Kissing-Balloon Dilatation of Side Branch Not Needed With One-Stent Bifurcation Approach

September 30, 2009

September 30, 2009 (San Francisco, California) — During a one-stent approach for the treatment of bifurcation lesions, the use of routine kissing-balloon dilatation of the side branch does not improve six-month clinical outcomes when compared with a strategy that does not include side-branch dilatation.

Presenting the results of the NORDIC-BALTIC Bifurcation Study III during the late-breaking clinical-trials session at the TCT 2009 meeting, lead investigator Dr Matti Niemela (University of Oulu, Finland) also noted that procedure and fluoroscopy times, as well as the use of contrast, were significantly increased with the kissing-dilatation strategy.

Asked about the two strategies during a press conference, Dr William Gray (Columbia University, New York), who was not part of the trial, said the study confirms the way most interventionalists have been practicing. "If you have TIMI 3 flow, basically an open vessel, the approach to that side branch is to leave it alone, largely," he said.

In the NORDIC study, 239 patients were randomized to the one-stent technique without a kissing balloon in the side branch vessel and 238 patients were randomized to the kissing balloon. Those included in the study presented with stable angina, unstable angina/non-ST-segment elevation MI, and silent ischemia.

At six months, there was no significant difference in the composite major adverse cardiovascular events (MACE) end point of cardiac death, index lesion MI, target lesion revascularization, or stent thrombosis between the two strategies. Procedure times were, on average, 14 minutes longer with kissing-balloon strategy, and fluoroscopy times were five minutes longer, both of which were statistically significant. More contrast was also used with the balloon dilatation of the side branch.

Commenting on the results of the study, Dr Roxana Mehran (Columbia University, New York) said that with the low MACE event rates, at 2.9%, she is not sure a 477-patient trial definitively answers the question as to which strategy is best and emphasized that a kissing-balloon strategy does play an important role in some settings.

"That's an important consideration so that people don't walk away with the wrong message. There are different bifurcations, large branches, in which not kissing could be really detrimental, and that's been shown in previous trials, especially if a two-stent technique is used."

Gray, however, pointed out that the two-stent strategy differs from the one-stent strategy and that with a one-stent approach not doing a kissing-balloon dilatation of the side branch seems reasonable. He agreed that the study was too small to make definitive conclusions about hard clinical end points.