A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a Non-Biodegradable Polymer in the Treatment of Patients with de novo Coronary Artery Lesions.  

A prospective, randomized, controlled, parallel two-arm multi-center study, comparing the ExcelTM DES to CypherTM DES in the treatment of patients with de novo coronary artery lesions.  

Initiated Time:  in 2008

Study sites number:  30 sites

Sample size: 1944 patients

• The Sirolimus eluting stent (SES) with biodegradable polymer maintained non-inferiority and improved long-term clinical outcomes compared to SES with durable polymer in terms of clinical efficacy and safety through 3 years

• Biodegradable polymer EXCEL stent demonstrated 28% risk reduction on the definite & probable stent thrombosis.

• The benefit of the Sirolimus eluting stent (SES) with biodegradable polymer emerged in the very late phase and was mainly driven by a lower risk of Target Vessel MI associated with definite or probable VLST

• Longer term follow-up will be necessary to find the potential divergence in outcome between the two different types of stents.

• These findings provide the basis for the proof of concept of biodegradable polymer DES