WASHINGTON -- Coronary bifurcation lesions can be safely stented with Cypher (sirolimus-eluting) stents using either a simple or complex strategy, with no significant difference in clinical endpoints, according to investigators here.
WASHINGTON, Oct. 27 -- Coronary bifurcation lesions can be safely stented with Cypher (sirolimus-eluting) stents using either a simple or complex strategy, with no significant difference in clinical endpoints, according to investigators here.
But stenting the main and side branches took more time, and 18% of patients who had complex stenting had cardiac biomarkers elevated to three times the upper limit of normal, said Andrejs Erglis, M.D., of Peter Stradins Clinical University Hospital in Riga, Latvia. This compared with 8% of patients who had the simple main-vessel-only stenting (P=0.011).
The bottom line is that "simple is better," Dr. Erglis said at the Transcatheter Cardiovascular Therapeutics (TCT) meeting here, reporting results of the Nordic Bifurcation Study. The results were published online simultaneously in Circulation, Journal of the American Heart Association.
The study, funded by Cordis, the Johnson & Johnson subsidiary that makes Cypher, recruited 413 patients with bifurcation lesions. Two hundred and seven patients were randomized to main vessel stenting with optional stenting of the side branch and 206 to main vessel plus side-branch stenting. All procedures used Cypher stents.
After six months there were no significant differences in cardiac death, myocardial infarction, target-vessel revascularization between the two strategies.
Importantly, given the ongoing concerns about stent thrombosis with drug-eluting stents, there was only one such case, and it occurred in the main-vessel-only arm.
In addition to longer procedure times, patients who had side-branch stenting, an approach often called "a full metal jacket," also had increased fluoroscopy times and used more contrast agents.
Three hundred and seven patients had quantitative coronary assessment at index procedure with follow-up angiography at eight months. In the main vessel plus side-branch stenting arm, 5.1% of patients reached the combined angiographic endpoint of diameter stenosis of more than 50% in the main vessel and occlusion of the side branch, versus 5.3% of patients in the main-vessel-only stenting arm (P=NS).
On average patients in both arms were in their early 60s and more than 75% were men.
Dr. Erglis said that several cardiologists have advocated the single-vessel, single-stent approach and he agreed, noting that in his opinion "a single vessel approach is always better."
But he said the evidence from the trial "makes it clear that either strategy can be safe and effective."
Roxana Mehran, M.D. of Columbia University in New York, commented that the results added to growing evidence that drug-eluting stents can be extended beyond current indications and "safely used in more complex, higher risk patients." Dr. Mehran, who is a Cardiovascular Research Foundation researcher, moderated the press briefing where the results were discussed.