ISAR-TEST-4

• Cardiac death, MI, or TLR at 12 months: 13.8% of the biodegradable polymer group vs. 14.4% of the permanent polymer group

• Cardiac death: 2.8% vs. 3.2% (p = 0.5)

• ARC definite/probable stent thrombosis: 1.0% vs. 1.5% (p = 0.29)

Trial design: Patients with stable coronary disease or ACS were randomized to the biodegradable polymer DES (rapamycin-eluting; n = 1,299) vs. permanent polymer DES (sirolimus-eluting, n = 652 or everolimus-eluting, n = 652). Mean follow-up was 1 year.

Results

Conclusions

• Among patients with either stable coronary disease or ACS undergoing stent implantation, a biodegradable polymer DES was non-inferior to a permanent polymer-based DES

• Biodegradable polymer DES associated with similar frequency of the composite endpoint of cardiac death, MI, or TLR at 12 months

Byrne RA, et al. Eur Heart J 2009;Aug 30:[Epub]

(p for non-inferiority = 0.005)

(p = NS)

Biodegradable polymer group

Permanent polymer group

%

Cardiac death, MI, or TLR at 12 months

Cardiac death