ISAR-SAFE Trial Summary: 6 vs 12 months of DAPT after DES PCI

isar safe trial

2015 ISAR-SAFE TRIAL M A randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting multicentre, double-blind, placebo-controlled, randomized controlled trial Objective: To compare the clinical outcome of 6 months of clopidogrel therapy to 12 months of clopidogrel therapy in patients on aspirin after drug-eluting stents (DES) implantation 4000 Patients Inclusion criteria: Patients receiving clopidogrel therapy at 6 (-1/+2) months after DES implantation due to symptoms or signs of coronary artery disease, i.e. even patients with acute coronary syndrome at the index-PCI 6 12 VS 6 months clopidogrel (n=1997) 12 months clopidogrel (n=2003) 1.5 PRIMARY OUTCOME Composite of death, MI, stent thrombosis, stroke, or TIMI major bleeding at 9M % Diff -0.1; Upper limit of one-sided 95% CI 0.5 P for noninferiority <0.001 SECONDARY OUTCOMES 1.6 0.4 All-cause mortality at 9 months % P=0.37 0.6 0.7 Myocardial infarction % 0.7 P=0.85 0.3 Stent thrombosis % P=0.74 0.2 Conclusion: In this trial no significant difference in net clinical outcome between 6 & 12 months of clopidogrel therapy after DES implantation was observed. The trial must be considered in view of its premature termination & lower than expected event rates. SS Sch├╝pke et al. Eur Heart J 2015;36(20):1252-1263