SPIRIT III trial shows fewer major adverse cardiac events

Late breaking results from the SPIRIT III trial, presented at TCT 2007, the annual scientific symposium of the Cardiovascular Research Foundation, show that after 12 months, there were significantly fewer major adverse cardiac events (MACE) such as heart attacks, deaths from cardiac causes or repeat procedures (angioplasty or surgery) to clear the original vessel blockage after using a Xience V everolimus-eluting coronary stent than a Taxus paclitaxel-eluting stent.

The rate of the primary endpoint, in-segment late loss (a measure of how much the artery re-narrows following stenting) was also reduced by 50% with the Xience V stent compared to Taxus. There were no significant differences in other secondary endpoints between the two stent types, including target vessel failure (a combination of repeat procedures anywhere in the involved blood vessel and adverse cardiac events), as well as stent thrombosis (dangerous blood clots that can form within the stent).

“Both the primary endpoint of the trial and the major secondary endpoint were met,” said Gregg W. Stone, MD, Chairman, Cardiovascular Research Foundation and Professor of Medicine, Columbia University Medical Center. “Moreover, the reduction in major adverse cardiac events with the Xience V stent compared to the Taxus stent is an important finding that signifies improved long-term outcomes for patients with heart disease. Given this positive finding, which has never before been seen in a pivotal drug-eluting stent vs. stent trial, coupled with the ease of use of Xience, will result in this device becoming a favored drug-eluting stent for clinicians treating coronary disease.”

“Further studies are required to determine whether there are meaningful differences between the two stent types in low frequency safety events, and in important subgroups,” Stone added.

SPIRIT III 12-Month Results

Everolimus-Eluting Stent Paclitaxel-Eluting Stent
Target Vessel Failure 8.3 percent 10.8 percent
MACE 5.8 percent 9.9 percent
Cardiac Death .8 percent .9 percent
MI 2.6 percent 3.7 percent
Ischemia-Driven TLR 3.3 percent 5.6 percent

The SPIRIT III trial was designed as a prospective, randomized, active-controlled, single blind, multi-center clinical trial, which enrolled 1,002 patients (65 different U.S. sites) with coronary artery disease.