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SYNTAX is the first randomized, controlled clinical trial to compare PCI using the TAXUS(R) Express2(TM) 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 versus 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).
In addition, the study showed that total medical costs were $5,693 lower for PCI than for CABG for the initial hospitalization (
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