Periprocedural antithrombotic therapy during PCI: Lessons from ISAR-REACT REACT. Deutsches Herzzentrum, Munich, Germany
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1 Periprocedural antithrombotic therapy during PCI: Lessons from ISAR-REACT REACT 1234trials 1,2,3,4 Adnan Kastrati Deutsches Herzzentrum, Munich, Germany 1
2 First ISAR Trial 517 Patients Antiplatelet therapy Anticoagulant therapy 257 Pts 260 Pts Stent ISAR, NEJM day FU 2
3 First ISAR Trial Dual antiplatelet therapy vs. anticoagulant therapy Bleeding events Ischemic Events ASS+Ticlopidine ASS+Ticlopidine ISAR, NEJM
4 The Difficult Balance Between Antiischemic and Pro Bleeding Effects 12,459 ISAR Patients Ndrepepa et al, Circulation
5 Adjunct antithrombotic therapy during PCI 10 Year Experience: ~20, pts with CAD and PCI Ndrepepa et al, Cardiology 2009 ISAR-REACT 1 NEJM 2004 ADP-receptor antagonist loading 45% Stable AP 15% STEMI 16% NSTEMI Unstable AP 24% BRAVE 1 JAMA 2004 BRAVE 2 JAMA 2005, 2009 BRAVE 3 Circulation 2009 ISAR-REACT REACT 4 NEJM 2011 ISAR-REACT REACT 2 JAMA 2006 ISAR-REACT 3 NEJM
6 Adjunct antithrombotic therapy during PCI ADP-receptor antagonist loading ISAR-REACT 1 NEJM % Stable AP 16% NSTEMI Unstable AP 24% ISAR-REACT REACT 4 NEJM 2011 ISAR-REACT REACT 2 JAMA 2006 ISAR-REACT 3 NEJM 2008 All double blind, bli d placebocontrolled ll dti trials 6
7 Stable Angina ISAR REACT REACT (1) 2159 Patients pre treated with 600 mg clopidogrel Heparin+ Abciximab Double-blind Heparin+ Placebo 1079 Pts 1080 Pts PCI ISAR REACT, NEJM
8 Death, MI, urg. TVR, % 5 Stable Angina ISAR REACT REACT (1) 4 4.2% 4.0% Heparin+Abciximab i i b vs. Heparin+Placebo RR = 1.05 [95% CI, ] Days after randomization ISAR REACT, NEJM
9 NSTE ACS ISAR REACT REACT patients with high riskacs Pre treated with 600 mg clopidogrel Abciximab Double-blind bli Placebo 1010 Pts 1012 Pts PCI ISAR REACT 2, JAMA
10 Death/MI/UTVR, % 20 NSTE ACS ISAR REACT REACT 2 Trop(+) or NSTEMI: RR=0.71 [ ] Abciximab vs. Placebo 5 Trop(-) or Unstable Angina: RR=0.99 [ ] Days after randomization ISAR REACT 2, JAMA
11 Stable and unstable angina ISAR REACT REACT 3 4,570 Patients pre treated with 600 mg clopidogrel Bivalirudin Double-blind Heparin 2,289 Pts 2,281 Pts PCI ISAR REACT 3, NEJM
12 Stable and unstable angina ISAR REACT REACT 3 Death, MI, urg. TVR, major bleeding (%) 10 Heparin 8 Bivalirudin RR=0.94 [95% CI, ], P= Days after randomization ISAR REACT 3, NEJM
13 Death, MI, urg. TVR (%) 10 Stable and unstable angina ISAR REACT REACT Bivalirudin Heparin 5.9% 5.0% 2 RR= [95% CI, ], 1 P= Days after randomization ISAR REACT 3, NEJM
14 Stable and unstable angina ISAR REACT REACT 3 Bivalirudin Heparin Incidence (%) 12 % 10 P=0.008 P= P= Major bleeding Minor bleeding Transfusion ISAR REACT 3, NEJM
15 Incidence (%) 12 % 10 Stable and unstable angina ISAR REACT REACT 3&3A Reduced dose of UFH in 2505 pts 9.9 Bivalirudin Heparin Heparin red. dose Major bleeding Minor bleeding Transfusion ISAR REACT 3A, Eur Heart J
16 ISAR REACT 4 Trial flow chart 1,721 Pts with NSTEMI Pre treated with 600 mg of clopidogrel Double-blind (double-dummy dummy drug) 861 pts 860 pts Abciximab Bivalirudin Bolus of 0.25 mg/kg Infusion of μg/kg/min for 12h Unfractionated heparin Bolus of 70 U/kg Bolus of 0.75 mg/kg Infusion of 1.75 mg/kg/hr for duration of PCI No PCI: 2 patients 2 patients 16
17 e Inciden nce (%) Cu umulativ IR4: Primary endpoint Death, large MI, utvr, major bleeding Relative risk, 0.99 (95% CI, ) P= Abciximab 10.9% Bivalirudin 11.0% Days since Randomization ISAR REACT 4, NEJM
18 Cu umulativ ve Inciden nce (%) IR4: Secondary efficacy endpoint Death, any MI, utvr Relative risk, 0.96 (95% CI, ) P076 P=0.76 Abciximab Bivalirudin Abciximab Bivalirudin Death, % Any MI, % utvr, % Days since Randomization 12.8% 13.4% ISAR REACT 4, NEJM
19 Cu umulativ ve Inciden nce (%) IR4: Secondary safety endpoint Major bleeding Major bleeding Relative risk, 1.84 (95% CI, ) P002 P=0.02 Abciximab 4.6% Bivalirudin 2.6% Days since Randomization ISAR REACT 4, NEJM
20 Major lessons from ISAR REACT 1,2,3&4 trials Early administration of an effective ADP receptor antagonist is of key importance in improving i the results of PCI Heparin without IIb/IIIa inhibitors is the most cost effective anticoagulant during elective PCI Bivalirudin is highly effective and the safest anticoagulant for PCI in patients with NSTEMI 20
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