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EVOLUTION Study

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



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