WASHINGTON, D.C.—There are similar safety and efficacy outcomes when the use of a drug-eluting stent (DES) is compared to CABG in patients with left main disease and three-vessel disease (3VD), according to newly reported SYNTAX data presented Tuesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Principal investigator Patrick W. Serruys, MD, PhD, head of the department of interventional cardiology at the University Hospital Rotterdam, Netherlands, presented the data on behalf of the SYNTAX investigators.
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 – DES or CABG in patients with complex coronary disease (either left main disease, or three vessel disease). The stent used in the trial was Boston Scientific’s Taxus paclitaxel-eluting stent.
The 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 percent, respectively). In addition, Serruys said that the overall safety measures of death, stroke and heart attack were similar: 7 percent for the patients that received a stent and 9.2 percent for the patients that received bypass surgery.
He added that most importantly, patients who received stents rather than bypass surgery had fewer strokes at one year (0.3 vs. 2.7 percent), with similar rates of death (4.2 vs. 4.4 percent, respectively).
In patients with three-vessel disease, Serruys reported that the safety measures were comparable. However, he noted that the data revealed 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 percent). The overall rates of death, heart attack or stroke were similar in the two groups, however (7.9 vs. 6.4 percent).
Data from the SYNTAX clinical trial also yielded a new tool to measure the complexity of coronary artery disease: The SYNTAX Score. The SYNTAX investigators said that the raw SYNTAX score is an effective predictor of MACCE. 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,” Serruys said.
“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, TCT co-chairman, professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University Medical Center in New York City.
“The trade-off of eight additional repeat revascularization procedures to prevent two 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,” Stone added.
The trial, which began in March 2005, will continue through April 2012.