Original Title: Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention? A Pre-Specified Analysis From the ZEUS Trial. Reference: Sara Ariotti et al. J Am Coll Cardiol Intv. 2016;9(5):426-436.
This work studied ischemic and bleeding events in high bleeding risk patients randomized to the zotarolimus eluting stent (ZEZ) Endeavor vs. conventional bare metal stents (BMS), followed by dual antiplatelet therapy (DAPT) in patients with both stable and unstable coronary artery disease.
Drug eluting stents are controversial in patients with high bleeding risk since prolonged DATP may poses safety concerns.
The ZEUS trial (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) was a multicenter, randomized and simple blind trial including 828 high bleeding risk patients randomized to ZES vs. BMS followed by 30 days of DAPT.
Primary end point was a combination of death, MI and revascularization at 12 months that occurred in 22.6% of patients in the ZES group vs 29% of patients in the BMS group (HR: 0.75; CI 95% 0.57 to 0.98; p=0.033).
This difference was basically driven by a lower AMI rate (3.5% vs. 10.4%; p<0.001) and a lower revascularization rate (5.9% vs. 11.4%; p=0.005) in the ZES group.
The definite/probable thrombosis rate was lower in the ZES group and bleeding events were similar in the two groups.
Conclusion
Zotarolimus eluting stents in high bleeding risk patients with stable or unstable coronary artery disease provide superior safety and efficacy than conventional bare metal stents.
Editorial Comment
Just one month DAPT was safe in this study but we should not generalize this benefit to all drug eluting stents until there is more information. The Leaders Free study on biolimus eluting stents published in NEJM this past October, also showed superior safety and efficacy in high bleeding risk patients with only one month DAPT.