The aim of this randomized double blind control trial was to validate the safety and efficacy of 6 months vs. 12 months clopidogrel treatment in patients receiving DES.
Primary end point was a combination of death, infarction, in-stent thrombosis, stroke and major bleeding. Secondary end point was the individual analysis of each one of the primary end point components. Recruiting saw early termination with 4000 patients, due to lower-than-expected event rates and slow recruitment.
Most patients were treated with new generation DES. Primary end point incidence was similar in both groups (1.3% for the 6 month group vs. 1.5% in the 12 month; p=0.5). Though not significantly, bleeding rate was lower at 6 months.
Conclusion
No significant differences were observed in both ischemic and bleeding events with clopidogrel at 6 and 12 months after DES stenting. Events rate was lower than expected, which led to early termination.
Stefanie Schulz Schüpke
2014-11-17
Original title: Randomized, Double Blind Trial of 6 Versus 12 Months Of Dual Antiplatelet Therapy After DES-Implantation (ISAR-SAFE).