P794Comparision of efficacy and safety of 3-month dual antiplatelet therapy(DAPT) versus 6-month DAPT following Coroflex ISAR sirolimus-eluting stent(C-SES) implantation

Abstract

Background: The minimal necessary duration of DAPT after DES implantation remains undetermined. C‐SES is the thinnest polymer‐free coated stent and the shorter duration of DAPT are expected possible. We aimed to compare efficacy and safety of 3‐month DAPT with 6‐month DAPT after C‐SES implantation. Methods: We planned to enroll and randomize 906 patients from 10 centers into 2 groups according to DAPT duration: 3‐month DAPT following C‐SES implantation versus 6‐month DAPT following C‐SES implantation. At present, 204 patients were randomly assigned and followed‐up 12 months: (3‐month DAPT, n=106) versus (6‐month DAPT, n=98). The primary end point was major adverse cardiac events (MACE) at 12 months defined as the composite of cardiac death, myocardial infarction (MI) related to the target vessel or target lesion revascularization (TLR). Results: Mean stent diameters/lengths were 2.97±0.34/20.89±4.18mm in the 3‐ month DAPT group and 3.00±0.37/20.05±3.95mm in the 6‐month DAPT group (P=0.628). There was no significant difference between the two groups in quantitative coronary analysis. MACE at 12‐month occurred in 3 (2.8%) patients in the 3‐month DAPT group compared with 0 (0%) patients in the 6‐month DAPT group (P=0.247). All occurred MACEs in the 3‐month DAPT group were TLR. There was no stent thrombosis or MI related target vessel in both groups. No major bleeding occurred in both groups. Conclusion: Both 3‐month and 6‐month DAPT after C‐SES implantation showed excellent results in respect of efficacy and safety. Three‐month DAPT didn't increase the risk of MACE including stent thrombosis at 12 months compared with 6‐month DAPT. However, this result was preliminary and need to be confirmed after our trial finish.