"The efficacy of the SES in native coronary arteries is proven -- but the safety and efficacy of drug eluting stents in the treatment of ISR is unclear. To help clarify these issues, we compared in-hospital and six month outcomes in patients with ISR treated either with SES or vascular brachytherapy (VB)," explains Emory Heart Center interventional cardiologist Peter C. Block, MD, the principal investigator of the study.
Using a retrospective non-randomized study design, the Emory team analyzed the U.S. nationwide post marketing surveillance registry maintained by Cordis (maker of the Cypher SES) which included 2063 patients implanted with Cypher SES between August of 2003 and December of 2003 -- 136 of whom had received SES for ISR.
The Emory researchers also identified 99 patients in the Emory cardiac databank who received VB as treatment of ISR between July of 2003 and January of 2004. These patients were contacted by telephone 4 to 8 months following their VB for a phone interview about their cardiac symptoms and outcomes.