"Both techniques have very effective results," said lead investigator Dr Paal Gunnes (Feiring Klinikken, Feiring, Norway) during a press conference announcing the results at the American College of Cardiology 2008 Scientific Sessions/i2 Summit-SCAI Annual Meeting in Chicago, IL. "The crush technique can pose a problem for side branches, and there is room for improvement, which can be done with increased force dilatation, the manner in which stents are crossed, and a comparison of various stent structures," said Gunnes.
The study, known as the Nordic Bifurcation Stent Technique Study, was a trial conducted by the Nordic-Baltic PCI study group, an independent group of interventional cardiologists who sought to compare two approaches to treating bifurcation lesions. With the culotte technique, two stents are placed into the diseased vessel, with one positioned in the main artery and the other in the side branch so that the two stents overlap in the main artery before the branch point. With crush stenting, a small portion of the side-branch stent extends into the main artery but is crushed against the wall of the main artery when the main-artery stent is expanded.
In total, 209 patients were randomized to crush stenting and 215 patients randomized to the culotte technique. Patients had stable or unstable angina or silent ischemia, and a majority had a bifurcation of the left anterior descending artery. Complete angiographic follow-up at eight months was available in 324 patients and showed no real difference between the two techniques, although the culotte technique was associated with single-digit restenosis, report investigators. In-stent restenosis with both techniques was localized mainly in the side branches, a problem that was also more common with the crush technique.
Nordic Bifurcation Stent Technique Study: Outcomes at eight months|
Variable
|
Crush stenting (%)
|
Culotte stenting (%)
|
p
|
|
Main-vessel and/or side-branch in-lesion diameter stenosis >50%
|
12.1 |
6.6 |
0.10 |
|
In-stent diameter stenosis >50%
|
10.5 |
4.5 |
0.046 |
|
Main-vessel in-lesion diameter stenosis >50%
|
4.7 |
2.0 |
0.19 |
|
Side-branch in-lesion diameter stenosis >50%
|
9.2 |
4.5 |
0.10 |
Gunnes said the culotte technique should not be used when there is a large difference in the size of the main artery and side branches, a situation that brings a small stent into the main vessel. Dr George Dangas (Columbia University Medical Center, New York), who moderated a press conference on the late-breaking trials, said the culotte technique might appear to be more technically demanding because of the increased number of required steps.
Gunnes said that investigators still do not know which stent structure is optimal for the crush technique but that the procedure is generally safe because operators "never lose the side branch; it never closes." With the culotte technique, the struts of the first stent must be crossed first, and there is the potential for closure in the vessel.
Dr Antonio Colombo (Columbus Hospital, Milan, Italy), who was the discussant during the late-breaking clinical-trials session, said it was important to note that two stents are required for bifurcation lesions. In the CACTUS study comparing the crush technique with provisional T-stenting, crossover from a single-stent approach was 31%. "The issue of what is the best technique when you need two stents is a relevant issue, and we need to know how to proceed," said Colombo.
In terms of the results from Nordic Bifurcation Stent Technique Study, he said that the culotte technique appears to be slightly superior to crush stenting but that more information on the side-branch dilatation with the crush technique is needed. The culotte technique, he said, requires side-branch dilatation, as well as discipline to do a good job.
Not everybody, however, is sold on the two-stent technique for bifurcation lesions. Dr Jurriën ten Berg (St Antonius Ziekenhuis, Nieuwegein, the Netherlands), senior investigator of the Dutch Stent Thrombosis Study presented yesterday, told heartwire that his center uses T-stenting in bifurcated lesions. "Crush stenting is never done," he said. "We don't like it; we've done it, but the risk is too high. Recurrence is also high. It's a lot of metal, and the idea is that if you put a lot of metal in the patient you put them at risk for a late-stent thrombosis. Be as sober as you can."
|
The Nordic Bifurcation Stent Technique Study was sponsored by an unrestricted grant from Cordis/Johnson & Johnson.
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