Guidant Report 12 Month Follow Up Results from Clinical Trials on Bioabsorbable Everolimus Eluting Stents

Guidant Corporation today announced results from two clinical trials evaluating everolimus eluting stents. Twelve-month results from the FUTURE II clinical trial will be reviewed by Beverly Lorell, M.D., Guidant vice president and chief medical and technology officer, during the company’s mid-quarter conference call tomorrow, Thursday, May 27. Thirty-day results from the SPIRIT FIRST feasibility study evaluating Guidant’s MULTI-LINK VISION® Coronary Stent System-based drug eluting stent system for the treatment of coronary artery disease were presented by Jan J. Piek, M.D., of the Academic Medical Center, Department of Cardiology, University of Amsterdam, today at the Paris Course on Revascularization (EuroPCR) conference taking place through Friday, May 28.    

The FUTURE II clinical trial compares an everolimus eluting coronary stent system that utilises a bioabsorbable polymer versus an uncoated metallic stent control in de novo (previously untreated) lesions in native coronary arteries.  Both the safety and efficacy results from FUTURE II at six months were sustained at 12-month follow-up; no new major adverse cardiac events (MACE) occurred in the everolimus eluting stent arm between the six and 12-month follow up period.  Thus, the 4.8 percent MACE rate observed at six months did not change at 12 months.  The MACE rate includes any deaths, heart attacks or target lesion revascularizations (a measure of the need for repeat intervention at the site of the original stent implantation) within the 12-month period.  The multicenter trial evaluated the everolimus eluting stent system in 21 patients; 43 patients received the uncoated metallic stent control.      

The SPIRIT FIRST clinical trial compares an everolimus eluting stent system utilizing Guidant’s cobalt chromium MULTI-LINK VISION Coronary Stent System platform with a durable polymer drug carrier, versus an uncoated MULTI-LINK VISION Coronary Stent System control.  SPIRIT FIRST reported 30-day MACE rates of 7.1 percent (2 patients of 28) in one arm and 0 percent in the other (0 patients of 32).  As defined in SPIRIT FIRST, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the 30-day period.  Because the study is blinded, it is not known at this time which group received the everolimus eluting coronary stent and which group received the control stent.  

“The results from FUTURE II further support the sustainability of the excellent data on the bioabsorbable everolimus eluting stent platform that we observed with FUTURE I at six and 12 months,” said Dana G. Mead, Jr., president, Vascular Intervention, Guidant.  “In addition, the 30-day MACE data from the SPIRIT FIRST study are consistent with historical 30-day MACE rates in drug eluting stents.  These results are encouraging and continue to reinforce our confidence in everolimus eluting stents. We look forward to reporting six-month follow-up data from SPIRIT FIRST later this year.”

 

Posted May 26th, 2004

 

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