"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.
Using the Cypher registry surveillance data and the Emory databank questionnaires, the researchers compared the baseline demographic variables, angiographic variables and frequencies of in-hospital and 6-month adverse events between patients who received SES or VB for in-stent restenosis.
"We found SES as treatment for ISR is at least equivalent, if not superior, to VB. There were no differences in clinical event rates at 6-month follow-up between the two treatments," says Emory Heart Center interventional cardiology fellow Fadi Alameddine, MD, lead author of the research presented at a poster session today. "However, SES was accompanied by a lower incidence of heart attacks both while the patients were still in the hospital and six months after discharge. The SES patients also had a lower rate of in-hospital total higher major adverse cardiovascular events."
Conventional VB treatment, which is a logistically demanding procedure, exposes patients to radiation and is associated with a risk of late restenosis (20 to 40 percent) and late thrombosis. However, whether SES is superior to VB long-term remains an open question, according to Dr. Alameddine. "That will be addressed by ongoing prospective randomized controlled multi-center studies. We should have those results in about six months," he notes.
Dr. Block disclosed a commercial relationship with Cordis-Johnson & Johnson.
The Emory Heart Center is comprised of all cardiac services and research at Emory University Hospital, the Carlyle Fraser Heart Center of Emory Crawford Long Hospital, the Andreas Gruentzig Cardiovascular Center of Emory University and The Emory Clinic. Ranked among the nation's top ten heart centers by U.S. News & World Report's annual survey, the Emory Heart Center has a rich history of excellence in all areas of cardiology and cardiac surgery --including education, research and patient care. It is internationally recognized as one of the birthplaces of modern interventional cardiology and was the site of the first coronary stent implantation in the United States, the only single site randomized comparison of angioplasty and bypass surgery, and pioneering work in vascular brachytherapy.