One Stent Still Better Than Two for Bifurcation Stenting

Shelley Wood

November 01, 2007

November 1, 2007 (Washington, DC) - Three new studies presented during the late-breaking clinical-trials session at the TCT 2007 meeting last week offer little rationale for using a second stent in a diseased side branch, meaning that until more study results are in, interventional cardiologists tackling a bifurcated lesion should still use a stent in the main branch, and, for the most part, stent the side branch only if absolutely necessary.

The Bifurcations Bad Krozingen study from Germany, presented by Dr Miroslaw Ferenc (Heart Center, Bad Krozingen, Germany), found no differences in angiographic or clinical outcomes at nine and 12 months, respectively, between patients treated with systematic T-stenting of both the main and the side branch and patients treated with main-branch stenting only, with provisional side-branch stenting. Cypher sirolimus-eluting stents were used in both arms of the study.

The Nordic Bifurcation II study, presented by Dr Matti Niemela (National Public Health Institute, Helsinki, Finland), also using the Cypher stent, compared two different two-stent approaches, the crush technique and the culotte technique, in 425 patients with anatomy suitable for treatment with two stents. At six months, the investigators saw no differences in the primary end point of cardiac death, MI, target vessel revascularization, and stent thrombosis between the two groups, although there was a trend toward more procedural biomarker elevation (three times the upper limit of normal) in patients treated with the crush technique.

With only preliminary data so far, Dr Antonio Colombo (Columbus Hospital, Milan, Italy) presented 30-day results from the CACTUS study, comparing the crush technique with provisional T-stenting. While the final six-month results will be presented at a later date, Colombo reported that the crossover from a single-stent approach was 31%. Side-branch mean luminal diameter was significantly larger if the side branch was stented, not surprisingly, but this approach was also associated with a numerically higher rate of stent thrombosis: 1.7% vs 0.5%.

Technical issues to resolve

To heartwire , Dr Jeffrey W Moses (Columbia University, New York, NY), who discussed the study results after their presentation at TCT, pointed out that it is "a little premature" to be making judgments about CACTUS, given the stage it's at. A "common theme," however, in some of the emerging bifurcation stent studies is the higher rate of stent thrombosis, even in the early days poststenting, when two stents are used.

"That indicates that there are, I think, technical issues with these approaches that increase the hazard of stent thrombosis. Unless we demonstrate a clear benefit to the patients, single-stent techniques are still, right now, preferred. . . . We'll see what happens with CACTUS, because I suspect with CACTUS that the technique is as rigorous as you can get in terms of trying to protect the side-branch stent, and if that turns out to be negative in terms of any benefit of the second stent, then I think you're going to have to wait for some of these specialized stents."

These include stents like the Devax drug-eluting bifurcation stent being studied in the DIVERGE registry, Moses noted. "The question is, will these stents change the game? Will they be safe enough in terms of thrombotic issues and effective enough in reducing side-branch restenosis to levels that become clinically meaningful for patients? That remains to be seen."

Intimidating territory

But Moses also believes that some of the general uncertainty over drug-eluting-stent (DES) safety in the past year has had an impact on interventional cardiologists who were pushing the boundaries with bifurcation stenting, effectively slowing down the rate of progress in this lesion subset. Now that there is a little more confidence in drug-eluting stents generally, he thinks the field may be "reinvigorated," potentially making inroads into the patient population currently being treated with open-heart surgery.

In his own practice, Moses says bifurcations make up 15% to 20% of cases, but he uses two stents only in relatively rare circumstances: for bailout angioplasty, which is "very infrequent," or for genuine bifurcation disease, where the side branch is large and has significant enough disease to guarantee that a provisional approach will fail.

Bifurcations likely make up a smaller proportion of vessels treated by other interventionalists, Moses acknowledged. "There are still some practices that are very intimidated by bifurcations. I get a sense, at least worldwide, that people are a lot more comfortable with them than are a lot of centers in the US for some reason. I think US doctors have to some extent become a little more risk-averse. Let's face it, the way to avoid all risk is to let the surgeon absorb all the risk."

Moses disclosed being a shareholder in Guided Delivery Systems.

The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

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