March 30, 2009 – Analysis of Boston Scientific’s SYNTAX trial found that while the overall cost effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery varied according to patient characteristics, PCI was more cost effective than CABG in patients with low or moderate coronary lesion complexity.
CABG was more cost effective than PCI in those with the most complex disease. The results also found that both PCI and CABG improved several quality of life measures.
David J. Cohen, M.D., M.Sc., director of cardiovascular research at Saint-Luke's Mid America Heart Institute and Professor of Medicine at the University of Missouri, presented annalysis of the data at the American College of Cardiology (ACC) Annual Scientific Sessions in Orlando, FL.
"This analysis demonstrates that the cost effectiveness of PCI versus CABG depends largely on patient characteristics, notably lesion complexity as defined by the SYNTAX Score," said Dr. Cohen. "The data on quality of life will be helpful to physicians and patients as they consider an appropriate course of treatment. Long-term results will be essential to providing more definitive guidelines for treating these complex coronary patients, and five-year follow up is planned for all patients in the SYNTAX trial."
SYNTAX is the first randomized, controlled clinical trial to compare PCI using the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System to CABG in patients with left main disease and/or significant narrowing of all three coronary arteries (three-vessel disease). According to published guidelines, these patients are traditionally treated with CABG, and they have been excluded from most prior drug-eluting stent clinical trials. The goal of the SYNTAX trial is to explore whether it is safe and effective to treat some or all of these 'surgical' patients with PCI using the TAXUS Express2 stent.
The cost-effectiveness analysis compared the relative benefits in overall quality of life to the relative U.S. health care costs, for both PCI and CABG. In those patients with low or moderate lesion complexity, PCI was favored, providing more quality-adjusted life years and lower net medical costs than CABG. For patients with the most complex disease -- and in whom the increase in repeat revascularization for PCI vs CABG was greatest, CABG provided slightly more quality-adjusted life years, with no significant difference in net medical costs at one year.
The results showed that both PCI and CABG demonstrated equivalent rates of "substantial improvement" in angina relief as compared to baseline at one, six and 12 months (57.6% PCI v. 58.3% CABG at 12 months) (p=statistically insignificant). The number of patients who reported being angina free was comparable for PCI and CABG at one month (64.4% v. 61.6%) and six months (68.5% v. 72.0%) (p=statistically insignificant for both), but was higher in the CABG group at 12 months (71.6% v. 76.3%) (p=0.05).
The safety and effectiveness of the TAXUS Express2 Stent System have not been established in patients with left main or three-vessel disease.
For more information:www.bostonscientific.com.