=1800 HORIZONS AMI, NEJM

18 Why bivalirudin is the preferred drug? Bivalirudin in STEMI Stone & Mehran, NEJM

19 Bivalirudin not only effective, but also cost effective Bivalirudin in STEMI Schwenkglenks et al, Heart

20 Does radial access obviate the need for bivalirudin during primary PCI? Adjusted OR Radial 0.42 [ 0.22, 0.82] Bivalirudin 0.75 [ 0.60, 0.93] 0.51 [ 0.23, 1.16] 0.59 [ 0.44, 0.78] Généreux, Mehran et al, Eurointervention

21 Why bivalirudin is the preferred drug? Bivalirudin in STEMI All cause Mortality Mehran & Stone, Lancet 2010 Stone & Mehran, Lancet

22 Bivalirudin, thepreferred antithromboticdrug in primary PCI 22