Oct. 14, 2008 Newly reported data presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF) from the SYNTAX clinical trial (SYNergy Between PCI With TAXUS and Cardiac Surgery) reveal similar safety and efficacy outcomes when the use of a drug-eluting stent is compared to heart bypass surgery in patients with left main disease.
Rates of major adverse cardiac and cerebrovascular events (MACCE) in patients with left main disease who received a stent were comparable with those who received bypass surgery (15.8% vs. 13.7% respectively). In addition, the overall safety measures of death, stroke and heart attack were similar: 7.0% for the patients that received a stent and 9.2% for the patients that received bypass surgery. Most importantly, patients who received stents rather than bypass surgery had fewer strokes at 1 year (0.3% vs. 2.7%, p=0.009), with similar rates of death (4.2% vs. 4.4 % respectively).
In patients with three-vessel disease, safety measures were comparable; however, the data reveal that patients who received angioplasty did show higher rates of revascularization and MACCE than those who received bypass surgery. In this group, the rate of revascularization in the stent group was higher (14.7% vs 5.4%, P<0.001). The overall rates of death, heart attack or stroke were similar in the 2 groups, however (7.9% vs 6.4%).
Data from the SYNTAX clinical trial also yielded a new tool to measure the complexity of coronary artery disease: The SYNTAX Score. The raw SYNTAX score is an effective predictor of major adverse coronary and cerebrovascular events, MACCE, according to the study. The trial data presented at TCT was used as part of calculating the score.
"The SYNTAX score is a new, innovative tool to describe the complexity of vasculature," said Patrick W. Serruys, MD, PhD, head of the Department of Interventional Cardiology at University Hospital Rotterdam, Netherlands and principal investigator of the study.
"SYNTAX has shown that TAXUS stents can be used safely rather than bypass surgery in the most complicated patients with coronary artery disease, those with left main and triple vessel disease." said Gregg W. Stone, MD, CRF Chairman, Professor of Medicine and the Director of Research and Education, Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital, Columbia University Medical Center. "The trade-off of 8 additional repeat revascularization procedures to prevent 2 strokes is more than acceptable. Moreover, the SYNTAX score will assist in assessing and determining whether stents or surgery are most appropriate for individual patients based on the severity of their disease."
The SYNTAX trial, with more than 1,800 participants in 62 European sites and 23 U.S. sites, is designed to determine the best treatment options – medicated stent or coronary artery bypass graft (CABG) in patients with complex coronary disease (either left main disease, or three vessel disease). The medicated stent used in the trial was a paclitaxel-eluting stent.
The trial, which began in March 2005, will continue through April 2012.
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